cyrilzakka/clinical-trials huggingface dataset:
Post-traumatic Headache Multidisciplinary Study

The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center

Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year

Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.

Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.

Eligibility Criteria:
Inclusion Criteria:

Patients with post-traumatic headache

-

Exclusion Criteria:

* Medication-overuse headache
Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery

Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* ASA II-III
* BMI 18-31
* elective minimally invasive cardiac surgery by right thoracotomy

Exclusion Criteria:

* asthma
* COPD
* previous lung surgery
* previous cardiac surgery
Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®

The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:

* Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy?
* What is the patients' perception?

Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.

At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary.

Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and ASA II patients;
* Age \> 21 years;
* Non-smokers or smokers \< 5 cig/day;
* Presence of periodontal disease;
* \>10 natural teeth;
* At least 2 teeth with pockets ≥5mm;
* Indications for carrying out at least one SRP (scaling and root planing) session;
* Signing of the written informed consent to participate in the study.

Exclusion Criteria:

* Severe general medical pathologies;
* Immunodeficiency states;
* Radiotherapy in the head and neck region;
* Uncontrolled diabetes or hypertension;
* Smokers \>5 cigs/day;
* Impossibility to carry out homogeneous and continuous follow-up;
* Documented allergy to chlorhexidine or hyaluronic acid;
* Taking drugs that cause alterations in the gums and oral mucosa;
* Pregnancy or breastfeeding;
* Presence of removable prostheses;
* Periodontal treatment in the previous 6 months.
Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia

Although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.


Eligibility Criteria:
Inclusion Criteria:

* mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change
* Men and women who were between 20 and 70 years of age
* Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
* Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol \<40 mg/dL, family history of coronary artery disease at age \<55 years in male or \<65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram
* Written informed consent.

Exclusion Criteria:

* pregnant or breast-feeding
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* thyroid dysfunction
* serum transaminase level \>2 times the upper limit of normal
* history of gall bladder disease
* chronic alcoholic
* serum creatinine level \>1.5 mg/dL
* history of myopathy
* history of acute myocardial infarction or acute stroke within 3 months before the study began
* acute or chronic infection or inflammation
* history of cancer
* history of adverse events associated with test drugs.
Effectiveness of Neck Isometric Exercises and Cervical Mobilization on Cervical Radiculopathy

Effectiveness of neck isometric exercises and cervical mobilization will be compared to observe the efficacy of these techniques on cervical radiculopathy

Two groups will be formed to observe the efficacy of neck isometric exercises and cervical mobilization on cervical radiculopathy by using NPRS, ROM and QoL tools.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with age between 25-50 years
* Patients referred from neuro and orthopedic departments with diagnosed cervical radiculopathy.
* Complaint of neck pain on neck bending with positive spurling's test.
* Complaint of neck pain, numbness and tingling in arm with positive spurling's test.

Exclusion Criteria:

* Cervical Trauma
* Any other orthopedic and neurological conditions of cervical spine.
* Fracture
* Malignancy
Bioimpedance Analysis for Follow-up of Dieters

Prospective, single arm, dietary intervention study.

This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.

We enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.

Exclusion Criteria:

* Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.
* Participants who, at the second visit, reported that they failed to adhere to the diet.
Visual Prognosis in Non-Penetrating Corneal Blast Injuries

The purpose of this study is to assess visual quality of patients with non-penetrating, non-metallic, stable corneal foreign bodies. Visual quality will be assessed by examining visual acuity, wavefront analysis and contrast sensitivity. Drawings, photographs, and confocal microscopy will be used to document clinical examination of the cornea at baseline and on follow-up examinations.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Access to medical care at Walter Reed Army Medical Center
* Age 18 years or older
* Corneal foreign bodies from blast injuries
* Available for evaluation at Walter Reed

Exclusion Criteria:

* Residual, recurrent or active ocular disease in the designated eye as determined by exam and history.
* Penetrating ocular trauma or injury to the posterior segment
* Prior history of ocular surgery
* Any physical or mental impairment that would preclude participation in any of the examinations.
* Any ocular abnormality other than corneal foreign bodies that have any impact on vision (i.e. other abnormalities from trauma such as retinal detachment, corneal laceration, traumatic cataract, or abnormalities unrelated to trauma such as herpes.
Capadenoson in Angina Pectoris

This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.


