cyrilzakka/clinical-trials huggingface dataset:
Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide.Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy used to treat depression and cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15 day treatment with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) can improve symptoms (motor symptoms and non-motor symptoms) in patients with MJD.

Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide. MJD shows remarked clinical heterogeneity and presents with various clinical manifestations, including cerebellar ataxia, limb incoordination, dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. No effective treatment is currently available for MJD.

Repetitive transcranial magnetic stimulation (rTMS)enables non-invasive modulation of cortical excitability. rTMS targeting cerebellar structures is capable of inducing long-lasting changes in the excitability of cerebello-thalamocortical pathways.

Subjects will be randomized in two groups, one receiving a consecutive 15-day treatment with 1 Hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation with identical parameters. Patients will be clinically assessed at baseline, during intervention period at 7 days and 15 days immediate after treatment.

Eligibility Criteria:
Inclusion Criteria:

1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.

2. SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents

Exclusion Criteria:

* 1. Patients who have concomitant epilepsy. 2. History of seizure or heat convulsion. 3. Patients on neuroleptics. 4. History or current unstable hypertension. 5. History of head injury or neurosurgical interventions. 6. History of any metal in the head (outside the mouth). 7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

  8. History of frequent or severe headaches. 9. History of migraine. 10. History of hearing loss. 11. History of cochlear implants 12. History of drug abuse or alcoholism. 13. Pregnancy or not using a reliable method of birth control. 14. Participation in current clinical study.
Effects of a Lifestyle Intervention on Gestational Diabetes Management

The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Eligibility Criteria:
Inclusion Criteria:

* high risk for gestational diabetes
* willing to make lifestyle changes
* history of diabetes

Exclusion Criteria:

* carrying more than one fetus
* history of chronic conditions except diabetes and hypertension
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.


Eligibility Criteria:
Inclusion Criteria:

* exposure to sulfur mustard
* worsening dyspnea during the last 10 days
* respiratory rate of \>25/min
* arterial pH\<7.35
* PaCO2 of \>50 mmHg
* PaO2 of \<50 mmHg

Exclusion Criteria:

* recent pneumothorax (\<1 month)
* severe respiratory failure or hemodynamic instability with forthcoming intubation
* FIO2 of \<0.4
* impaired consciousness or absence of patient cooperation
* facial lesions precluding NIPPV
Childhood Allergy and the Neonatal Environment

The purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. Previous birth cohort studies have found early-life environmental factors such as allergies, pollutants, viruses and bacteria have all contributed to the development of asthma and allergies. Investigators are doing this research because there continues to be a strong need to understand the root causes of asthma and allergies. The CANOE study is an observational cohort study, which means investigators are not asking participants or participant's child to change their medications and investigators will not be giving participants or participant's child a study drug.

The CANOE study will provide an opportunity to collect novel longitudinal samples not available from the current CANOE birth cohorts, as well as enhanced and standardized environmental sampling in early life. One of the main goals of this study is to gather data and specimens, beginning in the prenatal periods, that will assess environmental exposures to toxins and microbes, and host characteristics including genetics, epigenetics, gene expression, the proteome and metabolome, microbial colonization and viral respiratory infections. The main study outcomes will be important interim conditions (e.g., recurrent wheeze, early multiple sensitization) that are highly associated with the development of asthma. Additional outcomes (perinatal outcomes, growth, neurocognitive development) will be collected as part of the collaborative Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol.

Eligibility Criteria:
Inclusion Criteria:

1. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. The presence of paternal or sibling allergy or asthma will be ascertained by maternal report.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.

Exclusion Criteria:

1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.

   * Progesterone use is only an exclusion if currently being taken at time of enrollment for preterm birth. Previous use to prevent preterm birth or use at any time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted).
6. Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Acute Effect of Static Stretching and Muscle Warming on the Functional Performance of College Volleyball Athletes

The purpose of this study is analyze the effects of static stretching and active warm up, isolated and associated, in functional performance of the lower limbs in college volleyball athletes.

Study hypothesis:

H0: The stretching and / or warm up, alone or in combination, do not alter the functional performance of volleyball players.

H1: The stretching and / or warm up, alone or in combination, alter the functional performance of volleyball players.

