cyrilzakka/clinical-trials huggingface dataset:
Metformin in Psoriatic Arthritis

Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines. Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.

The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines.Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.

A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.

The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin resistance (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive 500mg/day retarded formulation of metformin (n=29) or placebo (n=29). Continuation of stable doses of MTX (25mg/week), NSAIDs, and/or corticosteroids (prednisone \<10 mg/day) was permitted. Metformin drug pause on the day of MTX was given. Folic acid supplementation was given to both groups. The primary clinical endpoint was the ACR 20% (ACR20) response at 24 weeks. Secondary endpoints included reduction in PASI score, Health Assessment Questionnaire- Disability Index (HAQ-DI) and Psoriatic arthritis response criteria (PsARC) score.

Eligibility Criteria:
Inclusion Criteria:

* Psoriatic arthritis patients

Exclusion Criteria:

* other inflammatory conditions
Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study

Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO) randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to early (before dismissal) graft angiography vs. no early graft angiography. Coronary angiography will be performed at 12 months, to determine whether compared to no early graft angiography, early graft angiography will result in:

1. lower per patient angiographic bypass graft failure (in at least one graft) rates (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy endpoint)
2. lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints)
3. lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (secondary endpoint)

Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at least one bypass graft at baseline (in the early graft angiography group only) and at 12-month angiographic follow-up to evaluate the structural bypass graft changes occurring after coronary artery bypass graft surgery (secondary endpoint).


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
3. Undergoing clinically-indicated coronary artery bypass graft surgery

Exclusion Criteria:

1. Positive pregnancy test or breast-feeding
2. Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
3. Serum creatinine \> 2.5 mg/dL or acute renal failure
4. Severe peripheral arterial disease limiting vascular access
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal varices, which are life-threatening complications of liver cirrhosis.

Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a life-threatening complication with mortality between 20-50%.

Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and treating the oesophageal varices.

In this study, investigators will evaluate the safety and efficacy of terlipressin - Glypressin 1 mg, powder and solvent for solution for injection.

The non-interventional observational study "Follow-up of Glypressin (terlipressin) clinical efficacy in the treatment of bleeding oesophageal varices" aims to demonstrate that administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients that present an important upper gastrointestinal bleeding, being suspected or diagnosed of liver cirrhosis, with bleeding oesophageal varices visualized endoscopically.

(An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of transfused blood).

Exclusion Criteria:

* Septic shock
* Patients with recent history of coronary insufficiency
* Uncontrolled arterial hypertension
* Chronic respiratory failure
* Symptomatic arteritis
* Chronic renal failure
* Pregnant women
* Hypersensitivity to terlipressin
* Patients with body weight below 55 kg
Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall

The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ED presentation. Primary objective of this study is to assess "fear of falling" 7 days after ED presentation with versus without a physiotherapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥65
* History of falls within the last 7 days
* Presentation to the ED of the University Hospital Basel

Exclusion Criteria:

* Inpatient disposition after ED work-up
* Immobilizing fractures of the lower extremities
* Inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment
* Prior enrolment in this trial
Evaluation of D-Fi for the Treatment of Wounds Due to DEB

The purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic Epidermolysis Bullosa.

CCB-EB-304 is a multi-center, intra-patient randomized and controlled, open-label, rater-blinded Phase 3 study of D-Fi for the treatment of persistent non-healing and recurrent DEB wounds in approximately 32 subjects. Each subject will serve as his/her own control. Each subject's target wounds will be paired then randomized to receive D-Fi (treatment wound) or remain untreated (control wound). One target wound pair will be identified for each subject.

Subjects will receive intradermal injections of D-Fi in each specified treatment wound in three or more treatment sessions. The first treatment session occurs at Day 1, the second at Week 8/Month 2 and the third at Week 16/Month 4. Additional treatment sessions may occur at Week 26/Month 6 and Week 32/Month 8 and Week 40/Month 10 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. Safety and efficacy assessments will occur at scheduled intervals through Week 48/Month 12, when the treatment period is completed, and a long-term safety follow-up period (through 15 years) commences for subjects who have received one or more D-Fi injections.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥2 years of age at the Screening visit
* Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.

Exclusion Criteria:

* Medical instability limiting ability to travel to the investigative site.
* Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
* The presence of COL7 antibodies.
* Evidence of systemic infection.
* Known allergy to any of the constituents of the product.
* Female who is pregnant or breastfeeding.
Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy

This trial studies hepatitis B screening strategies of new cancer patients scheduled to undergo chemotherapy. Patients with cancer and hepatitis B virus infection are at risk of reactivation of infection after chemotherapy. Hepatitis B virus infection reactivation can be prevented by starting antivirals before chemotherapy in patients who are hepatitis B virus infection positive. Hepatitis B screening may help doctors prevent the reactivation of hepatitis B virus infection after chemotherapy.

