cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
* Hoehn and Yahr Stage 1-3 in an "on" state;
* Require levodopa-containing medication regimen at least 4 times during the waking day;
* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
* Are on stable PD medication regimen.

Exclusion Criteria:

* Pregnant or lactating females;
* Previous surgery for PD or plan to have stereotactic surgery during the study period;
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Adequate lung function as measured by spirometry;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial.

Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.

The outcome measure focuses on motor recovery and will be assessed:

* one and two weeks before study intervention (baseline phase)
* five times during the study intervention
* one week after study intervention (follow-up)
* once after six and twelve months after start of the study intervention (follow-up).


Eligibility Criteria:
Inclusion Criteria:

* patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four)
* correlation of clinical symptoms with a brain imaging (CT or MRI)
* able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
* start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
* older than 13 years
* given written informed consent (or two independent witnesses)

Exclusion Criteria:

* intracranial or (chronic) subdural hemorrhages
* any additional neurological or psychiatric illnesses
* instable arrythmia
* not controlled or treated arterial hypertension
* ensured cardioembolic event
* anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
* certain anticonvulsiva or antihypertonica
* manifest hyperthyreosis
* dementia or terminal illnesses
* epilepsy, phaeochromocytoma or glaucoma
* women known to be pregnant or lactating
Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.

The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.


Eligibility Criteria:
Inclusion Criteria:

* History of first symptomatic \& documented episode of AF
* LVEF \> 40% and not on AAD and in sinus rhythm at time of recruitment

Exclusion Criteria:

* History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
* History of ablation for previous AF
* Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
* Severe symptoms during AF episode (e.g.syncope, chest pain)
* All types of treated arrhythmias other than AF
* History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
* Left ventricular ejection fraction (LVEF) ≤ 40%
* Bradycardia \< 40 beats/min and all ECG abnormalities: PR\> 240ms or QRS\> 120 ms or QTc\> 440 ms
* Brugada syndrome
* Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
* 2nd or 3rd degree atrioventricular (AV) block
* Sinus node dysfunction
* Severe hypertension with:Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic blood pressure ≥ 100 mmHg
* Left ventricular hypertrophy (LVH) with septal thickness \> 14 mm on Echocardiogram
* Implanted pacemaker
* Heart surgery within the last 6 months, or non-stable postoperative condition
* Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (Cockroft and Gault formula
* Uncorrected electrolytic abnormalities
* Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
* Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder

The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period.
* Eligible patients must have signed the informed consent and must meet all inclusion and exclusion criteria as determined during the screening visit.

Exclusion Criteria:

* Any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the Investigator's and Medical Monitor's assessment
* Any contraindication to Detrol LA or other anti-muscarinic medications
* Inability to consume 10 cc/kg of fluid within 30 minutes
* Regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100mL of wine or 285mL of beer or 30mL of hard liquor)
* Positive urine drug or alcohol at screening at screening
* Average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening
* QTcB value ≥ 450 msec at screening
* Poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study
* History of urinary retention or gastric retention
* Known history of narrow-angle glaucoma
* History of QT prolongation
* Known reduction in hepatic or renal function
* Concomitant Use of loop diuretics (eg. Furosemide)
* Concomitant use of a medication that is a potent inhibitor of CYP3A4
* Class IA or Class III antiarrhythmic medications
* Patient is unable and/or unwilling to adhere to Lifestyle Guidelines
* For women of child bearing potential, a positive serum β-hCG at screening or pre-dose, or an unwillingness to agree to adequate contraception from the time of screening until the completion of the study:
* Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
* Presence of urinary tract infection within 4 weeks of screening.
* Post-void residual of \>150 mL (bladder ultrasound).
Screening Instruments for Measuring Visual Symptoms in Victims of Concussion

Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment.

The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by:

1. developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI.
2. developing eye tracking based screening tools applicable both in- and outside of optometry clinics
3. examining relationships between self-reported data, eye tracking measurements and optometric measurements.

The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.


Eligibility Criteria:
Inclusion Criteria:

Individuals may be included if they:

* are adults between the ages 18 and 67
* have been diagnosed with mTBI by a doctor (emergency room or general practice) either exclusively or with another diagnosis e.g. fracture, neck trauma (doesn't apply to control group)
* can read and understand Danish
* continuously have symptoms related to trauma ≥ 2 months and ≤ 24 months after trauma origin (doesn't apply to control group)
* have best corrected visus at 0.8 or better in both eyes at distance and at near
* have given informed consent and willingness to participate in the study

Exclusion Criteria:

The following will be excluded if individuals:

* are diagnosed with one of the following neurological disorders: severe head trauma, brain tumor, Parkinson's disease, multiple sclerosis, dementia
* are diagnosed with a current active psychiatric disorder
* are diagnosed with one of the following somatic disorders which are unregulated: diabetes mellitus, metabolic disorders
* have a verified alcohol or drug abuse
* have amblyopia (that is, two lines difference or more in best corrected visus between the two eyes)
* have other visual problems such as constant strabismus, a history of strabismus surgery, congenital nystagmus and recognized eye illnesses such as glaucoma, age- related macular degeneration (AMD)
* have received vision therapy by an optometrist in relation to resent mTBI
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT

The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.

Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC) undergoing neoadjuvant chemotherapy; OR Patients with diagnosis of pancreatic adenocarcinoma undergoing neoadjuvant chemotherapy

Exclusion Criteria:

* Life expectancy less than 3 months in the opinion of the treating physician
* Patients unable to provide informed consent.
* Wheelchair bound patients/ physical immobility.
* Severe cardiopulmonary disease defined as NYHA class III or IV
* Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded.
* Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.
High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain

The goal of this interventional study is to compare efficacy of either standard versus supra-voltage radiofrequency cervical epidural injection in pain alleviation in population with chronic cervical radiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 70 years, both genders.
* American Society of Anesthesiologists (ASA) physical status grades I or II.
* Unilateral cervical radicular pain secondary to cervical disc prolapse affecting single nerve root which was refractory to conventional conservative and physiotherapy measures for 12 weeks or more.
* All candidates received 1 millilitre of 2% lidocaine via an ultrasound-guided diagnostic nerve block and informed at least 50% momentary reduction of their pain.
* Diagnosis was confirmed by cervical MRI and nerve conduction tests.

Exclusion Criteria:

* Refusal to participate.
* Cervical radiculopathy pain recurrence after surgery.
* Previous attempt of radiofrequency ablation.
* Concomitant coagulopathic state ( decompensated liver disease, clopidogrel use) .
* Metastatic lesion in the cervical vertebral column.
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.

Methods: We enrolled 231 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>=18 and Age \<=65. 2. Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies. Subjects are pre-identified

Eligibility Criteria:
Inclusion Criteria:

* Subjects have discontinued tofacitinib prior to the planned treatment duration in 2 completed Phase 2 studies; or have not enrolled in long-term extension studies.

Exclusion Criteria:

* No other subjects are eligible for this study
LXRA Gene Polymorphisms and Response to Fenofibrate

This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Eligibility Criteria:
Inclusion Criteria:

* Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
* Must be able to swallow tablets

Exclusion Criteria:

* Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
* Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
* Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
* Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.

The study is double-blind, placebo-controlled randomised trial and is composed from two parts. First part of the study aims to examine any difference in gut microbiota after postnatal antibiotic administration between the neonates who received probiotic Lactobacillus reuteri DSM 17938 or placebo and to compare the gut microbiota of patients to microbiota of healthy newborns. Second part of the study aims to determine whether probiotic L. reuteri DSM 17938 supplementation to antibiotic therapy has any beneficial influence on incidence of functional gastrointestinal disorders of infancy and body composition and bone density 6 weeks and one year after inclusion in the study.

Additionally the associations of the clinical parameters with the composition and developmental characteristics of fecal microbiota during antibiotic treatment in children will be evaluated; relevant clinical data such as mode of delivery, child's nutrition, health problems, growth and developmental attributes which could be found associated with fecal microbial community, will be tracked and statistically evaluated for the investigated population.

Eligibility Criteria:
Inclusion Criteria:

* term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection

Exclusion Criteria:

* gestational age under 37 weeks
* birth weight less than 2500 grams
* congenital malformations/syndromes
* perinatal hypoxia
* who had received probiotics before the randomization
* have had cow's milk protein allergy diagnosed during the study
* patient who will be treated with antibiotic for less than 5 days
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.

The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).


Eligibility Criteria:
Inclusion Criteria:

* Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
* Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
* Presence of fever defined as \> 38°C tympanic temperature or a history of fever within the last 24 hours

Exclusion Criteria:

* Mixed infection with other Plasmodium species
* Any criteria of severe or complicated malaria as defined by the WHO, 2010
* Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
* Presence of significant anemia as defined by Hb \<8 g/dL or Hct \< 25%
* A platelet count \< 50,000/μL
* Presence of febrile conditions caused by diseases other than malaria
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial

Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients

Exclusion Criteria:

* Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Intravenous Labetalol Versus Hydralazine in Preeclampsia

We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome


Eligibility Criteria:
Inclusion Criteria:

* patient with clinical diagnosis of sever preeclampsia

Exclusion Criteria:

Patient with history of previous intracranial lesion Patient with history of heart disease/allergy to drug Patient with history of arrhythmia/anticoagulation Any craniotemporal lesion

-