cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis

Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).

Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.


Eligibility Criteria:
Inclusion Criteria:

* MS patients aged over 18 years
* with gait problems related to spasticity of the triceps surae,
* walking 10 m in less than a minute,
* with or without technical assistance,
* with an EDSS of 6.5 or less
* triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.

Exclusion Criteria:

* Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.
* Intolerance to botulinum toxin;
* botulinum toxin injection in the previous three months.
SurePulse Oximeter - a Targeted Oxygenation Observation

This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the National Health Service (NHS).

Healthy volunteers who express an interest in the study and meet the eligibility criteria will be invited to participate in the study. This study will investigate the accuracy and safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels. This is done by measuring blood oxygen levels across a range of values in healthy adults. The measurements from the VS and VSP will be compared to the known correct value. The study follows the internationally agreed standard for pulse oximeter approval.

Agreeing participants will have their name, contact details, medical history, height, weight, date of birth, skin colour, emergency contact details and address recorded, as necessary to conduct the study. After completion of the eligibility and consent process, participants will be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire duration of the session. Oxygen levels will be reduced to a specific target for a few minutes at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their wrist; this will be used to take blood samples throughout the session. The blood samples will be taken, analysed and destroyed in the same room. The session should take approximately 1.5 - 2 hours in total.

The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device. This study is required for the SurePulse VSP to be regulatory approved, meaning it could then become available in the NHS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55
* Willing and able to provide written informed consent
* Healthy adult subjects (ASA 1)
* Non-smoker
* Willing and able to comply with study procedures and duration

Exclusion Criteria:

* Smokers or individuals exposed to high levels of carbon monoxide
* Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study
* Female subjects that are actively trying to get pregnant or are pregnant (conﬁrmed by Health Assessment Form). N.B. All female participants will be offered a pregnancy test
* Unwillingness or inability to remove coloured nail polish from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached
* Known health conditions disclosed on Health Assessment Form which mean that participant is not healthy
* Allergy to lidocaine
* Allergy to adhesives used in medical dressings or tapes
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions

The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.

Open label, balanced, randomized, two treatment, two-sequence, two periods, crossover, single dose, comparative oral bioavailability study in healthy, post menopausal women subjects under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects should be postmenopausal healthy women who have attained complete menopause naturally or surgically and have not had menstruation for at least one year and are not on hormone replacement therapy.
2. The subjects should have Estradiol level ≤ 20 pg/ml \& serum follicular stimulating hormone (FSH) level ≥ 50 mlU/ml during the screening.
3. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
4. The subjects should have a BMI between 18.5 to 26.4 (30-39 years), 18.5 to 27.8 (40-49 years), 18.5 to 28.4 (50-59 years) \& 18.5 to 27.5 (60-69 years) weight in kg/ height2 in meter.
5. The subjects should be able to communicate effectively with study personnel.
6. The subjects should be able to give written informed consent to participate in the study.

Exclusion Criteria:

1. The subjects who have a history of allergic responses to Anastrozole or other related drugs.
2. The subjects who are using female hormone replacement therapies, thyroid hormone replacement therapies, or antihypertensive therapies.
3. The subjects who have significant diseases or clinically significant abnormal findings during screening, (medical history, physical examination, laboratory evaluations, ECG, X-ray \& lower abdominal ultrasonography recordings).
4. The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
5. The subjects who have a history or presence of bronchial asthma.
6. The subject who have used of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
7. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
8. The subjects who are smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
9. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
10. The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
11. The subjects who have a positive hepatitis screen (includes subtypes A, B, C \& E).
12. The subjects who have a positive test result for Human Immunodeficiency Virus (HIV) antibody and / or syphilis Rapid Plasma Reagin, Venereal Disease Research Laboratory (RPR/VDRL).
13. The subject who received an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease

Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with PAD in grade IIa (Leriche-Fontaine Classification).

Exclusion Criteria:

* Subjects with dementia.
* Institutionalized Subjects in social health centers.
* Subjects with recent major surgery in the last year or lower limb amputations.
* Subjects with revascularization surgery of the lower extremities.
Safety and Efficacy Study of NFC-1 in Subjects Aged 12-17 Years With 22q11.2DS & Associated Neuropsychiatric Conditions

This is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17 years with 22q11DS who have a diagnosis of anxiety disorder, and/or ADHD, and/or ASD. Approximately 12 subjects will be initiated, dose optimized, and maintained on NFC-1 over a period of 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of a 22q11.2 deletion prior to screening.
* Subject has a diagnosis of anxiety disorder and/or ADHD and/or ASD based upon diagnostic evaluations performed at screening, history, and clinical judgement.
* Subject is judged to be in general good health, other than having anxiety disorder and/or ADHD and/or ASD and 22q11DS. Medical conditions related to 22q11DS must be clinically stable post surgical correction and/or medical management.
* Subject has no clinically significant abnormality on 12-lead electrocardiogram (ECG) performed at screening or baseline such as serious arrhythmia, bradycardia, tachycardia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
* Subject and parent/legal guardian understand the study procedures and agree to the subject's participation in the study as indicated by parental/legal guardian signature on the subject informed consent form and subject's signature on the assent form.

