cyrilzakka/clinical-trials huggingface dataset:
Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.

Left ventricular assist devices (LVAD) are becoming a destination therapy in patients with end-stage left ventricular dysfunction. Current generation pumps operate with a fixed rotation speed without the capability of automated speed adjustment. It was shown that acceleration of the pump speed during stress test increases the maximum exercise tolerance. Periodic aortic valve opening (AVO) is used to set up an optimal resting pump speed. The study aimed to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of AVO during the cardiopulmonary exercise test (CPET).

Patients with implanted third-generation LVADs with hydrodynamic bearing (HVAD, Medtronic, MN, USA) are prospectively enrolled. Two CPETs are performed after resting speed optimization. The first one with maintained baseline pump speed settings, and the second one with gradually increased speed depending on live echocardiographic imaging. The sequence of tests is random.

Eligibility Criteria:
Inclusion Criteria:

* Patients with implanted cardioverter-defibrillator and third-generation centrifugal CF-LVAD with hydrodynamic bearing (HVAD, Medtronic, Minnesota, United States), at least three months after surgery.

Exclusion Criteria:

* Hemodynamic instability.
* Non-therapeutic anticoagulation.
* Device or intracardiac thrombus.
* Inflammation.
* Active bleeding.
Effects of Treadmill Training on Motor Function, Balance, and Spasticity Reduction in Children With Cerebral Palsy

This study investigates the impact of treadmill training on motor function, balance, and spasticity reduction in children with cerebral palsy (CP). The study synthesizes existing research to provide insights into the effectiveness of treadmill training as an intervention for improving these key outcomes in children with Cerebral palsy

Cerebral palsy is a neurodevelopmental disorder characterized by impaired movement and posture due to non-progressive brain damage occurring before, during, or shortly after birth.this systematic review and meta-analysis comprehensively examines the effects of treadmill training on motor function, balance, and spasticity reduction in children diagnosed with cerebral palsy (CP).

The review includes studies published in peer-reviewed journals, databases, and relevant conference proceedings. Inclusion criteria encompass randomized controlled trials, quasi-experimental studies, and cohort studies evaluating treadmill training interventions in children aged 2-18 years with CP. Studies utilizing various treadmill training protocols, such as body-weight-supported treadmill training, overground treadmill training, or virtual reality-assisted treadmill training, are considered.

The primary outcomes assessed include changes in motor function, as measured by standardized assessment tools like the Gross Motor Function Measure (GMFM) or the Movement Assessment Battery for Children (MABC). Additionally, balance improvements are evaluated using validated balance assessment scales, while spasticity reduction is measured through clinical assessments, such as the Modified Ashworth Scale (MAS) or the Tardieu Scale.

The review aims to provide evidence-based insights into the efficacy of treadmill training as a rehabilitation intervention for children with CP, informing clinical practice guidelines and therapeutic decision-making. The findings contribute to our understanding of the potential benefits of treadmill training in improving motor function, balance, and spasticity in this

Eligibility Criteria:
Inclusion Criteria:

* Age 4 -12 years.
* Children having, I-II on GMFCM.
* Children diagnosed with spastic cerebral palsy.
* Children with will cognitive behavior

Exclusion Criteria:

* Misdiagnosed or not conform to Cerebral palsy.
* Children should be medically un stable uncontrolled seizures
* The children with mental retardation or other neurological disorders.
* Children with serve respiratory dysfunction, multiple contracture.
* Children with prior undone this type of training.
* Children with taking medication like muscle relaxant.
* Children having communication or hearing issues.
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit

Eligibility Criteria:
Inclusion Criteria:

* history of adult onset atopic dermatitis

Exclusion Criteria:

-
HairDx Analytical Validation Study

The HairDx Test reports genetic variants associated with the development of FPHL.

The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Females over the age of 18
* Overall good health
* Able to give informed consent
* Willing to collect saliva sample

Exclusion Criteria:

* Xerostomia (dry mouth)
* Inability to provide informed consent in English
* Inability to follow instructions for saliva sample collection
* Non US resident
Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）

This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.


