cyrilzakka/clinical-trials huggingface dataset:
Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients

With significant reductions in mortality and risk of progression to AIDS with antiretroviral therapy (ART), complications of long-standing HIV infection and treatment, including renal disease, have become increasingly important. Aging, concomitant metabolic diseases, and use of potentially nephrotoxic ART lead to higher risk for renal disease in HIV-infected persons.WHO encourage TDF as first line ARV regimen. The data on TDF related renal toxicity in Asian population is limited.

For this cohort, we plan to look at these topics:

1. proximal tubular dysfunction between TDF and non-TDF user
2. incidence and predictor of TDF related renal toxicity
3. TDF plasma concentrations
4. Pharmacokinetic of TDF when used with boosted DRV, boosted ATV, and boosted LPV in Thai population
5. Bone density and vitamin D in patients with and without hypophosphatemia.
6. Pharmacogenomic of TDF in Thai population

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years old.
2. HIV RNA \< 50 copies/ml (For ART-experienced group only).

Exclusion Criteria:

1. a history of Tc-99m DTPA allergy,
2. malnutrition (BMI \<18m2),
3. amputation,
4. bed-ridden,
5. currently taking cotrimoxazole or cimetidine,
6. acute deterioration of renal function within the last 3 months,
7. serum creatinine \> 1.5 mg/dl, or
8. pregnant/lactating.
Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension

Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows to the heart's left side, where the left ventricle pumps it to the rest of the body through the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year. The greatest number is reported in women between ages 20 and 40. However, men and women in all age ranges as well as very young children can develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and resulting in elevated blood pressure. However, it has not yet been reported regarding the genetic variants in Taiwan. Further details have been described in this project proposal.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as idiopathic pulmonary artery hypertension and associated family

Exclusion Criteria:

* none
Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer bleeding.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly consumed drugs worldwide for the relief of pain and arthritis. However, the use of NSAIDs increases the risk of ulcer bleeding by 4-fold. Current evidence indicates that combination of conventional NSAIDs and a proton pump inhibitor (PPI) reduces the risk of ulcer complications. The alternative strategy is to replace conventional, non-selective NSAIDs with NSAIDs selective for cyclooxygenase-2 (COX-2 inhibitors). Recently, there are concerns about the cardiovascular safety of COX-2 inhibitors and conventional NSAIDs. Because of such concern, patients requiring anti-inflammatory analgesics who have cardiovascular risk factors (e.g. smoking, hypertension, hyperlipidemia, diabetes) should receive prophylactic low-dose aspirin. However, concomitant low-dose aspirin negates the gastric sparing effect of COX-2 inhibitors and augments the gastric toxicity of nonselective NSAIDs. Thus, gastroprotective agents such as PPIs should be co-prescribed to patients with high ulcer risk who are taking aspirin plus a COX-2 inhibitor or a nonselective NSAID.

Eligibility Criteria:
Inclusion Criteria:

1. age \>18,
2. a history of endoscopically proven gastroduodenal ulcer bleeding,
3. H. pylori negative
4. a history of cardiothrombotic disease requiring ASA, and
5. anticipated regular use of NSAIDs for the duration of trial

Exclusion Criteria:

1. concomitant use of anticoagulants;
2. a history of gastric or duodenal surgery other than a patch repair;
3. the presence of erosive esophagitis,
4. gastric outlet obstruction,
5. renal failure (defined by a serum creatinine level of more than 200 umol/L),
6. pregnancy,
7. terminal illness, or
8. cancer
Study of Organ Perfusion in Heart Transplantation in Children

The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to \<18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:

to compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.

Participants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.

Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in patients with end stage heart failure when other treatments have failed.

The surgical procedures for orthotopic heart transplantation are essentially the same in adult and paediatric patients . Due to anatomical variants in congenital heart disease the procurement procedure may be modified with regard to the extent of the Vena cava superior and the great vessels. In implantation most frequently the bicaval technique is used but the biatrial technique which is leaving the back wall of both atria in situ may also be employed.

A main difference between adult and paediatric heart transplantation (HTx) are the indications for transplantation: In adults the majority of patients undergo HTx as treatment of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other treatments have failed. Infants younger than one year of age congenital heart disease (CHD) is the most common diagnosis representing more than every second case followed by dilated cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery and in whom myocardial dysfunction develops later .

