cyrilzakka/clinical-trials huggingface dataset:
The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.

The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.

Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm

Eligibility Criteria:
Inclusion Criteria:

1. Men and women at the age of 18 or older
2. Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
3. Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
4. Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study

Exclusion Criteria:

1. Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
2. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
3. Subjects with secondary blepharospasm
4. Subjects with the hemifacial spasm
5. Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
6. Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
7. Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
8. Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
9. Pregnant and lactating women
10. Women of childbearing potential who are planning to become pregnant within the next 3 months or are not using an appropriate method of contraception (contraceptive methods with an annual failure rate of less than 1% if used properly and continuously, including implant, injection, oral contraceptive, at least one barrier method such as intrauterine device \[IUD\], hormone IUD, abstinence, or vasectomized partner)
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Participants With Glycogen Storage Disease Type III

The primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type III (GSD III).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of GSD III, confirmed by amylo-alpha-1,6-glucosidase 4-alpha-glucanotransferase (AGL) sequencing or glycogen debranching enzyme (GDE) enzymatic testing

Key Exclusion Criteria:

* Participant is unwilling to remain blinded to continuous glucose monitor (CGM) data for the first 13 weeks of the study, or the Investigator determines that blinding would compromise subject safety
* Presence or history of any condition that, in the view of the Investigator, would interfere with participation or pose undue risk
* Use of any IP or investigational medical device within 30 days or 5.5 half-lives, whichever is longer, prior to screening, or during the study

Note: Other criteria may apply per protocol
Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia

The purpose of this clinical trial is to understand the effect of different ventilation patterns during surgery on postoperative cognitive impairment in elderly patients with abdominal wall hernias. It will also explore how to reduce the incidence of postoperative cognitive impairment. The main questions it aims to answer are:

* Does the mode of ventilation affect the incidence of postoperative cognitive impairment in elderly patients?
* Does optic nerve sheath edema affect the incidence of postoperative cognitive impairment in elderly patients? Researchers will monitor patients with different ventilation patterns intraoperatively and investigate postoperatively to see if the ventilation pattern affects postoperative cognitive impairment.

Participants will:

* Randomly assigned to groups with different ventilation patterns
* Record various values during surgery by the researchers
* Presence of cognitive impairment assessed by cognitive scales after surgery


Eligibility Criteria:
Inclusion Criteria:

* Age: 65-90 years
* patients with abdominal wall hernias
* American Society of Anesthesiologists general status (ASA-PS) classes II and III.

Exclusion Criteria:

* Emergency (rather than elective) surgery or other types of surgery required
* More than one surgery required during hospitalization
* Preoperative demonstrated inability to communicate (due to coma, severe dementia, Parkinson's disease, severe hearing or visual impairment, or speech impairment).
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Eligibility Criteria:
Inclusion Criteria:

* Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
* Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
* Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 \< 0.1 μM
* Cluster of differentiation (CD)4+ T-cell count \> 50 cells/mm3

Exclusion Criteria:

* History (or evidence at Screening) of genotypic resistance to any component of the study regimen \[ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)\]
* Certain laboratory and electrocardiogram (ECG) values
Gaze and Stair Walking in Patients With Vestibular Dysfunction

The aim of this study is to assess the differences in gaze and gait during the stair and ramp negotiation (+transition to normal level walking) between healthy controls and vestibular patients (fallers and non-fallers).

For a better understanding of falls in patients with vestibular disorders it might be important to identify the challenging environmental that provoke functional deficits; e.g. stair or ramp negotiation. The three steps at the ground and at the top of stairs is the most common location for missteps and stair accidents. This is supported by the observation made in a 12-month prospective study were 32% of the falls happened during the last step going down stairs in vestibular patients.

It remains open if patient's vestibular dysfunctions have a different gaze or gait behavior than healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* All included patients are diagnosed with single or two-sided vestibular dysfunction.
* Adult male and female participant's (≥18 years)
* Signed informed consent after being informed

Exclusion Criteria:

* Benign paroxysmal positional vertigo
* Acute pain
* Walking disability (independent walking distance \<10 meters)
* Uncontrolled cardiovascular disease (e.g.: uncontrolled blood pressure)
* Gait problems caused by Hip or knee endoprothesis
* Weakness due to neurological problems
* Known or suspected non-compliance
* Contraindications on ethical grounds
Use of Mobile Phone Application for Asthma Sele Management

This study aimed to assess the feasibility and acceptability of self-management provided through a mobile application.