Eligibility Criteria:
Inclusion Criteria:

* IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management;
* Dlco (corrected for Hb): 30%-79% predicted of normal;
* FVC\>= 50% predicted of normal;

Exclusion Criteria:

* FEV1/FVC\< 0.7;
* PaO2 in resting state without oxygen inhalation \< 50mmHg;
* Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator;
* Poorly controlled cardiovascular and cerebrovascular diseases;
* Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone \> 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment;
Endogenous Opioid Modulation by Ketamine

Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* DSM-5 major depressive disorder
* Current moderate-to-severe, treatment-resistant, depressive episode
* Patient Health Questionnaire (PHQ-9) total score ≥ 10
* PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
* PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
* Medical documentation of depression for at least 2 months
* Inadequate response to at least one adequate antidepressant medication trial in the current episode

Exclusion Criteria:

* Current episode duration \>5 years
* Moderate-to-severe DSM-5 substance use disorder (past year)
* Cognitive disorder (past year)
* Post-traumatic stress disorder (past year)
* Obsessive compulsive disorder (past year)
* Personality disorder (past year)
* Positive urine drug screen
* Psychotic symptoms
* Mania
* Significant neurologic disorder or injury
* Breastfeeding or pregnancy
* Imminent suicide risk
* Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
* Other unstable psychiatric or medical condition requiring a higher level of care
* Contraindication to ketamine, MRI, or PET
PENTHROX™ in the Canadian Emergency Department (ED)

This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.

The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.

Eligibility Criteria:
Inclusion Criteria:

1. Conscious adult patients: ≥ 18 years of age
2. Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as

   * Musculoskeletal injuries and physical wounds
   * Fractures
   * Lacerations
   * Burns
   * Dislocations
   * Contusions
   * Injury due to foreign bodies
3. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

1. Multi-level trauma
2. Women of child bearing potential who are pregnant or peri partum, including labour
3. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
4. Clinically significant renal impairment
5. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
6. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
7. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
8. Exacerbation of an underlying condition (i.e., chronic pain)
9. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
10. Clinically evident respiratory impairment as per the opinion of the investigator
11. Prior treatment with PENTHROX within 3 months
Development of a New HIV Vaccine

The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the immune response to the vaccine. Only some HIV genes are used to make the vaccine and therefore the vaccine cannot itself cause HIV or AIDS.

HIV-1 presents several challenges to vaccine design, including: 1) high mutation rates resulting in tremendous diversity of virus envelope, the target of neutralizing antibody, such that antibody elicited to one envelope may not protect from virus with a distinct envelope; 2) envelope from infected persons differs from envelopes obtained from T-cell line cultures, the usual source of envelope for vaccines; and 3) envelope glycoprotein exists as oligomers on the virion surface, not as the monomers used in previous vaccines. This study will test a new vaccine that has been designed to meet these challenges by delivering diverse, patient-derived, oligomeric envelopes to induce multiple type-specific responses capable of recognizing native envelope on natural variants. The vaccine vector used in this vaccine trial is recombinant vaccinia virus based on the NYCDH vaccinia isolate.

Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one year. Laboratory tests will be performed at 10 study visits to monitor the participants' immunologic response and assess the safety of the vaccine. Patients will also have numerous HIV tests throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 negative
* Availability for one year of follow-up
* No evidence of previous smallpox vaccination
* Acceptable methods of contraception

Exclusion Criteria:

* Immunosuppressive or chronic illness
* Medical or psychological conditions which could affect compliance
* High risk for HIV infection
* Live attenuated vaccines within 60 days
* Experimental agents within 30 days
* Blood products within past 6 months
* Eczema
* Pregnant or lactating women
* Household contact with immunodeficient person, pregnant woman, or child less than 12 months of age
* Allergy to gentamicin
Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail

A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.

The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".

The Paris jail "La Santé" welcomes 600 men who stay 5 month on average. Each year, there are between 30 to 40 diabetic patients. In the jail there's a sanitary unit who is a unit of internal medicine of Cochin hospital. This unit includes nurses, pharmacists and medical doctors.

We propose to include in this study all diabetic patients (type 1 and 2) with the realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic (knowledge of the disease, food, physical Activity and care of feet, the therapeutics)

Eligibility Criteria:
Inclusion Criteria:

* Male patient detained in the MAPLS of more than 18 years
* Patient prisoner in the MAPLS for more than 15 days
* Patient follow-up for a diabetes of type 1 or type 2
* Patient informed about the study and not having opposed to this one
* Patient taken out of the disciplinary district which had previously been included for this motive

Exclusion Criteria:

* Patient considered incapable by the investigator to follow an ETP program
* Patient having a bad understanding of the spoken French language
* Patient whose duration of confinement known about the MAPLS is strictly lower than 1 month in the inclusion during the year 2013/2014
* Patient prisoner in the district of isolation
* Patient prisoner in the disciplinary district in the inclusion
* Patient prohibition to communicate with another prisoner already registered on the session to come
Effect of Different Intensities of Exercise on Daily Energy Expenditure With Physical Activity in Overweight Boys

The main purpose of this study is evaluate the effect of different intensities of exercise (moderate vs. intense) on the daily energy expenditure in overweight adolescents.