Eligibility Criteria:
Inclusion Criteria:

* Age from birth to less than18 years
* Recipients awaiting their first transplant
* Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
* written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
* Patient listed on the waiting list for heart transplantation

Exclusion Criteria:

* Patients who have participated within 30 days or are still participating in any other interventional studies
* history of severe organic disease other than concerning the heart
* history/demonstration of HIV antibodies or AIDS
* multiorgan transplantation
* machine-perfused organ
* the explantation team is affiliated to another clinic than transplantation team
* Failing Fontan patients
* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
* Pregnancy and lactation
Motorised Probe Holder Assisting Prostate Biopsies

Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.


Eligibility Criteria:
Inclusion Criteria:

* of-age patient
* patient for whom a prostate biopsies session is planned
* patient affiliated to the social security or equivalent
* patient having a target identified on MRI
* Written informed consent

Exclusion Criteria:

* contraindication
* patient wearing a mechatronic device
* patient concerned by the L1121-6 à 8 of the health public code
CTO Registry From Insight of IVUS in Fuwai Hospital

To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent contemporary percutaneous coronary intervention (PCI) techniques, we design this single-center, large-sample, prospective registry with five-year clinical follow-up, based on the intravascular ultrasound (IVUS) finding.

The study plan to include the patients with a CTO lesion in one of the three main epicardial coronary artery (diameter more than 2.5 mm) as the only target lesion. The CTO lesion is defined as 0 grade of thrombolysis in myocardial infarction (TIMI) flow with evidence of occlusion duration more than 3 months. All the PCI procedure will be performed by a group of certified operators in Fuwai Hospital, Beijing, China. All patients evaluate IVUS with automatic pullback (Opticross, Boston Scientific, US) performed after wire crossing. All the included patients are planned for five-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient \>18 years old
* Thrombolysis in myocardial infarction trial (TIMI) 0 grade.
* Evidence of occlusion period more than 3 months.
* Patients eligible for PCI.
* Patients eligible for coronary artery bypass graft (CABG).
* Target vessel is one of the three main epicardial coronary arteries.

Exclusion Criteria:

* Acute myocardial infarction with ongoing ST-elevation
* Target vessel is left main or graft vessel.
* Target vessel diameter \< 2.5 mm.
* Other situations ineligible for PCI judged in clinical practice.
* Left ventricular ejection fraction \<30%
Diet in Pediatric Crohn´s Disease Treated With Biologics

Cded in remission patients with high calprotectin

Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age
* With a diagnosis of CD
* Who have completed remission induction with biologic therapy
* Who are on maintenance biologic therapy
* Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).

Exclusion Criteria:

* Children who are unable to receive enteral dietary intake
* Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
* Children already on special diets
Feasability, Validty and Reliability of Inertial Sensors

This study has 3 aimes:

1. To investigate the feasibility of using IMUs (Xsens, MVN Studio) during functional tasks to assess upper limb kinematics in pwMS and stroke survivors. On the one hand, the feasibility of performing the tasks will be investigated . On the other hand, does the XSens give valuable data?
2. To investigate the discriminative validity of kinematic measurements of upper limb movements post-stroke and pwMS in comparison with gender and age-matched healthy controls
3. To investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwMS and stroke survivors

It is a cross-sectional case-controlled observational study, with 3 different groups: 25 Persons with Multiple sclerosis, 25 stroke patients and 50 healthy controls, matched by age and gender.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for all participants: Healthy controls, pwsMS and stroke patients

* No orthopedic or neuro-muscular impairments in the upper limb
* Age \> 18 years
* Able to understand and execute the test instructions
* Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
* Able to move a joint (wrist, elbow or shoulder) in the upper limb against gravity without resistance (Medical Research Council) (16).

Inclusion criteria for PwMS:

- Diagnosed with MS using McDonald criteria (17)

Inclusion criteria Stroke patients

* First- ever single, unilateral (ischemic or hemorrhagic)
* At least one month after stroke
* No apraxia or hemi spatial neglect

Exclusion Criteria:

Exclusion Criteria for pwMS only:

* a relapse 3 months before the start of the study
* A change of symptomatic medication during the testing period

Exclusion Criteria:

- People with predominantly ataxia or tremor are excluded from the reliability part of this study
Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09

The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent/assent prior to video collection and data abstraction.
* Documented informed consent/assent in Study ALX-HPP-502.
* Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.
* Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye

Exclusion Criteria:

* There are no exclusion criteria for this study
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.

