cyrilzakka/clinical-trials huggingface dataset:
Moexipril for Primary Biliary Cirrhosis

The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo risk score, and health-related quality of life in patients with primary biliary cirrhosis (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).

Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease of presumed autoimmune cause characterized by progressive inflammatory destruction of interlobular and septal bile ducts, resulting in fibrosis and eventual cirrhosis (1). In PBC patients, the most disabling symptoms are fatigue and pruritus which diminish health-related quality of life (HRQL. Ursodeoxycholic acid (UDCA), at a dose of 13 to 15 mg/kg per day, is a safe and effective medical therapy for most patients with PBC. Nevertheless, UDCA therapy has not ameliorated symptoms associated with PBC. Some UDCA-treated patients show progressive disease resulting in the liver transplantation or death from liver-related causes. For these patients, who show a persistent elevation of serum alkaline phosphatase at least twice the normal level after 6 months of UDCA monotherapy (incomplete responders), the evaluation of combination therapy in clinical trials has been recommended.

Moexipril is a long-acting, nonsulfhydryl ACE inhibitor with lipophilicity, and so can readily penetrate lipid membranes and thus target tissue ACE in addition to plasma ACE. This drug also demonstrated antioxidative properties in addition to efficiently controlling blood pressure in hypertensive postmenopausal subjects. Moreover, quality-of-life data suggest favorable effects of moexipril treatment in a patient population at high cardiovascular risk. The tolerability and safety profile of moexipril resembles that of other ACE inhibitors along with no reports of hepatotoxicity in controlled trials. Hence, moexipril is an attractive drug for evaluation in patients with chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* PBC patients treated with UDCA (daily dose of 13 to 15 mg/kg for at least 6 months) and an incomplete response defined by persistent elevation of serum alkaline phosphatase activity at least 2 times the upper limit of normal

Exclusion Criteria:

* age less than 18 years
* pregnancy or nursing
* anticipated need for liver transplantation within 1 year with less than a 80% one-year survival determined by the Mayo risk score
* complications of cirrhosis such as recurrent variceal hemorrhage, portosystemic encephalopathy, and refractory ascites
* history of coexistent severe cardiovascular disease including aortic stenosis
* history of coexistent severe renal disease (defined as elevation of serum creatinine more than 1.5 mg/dL) including renal artery stenosis
* history of allergy to ACE inhibitors
* current use of an ACE inhibitors or AT1 receptor antagonists in the past 3 months
* previous treatment with immunosuppressive agents or any experimental drug in the preceding 3 months.
Music Intervention in Exercise and Sport on Problematic Smartphone Use, Psychopathological Symptoms Among College Students

This study is to examine the effect of music intervention in exercise and sport on problematic smartphone use, psychopathological symptoms, self-esteem, and impulsivity traits in smartphone users among Chinese college students. The aim is to compare the effects of the combination of exercise and sport with fast-tempo music, slow-tempo music, and no music.


Eligibility Criteria:
Inclusion Criteria:

* University students aged between 18 and 25 years old (male or female)
* No cognitive impairment and able to complete the questionnaire clearly

Exclusion Criteria:

* Students with recent injuries such as broken bones, congenital diseases such as heart disease, or other status conditions that prevent them from playing moderate-to-high-intensity sports
* Excluded students with mental diseases, physical disabilities, or those who were unable or unwilling to participate in the trial
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer

This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
* ECOG 0 or 1
* Measurable disease

Exclusion Criteria:

* Prior first line therapy for advanced disease
* Significant bulk of metastatic disease or rapid progression
* If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen

Other protocol-defined inclusion/exclusion criteria may apply
The Research of Standard Diagnosis and Treatment for Severe HSP in Children

This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.

Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.

In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.

The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.

Eligibility Criteria:
Inclusion Criteria:

* Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days

Exclusion Criteria:

* The children with congenital diseases
Administration of Oxygen to Cluster Headache Patients

This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.


Eligibility Criteria:
Inclusion Criteria:

* episodic cluster headache
* regular occurance of attacks and cluster for 2 years
* 2-8 attacks / day
* cluster periods of over 14 days
* duration of current cluster period max 14 days
* ability to differentiate between attacks of CH and other forms of headache

Exclusion Criteria:

* Changes in prophylactic treatment a week before trial
* pregnancy or breastfeeding women
* serious somatic or psychiatric disease
* COLD
* chronic or primary or secondary headache \> 14 days / month other than CH
* alcohol abuse
Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.

Patients with localized gastric cancer often relapse either locally or systemically. A strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved the feasibility of administering FOLFIRI regimen as adjuvant chemotherapy combined with adjuvant chemoradiation in patients with excised with curative intend gastric cancer. It would be important to improve the treatment involving active regimen as adjuvant chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0
* No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason
* Patients must have a life expectancy of at least 16 weeks and a performance status of \< 2 ECOG scale
* Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
* Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \> 2.000/µL, and platelet count of \> 100.000/µL), adequate liver function (bilirubin \< 1,5 mg/dl), and adequate renal function (creatinine \< 1,5 mg/dl
* Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

* Patients with T1N0 carcinoma
* Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively)
* Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes
* Evidence of metastatic disease to distant organs
* Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection
* Patients with diabetic neuropathy
* Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
* Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin)
* Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment
Addition of Azathioprine in IBD Patients With Immunogenic Failure

Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

The aim of the study in these patients with an immune mediated pharmacokinetic failure was to compare two strategies:

Switch to a second anti-TNF alone or switch to a second anti-TNF with addition of azathioprine

Comparing rates of clinical failure, rates of immunogenic failure and finally adverse events during a follow-up of 24 months

Eligibility Criteria:
Inclusion Criteria:

* IBD Patients in clinical failure under anti-TNF (Infliximab (IFX) or Adalimumab (ADA) in monotherapy at the optimal dose) ADA: 40mg/7 days, IFX: 10mg/kg/8 weeks Active disease CD: HBI \> 5 with Calprotectin \> 250 µg/g stool UC: Total Mayo Score \> 4 with an endoscopic subscore \> 1 Anti-TNF monotherapy for at least 4 months and optimization for at least two months
* Patients with an immune mediated PK failure Undetectable rates of anti-TNF and high Ab against anti-TNFs \> 20ng/mL for ATI and AAA (Elisa Theradiag) on two consecutive samples
* Patients who have agreed to and signed the consent form

Exclusion Criteria:

* Unclassified colitis
* Pregnant woman
* Crohn's disease CD with a exclusive anoperineal phenotype
* Contraindication or intolerance to azathioprine
* Primary non-responder patients To the first anti-TNF or After the switch to a - second anti-TNF
* Ostomy
A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e).

Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Normal history and physical exam.
* Negative ELISA for HIV.
* Negative HIV p24 antigen test.
* Normal urinalysis.

Prior Medication: Required:

* Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
* History of immunodeficiency or chronic illness.
* Hypersensitivity to insects.
* Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.

Patients with the following prior conditions are excluded:

* History of immunodeficiency or chronic illness.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood or blood product transfusion within the past 6 months.

Risk Behavior: Excluded:

* Intravenous drug use.
* More than 2 sexual partners.
Postural Stability, Pelvic Floor Dysfunction, Respiratory Muscle Strength in Post-partum Women With Diastasis Recti

The aim of this study is to determine the effect of inter-rectus distance on postural stability, pelvic floor dysfunction and respiratory muscle strength in women with diastasis recti abdominis.

Diastasis of recti abdominis muscles (DRAM) is defined as a separation of the two rectus abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. It is very common during pregnancy and may continue for eight weeks in postnatal period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRAM. The abdominal wall is one of the key point for body posture, trunk and pelvic stability. However, in our best knowledge, there is no study in the literature that evaluates women with and without DRA in terms of components related to postural control systems.

Eligibility Criteria:
Inclusion Criteria:

* Post- partum women (min 8 weeks - max 5 years)

Exclusion Criteria:

* Having a neurological, orthopedical or any other condition which affect postural stability.
What Technique for Caudal Block in Children: Conventional or Ultrasound-guided

The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.

The primary endpoint was the success rate of each technique. We also collected the time taken for each technique, the number of punctures, and the incidence of complications (subcutaneous infiltration, intravascular injection).

Children were randomized to receive a caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E) at a dose of 1 ml/kg of 0.25% bupivacaine, not exceeding 20 ml.

Eligibility Criteria:
Inclusion Criteria:

* children aged between 6 months and 6 years, ASA 1 , underwent elective surgery

Exclusion Criteria:

* severe systemic diseases, previous neurological or spinal disorders, coagulation abnormalities, allergies toward LAs, local infection at the block site
Endothelial Glycocalyx Damage in Brain Death Organ Donors

The study aims the assessment of endothelial glycocalyx (EG) degradation in deceased organ donors. There is a lack of organs for the transplantation program. By the description of the EG status, we can open room for organ optimization before transplantation and improve the organ function after transplantation in marginal donors.


Eligibility Criteria:
Inclusion Criteria:

* patients in critical condition declared as brain dead by clinical examination

Exclusion Criteria:

* N/A
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation

The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.

Prospective, cross-over trial enrolling neonates \<28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).

Eligibility Criteria:
Inclusion Criteria:

* premature infants born \<28 weeks of gestation
* respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
* stable condition with pH (acidity of blood)\> 7.2 and pCO2 (carbon dioxide partial pressure) \<60 mmHg in the blood gas analysis
* no identified genetic syndromes and serious congenital malformations

Exclusion Criteria:

* lack of written consent of patients' parents
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban

The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2\*5 mg tablets and 1\*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.

Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.

The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* 18 to 45 years of age
* Body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

* Conspicuous findings (medical history, screening)
* History of relevant diseases (internal organs, central nervous system or other organs)
* Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
* Febrile illness within 1 week before the start of the study
* History of severe allergies, non-allergic drug reactions, or multiple drug allergies
* Hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
* Known coagulation disorders, known disorders with increased bleeding risk, known sensitivity to common causes of bleeding
The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy

This study will be conducted to investigate the effects of video training given to caregivers of patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients and caregivers to gastrostomy. A single-group quasi-experimental study was planned to determine the effect of training on the compliance of patients and caregivers to gastrostomy and the caregiver's gastrostomy care skills. The universe of the study will consist of caregivers who met the inclusion criteria for the study in which gastrostomy procedure was performed for the first time at Beykoz State Hospital between the dates of September 1, 2024 and March 31, 2026. G\*Power power analysis was performed to determine the sample size. According to Cohen's effect size coefficients; according to the calculation made assuming that it will have a large effect size (d=0.8), it was decided that there should be at least 20 people with α=0.05 level, 95% power; considering the losses, it was decided to include 25 people in the study. Statistical Package for the Social Sciences 26 program will be used for statistical analyses of the data obtained from the study. While evaluating the study data, descriptive statistical methods (mean, standard deviation, median, frequency and ratio) as well as Shapiro Wilks test and Box Plot graphics will be used in the evaluation of the distribution of the data. Student t test, Oneway Anova test will be used in the evaluation of variables showing normal distribution and Bonferroni test will be used in the determination of the group causing the difference. Paired Samples t test will be used in the evaluations within the groups. Mann Whitney U test, Kruskal Wallis test will be used in the evaluations of variables not showing normal distribution and Dunn test will be used in the determination of the group causing the difference. Wilcoxon Signed Rank test will be used in the evaluations within the groups. Pearson or Spearman's correlation analysis, linear regression modeling will be done in the evaluation of variables. Chi-Square test and Fisher's Exact test will be used in the comparison of qualitative data. The results will be evaluated at a confidence interval of 95% and significance at p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

Having undergone percutaneous endoscopic gastrostomy for the first time. Not having cancer. -

Exclusion Criteria:

Being over 18 years old, Being able to communicate in Turkish, Being able to read and write, The caregiver will be involved in the percutaneous endoscopic gastrostomy care of their patient.

Not being a healthcare professional.

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