This is a cross-over study containing 11 volleyball athletes randomly divided into 5 groups: control (C), warming-up (gAQ), stretching (gAL), warming-up and stretching (gAQAL), stretching and warming-up (gALAQ). All subjects underwent the evaluation measures of functional performance that were conducted pre and post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. being male;
2. were aged between 18 and 28 years of age;
3. no previous history of orthopedic disorders, rheumatic disorders, cardiovascular, metabolic and / or vestibular and neurological disorders that prevent them from participating in the study dysfunctions;
4. no history of injury, trauma or disease in the lower limbs in the last six months, without surgery;
5. participate in the University Selection UFRN;
6. training time display mode in the above two years with a frequency of at least three times a week.

Exclusion Criteria:

1. presence of injury during the survey period;
2. not conduct evaluative and intervention procedures;
3. waiver to participate.
Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections

This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.

* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.
* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation.


Eligibility Criteria:
Inclusion Criteria:

* We will include adult patients (age ≥ 18 years)
* Undergoing open abdominal surgery during the study period.
* Open abdominal surgery will include any abdominal procedure entering the peritoneal cavity through a midline incision with a skin incision that is 5cm or greater.

Exclusion Criteria:

* Patients with planned minimally invasive surgery including laparoscopic or robotic surgery as these patients have lower rates of surgical site infections (SSIs). Patients who have a laparoscopic or robotic surgery converted to open surgery will be excluded.
* Appendectomy and cholecystectomy as these patients have lower risk of SSI.
* Vascular, gynecological, obstetric, urological or transplantation.
* Trauma patients.
* Patients without source control at the index operation including those with an open abdomen, no fascial closure, or temporary abdominal closure device (such as abthera dressing).
* Pediatric patients (age\<18 years).
* Patients who decline swab/specimen collection.
Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)

The purpose of this proposal is to understand how the Vibrant Health Ultimate whole-body vibration (WBV) machine affects pain and inflammation in older adults. The investigators' hypothesize that sub-acute (12 weeks) WBV will lead to improvement in the level of knee pain and improve vascular function via a decrease in systemic inflammation.

Knee osteoarthritis (KO) is a leading cause of disability and medical cost. Whole body vibration (WBV) has emerged as an exercise alternative that may be more tolerable than traditional forms of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise, research supports that WBV can be very beneficial for your health. In fact, a single bout of WBV increases circulating concentrations of inflammatory markers. WBV is safe and effective, WBV training has been conducted in obesity, elderly, patients with diabetes, patients with lung disease, as well as patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Osteoarthritic knee pain for at least 6 months.
* Mean and women
* Ages 40-75 years old

Exclusion Criteria:

* \<40 years old or \>75 years old
* History of balance issues
* History of falls
* Epilepsy
* Pregnancy
* The use of whole-body vibration in the past 6 months
* Previous knee surgery within last 3 years
* Unable to stand for at least 20 minutes (for whole body vibration training)
H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009

The goal of this study it to rapidly create a brief registry of pregnant women who receive the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1 2009/2010 influenza season.

For Part 1, a brief amount of data will be collected on each woman at the time of her vaccination. These data will be filled out on a single data collection sheet by her Obstetrics Clinic physician or nurse, which will be completed at the time of her vaccination.

For Part 2, after a woman's expected delivery date, data sources will be used for participants. Two groups of non-vaccinated controls will be derived from the provincial perinatal databases:

1. The active non-vaccinated controls will be recruited from the concurrent year, matched to women who were vaccinated in 2009/2010. For each of the three perinatal databases, 5 non-vaccinated active controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
2. The passive non-vaccinated controls will be derived from the preceding year (i.e., 2008). For each of the three perinatal databases, 5 non-vaccinated passive controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.

For women who delivered in Ontario, the Niday Perinatal Database will be used. (https://www.nidaydatabase.com/info/index.shtml).

For women who deliver in British Columbia, their data will be linked to the British Columbia Perinatal Database Registry (http://www.bcphp.ca/Database%20Content.htm). Women who deliver in Nova Scotia will be linked to Nova Scotia Atlee Perinatal Database (http://rcp.nshealth.ca/rcp_3347.html).

Information that will be obtained is as follows:

* Actual delivery date (DD/MM/YYYY)
* Number of infants delivered
* Mode of delivery (vaginal for Caesarean)
* Liveborn or stillborn
* Presence of a congenital anomaly
* Presence of intrauterine growth restriction or small-for-gestational age birthweight
* Presence of a neonatal infection
* Presence of neonatal sepsis
* Need for ventilation of the neonate
* Need for Neonatal Intensive Care of the Neonate.

