cyrilzakka/clinical-trials huggingface dataset:
Broccoli Supplement Dose Response

Do daily high (4 tablets) or intermediate (2 tablets) administration of the broccoli-based dietary supplement Avmacol® have improved bioavailability over a broccoli sprout beverage rich in sulforaphane and its biogenic precursor, glucoraphanin? The beverage formulation has been used successfully in the investigators' previous intervention studies in regions of China with high levels of air pollution to reduce the body burden of carcinogenic and toxic pollutants. The investigators seek to evaluate a more stable, less expensive formulation of a broccoli sprout preparation that can be used for disease prevention in future studies.

The investigators will conduct a 3-armed placebo-controlled 16-day intervention with the dietary supplement Avmacol® to determine the bioavailability with repeated dosing of a simple tablet-based intervention in the study participants. As shown in Scheme 1, the 3 arms are: 1) 4 tablets of Avmacol® daily for 14 days; 2) 2 tablets of Avmacol® daily for 14 days together with 2 placebo tablets to maintain parity in consumption; and 3) 4 placebo tablets daily for 14 days. In addition, all participants will receive 4 placebo tablets for 2 consecutive run-in days prior to commencing intervention in the 3 distinct arms. Consecutive overnight (12-hour) urine samples will be collected during the 2-day run-in, the 14-day intervention and during a 5-day run-out period (total = 21 days). Additional day-time urine collections will be made at 2 timepoints: the day after administration of Avmacol® tablets begins and the day after the last administration of Avmacol® tablets. A blood sample will be collected at the beginning of the run-in and after the last Avmacol® dose (Day 17 for intervention groups, and for the placebo group) from each participant. The tablets will be taken before dinner each day.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 and ≤ 70 years who are residents of Qidong, China.
2. Able to provide written, informed consent.
3. Normal physical examination and medical history indicative of good general health with no history of chronic illness.
4. No hepatomegaly by clinical exam;
5. Normal liver function tests (ALT, aspartate aminotransferase (AST), bilirubin);
6. Normal renal function tests (creatinine, blood urea nitrogen (BUN), urinalysis);
7. Serum alpha-fetoprotein (AFP) negative.

Exclusion Criteria:

1. Pregnant (positive human chorionic gonadotropin (HCG) strip test)
2. Current or former diagnosis of cancer, with the exception of non-melanomatous skin cancer.
Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and Body Mass Index (BMI) between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
Impact of Visualisation an Explanatory Video on the Quality of Bowel Preparation

The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation.

The prescription of colonoscopy is performed by a gastroenterologist, who chooses the type of bowel preparation. During this consultation, the doctor explains to the patient the bowel preparation, then gives the patient the prescription with the type of product and a sheet explaining the diet without residues.

The time between this consultation and the colonoscopy is sometimes long. The idea of this study is to accompany this information on intestinal preparation with a video that details the different stages of intestinal preparation by MOVIPREP. Indeed, studies have in the past shown an improvement in the quality of intestinal preparation with the help of better information to patients (educational booklet, or smartphone application)

Eligibility Criteria:
Inclusion Criteria

* Major patient
* Patient with first indication of colonoscopy
* Colonoscopy performed in outpatient with preparation by MOVIPREP
* Patient affiliated with Social Security
* Informed consent signed by the patient

Exclusion Criteria:

* Hospitalized patients
* With no Internet access, or no access to the email
* Blind patients
* Patient who don't speak French
* Pregnant woman
* Severe constipation (3 stools/week) or long-term laxatives
* History of partial or total colectomy
* Other preparation product
APPI-Cost Trial for Perforated Appendicitis

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.


Eligibility Criteria:
Eligibility for Enrollment

Inclusion Criteria:

* Plan to undergo appendectomy for acute appendicitis

Exclusion Criteria:

* Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
* Allergy to iodine
* Uncontrolled hyper- or hypothyroidism
* Renal dysfunction
* Pregnant or breastfeeding
* Primary language neither English nor Spanish
* Lack of functioning telephone or email account
* Incarcerated or in police custody

Eligibility for Randomization

Inclusion Criteria:

* Enrolled in study preoperatively
* Intraoperative diagnosis of perforated appendicitis

Exclusion Criteria:

* Non-perforated appendicitis
Topical Timolol Benefit in Venous Ulcers

Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their management. At the origin of high health costs and strong repercussions on quality of life for patients, they require long management and may be subject to possible complications.

In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.

Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous ulcers with topical timolol.

Abstract: Complicating severe stages of chronic venous insufficiency, venous leg ulcers are common in dermatology and responsible for important health care costs. Healing remains long with many persistent cases after one year, despite compression and local dressings. Several pharmacological studies have demonstrated a benefit of beta-blockers on the wound healing process: present in the skin, the beta-adrenergic receptors play a role in wound healing. Their stimulation inhibits healing while blocking them promotes angiogenesis, fibroblast migration and keratinocyte migration. Using the topical timolol in several patients seems to confirm these effects: all ulcers treated with timolol healed in a few weeks whereas they did not evolve under local care and compression.

