cyrilzakka/clinical-trials huggingface dataset:
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.

Diabetic foot ulcers (DFUs) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the United States and posing a substantial burden on patients and society. Despite treatment, up to 23% of DFUs remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs, especially in cases of neuropathy. While standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. To tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (OT), aiming at fostering consistent self-care habits and routines.The objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 21 years
* Healed diabetic foot ulcer within the past twelve months
* Able to walk independently (use of a cane is acceptable)

Exclusion Criteria:

* Current active diabetic foot ulcer
* History of amputation beside toe or part of the foot
* Non-ambulatory at baseline
* Self-reported deafness/blindness.
Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting

Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the inclusion criteria:

* Documented heart team (as per guidelines) decision for revascularization via PCI
* Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches \>2.5mm and with a stenosis \>50% and clinical indication to percutaneous intervention, including:

  * Ischemic symptoms, OR
  * Positive non-invasive imaging for ischemia, OR
  * Positive Flow Fractional Reserve (FFR), OR
  * mean lumen area (MLA) \<6mm\^2 for the left main or \<4mm\^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT)
* Vessel diameter ≤5.00mm
* True bifurcation lesion type 1,1,1 or 0,1,1
* Patient ≥18 years old

Exclusion Criteria:

* Cardiogenic shock
* Trifurcation if all vessels are ≥2.75mm diameter
* Either bifurcation vessel not suitable for stenting
* History of stenting in target bifurcation lesion
* Participation in another investigational drug or device study
* Patient unable to give informed consent
* Women of child-bearing potential or lactating
* In-stent restenosis
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.

This implementation research study used a quasi-experimental, mixed method design with two arms. Two districts in Arsi Zone in Ethiopia's Oromia Region (Hitosa and Lode Hitosa) were selected for the study. In each district, one primary health care unit (PHCU) - a public health center and its satellite health posts - was randomly assigned to the intervention arm and one to the comparison arm.

PPFP counseling, services, and documentation were strengthened through training and supervision at health centers in both intervention and comparison PHCUs, consistent with Government of Ethiopia policies and guidelines. Only the intervention arm received the community-based intervention. The community-based intervention involved training Health Extension Workers (HEWs) who staff health posts, make outreach home visits, and support volunteers under the government's Development Army. HEWs were trained on PPFP with a refresher on implant insertion. The community invention also involved giving tools to HEWs and volunteers to help them track women's PPFP preferences and pregnancy risk.

The study objectives are to:

1. Assess the effect of systematically integrating PPFP messages into contacts with the health system on uptake of PPFP through 12 months postpartum using a 'dose-response' analysis based on the number of contacts
2. Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites
3. Explore the acceptability and feasibility of tracking PPFP and reviewing data at health centers and HEWs and volunteers using record keeping and review processes to track women's decision-making and contraceptive use from pregnancy through 12 months postpartum
4. Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

1. Women

   * Pregnant at time of enrollment
   * Willing to give informed consent
2. Provider interviews

   * Providers providing PPFP messages or services in study area
   * Willing to give informed consent

Exclusion Criteria:

1. Women

   * Not pregnant at time of enrollment
   * Living outside study area
2. Provider interviews

   * Not working in antenatal, labor \& delivery, postnatal, or immunization care
Asthma in the Elderly: A Study of Choline Supplementation

Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.


Eligibility Criteria:
Inclusion Criteria:

* Asthma

Exclusion Criteria:

* No history of smoking more than 10 pack/years,
* no gastrointestinal cancers,
* no liver or kidney disease,
* no bipolar disorder.
Pleural Carcinomatosis Tissue Banking

Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Malignant pleural effusion with or without prior histological or cytological diagnosis
* Patient eligible for a pleural biopsy for diagnostic purposes and validated in a multidisciplinary consultation meeting
* Having given their free and informed writing consent
* Affiliated to a social security system or assimilated

Exclusion Criteria:

* Malignant pleural mesothelioma
* Contraindication to general anesthesia
* Pregnant or breastfeeding woman, or is of child bearing potential and who did not agree to use highly effective methods of birth control throughout the study.
* Patient participating in a interventional study likely to interfere with this study
* Patient benefiting from a legal protection measure (guardianship or curatorship)
Nesiritide - Dilated Cardiomyopathy

Nesiritide is a rapid vasodilator that mimics the action of an endogenous hormone - human B-type natriuretic peptide (BNP). BNP is produced naturally in the ventricles of the heart in response to stretch.

Nesiritide decreases systemic vascular resistance (SVR), pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), and mean pulmonary arterial pressure. Nesiritide does not affect the heart rate, but does increase the stroke volume and consequently cardiac output, resulting in a decrease in the symptoms of decompensated heart failure. It is generally well tolerated, with the major negative side effect being hypotension. When compared to standard therapy consisting of dobutamine and nitroglycerin, nesiritide had similar vasodilatory effects, but showed a lower incidence of arrhythmia.

Nesiritide has been approved for IV treatment of patients with acutely decompensated congestive heart failure. Although studies have tested the effectiveness and safety of nesiritide in adult CHF patients, this has not been done in children.

Subjects enrolled in this study will be pediatric (\<21 years) patients carrying a diagnosis of dilated cardiomyopathy with decompensated congestive heart failure. The standard of care for these patients is to undergo cardiac catheterization with placement of a Swan-Ganz catheter for hemodynamic monitoring. Subjects will be randomly assigned to receive either Nesiritide or placebo (5% Dextrose). The infusion will then be continued for a total of twenty-four hours. During this one day period, measurements of systemic blood pressure, central venous pressure (right atrial pressure), pulmonary capillary wedge pressure, cardiac output, mixed venous saturation, pulmonary vascular resistance, and systemic vascular resistance will be measured at regularly scheduled intervals. The Swan-Ganz catheter will remain in place for 2 hours after the discontinuation of study drug, and then removed.