The chronic nature of asthma management requires a long-term approach taking into account the variability of disease symptoms, triggers and exacerbations. Several current guidelines advocate for self-management as part of standard care. Low-income countries (LMICs) such as Malawi are experiencing an increase in the burden of disease which hinders delivery of self-management services. Mobile phone health applications (mHealth) has been reported as an effective and cost-effective tool in the monitoring and management of asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Be aged 10 years and over
2. Have a Physician diagnosis of asthma and be prescribed a salbutamol inhaler
3. Reside in Blantyre
4. Participants should be able to read and write either English or Chichewa with Minimum standard 5 eductaion

Exclusion Criteria:

1. Cognitively impaired
2. Presence of coormobities
3. Refues to consent
4. Presence of active lung disease other than athsma
A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor

A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults with Tinea Versicolor (DBI-202).


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent.
2. Male or Female Subjects of any race 18 - 65 years of age.
3. Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back).
4. A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site.
5. Agree to not use soap and water on the chest and back for at least 12 hours before the study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study.

Exclusion Criteria:

1. Females who are pregnant, planning a pregnancy, or breastfeeding.
2. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.
3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below).
4. Known sensitivity to any of the components of the study medication.
5. Use of a prescription or non-prescription topical treatment on the targeted TV anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids).
6. Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4 weeks, Use of medicated shampoos and/or soaps within the previous 4 weeks.
7. Treatment of any type of cancer within the last 6 months.
8. History of any significant internal disease which contraindicates use of live microbiome (e.g. leukemia, liver failure, cardiovascular disease).
9. Subjects who are known to be allergic to any of the test product(s) or any components in the investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure (IB).
10. AIDS or AIDS related complex by medical history.
11. Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease.
12. Any subject not able to meet the study attendance requirements.
13. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1

Key Exclusion Criteria:

* History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\])
* History of premalignant and malignant disease including solid tumors and hematologic malignancies
* Known allergy to any interferon or any component of BIIB017
* Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Transcranial Direct Current Stimulation in Stroke Rehabilitation

This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.

The patients were divided in 2 groups by a randomisation procedure. All patients participated for 2 months in the study. Group 1 received true tDCS in the first month followed by SHAM stimulation in the second month. Group 2 received SHAM in the first month and true stimulation in the following month. Four stimulations of 20minutes were provided during 4 weeks before before changing stimulation intensity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
2. Age between 18-75 years
3. Hospitalised in rehabilitation Hospital Hof Ter Schelde
4. Capable of understanding and giving informed consent

Exclusion Criteria:

1. Cerebellum or brainstem lesions
2. Recently multiple lesions and older lesions which are manifested clinically.
3. History of severe substance abuse (alcohol, drugs, benzodiazepines)
4. Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
5. History of epileptic insults, not caused by the stroke
6. Severe organic co morbidity
7. Psychiatric disorders or history of psychiatric disorders
8. Pace maker / internal defibrillator
9. Pregnancy
Fluid Status in Valvular Heart Disease

By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.

Volume overload and abnormal fluid distribution are hallmarks in the syndromes of acute and chronic heart failure (HF) as well as valvular heart disease (VHD). Most patients, at some point in their disease progression, present acutely to an emergency department, where they will typically show symptoms of progressive volume overload.

Most patients respond well to standard diuretic therapy, usually at the costs of impaired renal function. Based on the assumption that clinically overt fluid overload is the result of progressive fluid accumulation, current European Society of Cardiology (ESC) and American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines recommend a correction of volume status using diuretics, to reduce the total fluid volume. However there is no consensus on how to define fluid overload quantitavely.

In patients undergoing dialysis, bioelectrical impedance spectroscopy / body composition monitoring (BCM) is a well established tool to assess fluid status, allowing quantitative measurement.