The purpose of this study is to demonstrate whether there is an interest in topical timolol for venous leg ulcers in combination with compression and wound dressings versus placebo. The primary endpoint is to evaluate the healing rate to W12. The effects will be evaluated with photography, evaluation of the surface of the ulcer at W12 compared to W0. The research of side effects will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to a social security scheme patients
* Informed consent
* Patients over 18 years
* Ulcer lasting for at least 24 weeks with no improvement observed after 4 weeks of well conducted treatment (compression and local care)
* Presence of one or more venous leg ulcers (objectified by a Doppler ultrasound dated within 6 months and ABPI ≥ 0.8)
* Ulcers with a surface of 5 to 50 cm ² and at granulation stage
* Study ulcer must be at least 2 cm from Any Other ulcer on same extremity.
* If several ulcers present, the greatest is selected
* Granulation tissue ≥ 50%

Exclusion Criteria:

* Minors under guardianship, deprived of liberty, not looking at treatment, lack of signed consent, pregnant women, demented patients
* Ulcer lasting for less than 24 weeks
* Granulation tissue \<50%
* Obliterative arteritis (ABPI \<0.8)
* Infection of the ulcer (need to treat the infection before any inclusion criteria be compatible)
* Non-cardioselective beta-blocker treatment
* Bradycardiac treatment
* Patients under diltiazem, verapamil (calcium antagonists)
* Reaching underlying noble structures, tumor acutisation wound
* Immunosuppression
* Diabetes unbalanced (HbA1c\> 8%)
* Severe Malnutrition (albumin \<25g / L)
* Anemia \<10g/dl
* Contraindication to beta-blockers
Genotype Expression and Phenotype of Endothelial Cells, Carrying an ACVRL1, ENG or SMAD4 Mutation, in Response to BMP9 for the Identification of New Therapeutic Targets in Hereditary Haemorrhagic Telangiectasia

Hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome patients are carriers of a heterozygous mutation of the activin receptor-like kinase 1 (ACVRL1), Endoglin (ENG) or Mothers against decapentaplegic homolog 4 (SMAD4) gene. HHT involves the Bone Morphogenetic Protein 9 (BMP9)/Activin receptor-Like Kinase 1 (ALK1)-endoglin signalling pathway. BMP9 is a growth factor that binds to ALK1 receptor and to endoglin its co-receptors and physiologically activates Smad signaling pathway. Endothelial cells in HHT patients display half expression of functional ALK1 receptors or endoglin co-receptors or of the transcription factor SMAD4, which should lead to effects on the functions of these cells.

The identification of differences in gene expression between endothelial cells from HHT patients and healthy donors will allow the identification of new functions or new target pathways for therapy. Circulating endothelial cells are rare in the bloodstream in adults, but are present in greater quantities in cord blood.


Eligibility Criteria:
Inclusion Criteria:

* Newborn whose parents :

  * are adults
  * are affiliated to a social security or similar
  * are not subject to any legal protection measures
* Newborn child with one parent who has monitored for HHT confirmed by molecular biology (carrier of a mutation of the SMAD4, ENG or ACVRL1 gene).
* Consent signed by the two representatives of parental authority

Exclusion Criteria:

* One of the two parents opposes donating the umbilical cord blood and the umbilical cord for research
* One of the two parents opposes genetic testing
* Patient for whom it was not possible to obtain umbilical cord blood after delivery for technical or medical reasons.
Interval-training and Appetite Regulation in Patients With Type 2 Diabetes

Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.

This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.

Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. One hour of rest (CON)
2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.

After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* BMI \> 25

Exclusion Criteria:

* Pregnancy
* Smoking
* Contraindication to increased levels of physical activity
* Eating disorder
* Insulin dependence
A Clinical Trial of STP0404 in Adults with HIV-1 Infection

The purpose of this study is to evaluate the antiviral effect, safety, tolerability, and pharmacokinetics of STP0404 in adult participants living with Human Immunodeficiency Virus Type 1 (HIV-1) infection.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed HIV-1 infection in the documented medical record or at screening.
* Have never received any ARTs (i.e., treatment-naïve) before screening or only received one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. Participants with a documented history of PrEP and/or PEP therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion.
* Have a CD4+ cell count ≥200 cells/mm3 at screening.

