cyrilzakka/clinical-trials huggingface dataset:
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 5 years of age
* Weight greater than or equal to 30 kilograms
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
* Any of the following by transthoracic echocardiography:
* For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg
* For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg

Exclusion Criteria:

* Active endocarditis
* Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
* Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
* Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
* Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
* Known intravenous drug abuse
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups

Urinary tract infections are very common in pediatrics. Urinary antibiotic prophylaxis is commonly used in children with malformative uropathies. Long-term, low-dose antibiotic prophylaxis with trimethoprim-sulfamethoxazole has been associated with a decrease in the number of urinary tract infections in susceptible children, but not systematically with a decrease in the risk of renal scarring (depending of uropathy stage).

Long-term antibiotic prophylaxis has implications for the acquisition of antibiotic resistance. A child receiving antibiotic prophylaxis for urinary tract infection is around 6 times more likely to develop a multidrug-resistant infection. In the general population, the microbiota of children treated with curative antibiotics is less diverse in terms of species and strains. In addition, short-term compositional changes are observed between consecutive samples of children treated with antibiotics.

The gut microbiota modulates the immune system, in particular via metabolites (SCFA, polysaccharide A) produced by bacteria that modify the expansion and function of regulatory T-cells. The disturbances of the intestinal microbiota play a role in the medium and long term on the acquisition of pathologies, such as atopy.

The study authors wish to describe the intestinal microbiota of children with vesico-ureteral reflux treated long-term with trimethoprim-sulfamethoxazole and compared it those not receiving antibiotic prophylaxis and to healthy children.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Patient with no objection to participation in the study from the parent or guardian
* Child with a diversified diet.

  o Specific inclusion criteria for group 1 (cases):
* Child with grade 3 or higher vesicoureteral reflux.
* Child on trimethoprim-sulfamethoxazole therapy for at least 5 months.

  o Specific inclusion criteria for group 2 (controls):
* Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment.

  o Specific inclusion criteria for group 3 (healthy controls):
* Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment.

Exclusion Criteria:

* Chronic digestive pathology
* Acute gastroenteritis or infectious colitis within last 15 days.
* Curative antibiotic therapy taken less than one month ago.
* Chronic inflammatory bowel disease or other localizations
* Congenital or acquired immune deficiency (current treatment with methotrexate, biotherapies, immunosuppressants)
* Patient participating in a category 1 trial likely to modify the intestinal microbiota.
* Patient in an exclusion period determined by another study.
* Patient under court protection, guardianship or curatorship.
* Patient for whom it is impossible to give informed information to person with parental authority.
Hypogonadism in Young Men With Type 2 Diabetes

Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.

This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.

Eligibility Criteria:
Inclusion Criteria:

* T2D Males with age 18-40 years

Exclusion Criteria:

1. planning to have children in the next one year
2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
3. PSA \> 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
4. Hemoglobin A1c \> 8%
5. Hematocrit \> 50%
6. History of obstructive sleep apnea
7. Congestive heart failure
8. Use of thiazolidinediones or exenatide
9. currently suffering from depression, with or without treatment
10. history of severe depression in the past which needed hospitalization
11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
12. Coronary event or procedure in the previous 6 months
13. Hepatic disease (transaminase \> 3 times normal) or cirrhosis
14. Renal impairment (serum creatinine \> 1.5)
15. HIV or Hepatitis C positive status
16. Participation in any other concurrent clinical trial
Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management

Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.

Current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. Self-assembling peptide matrix (P11-4) supplied commercially as Curodont D'Senz (CS) gel (Credentis AG, Windisch, Switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. Self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of DH and may open up new horizons in the treatment of dentin hypersensitivity. Of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. They hypothesized that laser favor the durability of the desensitizer for extended time. Some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18-60 years old.
* Non-smokers.
* Disease-free patients.
* Good oral hygiene.
* Having at least one teeth suffering from cervical dentin hypersensitivity with VAS pain score ≥5
* Recording pain to thermal, mechanical or tactile stimuli.
* Acceptance to participate in the study

Exclusion criteria:

* Smoking and bad oral hygiene.
* Presence of carious lesions, restorations or fracture in the test area.
* Presence of painful pathology restored less than three months in the test area.
* Using any desen¬sitizing agents.
* Undergo any peri¬odontal surgery in the last 6 months.
* Drug abusers.
* Administration of potent analgesics or anti-inflammatory drugs.
Individual Patient Compassionate Use of Mirdametinib

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
* Patient does not qualify to participate in an ongoing clinical trial.
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

Specifically the investigators want to study about :

1. The differences in serum levels of matrix metalloproteinase-9 in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
2. The differences in serum tissue inhibitor of metalloproteinase-1 levels in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
3. The differences in left ventricular structure in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.
4. The differences in left ventricular function in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 6 months - 18 years.
2. Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria.
3. Patients who will undergo intervention with transcatheter closure.

Exclusion Criteria:

1. Patients who experienced acute infections before the procedure.
2. There are other heart defects that require surgery.
3. There is a hereditary, genetic disorder, syndrome or other chronic disease.
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation

Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium.

Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated.

Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome.

For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.


Eligibility Criteria:
Inclusion Criteria:

* Urolithiasis Uric defined by more than 90% of uric acid anhydrous and / or dihydrate or calcium lithiasis defined by more than 90% mono calcium oxalate and / or dihydrate, and / or carbapatite and / or brushite;
* Overweight and obesity defined by 25 \<BMI \<35 kg / m2

Exclusion Criteria:

* staghorn lithiasis, stones struvite or cystine;
* Primary hyperparathyroidism;
* Hyperthyroidism;
* Any form of calcium or uric lithiasis secondary;
* Abnormal kidney structure (cysts, cortical thinning, kidney tumor);
Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda

The purpose of this study is to assess acceptability and side effects of a low-dose injectable contraceptive formulation which is delivered under the skin (subcutaneously), as compared with injectable contraception delivered into the muscle (intramuscularly) among adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable contraception. The investigators will also assess experiences experiences delivering these two types of injections among health care providers working within the HIV care clinics.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Woman aged 18-45
* Wishes to prevent pregnancy by use of injectable contraception and intends to continue using injectable contraception for next nine months
* Medically eligible for injectable contraception
* Capable of providing informed consent
* Willing to provide contact information
* Agrees to trial participation
* Intends to live in the area for the next nine months
* May or may not be currently using a first-line antiretroviral therapy regimen (includes: AZT/3TC/EFV; AZT/3TC/NVP; CBV/EFV; D4T/3TC/EFV; D4T/3TC/NVP; TDF/3TC/EFV; TDF/3TC/NVP)

Exclusion Criteria:

* Currently pregnant
* Desires pregnancy within next nine months
* Contraindications to using injectable contraception
* On second-line antiretroviral therapy regimen
Clinical Effect of Rebamipide on Chronic Gastritis

To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
* diagnosed as chronic gastritis with endoscopic and pathological methods
* agree to join in this clinical trail

Exclusion Criteria:

-
Young Men and Media Study

Adolescent sexual minority males (ASMM) continue to account for a disproportionate number of HIV infections in the United States. Racial and ethnic minority populations are particularly affected. Increased HIV rates reflect sexual risk behaviors during early sexual experiences. Research suggests that initial sexual risk-taking occurs during adolescence among sexual minority males. Therefore, it is important for HIV prevention interventions to target adolescent sexual minority males. Targeting sexual minority males during adolescence will help them learn and establish healthy sexual behaviors early in their psychosexual development, which will have both immediate and long-term health benefits.To promote adolescent sexual minority males' critical examination of online media and decrease their sexual risk-taking, this study proposes an exploratory clinical trial to pilot test an online sexual health media literacy intervention that was developed during formative research for feasibility and acceptability. Overall, the proposed research has the potential to reach a wide audience of sexual minority males early in their sexual development, ultimately decreasing their sexual risk-taking and reducing the number of new HIV infections in this population.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as sexual minority
* Have intentionally accessed SEOM
* Have a valid personal email address
* Be a US resident
* Be new to the study

Exclusion Criteria:

* Are unwilling or unable to provide informed assent
* Are unable to understand and read English
* Do not have the appropriate device and necessary software to experience all the intervention content
Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents

The "Insul-In This Together" intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.

This study will collect survey and biomedical data to assess this program in a randomized controlled trial with 165 families (including an adolescent and parent/caregiver) will be enrolled, complete surveys, provide biomedical data via continuous glucose monitors and receive a 6-week psychosocial intervention. The results of this study will inform future intervention redesign to provide more judicious interventions to be disseminated across diabetes care.This study will evaluate the relative efficacy of each of the individual intervention components and also identify the mechanisms of actions (mediators) that are most impacted by these types of interventions as well as most linked to long-term outcomes for adolescents.

Eligibility Criteria:
Inclusion Criteria:

1. Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months
2. Teen subject is age 12-19 years at time of screening (no age limit for parent participants)
3. Participation of at least one cohabitating parent/caregiver.

Exclusion Criteria:

1. Subject lacks access to a smartphone or Wi-Fi via computer
2. Subject has restricted or no English proficiency
3. Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study
IBI188 Combination Therapy in Solid Tumors

A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies


Eligibility Criteria:
Inclusion Criteria:

1. Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
2. Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
3. Able to provide archived or fresh tumor tissue samples for biomarker assessment.
4. Have at least one measurable lesion according to RECIST version 1.1.
5. ECCG PS score of 0-2.
6. Adequate organ and bone marrow functions .
7. Life expectancy ≥ 12 weeks.
8. Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
9. Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and \< 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.

Exclusion Criteria:

1. Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
3. Concurrent participation in another clinical study.
4. The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
5. Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
6. Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
7. Known hypersensitivity to IBI188 or any ingredient in the study drug product.
8. History of other primary malignancies.
9. Female subjects who are pregnant or lactating.
10. Other ineligible conditions considered by the investigator.