Eligibility Criteria:
Inclusion Criteria:

* The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
* Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
* Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks

Exclusion Criteria:

* Inability to withdraw current anti-anginal therapy
* Inability to withdraw any concomitant therapy that would interfere with interpretation of study results
Pharmacogenetic Testing in an Outpatient Population of Patients With Depression

This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).

This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS). Prospective data will be collected on all subjects until study completion at 24-25 weeks post enrollment. Claims data may be reviewed per pay, if such data are readily available in a timely manner.

Eligibility Criteria:
Inclusion Criteria:

* Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
* Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
* Taking or be newly prescribed an anti-depressant or anti-psychotic medication
* Able to provide informed consent
* Prescribing physician practices at the Avera Medical Group University Psychiatry Associates clinic in Sioux Falls, SD

Exclusion Criteria:

* Pregnant or breastfeeding
* Active and/or unstable diagnosis of substance abuse, excluding nicotine
* Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schizoaffective disorder, or personality disorder
High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike

Although High-intensity interval training (HIIT) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (MICT) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. Our study aims to investigate the feasibility of the HIIT program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.

Study design, setting, and ethical considerations:

This study will be a prospective pre-post study that will be conducted at the university hospital of Parakou in Benin. The study protocol will be submitted to the ethics committee of Hasselt University in Belgium and the local biomedical ethics committee of the University of Parakou, Republic of Benin.

Interventions:

The experimental protocol will be preceded by 30 minutes of conventional physiotherapy, including neuromuscular interventions (balance training, postural awareness), musculoskeletal interventions (passive range of motion, stretching, strengthening), and lower-intensity overground walking. The conventional physiotherapy will be followed by 15 min of the rest period, then the experimental protocol consisting of a HIIT program on a recumbent cycle SOLE R92 (HIIT-REC) will be performed three times per week for six successive weeks.21 Training will be performed on non-consecutive days, thereby permitting recovery between sessions. The HIIT procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). The training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5.22 All sessions will be supervised and performed individually with verbal encouragement.

Eligibility Criteria:
Inclusion Criteria:

1. first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
2. muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3;
3. Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
4. able to walk at least 5 meters independently with or without assistive devices and understand spoken instructions;
5. living in Parakou or the surrounding area and wishing to undergo the program at the hospital.

Exclusion Criteria:

Participants:

1. unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate;
2. cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy);
3. primary orthopedic conditions (fractures, active rheumatoid arthritis);
4. other neurological diseases such as (Parkinson's disease and Alzheimer's disease).
Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways

The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
* Tumors \< 2 cm from trachea or zone of proximal bronchial tree (central tumors)
* Each tumor \< 5 cm in size prior to treatment
* Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
* Criterion for medical inoperability include:

  * Overall clinical assessment at the UCLA thoracic tumor board
  * Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below:
* Modified ACOSOG Criteria for medical inoperability:

  * Major Criteria: FEV1% \< 50% or \< 1L and DLCO \< 50%
  * Minor Criteria: Age \> 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg
* Age \> 18 years old
* KPS \> 70
* If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Prior thoracic radiation near the targets of interest
* More than 2 central tumor targets per patient
* Active infections requiring systemic antibiotics
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers.

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers. This is a Phase 1, open label study (all patients involved know the identity of the drug). Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis. Plasma and urine samples will be assayed for ceftobiprole. Samples will be collected over a 48 hour period of time. Safety evaluations will include monitoring of adverse events, clinical laboratory tests (hematology and serum chemistry in all patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital signs, physical examination, and recording of concomitant medications. Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of ESRD and requiring hemodialysis treatment 3 times per week

Exclusion Criteria:

* History of repeated severe nausea
* History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Recent febrile illness
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study

Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management.

This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.

Exclusion Criteria:

* Patients who are admitted and die or are discharged within 12 hours
* Patients re-admitted to ICU during the index ICU enrolment month
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA

  * Stable anti-retroviral regimen for at least 3 weeks prior to enrollment
  * Capable of giving informed consent
  * Age 18 years and older

Exclusion Criteria:

* Neoplasms
* Women who are pregnant or nursing
* History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
* Current use of phenobarbital, phenytoin, or rifampin
* Any major surgery within 4 weeks of enrollment
* Blood transfusion within 4 weeks of enrollment
* Inability to tolerate oral medication
* Inability to tolerate venipuncture, venous access, or genital tract sampling
* History of recent (within 6 months) drug or alcohol abuse
* Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study
* Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator
* History of allergy to study medication or related compounds