Exclusion Criteria:

* Have a hepatitis B surface antigen or positive hepatitis C virus antibody at screening. An HCV confirmation (HCV RNA test) will be performed at a central laboratory if the HCV antibodies screening result is positive. If the HCV RNA test result is negative, the participant will be eligible.
* Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine. However, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decision shall rely on the investigator's medical judgment and should be documented.
* Have a history of regular alcohol consumption, defined as an average weekly intake of \>14 drinks (males) or \>7 drinks (females), within 6 months of screening and/or has positive alcohol screen at screening and baseline.
* Have received the following treatments as PrEP or PEP (≥1 dose) prior to screening: monoclonal antibodies, HIV-1 maturation inhibitors, and long-acting INSTIs (such as cabotegravir).
* Pregnant or lactating females.
* Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months.
* Participant received any allosteric HIV-1 integrase inhibitor (ALLINI, ≥1 dose) and/or received any long-acting ARVs (marketed or investigational, ≥1 dose) prior to screening.
* Have previously failed an INSTIs-containing regimen.
Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine

The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided.

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
TruGraf Utilization in High IPV Levels

Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft survival. The prevalence of patients with high IPV is higher in African American patients (1-5). At the kidney transplant program of the University of Maryland, our investigators follow over 2.800 patients, with approximately 50% of the patients being of African American heritage, thus an ideal setting for the study.

Study Population: Kidney transplant recipients with stable renal function with regular follow-up at the University of Maryland post-transplant clinic with at least 3 levels deemed as appropriately 12-hour trough levels within 3-36 months post-transplant.

Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (\< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.

Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).

Patients will be tested with TruGraf one time during the study.

Eligibility Criteria:
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:

1. Are males or females of at least 18 years of age.
2. Have the ability to understand the requirements of the study and are able to provide written informed consent.
3. Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
4. Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels)
5. Kidney transplant patients who \>90 days (+/- 2 weeks) post-transplant will be included in this study
6. Patients with at least 3 tacrolimus trough levels( deemed as appropriately 12-hour trough levels) within 3-36 months post-transplant

Exclusion Criteria: Patients who meet any of these criteria are not eligible for enrollment:

1. Inability or unwillingness to provide informed consent.
2. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
3. Recipients of previous non-renal solid organ and/or islet cell transplantation.
4. Infection with HIV.
5. Infection with BK nephropathy.
6. Patients that have nephrotic range proteinuria (urine protein \>3 gm/day).
Modulated Accelerated RAdiotherapy in Early Breast Cancer

This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.

Eligibility Criteria:
Inclusion Criteria:

* confirmed histologic evidence of pTis-pT3 breast cancer
* breast conservative surgery
* post menopausal status
* clear surgical margin

Exclusion Criteria:

* pT4
* positive or close resection margins
* 3 or more metastatic axillary nodes
* nodal irradiation
* M1
Temperature Management on Postoperative Delirium

Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Classified as American Society of Anesthesiologists I-III
* Hip surgery patients who agreed to the study

Exclusion Criteria:

* Non-consent to participate
* Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
* Coma, dementia, or language impairment affecting communication and assessment
* History of neurosurgery
* Use of antipsychotic medication preoperatively
* Body temperature exceeding 38°C within 24 hours before surgery.
Evaluation of Patients' Knowledge of Their Vaccination Status and Their Relationship to Vaccination at Melun Hospital

The goal of this observational study is to learn about the rate of knowledge of own vaccination status among patients hospitalized at Melun hospital. The main questions it aims to answer are:

* the rate of knowledge of its vaccination status among patients hospitalized at Melun hospital
* hospitalized patients' attitude to vaccination in general. Evaluate the number of patients wishing to update their vaccination status. Observe the influence of various factors (gender, occupation, presence or absence of GP, chronic illness) on vaccination status in Melun, France Participants will be asked to complete a questionnaire during hospitalization.

As part of the national "European Vaccination Week" event organized by the French Ministry of Health and Prevention, we are asking a sample of patients hospitalized in our hospital to complete a questionnaire on their knowledge of their vaccination status, and to assess their relationship with vaccination.

Questionnaire administered to patient during hospitalization (n=140 patients). Patients randomly selected by the Department of Medical Information of the hospital at the beginning of the survey week.

Patients randomly selected from each of the 10 departments of the CH of Melun (internal medicine, infectious diseases, gastroenterology, pneumology, surgery, BCR medicine, cardiology, nephrology, follow-up care and rehabilitation and geriatrics) and accompanied to complete a questionnaire set up by the Public Health Unit (USP) and Hygiene Operational Team (EOH) of the CH of Melun.

Eligibility Criteria:
Inclusion Criteria :

* French-speaking and non-demented patient : able to speak and understand French and without dementia
* Adult patient (Age ≥ 18 years)
* Main place of residence in France
* Hospitalized in a department of the CH of Melun

Exclusion Criteria :

* Does not speak French or dementia
* Patient's refusal to participate in the study