Exclusion Criteria:

* Subject has a diagnosis of co-morbid major psychiatric disorders (ie, aside from anxiety disorder, ADHD, and/or ASD), including major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability, which in the opinion of the investigator may interfere with the conduct of study evaluations.
* Subject has an IQ \< 65 as determined by the Wechsler Abbreviated Scale of Intelligence.
* Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by his/her participation in the study.
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or disease which is not currently stable clinically. Subjects with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator.
* Subject has a history of stroke, chronic seizures, or other major neurological disorder which, in the opinion of the investigator, would interfere with the subject's ability to participate and/or be evaluated in the trial.
* Subject is currently considered at risk for suicide (in the opinion of the investigator), has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
* Subject has taken any antidepressants, antipsychotics, anxiolytics, or non-stimulant ADHD medication within 30 days of the Screening Visit.
* Subject is taking a prohibited medication
Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders

To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.


Eligibility Criteria:
Inclusion Criteria:

* patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria,
* absence of temporomandibular disc displacement with or without reduction,
* good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles),
* full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses

Exclusion Criteria:

* earlier splint therapy,
* pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants),
* injury of masticatory organ,
* undergoing orthodontic treatment,
* inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia
Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication

Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.


Eligibility Criteria:
Inclusion Criteria:

* outpatients aged 18-70 years
* confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
* an intention of H. pylori eradication treatment and have written inform consent
* ability to read short messages on the mobile phone

Exclusion Criteria:

* advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
* allergy to any of the drugs used in this study
* previous Helicobacter Pylori eradication treatment
* pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
* taking antibiotics or PPIs or bismuth salts within four weeks
* previous gastrointestinal surgery
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

RATIONALE:

The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE:

This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.

This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.

* Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
* Comprehension of information contained in the drug facts box

Eligibility Criteria:
Inclusion Criteria:

* Age 35-70 year old in household selected by random digit dialing

Exclusion Criteria:

* Non-English speaking
Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Persistent AF (ECG documentation).
3. Indication for AF ablation.
4. LVEF ≥ 50%
5. Able to provide written informed consent
6. Able to comply with the requirements of the study

Exclusion Criteria:

1. Reversible cause of atrial fibrillation
2. Previous AF ablation therapy
3. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
4. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
5. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
6. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
7. Inability to undergo D-SPECT and CT imaging
Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis

The primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of \[D5\] Phenylalanine \& \[D5\] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance exercise and at rest, with the two tracers provided as a 'intrinsically labeled' bolus. Other outcomes will relate to molecular regulation of protein synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male and female, recreationally-active participants.
* Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix B).
* Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
* Participants will be aged 18-35 years old.
* Participants are willing to abide by the compliance rules of this study.
* Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

Exclusion Criteria:

* Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor.
* Self-reported regular tobacco use.
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
* Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
* Use of birth control and discontinued use within the last 3 months (female participants).
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Ability to give informed consent

Exclusion Criteria:

1. Pregnancy
2. Esophageal varices
3. Prior esophageal or gastric surgery
4. Active gastrointestinal bleeding
5. Evidence of esophageal malignancy
6. Inability to provide informed consent
Efficacy and Safety of Ainuovirine Treating With AIDS Patients

Ainuovirine is the third generation of non nucleoside reverse transcriptase inhibitors(NNRTIs), for the treatment of HIV-1 infected adults. The existing clinical studies show that Ainuovirine is safe and potent, it solves the problem from the first-generation NNRTIs such as Efavirenz with large side effects and the second-generation like Rilpivirine not suitable for high viral load, but there are no relevant data or reports on the efficacy and safety of Ainuovirine in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of ART regimens containing Ainuovirine for HIV-infected patients in real clinical environment, in further to guide clinical application.

This study is an open-label, multicentered, single-arm and phase IV clinical trial.

450 HIV-infected patients who received Ainuovirine regimen (150mg, oral, qd) were included. At day 1 (1st collection as day 1), 3rd, 6th, 9th, 12th month, the rate of viral suppression and CD4+T cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.

Other indicators:

Demographic data (including gender, ethnicity, age, height, education level, occupation, route of infection), past medical history, smoking history, drug abuse history, hepatitis B markers, hepatitis C antibody, B ultrasound, chest X-ray, electrocardiogram, pregnancy test (Females of childbearing age): Day 1 (1st collection as Day 1), 1 time in total.

Vital signs (heart rate, blood pressure), body weight: 5 times on day 1 (the 1st collection was taken as day 1), 3rd, 6th, 9th, and 12th months.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of HIV infection 18-60 years old Patients who are prescribed to take Ainuovirine regimen . Sign informed consent

Exclusion Criteria:

1. Patients who are participating in other interventional clinical trials;
2. Patients who previously participated in the ACC007 study.
Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.

Evaluating of eVOCs profiles by proton mass spectrometry with a time-of-flight (PTR-TOF) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders.

The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in the study;
2. Age 18 and over;
3. Clinical diagnosis of one of chronic respiratory diseases (COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis or other interstitial lung disease).

Exclusion Criteria:

1. Unable to sign informed consent;
2. Respiratory disease (for controls);
3. Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
4. Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;
5. Oncology;
6. Previous lung transplantation (for patients with respiratory diseases);
7. Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);
8. Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);
9. Pregnancy.