PRIMARY OBJECTIVES:

I. To derive a selective screening strategy that optimizes the identification of positive hepatitis B virus (HBV) infection cases in comparison to widespread screening of new cancer patients undergoing chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the prevalence of risk factors among patients with unknown HBV infection status as well as among patients known to have HBV infection, determine the incidence of reactivation of hepatitis B virus (HBV) infection, rates of disruptions in cancer therapy, co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV), and mortality rates.

OUTLINE:

Patients with unknown HBV infection status undergo 3 HBV screening tests (hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[anti-HBc\], and hepatitis B surface antibody \[anti-HBs\]) before chemotherapy. Patients with known HBV infection status undergo either HBsAg or anti-HBc screening tests if there is no evidence of HBV testing in the last 3 months. All patients complete HBV risk assessment survey.

After completion of study, patients with HBV infection are followed up every 3 months for at least 12 months after completion of chemotherapy or end of study period.

Eligibility Criteria:
Inclusion Criteria:

* UNKNOWN HBV INFECTION STATUS/ KNOWN HBV INFECTION STATUS: MD Anderson patients with clinically confirmed cancer who present for their first chemotherapy appointment in the Ambulatory Treatment Center (ATC).
* KNOWN HBV INFECTION STATUS: Patients with evidence of HBV infection by either:

  * Patients who have had a positive HBsAg or anti-HBc test performed outside of MD Anderson within the last 3 months, and they have documented results in the electronic medical record at MD Anderson, AND/OR
  * Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other Federal Drug Administration \[FDA\]-approved anti-hepatitis B drug) for the treatment of HBV infection.

Exclusion Criteria:

* UNKNOWN HBV INFECTION STATUS: Patients who have had a positive HBsAg or anti-HBc test performed outside of MD Anderson within the last 3 months, and they have documented results in the electronic medical record at MD Anderson.
* UNKNOWN HBV INFECTION STATUS: Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other FDA-approved anti-hepatitis B drug) for the treatment of HBV infection.
Investigating the Effect of Respiratory Exercise Diary on Pain in Cardiovascular Surgery

The study was carried out to evaluate the effect of respiratory exercise diary use on postoperative pain in patients undergoing elective cardiovascular surgery in a training and research hospital in Istanbul.

The randomised controlled experimental study was conducted between 11 July 2024 and 11 January 2025 in the cardiovascular surgery inpatient wards of a training and research hospital in Istanbul. The study was conducted with a total of 74 patients, 37 in the control group and 37 in the intervention group. Data were collected by the researcher through face-to-face interviews with the patients. 'Patient Identification Form', "Visual Analogue Scale (VAS)", "Respiratory Exercise Diary" were used.

Eligibility Criteria:
Inclusion Criteria:

* No barriers to verbal communication (mental, physiological and psychological)
* Patients undergoing elective cardiovascular surgery,
* Individuals who agreed to participate in the study,
* Patients whose haemodynamics are suitable for respiratory exercise

Exclusion Criteria:

* Being in the intensive care unit after surgical intervention,
* Patients undergoing re-operation after surgical intervention,
* Those who do not accept the study or who want to leave during the study.
Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus

This study is designed to observe human consuming effect of a beauty drink powder and combined use with a cosmetic apparatus. It is a randomized, double-blind, and placebo-control study. The target enrollment of subjects is 160 and 4 arms are included, a placebo control, drink powder alone, cosmetic apparatus alone, and drink powder plus cosmetic apparatus. Effects on skin dullness, skin tone unevenness, skin dryness, skin elasticity, wrinkle and fine line are evaluated. Both objective and subjective methods are used for efficacy evaluation. Data are collected at baseline, week 4, week 8, and week 12 after treatment.

In this study, objective parameters are measured by the instruments as following: VisioScan VC20 is used for skin roughness and wrinkle assessment, chromameter CR-400 is used to assess skin color, skin gloss is assessed by Glossymeter, skin hydration is assessed by Corneometer, TEWL is assessed by Vapometer, and skin elasticity is assessed by Cutometer. VISIA-CR and VISIA-7 are used in skin radiation and wrinkle visualization.

Clinical assessment is performed by expert visual grading on

* Skin evenness
* Skin radiance
* Skin elasticity
* Skin smoothness
* Skin firmness
* Skin moisture
* Skin plumpness

Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy male or female
* Subjects with skin problems such as skin dullness, skin tone unevenness, skin inelasticity, skin dryness, and wrinkle/fine lines.
* Subjects without any other chronic or on treatment diseases
* Subjects are voluntary to participate the trial and signed informed consents.
* Subjects are voluntary to follow all evaluation criteria

Exclusion Criteria:

* Subjects have a plan to be pregnant, or are in pregnancy or lactation period;
* Not participated any clinical trial or evaluation within nearly 1 month;
* Used anti-histamine medication within nearly one week or immunosuppressor within nearly one month
* Used any anti-inflammation drugs at test site within nearly two months
* Subjects who have any skin diseases (psoriasis, eczema, skin cancer etc.)
* Subjects with Type I diabetes
* Subjects who currently are receiving asthma or other chronic respiratory diseases treatment
* Subjects who are receiving anti-cancer chemotherapy in nearly 6 months
* Subjects who have anyother health problem or chronic diseases
* Subjects who have externally used Vit A, a-hydroxy acid, salicylic acid, hydroquinone within nearly 3 months or prescription medicines, oral contraceptive within nearly 6 months
* Expert or professional person evaluate have other iatrogenic reason may impact the evaluation results
Maternal And Fetal Outcomes in Pregnant Women With Liver Disease

Liver disease complications during pregnancy can impact maternal and neonatal health, though not many studies are on view to investigate maternal and fetal outcomes in Pakistani pregnant women. So, this study was aimed to determine the maternal and fetal outcomes among pregnant females with liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant females with liver disease
* With gestational age \> 24 weeks
* Any parity or gravidity status

Exclusion Criteria:

* Pregnant females with renal disease or any kind of malignancy
Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee

ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.

The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.

This prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from Knee osteoarthritis

Parameters used to determine treatment outcomes include: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC Index), Evaluation of Quality of Life and Handicap and Assessment of therapeutic efficacy

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged over 40
* Suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months
* Patient able to understand the trial procedure and give his/her consent to take part, in writing
* Patient geographically stable during the trial
* Patient affiliated to the French social security regime or benefiting from such a French regime.

Exclusion Criteria:

* Inflammatory arthritis
* Progressive infectious condition of the knee being studied
* Previous treatment with viscosupplementation for at least one year
* Injection of corticoids into the knee studied for less than three months
* Known hypersensitivity to hyaluronic acid or substances with similar activity
* Anticoagulant treatment in progress
* Insulin-dependent / type I diabetes
* Pregnant or breast-feeding women
* Patient under guardianship or tutorship or under judicial protection
* Patient currently taking part in another clinical research study.
Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life

Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.


Eligibility Criteria:
Inclusion Criteria:

* Adult Subjects (From 16 to 85 years old)
* The subjects with GERD symptom who received 8 week PPI therapy

Exclusion Criteria:

* Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
* Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks
A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients

This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function
* For Pre-allo Part A (before stem cell transplant): Relapsed or refractory AML (greater than 5% blasts)
* For Pre-allo Part A (before stem cell transplant): Availability of an HLA matched related or unrelated donor
* For Pre-allo Part A (before stem cell transplant): Eligible for an allogeneic hematopoietic stem cell transplant
* For Post-allo Part B: Transplant must have been performed with active AML (greater than 5% blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to 1,000 and platelet greater than or equal to 50,000)
* For Post-allo Part B: Treatment must begin at least 42 days, but no more than 100 days post-transplant.

Exclusion Criteria:

* Inadequate heart function
* Inadequate lung function
* Previous central nervous system leukemia
* Any history of another metastatic malignancy
* Anti-leukemia treatment within14 days of study drug (other than hydroxyurea or 6-mercaptopurine), immunosuppressive therapy (except for GVHD treatment/prophylaxis in Part B), or investigational agents
* For Pre-allo Part A (before stem cell transplant): Partially matched donors (related or unrelated) and umbilical cord blood cells are excluded as the source of hematopoietic stem cells
* For Pre-allo Part A (before stem cell transplant): Prior alloSCT
* For Post-allo Part B: Active GVHD Grade 2 or higher
* For Post-allo Part B:History of veno-occlusive disease requiring defibrotide
* For Post-allo Part B: History of Grade 2 or higher hepatic GVHD
* For Post-allo Part B: Concurrent use of corticosteroids equivalent of prednisone at a dose of greater than 0.5 mg/kg