The objectives of this study are:

1. To assess the efficacy of Nesiritide therapy in decreasing the pulmonary capillary wedge pressure, right atrial pressure, and systemic vascular resistance in children with dilated cardiomyopathy.
2. To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing cardiac index in the above mentioned population.
3. To assess the safety of both bolus administration and continuous infusion of Nesiritide in children with dilated cardiomyopathy.
4. To assess the pharmacokinetics of Nesiritide in this population.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of dilated cardiomyopathy
2. Less than 21 years of age
3. Patient admitted to the intensive care unit
4. Patient requiring placement of a Swan-Ganz catheter
5. Patient's hemodynamics or clinical condition requires the use of a Swan-Ganz catheter for 26 hours following the cardiac catheterization.
6. Patient has signed an IRB approved consent form.

Exclusion Criteria:

1. Severe hemodynamic instability including patients requiring ECMO
2. Cardiac catheterization not indicated
Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics

this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients

Sixty patients randomised into two groups, 30 patients in experimental group (oblique orientation) and 30 patients in control group (transverse orientation). All cannulation took place in the operation room. Patients underwent general anesthesia and placed in supine position. Standard monitoring (electrocardiogram, non-invasive arterial pressure, pulseoxymetry) was carried out during the procedure for all patients. Before preparation of the skin, a pre-procedure ultrasound examination was performed to verify internal jugular vein patency, and its diameter was measured. Once the side had been chosen, the cannulation was performed following a sterile technique. All procedure were performed by Seldinger technique, with 22 Gauge IV catheter attached with 3 ml syringe as introducer needle. The vascular puncture was performed under ultrasound guidance, using a single-person technique. With transverse orientation, the transducer was placed transversally over the neck, and once the vein was visible in the middle of the ultrasound image, the needle was inserted in the plane perpendicular to the long axis of the transducer. With oblique orientation, the operator first obtained a transverse view of the vein and then rotated the transducer to 45 degrees (midway) between transverse and longitudinal view.

Eligibility Criteria:
Inclusion Criteria:

* patients age 3 months to 12 years old, weight 5-20 kg, male or female
* who undergo heart surgery and indicated to have central venous cannulation
* American Society of Anesthesiologist Physical Class 1-3
* Family or representation of the patients agreed to participate in this study and sign informed consent

Exclusion Criteria:

* history of surgery in the area of cannulation
* already placed central venous cannulation \<72 hours in the same venous
* sign of infection, hematoma, emphysema, in the area of cannulation
* history of cervical trauma
* severe hemostatic disorder (International Normalized Ratio\>2, thrombocyte \<50.000, Prothrombin time\>1.5 times, Activated Partial Thromboplastin Time \> 1.5 times
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions

A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions

APR003 is a small molecule TLR7 agonist that concentrates in the GI, and liver with limited systemic exposure. It is designed to increase the therapeutic window of a TLR7 agonist by minimizing the side-effects associated with generalized systemic immune activation and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 or 1
* Must have disease that is considered non-surgically resectable.
* Relapsed or persistent/refractory to at least two prior systemic treatment regimens for locally advanced or metastatic disease considered to be standard-of-care (SOC).
* Must have previously received an irinotecan or oxaliplatin-based therapy, as well as a targeted antibody therapy for metastatic disease
* Tumors that are MSI-H/dMMR must have previously received checkpoint inhibitor therapy
* Adequate hepatic function
* Adequate renal function
* Normal coagulation panel
* Willingness to use effective contraception

Exclusion Criteria:

* Current or history of CNS metastases
* Significant cardiovascular disease
* Pregnant or breastfeeding
SDF Application in Oral Cancer Patients to Prevent Dental Caries

The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.

Head and neck cancer has increased in Texas over the last two decades. Radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. Silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. The objective of the research is to conduct a single site pilot RCT (NIH Stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 PPM fluoride gel for prevention of radiation-induced dental caries over 6 months. Eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. The proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. The primary outcome is dental caries surfaces at 6 months post-radiotherapy (DMFS).Secondary outcomes are The Gingival Index, Gingival Bleeding Index, MDASI-HN, and Oral Health Quality of Life score will be secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Head and Neck cancer

Exclusion Criteria:

* Prognosis less than 1 year
* Radiation field of treatment does not involve jaws
Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift

Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction.

Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently.

A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions.

The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level.

Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.


Eligibility Criteria:
Inclusion Criteria:

* • Patient aged 18 to 80 years old

  * Patient with OSA (AHI ≥ 15 events/hr)
  * Patient not receiving any treatment for their OSA
  * Patient able to provide written informed consent
  * Patient able to participate in regular physical activity (no medical contraindication to exercise)

Exclusion Criteria:

* • Pregnancy

  * Person deprived of liberty or subject to a legal protection measure
  * Patient presenting a condition that can influence the results. (According to the investigator's judgment, i.e. heart failure, venous insufficiency).
  * Vulnerable person or legally protected adult.
  * Patients already included in another interventional study
  * BMI \> 30 kg/m²
  * Patient taking diuretics
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors

Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.

IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In the Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg), in combination with Sintilimab 200mg, will be tested. After completion of the dose escalation phase, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg, in combination with Sintilimab 200mg) will be expanded to 10 patients each.

IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody.

Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal antibody.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment
* 18 to 75 years old
* Life expectancy ≥ 12 weeks
* At least 1 measurable lesion
* ECOG PS score 0 or 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
* Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
* Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
* Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
* Major surgery in the 4 weeks prior to 1st dose of investigational drug
* 30Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug
* History of autoimmune disease
* Symptomatic CNS metastasis