The specific objectives are:

1. Assess and quantify the existence of compensatory effect of exercise on subsequent physical activity.
2. Compare the amount of daily physical activity in adolescents subjected to different protocols of training intensity.

Eligibility Criteria:
Inclusion Criteria:

overweight 6th and 7th grades students consent form signed by parents / tutors

Exclusion Criteria:

diabetes mellitus hypertension or reported cardiovascular disease
tDCS and VI to Treat Neuropathic Pain and Function in SCI

Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain

Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients.

Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program.

In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).

Eligibility Criteria:
Inclusion Criteria:

1. patients hospitalized in spinal cord rehabilitation department
2. neuropathic pain following spinal cord injury
3. able to seat on a wheel chair
4. able to understand and comply with basic instructions
5. Hebrew speakers

Exclusion Criteria:

1. epilepsy
2. pregnancy
3. non-neuropathic pain
4. medical condition that affect cognitive functioning
5. medical condition other then the spinal cord injury that affect functioning
Probiotics, Immune Function, and the Brain in Alcohol Consumers

This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).

This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease also may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit 15 non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1 is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy drinkers.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old;
* Able to speak and read English well enough to complete study procedures;
* Meets NIAAA guidelines for heavy drinking in the past 30 days.

Exclusion Criteria:

* Chronic disease requiring daily use of medication;
* Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
* Self-reported history of liver disease;
* Antibiotic or probiotic use in past 1 month;
* Positive urine drug test;
* History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
* Safety contraindication for MRI (e.g., ferromagnetic implant in the body, claustrophobia);
* Head trauma with loss of consciousness \>10 min;
* Pregnant, breastfeeding, or not using effective birth control;
* Unable to complete the study visits due to time or scheduling constraints;
* Weight \<110 lbs.
* Conditions of immunodeficiency, such as HIV infection, primary immune deficiency, or taking immune-suppressant medications.
Genetic Analysis of Keloids

Keloids have a strong genetic component. The goal of this study is to identify genes and regulatory elements on chromosomes that are the cause for keloids or contribute to keloid scarring.

Keloids are scars that keep growing beyond the border of the original wound. They typically persist for several years, expand for an extensive period of time and are sometimes called benign tumors. Keloids often have a lumpy surface and are often tender, itchy or inflamed around the growing border.

Keloids in most keloid patients do not run in the family. In the inheritable form of keloids it is possible that there is one major gene mutation that puts family members at risk for developing keloids. There may be other variations in the DNA (DNA makes up the chromosomes) that determine whether keloids become large and aggressive or stay small and without many symptoms.

For this study we will:

* Send out study participation kits and consent by phone
* Collect a saliva sample from eligible individuals
* Obtain information regarding the keloids
* Document keloids with photos
* If keloid patients undergo keloid surgery we ask to obtain some scar tissue that would otherwise be discarded
* Isolate DNA from the saliva sample
* Perform genetic analyses of the DNA with the most up-to-date methods available to identify genetic variations
* Study in the laboratory why the genetic variations cause keloids

Eligibility Criteria:
Inclusion Criteria:

* keloids;
* unaffected individuals only if part of a participating keloid family

Exclusion Criteria:

* no keloids;
* unaffected individuals only as part of a participating keloid family
CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.

Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study:

1. Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow.
2. Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging
3. Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used;

   * up until the part of the lead implantation workflow that is the scope of this investigation.
   * As a bailout, when the operator declares failure to attempt.


Eligibility Criteria:
Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.

Inclusion Criteria:

1. Subject must be aged \>18 years.
2. Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. Subject is scheduled for a de novo pacing lead implantation or system upgrade .

Exclusion Criteria:

1. Patients for whom previous CRT or conduction pacing implantation has failed.
2. Patients considered for leadless cardiac pacing system.
3. Patients undergoing a system revision for infection or malfunction.
4. Patients undergoing planned, urgent or emergency lead revision or lead extraction.
5. Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
6. Patients included in a clinical registry or clinical trial for an investigational product.
7. Pregnant women.