For Part 3, between 18-24 months after a woman's actual delivery date, a woman may be telephoned at her home to ask her about the health and developmental milestones of her baby. This phase may or may not be done, but consent will be obtained nonetheless.

Eligibility Criteria:
Inclusion Criteria:

* Received the H1N1 vaccine during pregnancy

Exclusion Criteria:

* None
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions

A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical follow-ups take place at 1 month and yearly up to three (3) years.

The objective of this trial is to assess the safety and clinical performance of the ORSIRO drug eluting stent in patients with single de-novo coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years old;
2. Clinical evidence of ischemic heart disease and / or a positive functional study. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4 ), or documented silent ischemia;
3. Single de novo lesion with ≥50% and \<90% stenosis in 1 coronary artery;

Exclusion Criteria:

1. Documented left ventricular ejection fraction (LVEF) ≤30%;
2. Unstable angina pectoris(Braunwald Class A I-III)
3. Three-vessel coronary artery disease
4. Evidence of myocardial infarction within 72 hours prior to the index procedure;
5. Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately premedicated), cobalt-chromium (CoCr), Poly-L-Lactidic Acid (PLLA), silicon carbide (aSiC:H)
6. A platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3;
7. Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150µmol/L);
8. Total occlusion (TIMI 0 or 1);
9. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
10. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
11. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
12. Target lesion is located in or supplied by an arterial or venous bypass graft;
13. Ostial target lesion (within 5.0mm of vessel origin);
14. Target lesion involves a side branch \>2.0mm in diameter;
15. Unprotected Left main coronary artery disease (stenosis \>50%);
Self-selection Study of the Toothwave Toothbrush

This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).

The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.

All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual).

Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content.

The study will not include treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female equal to or greater than 18 years of age.
2. Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
3. Subject is capable of understanding and is willing to sign informed consent.

Exclusion Criteria:

1. Current or history of oral cavity cancer or oropharyngeal cancer.
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.

Modified Inclusion Criteria for contraindicated subjects:

1. Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
2. Subject is pregnant or nursing (lactating).
Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)

A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.

The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4.

Eligibility Criteria:
Inclusion Criteria:

* Ages 23 to 33.
* Skin tone varied from light to dark.

Exclusion Criteria:

* Smokers
* Anemic
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

1. Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
2. Recurred or did not alleviate after the previous treatment.
3. Have at least one measurable lesion.
4. With a life expectancy of ≥3 months.
5. Male or female ≥ 18 years old.
6. ECOG performance status of 0-1.
7. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Amyloidosis, plasma cell leukemia.
2. Corrected serum calcium\>3.4mmol/L(13.5mg/dl).
3. Presence of metastasis to central nervous system.
4. Treatment of other investigational products.
5. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
6. Known history of hypersensitivity to any components of HRS-3738.
7. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA)

This dose-escalation study is aimed at investigating a novel application for artesunate in the treatment of Friedreich ataxia. It will evaluate this novel application of oral artesunate using a surrogate biological marker as primary endpoint in a phase I-II open trial


Eligibility Criteria:
Inclusion Criteria:

* Patients with FA confirmed by genetic analysis
* Weight of at least 50 kg
* Compliant patient agreeing to come to all protocol visits
* Signature of consent form by patient or parents of minor patient
* Patients with no treatment during 30 days prior to the first intake of study drug, except cardiac, diabetes and spasticity treatments
* Patients agreeing to use effective contraception for the duration of the study and up to 91 days after the last dose of the study treatment
* Affiliation to an Health Insurance Scheme of beneficiary of such a scheme

Exclusion Criteria:

* Patient under justice protection
* Female patients
* Abnormal biological values of renal and liver functions and cell blood count (CBC)
* Progressive associated disease
* Treatment interfering with iron transport within 30 days before first intake of artesunate
* Participation to another clinical trial
* Hypersensitivity to artesunate or to any component of the drug
* Blood potassium lower than normal value
* QT / QTc interval \> 450 ms on the ECG performed at inclusion
* Congenital long QT syndrome
* Family history of sudden cardiac death before the age of 50
* Heart disease: ischemia or myocardial infarction, congestive heart failure or conduction disorder in the 6 months preceding inclusion
* History of arrhythmia
* Electrolyte imbalances: hypomagnesemia, hypocalcemia
* Bradycardia (\<50 beats per minute)
* Acute neurological events within 6 months prior to inclusion