cyrilzakka/clinical-trials huggingface dataset:
The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

The aim of this study is to mechanically characterise saphenous and popliteal vein segments that have been deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery.

By characterising the stress-stretch relationship of the vein vessel wall, treatment techniques can be better understood. Mechanical device design can be bteer informed and the the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients aged 18 years or older
* Patients undergoing varicose vein procedures or;
* Patients undergoing lower limb amputation or;
* Patients undergoing lower limb bypass surgery

Exclusion Criteria:

* Patients unable to give informed consent
* Seriously ill/unconscious patients
To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

This is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD). Enrollment into the study will be from eligible participants who have completed participation in Protocol 31-08-255 \[NCT01111539\], 31-08-256 \[NCT01111552\], or 31-08-263 \[NCT01111565\] ("rollover" participants).


Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in Protocol 31-08-255, 31-08-256, or 31-08-263.

Exclusion Criteria:

* Participants with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode.
* Participants with a diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder.
* Participants with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
* Participants experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.
* Participants who have met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for substance abuse in the past 6 months (prior to the Baseline Visit) and/or dependence up to and including the past 12 months (prior to the Baseline Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. Participants with two positive drug results for cocaine should be excluded from the study.
* Participants with hypothyroidism or hyperthyroidism.
* Participants with a significant risk of committing suicide based on history, investigator's judgment, and/or evaluation based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
* Participants with insulin-dependent diabetes mellitus (IDDM).
* Participants with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc.
Active Removal of IntraCerebral Hematoma Via Active Irrigation

Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.

The ARCH study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with IRRAflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tPA. This might affect the patient neurological outcome assessed by GCS and mRankin scale.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age
2. Need of EVD
3. Active treatment
4. Signed informed consent obtained

   a. Based on institutional and country laws
5. Spontaneous ICH with maximum 30 square cm's
6. If needed, normal coagulation profile (PT, PTT, platelet count)
7. Treatment within 72 hours of ictus
8. Ability to administer 2.0 mg of tPA per day for 3 days

Exclusion Criteria:

1. Age \< 18 years
2. No need of EVD
3. Patient has fixed and dilated pupils
4. Coagulopathy uncorrectable
5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement)
6. Pregnant women
Cardiovascular Disease Knowledge/Morbidity--Socioeconomic Cohort Outcomes

To elucidate the interrelationship of level of cardiovascular disease knowledge and subsequent clinical health status by merging population-based cardiovascular disease risk factor survey data with patient-level hospital data. The overall goal was to assess outcomes in the positive/negative association between level of cardiovascular disease knowledge and incidence and relative degree of morbidity among a cohort with and without major cardiovascular disease risk factors.

BACKGROUND:

Evidence shows a growing disparity in the prevalence of modifiable risk factors and incidence of cardiovascular disease between upper and lower socioeconomic status (SES) individuals. Trends in knowledge about risk factors and risk reduction strategies parallel these findings. Research determining the differential association between level of cardiovascular disease knowledge and subsequent clinical health status had not been conducted.

DESIGN NARRATIVE:

Analyses were stratified according to SES (via years of formal education), controlling for age, gender, and ethnicity (Latino/Anglo). Sociodemographic, physiologic, and knowledge measurements were available on each participant. Morbidity estimates and clinical health status indicators were available via primary and secondary discharge diagnostic codes from public-use hospital discharge databases collected on all California hospital admissions for the entire study period. The Stanford Five City Program data were merged with the hospital discharge data, matching on survey participant's social security number which was subsequently converted to a unique personal identifier. Baseline 1989/90 and 1991 through 1995 longitudinal outcomes were assessed.

There were three main aims, all of which had epidemiologic and cardiovascular disease health policy prevention implications: Aim 1: Characterize the distribution of hospitalized versus non-hospitalized SES sub-cohorts according to level of C.D. knowledge, physiologic risk factor prevalence, and clinical morbidity prevalence. Aim 2: Test the hypothesis that morbidity differences between hospitalized SES sub-cohorts would vary as a function of baseline level of cardiovascular disease knowledge and risk factor prevalence. Aim 3: Test the hypothesis that morbidity would rise among hospitalized lower SES sub-cohorts, resulting in widening health status disparities by the end of the study period. Parametric and nonparametric analytic methods were used, including analysis of variance and covariance, and various regression techniques.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Protocols for Prevention of PPH During CS in High Risk Group

PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant full term\>37 w 2. Maternal age 19- 40 3.physical state 1\&2 4.patient willing to enter the study

Exclusion Criteria:

* 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Ulcerative Colitis

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Ulcerative Colitis

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age.
3. Diagnosis of Ulcerative Colitis

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects

This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of elimination of a single oral dose of 400 mg \[14C\]LX4211 to healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 to ≤55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Historically able to produce a minimum of 1 bowel movement per day
* Willing and able to provide written informed consent

Exclusion Criteria:

* Female
* Receipt of any investigational drug within 30 days prior to Dosing, or investigational protein or antibody-based therapeutic agents within 3 months prior to Screening
* Prior exposure to LX4211
* Use any tobacco product within 2 months prior to Screening and while participating in the study (Day -1 through Discharge)
* History of bariatric surgery or any other GI surgery that may induce malabsorption
* History of any major surgery within 6 months prior to Screening
* History of renal or hepatic disease, or significantly abnormal kidney or liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or GI abnormality
* History of any active infection within 14 days prior to Dosing
* History of alcohol or substance abuse within 2 years prior to Dosing
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Donation or loss of \>400 mL of blood or blood product within 3 months of Dosing
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse at Screening or Day -1
* Positive breath test for alcohol at Screening or Day -1
* Participation in \>1 other radiolabeled investigational study drug trial within 12 months prior to Day -1
* Exposure to significant radiation within 12 months prior to Day -1
Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Background:

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Methods:

This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).