The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a non-surgical treatment for patients with emphysema. The IBV Valve System does not require traditional surgery or surgical incisions. The valves are placed during a bronchoscopic procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status. Although the valves are intended to be permanent, they are designed to be removed if necessary.

The IBV Valve Trial is a randomized, blinded trial. This means that participants are divided into two groups but do not know to which group they have been assigned.

The IBV Valve Treatment Group receives valves, and the Control Group does not. A random selection process decides the group assignments (participants will not be able to choose their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss) to be assigned to one group or the other.

All Participants in this Clinical Trial will:

Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs.

Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the Treatment Group or the Control Group.

Receive regular periodic check-ups and health assessments throughout the 6 month trial period.

The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV Valve Treatment Group and the Control Group.

At the completion of their 6-month visit, participants will be told if they were assigned to the Treatment Group or the Control Group. If participants were assigned to the group that did not receive valves (the Control Group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment.

Eligibility Criteria:
Inclusion Criteria:

* Candidates have mostly upper lobe, severe emphysema.
* Must be able to participate in standard exercise testing.
* Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
* Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
* Willing to participate in multiple visits to a medical center for health assessment tests.
* Willing to have a minimum of one overnight stay in the hospital.

Exclusion Criteria:

* Evidence of another co-existing major medical disease.
* Unable to tolerate, flexible bronchoscopy procedures.
* Active asthma, chronic bronchitis.
* Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
* Has had prior lung volume reduction surgery.
0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation

Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.

0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of primary corneal epithelial abrasion;
* Monocular onset;
* Corneal epithelium was defected and fluorescein sodium staining was positive.

Exclusion Criteria:

* Corneal epithelial defect complicated with infection
* Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)
* Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases
Oral Herbal Combination Formulation and Hair Growth in Women

The purpose of this research is to test the effects of an herbal combination formulation on hair growth in women with self-perceived hair loss.The information from this study may help to better understand how certain herbal supplements can affect hair growth. This may lead to better understanding of the hair, hair loss and help develop naturally-based treatment regimens in the future.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Subject must be able to read and comprehend study procedures and consent forms.
* Women with self-perceived hair loss as confirmed by the investigator.
* Willing to maintain the same hairstyle, hair color, hair length and hair regimen throughout the study period. Subjects with color-treated hair will have the color treatment performed at the same time interval prior to each visit (if the color treatment was done 1 week prior to Visit 1, it should be repeated 1 week prior to Visit 2).
* Willing to keep diet and exercise routine consistent throughout study

Exclusion Criteria:

* Subjects should be generally healthy and have no smoking history in the past one year.
* Subjects must have no history of diabetes, metabolic syndrome, HIV, immune deficiency, autoimmune disease known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
* Women who are pregnant, planning to become pregnant or breastfeeding
* Those who are unable to discontinue medicated shampoos or topical scalp medications for two weeks prior to and during the study.
* Those who are unable to discontinue supplements containing Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa for one month prior to starting the study
* Those who have a known allergy to Eclipta alba, Emblica officinalis, Centella asiatica or Hibiscus sabdariffa
* Use of hair regrowth products in the previous 6 months
* Using or planned use of non-breathable wigs
* Those with a history of hair transplantation procedure
* Presence of other dermatological disorders causing alopecia
* Chemotherapy, radiation therapy or laser therapy (of scalp) in the last 6 months
* Light therapy in the past 3 months
* Participants using hormonal birth control unless on a stable / unchanged regimen for at least 3 months.
* Systemic treatment during the last 3 months before study inclusion that could interfere with the study medications (ie, minoxidil, corticosteroids, Aminexil, topical estrogens, ketoconazole, beta blocker, cimetidine, diazoxide, isotretinoin or vitamin A intake \>10,000 IU/d)
* Use of ocular prostaglandins for less than 4 months before first study visit
* Those that are prisoners or cognitively impaired