cyrilzakka/clinical-trials huggingface dataset:
Epicardial Mitral Repair Trial - ENRAPT-MR

Mitral Touch System

This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

Eligibility Criteria:
Inclusion Criteria:

* Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic
* Patient is 18 years of age or older
* Patient is willing and able to sign informed consent form

Exclusion Criteria:

* History of endocarditis or current endocarditis
* Structural abnormalities of the leaflets and papillary muscles\*
* Dysfunctional chordae\*
* Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy\*
* Ejection fraction \<25%
* New York Hheart Association (NYHA) class IV
* MV diameters \> 7cm
* Myxomatous Mitral regurgitation
* Renal insufficiency (eGFR \&lt; 30 ml/min)
* Severely calcified (posterior) Mitral Valve annulus
* Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
* Any coronary artery calcification at site of placement as determined by angiogram.
* Abnormal cardiac anatomy discovered prior to surgery or during procedure.
* Pericardial adhesions

  * NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch
Tolerance of Teeth Brushing During Prolonged Aplasia

It is currently not allowed for patients with prolonged aplasia, following intensive chemotherapy, to brush teeth due to the risk of damaging the oral mucosa with risk of haemorrhage and infectious entrance door. Mouthwash is currently prescribed to prevent these complications. Many patients, however, ask to brush their teeth for greater comfort and a feeling of well-being.

Some haematology services allow tooth brushing while others prohibit tooth brushing without study.

Investigators wanted to conduct a study to assess the feasibility, the safety of tooth brushing for aplastic patient comfort, hemopathy and/or chemotherapies causing mucous membrane alteration that increases infectious risk and the risk of gingivorragia.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized Patients in protected area of the Blood Disease Service with predictable prolonged aplasia and risk of mucite
* Acute myeloblastic leukemia undergoing induction or consolidation treatment
* Acute lymphoblastic leukemia under induction treatment
* Patients affiliated or beneficiaries of a social security
* Written inform consent

Exclusion Criteria:

* Patients with removable complete dentures
* Constitutional disorder of coagulation
* Hematopoietic stem cell allogreffe
* Therapeutic intensification with autograft of haematopoietic stem cells
* Patient unable to provide oral care alone (brushing teeth or mouthwash)
* Already included in the study
* Pregnant women, lactating mothers
* Persons deprived of liberty by an administrative or judicial decision
* Persons undergoing psychiatric care under duress
* Adults who are subject to a legal or non-state protection measure to express their consent
Effects of Complex Training On Pain and Posture In School Going Children With Heavy Bags Packs

As the issues of related to heavy bag packs are increasing with every day so the complex training program along with postural training may prove to be an effective protocol in dealing with issues


Eligibility Criteria:
INCLUSION CRITERIA:

* Children with age between 12 to 15 years.
* Children with normal BMI (5th - 85th percentile).
* Students carrying bags with 15% of body weight.

EXCLUSION CRITERIA:

* Children with any physical disability ( Spinal cord injury, Cerebral palsy, Multiple sclerosis, and Epilepsy)
* Children using single-strap bags.
* One-sided shoulder elevation.
* Children using handbags or trolley bags.
Cohort of Hepatitis B Research of Amsterdam

Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus (HBV). Infection can result in an inflammation of the liver parenchyma with various clinical manifestations ranging from an asymptomatic course to jaundice. After contact with the virus the immunological response of the host determines the clinical outcome leading to either viral clearance or a chronic infection.

Although several factors are responsible for the development of chronic HBV-infection, one of the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing T helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to liver failure.

Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral load is a strong predictor for the development of cirrhosis, independent of hepatitis B e- antigen status and serum alanine transaminase level. It is unclear whether these results can be extrapolated to non-Asian (Caucasian and African) populations because of differences in host (HLA background) and viral (HBV genotype) factors.

The aim of this study is to elucidate the question whether historic HBV viral load is associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.

During one visit, the nurse will assess the quality of life of the included patients with the use of a health assessment questionnaire. This questionnaire is derived from a standardized questionnaire to assess the quality of life in patients, the SF-36. Participation will require a single visit to the outpatient clinic of Public Health Service. During this visit a short history and physical examination related to chronic liver disease will be performed. During the same visit a single venapunction and a single hepatic elastography (fibroscan) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg-positivity
* Serum sample available from the screening programme at the Public Health Service
* Still living and alive in Amsterdam or Diemen and address traceable by general practitioners or municipal authorities.
* Non-Asian (both parents not born in Asia)
* Between 18-65 years old
* Capable of giving informed consent and capable of traveling to the Public Health Service

Exclusion Criteria:

* Subjects coinfected with human immunodeficiency virus (HIV)
* Subjects coinfected with hepatitis D virus (HDV)
* Subjects coinfected with hepatitis C virus (HCV)
* Subjects who are unable to come to the outpatient clinic
* Subjects incapable to give informed consent due to legally incompetence
Developing a Diabetic Foot Ulcer Protocol

The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.

This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics.

The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care.

Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria.

