cyrilzakka/clinical-trials huggingface dataset:
Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.

Endoscopic hemostasis and proton pump inhibitor (PPI) constitute the cornerstone in the management of peptic ulcer bleeding (PUB), which remains a prevalent disorder associated with substantial morbidity and mortality. Clinical effectiveness of PPI in the management of patients with PUB has been established by compelling evidence derived from a number of randomized trials. However, whether different PPIs are equally effective has not been investigated. Esomeprazole, the S-isomer of omeprazole, may achieve faster, more profound and steady acid suppression than other PPIs, but it remains undetermined whether the superiority of pharmacologic efficacy may be translated into advantages in clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years
* undergo emergent endoscopy within 24 hours of presentation
* have peptic ulcers in the gastroesophageal junction, stomach, or duodenum
* high-risk stigmata of peptic ulcers: Forrest classification IA\~IIB
* endoscopic hemostasis by thermocoagulation or clip placement

Exclusion Criteria:

* pregnant or lactating
* written informed consent not obtained
* initial endoscopic hemostasis fail
* bleeding tendency (platelet count \< 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants)
* PPI use within 14 days of enrollment
* comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis)
* bleeding gastric cancers
A Comparison Between 5% Albumin and 6% Hydroxyethyl Starch 130/0.4 in Priming Solution for Cardiopulmonary Bypass and Post-bypass Maintenance Fluid in High-risk Patients

It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited, because it is expensive and can rarely cause infection.

Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced impairment in fibrin formation and clot strength in thromboelastometry tracings.

Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the risk of reoperation. Therefore it is important to avoid administration of fluids that can inhibit homeostasis after CPB.

The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA.


Eligibility Criteria:
Inclusion Criteria:

* patients who have uncontrolled medical problems, life-threatening cardiac disease, complex cardiac surgery, or emergency operation

Exclusion Criteria:

* patients who had received warfarin, heparin, acetylsalicylic acid, or antiplatelet drug within 5 days before surgery
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer

This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with histologically or cytologically confirmed breast cancer.
2. Patients with inoperable or recurrent metastatic breast cancer regardless of the metastatic site and number, excluding symptomatic central nervous system metastases.
3. Patients with HER2-negative disease confirmed as ISH negative or IHC 0, 1+ or 2+ (Those with IHC 2+ are eligible, if the additional ISH test results are negative. Those are ineligible who are with any positive results of estrogen receptor or progesterone receptor test on primary and recurrent lesion).
4. Patients who are resistant to hormone therapy.
5. Patients with indication for the first or second line chemotherapy in HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who are scheduled to receive the chemotherapy.
6. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status score 0-3 at the time of enrollment.
7. Patients with adequate bone marrow and major organ function judged by the primary physician.
8. Patients who have signed written informed consent to participate in this study.

Exclusion Criteria:

1. Patients with symptomatic metastasis in the central nervous system.
2. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in the treatment.
3. Patients who are considered to be inappropriate for the study participation by the primary physician.
Glycemic Control with Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination

The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

This study aims to demonstrate that a poly-pill approach combining metformin, linagliptin, and empagliflozin will provide an effective and safe treatment option for managing type 2 diabetes mellitus (T2DM). By focusing on the reduction of HbA1c levels and enhancing patients' quality of life, this simplified approach is expected to streamline medication regimens, reduce pill burden, and improve treatment adherence. Furthermore, the study anticipates that this combination therapy will positively influence weight management and lower the incidence of hypoglycemic events, addressing common challenges in T2DM management. As T2DM prevalence continues to rise, especially in low- and middle-income countries, the poly-pill strategy may offer significant benefits, promoting better compliance, affordable low-in-cost treatment, and facilitating improved long-term health outcomes. Through this research, the study intends to provide strong evidence supporting the poly-pill regimen as a viable and impactful option for global T2DM management.

Eligibility Criteria:
Inclusion criteria

1. Patients of any gender
2. Patients aged between 18-80 years
3. Patients having HbA1c 8 % or above
4. Patients diagnosed with type II diabetes (more than at least 06 months)
5. Patients already on at least 02 or more anti-diabetic agents
6. Patients not allergic to empagliflozin, linagliptin, or metformin

Exclusion criteria

1. Patients with age less than 18
2. Patients with Type-I diabetes
3. Patients having diabetes for less than 06 months
4. Patients on GLP-1 and GIP
5. Patients who are pregnant or lactating females
6. Patients with decompensated chronic liver disease (DCLD)
7. Patients with eGFR less than 30 ml
8. Patients with end-stage heart failure (NYHA Class 4)
9. Patients who are allergic to empagliflozin, linagliptin, or metformin
10. Patients who are not willing to consent
11. Patients who are unable to give medical history
Overnight Feeding Study in Glycogen Storage Disease Type 1

In this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult GSD 1 patients. Three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (UCSS, "Maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. During each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. Between the interventions, the patients follow their normal prescribed diet.


Eligibility Criteria:
Inclusion criteria:

* Glycogen storage disease type 1 (type 1a and 1b)
* Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.

Exclusion criteria:

* Unstable night-time glucose control during the last 8 weeks with frequent (\> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
* Pregnancy or breast feeding
* Drug or alcohol abuse
* Acute gastrointestinal problems (e.g. acute gastroenteritis)
* Known malignancy (e.g. hepatocellular carcinoma)
Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem

The cemented femoral stem have impact on increase on systemic parameters.

Evaluation of the level of histamine, C-reactive protein (CRP) and leukocytes formula, IL1b, TNF alpha, IL6 and the reflection of changes of these parameters in the intra-operative course of hip replacement.