During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* with hepatocellular carcinoma

Exclusion Criteria:

* severely-ill patients
* With other system comorbidities,
* presence of extrahepatic metastasis,
* patients who dropped from the follow-up list after treatment.
Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.

The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.

After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

Eligibility Criteria:
Inclusion Criteria:

1. Medically- free of any systemic disease
2. Male or female
3. Patients with age range 25-45
4. Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
5. Teeth with mature root
6. Restorable teeth
7. Teeth without calcified root canals
8. Teeth without root caries
9. Teeth without internal or external root resorption
10. Teeth with no sign of crack formation
11. Teeth without anatomic abnormalities

Exclusion Criteria:

1. Pregnant females.
2. If analgesics have been administrated during the past two weeks preoperatively.
3. Patients having bruxism or clenching.
4. Multi rooted or multi canaled teeth.
5. Patients with swelling or acute peri-apical abscess.
6. Previously endodontically treated teeth
7. periodontally affected teeth .
Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

The purposes of this study are

1. To explore effect of sarcopenia on recovery of post stroke hemiplegia
2. To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function
3. To quantify and qualify post stroke loss of muscle mass
4. To validity the use of echointensity and elastography in evaluation of sarcopenia.

By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke complications that is closely related to worth functional outcome, thereby emphasizing the importance of evaluation of sarcopenia as well as its prevention.

Sarcopenia occurs frequently among old population. The changes can rather occur earlier after trauma or generalized illness. However, the nature of these sarcopenia is different from that of geriatric population. Post stroke sarcopenia is underestimated however reduction in the motor uni number begins within 4 hours post stroke and after 3 weeks, sarcopenia can be seen in both hemiplegia and normal side. This muscular weakness can hinder functional recovery process.

Eligibility Criteria:
Inclusion Criteria for stroke patients

* First ever subacute stroke patients whose lesions were confirmed in brain imaging (MRI/CT)
* Patients who did not have difficulty in premorbid ambulation or activities of daily living.
* Patients who can follow 1 step obey
* Patients who can perform hand function test
* Patients whose laboratory tests, neurologic, cognitive, and dysphagia evaluations are completed within 1 month from the onset date.
* Patients who admitted/transferred into our department for at least 4 weeks, following conventional rehabilitation protocols.
* Patients with at least 2 of MRS(Modified Ranking Score) and FAC(Functional ambulation category) scores.

Exclusion Criteria: for stroke patients

* Patients who do not meet the above listed criteria
* Patients with double hemiplegia
* Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.
* Patients with joint contracture who are difficult to perform sonographic evaluation.
* Traumatic brain injury patients.

Inclusion Criteria for normal subjects

* Subjects who can walk independent without any difficult
* Subjects without history of CNS or PNS lesion
* MRS(Modified ranking scale) \<=2
* FAC(functional ambulation category) \>=2

Exclusion Criteria for normal subjects

* Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft

Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG

In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).

All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.

Eligibility Criteria:
Inclusion Criteria:

* Patient who are going to have elective CABG
* Signing informed consent

Exclusion Criteria:

* EF\<35%
* Bradycardia\<60 per min
* Hypotension\< 100 mmhg
Dry Needling in Subjects With Delayed Onset Muscle Soreness

Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham


Eligibility Criteria:
Inclusion Criteria:

* The participants of the study will be any healthy male or female between
* age of 18 to 35
* able and willing to perform an exercise protocol using the gastrocnemius muscle
* willing to receive either sham or dry needling intervention

Exclusion Criteria:

* current muscular pain
* prior trigger point therapy in the past 6 months
* medications that affect muscle function
* injury in the past 6 months
* any health condition that prevents exercising
* recent surgery
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)

Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed consent form (ICF),
* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
* Did not change use of vitamin D conatining drugs/supplements for last 6 weeks
* Willingness to follow all study procedures

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Change in use of food supplements containing Vitamin D in last 6 weeks
* Acute ilness
* Mental incapacity that precludes adequate understanding or cooperation.
Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction

The purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in Levanger, compared to an interval treadmill training program. The subjects participating in the study are patients with myocardial infarction. The maximal oxygen consumption of the subjects will be tested before and after the training period.

The purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in Levanger, compared to an interval treadmill training program. The subjects participating in the study are patients with myocardial infarction. The maximal oxygen consumption of the subjects will be tested before and after the training period.

Primary outcome: Maximal oxygen consumption Secondary outcomes: Blood values (for endothelial function, blood lipids, etc), flow mediated dilatation, quality of life (SF 36 and MacNew), weight, BMI, heart rate fall 1 minute after stopping the maximal treadmill test.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction 2-12 weeks ago

Exclusion Criteria:

* Heart failure
* limitations to walking on a treadmill
* failure to reach a maximal pre-test(\> NYHA class II)
* uncontrolled hypertension
* COPD
* pregnancy
* kidney failure (creatinin \> 140)
* drug abuse
* left ventricle EF \< 30%