Frequency of visits will be:

* patients with monitored Air-boot: weekly
* all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks.

Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.

Eligibility Criteria:
Inclusion Criteria:

* Adult - over 18 years of age
* Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
* No evidence of circulatory compromise

  * Posterior tibial or pedal pulse present on palpation
  * No pallor on elevation
  * No dependent rubor
* Loss of sensation on forefoot using monofilament
* Wound or callus on only 1 foot
* Wound Classification - Wagner Grade 1, non-infected

  * Ulcer present for 1 - 3 months
  * Ulcer of forefoot only
  * No previous ulcer of that foot or amputation of either extremity
  * Wound size \< 1" diameter
  * Wound bed pink

Exclusion Criteria:

* Diagnoses with unpredictable trajectory or healing ability, i.e.

  * Psychiatric disorders
  * Cancer
  * ESRD not eligible for dialysis
  * HIV
* Previous lower extremity amputation
* Charcot foot
* Evidence of circulatory compromise

  * Absence of pulses
  * Decreased capillary refill (\> 3 seconds)
  * Trophic skin changes - shiny, hairless toes
  * Ankle Brachial Index \< 0.8
Metabolic Effects of Fructose Intake

The goal of this clinical trial is to learn how fructose ingestion affects metabolic factors in healthy adults aged 18-64, with a BMI between 19 and 30 kg/m², of any sex or gender. Specifically, the study aims to examine the impact of fructose compared to glucose on circulating metabolic factors including the soluble leptin receptor.

The main questions it aims to answer are:

How does fructose ingestion influence levels of circulating metabolic markers, including the soluble leptin receptor? Does fructose consumption have different metabolic effects compared to glucose?

Participants will:

Complete a screening phone call to review their health history and eligibility.

Attend two in-person visits at least two weeks apart, where they will:

Fast for 8 hours beforehand. Consume a beverage containing either 75g of fructose or glucose. Have blood drawn at regular intervals for up to 5 hours after consumption to measure circulating levels of metabolic markers.


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be between 18 and 64 years old.
* BMI: Participants must have a Body Mass Index (BMI) between 19 and 30 kg/m² (healthy weight to slightly overweight).
* Health Status: Participants must be healthy volunteers with no significant medical conditions.
* Sex/Gender: Both males and females are eligible to participate.

Exclusion Criteria:

* Known significant medical illness, any medications except oral contraceptives, history of fructose intolerance, pregnancy. We will not enroll BCM Medical students or individuals who work directly for any of the study investigators.
Azithromycin as Host-directed Therapy for Pulmonary Tuberculosis

Rationale:

Treatment in tuberculosis (TB) is focused on eradication of the bacterial infection, however, after treatment approximately half of patients are left with a significant and permanent respiratory impairment. Adjunctive host-directed therapies are being investigated to modulate host immune responses to target mycobacterium tuberculosis (Mtb) infection and/or reduce excessive inflammation, prevent pathological tissue damage, preserve lung function and enhance effectiveness of standard drug therapy, while nonetheless eliminating Mtb. Macrolide antibiotics have previously been used in the treatment of multidrug-resistant TB. In addition to their antibiotic effects, macrolides have also been recognized to induce anti-inflammatory and immunomodulatory effects in other lung diseases.

Objective:

To investigate the immunomodulatory effects of azithromycin in tuberculosis patients receiving standard therapy (isoniazid, rifampicin, pyrazinamide, ethambutol (HRZE))

Study design:

A prospective, randomized open label intervention trial to investigate the immunomodulatory effects of azithromycin

Study population: 24

Intervention: azithromycin 250 mg once daily or standard of care (control)

Main study parameters/endpoints:

1. To assess whether azithromycin enhances resolution of systemic inflammation in patients with drug susceptible pulmonary TB receiving standard treatment.
2. To assess whether azithromycin on top of standard treatment in patients with drug susceptible pulmonary TB reduces airway inflammation and reduces tissue degradation and remodeling
3. To investigate whether these effects are associated within shortening of the time to sputum conversion.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of drug sensitive pulmonary tuberculosis (molecular test; identification Mtb complex; absence of resistance genes such as rpob, inha, katg)
* Written informed consent

Exclusion Criteria:

* Patient reported previous history of treatment for tuberculosis
* Patients younger than 18 years
* Pregnancy or breast feeding
* Patients with hypersensitivity to macrolide antibiotics
* Treatment with any macrolide in the previous month
* Treatment with any tetracycline in the previous month
* Treatment with any inhaled or oral corticosteroid in the previous month
* Concomitant treatment with analgesic (NSAIDs)/immunosuppressant drugs (except paracetamol).
* Treatment with digoxin
* Patients with gastrointestinal complaints, like diarrhea and vomiting (≥grade 2, observed)
* Other known respiratory diseases, including bronchiectasis, pulmonary fibrosis, pulmonary vascular disease or lung cancer
* HIV-1 infection or AIDS
* Impaired liver function (Child-Pugh score C)
* Patients with a known QTc ≥500 ms. An electrocardiogram (ECG) will be recorded.
* Inability to spontaneously produce sputum upon diagnosis
Effect Of Rilapladib (SB-659032) On Platelet Aggregation

The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with QTc \< 450 msec as measured at screening.

Exclusion Criteria:

* History of asthma.
* Smokers.
Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy

All patients will receive the same dose of the study treatment over 6 months. For each participant the study will last approximately one year with follow up visits after the treatment period of 6 months is completed. The visits will include blood draws, vital sign checks, neurological and physical exams, pulmonary testing with forced vital capacity (FVC), and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable or definite ALS
* ALSFRS-R score \>25 and FVC score ≥ 60% predicted
* If currently taking Riluzole and/or Edaravone/Radicava must be on stable dose for 3 months prior to Baseline/Screening. If the dosing has not been stable for 3 months prior to Baseline/Screening or if stopped due to an adverse event, the waiting period off the medication will be 7 days. If not on either of these medications may start if desired either or both medications after enrollment into study.

Exclusion Criteria:

* Diagnosis of probable or definite ALS more than 3 years prior to study enrollment
* Diagnosis or previous history of ischemic stroke, brain tumor, uncontrolled diabetes, renal insufficiency, or severe hypertension.
* Diagnosis or previous history of comorbid progressive neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy Body disease, Pick's disease, Huntington's disease, Progressive Supranuclear palsy. ALS patients diagnosed with frontotemporal dementia will not be excluded from this study.
* Diagnosis or previous history of symptomatic peripheral neuropathy. Patients with findings of peripheral neuropathy on electrodiagnostic tests only but no clinical symptoms at the time of enrollment are eligible.
* Undergoing any chemotherapy or radiation therapy for any cancer
* Any medical condition likely to interfere with the conduct of the trial or survival of the patient during this study period
* Pregnant women or women who are breast feeding
* Has taken L-Serine supplement within 30 days prior to start of study drug
Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

The primary purpose of the study is to test the feasibility of a protocol of enhanced recovery after surgery for reducing the total length of hospital stay in a large scale setting

This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients undergoing a sleeve gastrectomy Patients having signed the informed consent Patients over 18 year old ASA 1-3 Obesity with indication for surgery according the guidelines of the French High Authority for Health BMI \< 50 kg/m2 No contra-indication for general anesthésia

Exclusion Criteria:

contra-indication for general anesthésia Age under 18 years ASA 4 BMI \> 50 kg/m2 Patients having other serious comorbidities: cardiac, pulmonary, diabete, immunodepression, coagulopathy ou anticoagulant therapy Pregnancy Patients living alone
Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.

To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.

The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Group A received FES by using the WalkAide foot drop stimulator while group B received TheraTogs. Patients' evaluation will be carried out before and after training to assess gait and balance performance.

Eligibility Criteria:
Inclusion Criteria:

* Their weight should be less than 40 kg.
* The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
* Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
* They can walk 10 min conditionally without an orthosis.
* Ought to be intellectually skilled and ready to comprehend and take after directions.
* They will have neither serious nor recurring medical complications.
* Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
* No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
* Peroneal nerve and the proximal leg muscles ought to be in place.
* They ought to have no significant issues influencing balance other than spasticity.

Exclusion Criteria:

* Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
* Children with visual, auditory or perceptual deficits.
* Children with surgical interference for the lower limb.
* Children with seizures or epilepsy.
* Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
* Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.


Eligibility Criteria:
Inclusion Criteria:

* triglycerides 150-500 mg/dL
* age 21-65 years
* generally healthy
* body mass index (BMI) 20-39 kg/m2

Exclusion Criteria:

* smoking
* premenopausal (if female)
* use of hormone replacement or oral contraceptives
* use of lipid lowering or blood pressure medication
* hypertension (blood pressure \> 150/95 mm Hg)
* peripheral vascular disease
* heart disease, diabetes, or stroke
* inflammatory disease (e.g. rheumatoid arthritis or Crohn's)
* elevated liver enzymes
* high intake of omega-3 containing foods
* allergy to adhesive or latex
* use of aspirin, anticoagulants, or SSRI
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.

Exclusion Criteria:

* Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
* Preexisting abnormalities in liver function, kidney function or haematological abnormalities
* History of malignancy within the last 5 years
* Uncontrolled hypertension
* Pregnancy or lactation; wish for pregnancy during the treatment period
* Infections requiring continued therapy
* Known positivity for HIV
* Evidence of drug and/or alcohol abuse
Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat

The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Type I or II Hereditary Angioedema (HAE) adolescent and adult post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age.
* Able to provide written, informed consent or assent.
* Confirmed diagnosis of HAE Type I or II.

Exclusion Criteria:

* Confirmed diagnosis of HAE with nC1-INH or acquired angioedema.
* Confirmed pregnancy or breast-feeding.
* Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
* Known hypersensitivity to sebetralstat or its excipients.
* Patient with a medical history or known to have severe hepatic impairment (Child Pugh C).
* Patients who require sustained use of strong cytochrome P450 3A4 inhibitors or inducers.