Implantation of total endoprosthesis is a very common surgical procedure and is performed with and without bone cement.

In most cases during cementation of the femoral component there are changes in blood pressure, SpO2, heartbeat and other vital parameters which can cause complications during surgery.

Comparing the system parameters between the two groups and deriving these results will help the medical staff to be more professionally prepared to resolve possible complications.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were as follows:

* All patients willing to participate who underwent cemented and uncemented THA,
* With no limit on age

Exclusion Criteria:

The exclusion criteria were patients with:

* Periprosthetic fractures,
* Pathological fractures
* THA revision
* ASA IV
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors

The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults, aged greater than or equal to (≥) 18 years.
* Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma

  * that is refractory to standard therapy known to provide clinical benefit for their condition OR
  * have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR
  * have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR
  * for which no standard therapy is available
* Measurable disease according to RECIST version 1.1.
* Malignancy not currently amenable to surgical intervention.
* ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
* Other protocol defined exclusion criteria could apply
Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

The main objective of this study is to investigate the association between the presence of HPV infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction.

The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.

The secondary objectives of this study are:

A. To study the alterations of sperm present in infertile men according to the presence of HPV in semen.

B. Identify the specific HPV genotypes involved.

C. To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)

D. To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.

E. To study a potential link between HPV and fetal malformations.

Eligibility Criteria:
Inclusion Criteria:

* Both members of each couple must have given their free and informed consent and signed the consent
* Both members of each couple must be members or beneficiaries of a health insurance plan
* The patient (woman) is available for follow-up after a possible pregnancy
* The patient (woman) is under 43 years of age
* The patient (man) is under 60 years of age
* Couple consulting for infertility services in the participating reproductive medicine centers

Exclusion Criteria:

* One or both members of the couple are involved in another study
* One or both members of the couple are in an exclusion period determined by a previous study
* One or both members of the couple are under judicial protection or under any kind of guardianship
* One or both members of the couple refuse to sign the consent
* It is impossible to correctly inform one or both members of the couple
* The patient (woman) has a contra-indication (or an incompatible combination therapy) for treatment necessary for this study
* The source of sperm is a donor (i.e. it is not possible to obtain a sperm sample from the biological father for use in HPV testing).
Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)

We propose to test an evidence-based wheelchair skills training program to optimize wheelchair safety and performance in veterans with SCI. The proposed training program incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and addresses recommendations in a new clinical practice guideline. Given the difficulty in translating wheelchair skills learned in a therapy clinic with "real world" problems in the home and community post-discharge, we are proposing to conduct the wheelchair skills training in and around the veteran's home. The immediate goal is to enhance ability, performance time, safety, community participation, and quality of life, while minimizing physical strain. The ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote successful aging with a disability.

The purpose of this 3-year randomized controlled clinical trial is to evaluate use of a community-based wheelchair skills training program (WSTP). Objectives include:

1. Determine the immediate and sustained effects of a WSTP on ability, performance time, and physical strain.
2. Examine the effects of mediating and moderating variables on ability, performance time, and physical strain.
3. Examine the effects of a WSTP on safety, community participation, and quality of life.
4. Promote dissemination of WSTP in VA SCI Centers through two key activities: (a) Design innovative marketing plans to increase participation and promote patient-centeredness based on patient-perceived benefits. (b) Estimate health care resources needed to add home-based

Eligibility Criteria:
Inclusion Criteria:

* SCI for at least 1 year (neurologically stable)
* Level of injury: C6 and below who use manual wheelchair as a primary means of mobility
* Able to self-propel wheelchair
* Between the ages of 18-75
* Able to follow simple instructions

Exclusion Criteria:

* Progressive disease (e.g. spinal tumor)
* Extended bedrest for more than 30 days
* Ventilator-dependent
* Any cardiac or respiratory condition that would limit subject's physical performance
* Unstable medical conditions
* Use power wheelchair or scooter as primary means of mobility
* Pregnancy
School-located Influenza Vaccination Clinics for Adolescents

A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).

The overarching goal of the study was to evaluate the effectiveness and cost-effectiveness of offering school-based influenza vaccination clinics during school hours on influenza vaccination rates. A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics including urban/suburban,school grade-span (6-8th, 9-12th), school size, percent of students eligible for free or reduced school lunch, and influenza vaccination rates in the previous season among students in the school. School were randomized within pairs, with one school offering a school-based influenza vaccination clinic or and one school not offering the clinic (control).

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled students of a participating school

Exclusion Criteria:

* Not a currently enrolled student of a participating school
Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study

The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .

Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.


Eligibility Criteria:
Inclusion Criteria:

* Subject over 18 years of age
* Subject presenting to the investigation centre as part of its usual management (prevention, screening, tracking)
* Subject who has been vaccinated and/or wishes to be vaccinated
* Subject able to understand the purpose of research that has given free and informed express consent
* Member or beneficiary of a social security scheme

Exclusion Criteria:

* Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative
Text Messaging Pilot Study

This pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness of text messages designed to encourage shared reading among urban parents. We hypothesize that parents will report reading more often to their children after receiving the text messages.

This is a single arm, pilot study. The participants enrolled will receive two text messages per week for a 4 week period (a total of 8 messages). At the end of the study period we will assess change in number of reading occurrences using a validated measure. Parents will also complete a brief acceptability survey.

Eligibility Criteria:
Inclusion Criteria:

1. Preferred language either English or Spanish,
2. Parent or legal guardian,
3. Age ≥ 18,
4. Willing to accept text messages

Exclusion Criteria:

1. Individuals unable to provide consent
2. Individuals who do not meet inclusion criteria