This study aims to

1. Establish a database reflecting the fluid status assessed by BCM of patients presenting with valvular heart disease according to current guidelines
2. Monitor fluid status assessed by BCM during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease
3. Assess the association between severity of valvular heart disease assessed by echocardiography and/or cardiac magnetic resonance imaging, fluid status assessed by BCM, and clinical as well as laboratory parameters assessed during clinical routine
4. Assess the relationship between fluid status assessed by BCM and cardiovascular outcome

Eligibility Criteria:
Inclusion Criteria:

* Valvular stenosis and/or regurgitation of all severities as defined by current recommendations
* informed consent
* willingness to perform follow up visit

Exclusion Criteria:

* \<18 years old
* pregnancy
* unwillingness to paricipate
Atrial Fibrillation Force Contact Ablation Study

This study will be divided into two phases. The purpose of the Phase I registry is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.

In Phase II of the study, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the THERMOCOOL® SMARTTOUCH™ catheter.

Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population above the age of 65 years. The use of percutaneous catheter ablation for symptomatic management has increased over the last decade. It is well established that AF ablation is superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success rates with a single procedure for paroxysmal AF is approximately 80% with the majority of recurrence due to recovery of lesions or "gaps" found at repeat procedures.

In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo ablation using a newly Health Canada approved catheter with SmartTouch technology that enables the measurement of catheter tip contact force and direction inside the heart. The purpose of Phase I of the study is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.

The secondary objective will be to assess whether lesion recovery, as assessed in redo procedures, corresponds to contact force measurements. It is hypothesized that gaps found on repeat procedures will correspond to ablation lesions associated with a lower contact force.

In Phase II, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the SmartTouch catheter. It is hypothesized that the open use of contact force data will decrease the procedural time and number of lesions to achieve bidirectional pulmonary vein isolation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or greater.
* Patients undergoing first-time pulmonary vein catheter ablation for AF.
* Patients with paroxysmal AF. Paroxysmal AF will be defined as symptomatic episodes of AF lasting less than 7 days or treated with cardioversion(s) within 48 hours of onset.
* At least one episode of AF must have been documented on telemetry, ambulatory monitor, or 12-lead ECG.
* Patients must be able and willing to provide written informed consent to participate in the clinical study.

Exclusion Criteria:

* Patients with a history of any previous ablation for atrial fibrillation.
* Patients with a previous atriotomy scar, ie. Mitral or tricuspid valve replacement or repair, ASD surgery, cardiac transplant.
* Patients with an intracardiac thrombus
* Patients who are or may potentially be pregnant.
Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?

Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that clinical regression seen precociously is a predictive factor of survival without relapse. But there 's no study confirming that point.

This context takes us to evaluate if there is a predictive factor in MRI to final clinical result.


Eligibility Criteria:
Inclusion Criteria:

* patient with anal canal cell carcinoma histologically proved
* patient with initial MRI and follow up MRI in Hospital St Joseph's radiology yard.
* patient for whom a radio chemotherapy treatment decision was taken.

Exclusion Criteria:

* patients with already metastatic lesions
Estradiol Effects on Alcohol Across the Menstrual Cycle

This study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. Identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women.

In this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol.


Eligibility Criteria:
Inclusion Criteria:

* female
* regular menstrual cycle
* consume alcohol at least once per week
* no history of drug or alcohol dependence

Exclusion Criteria:

* use of hormone-based medications
* irregular menstrual cycle
* current pregnancy
* primary sensorimotor handicap
* frank neurological disorder
* pervasive developmental disorder
* frank psychosis
* diagnosed intellectual disability
* medical condition contraindicating alcohol use
* substance abuse history (except nicotine)
* body mass index (BMI) 30 or above
* alcohol abstainer
A Study of LY2940680 in Healthy Participants

This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive

Exclusion Criteria:

* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
* Have donated blood of more than 500 milliliters (mL) within the last month
* Have participated in a \[\^14C\]-study within the last 6 months prior to admission for this study
* Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
* Have a pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose