cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, no gender limitation;
2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
3. Expected survival of ≥ 3 months;
4. The tumor specimens were PD-L1 positive (CPS ≥ 1)；
5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
7. Patients informed about the purpose and course of the study and provided a written consent to participate.

Exclusion Criteria:

1. Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;
2. Patients with positive HER-2；
3. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
4. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
5. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
6. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.
Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

oral administration of Tegio capsules for 12 months for NPC patients with high risk of metastasis (AJCC stage T3-4N2M0 or T1-4N3M0) was tested trying to reduce distant metastasis，safety was also evaluated.

In this study, NPC patients (stage T3-4N2M0 or T1-4N3M0) who finished the curative chemoradiation will be randomized to the observation group and treatment group (60 mg bid, p.o.，d1-28，q6wks; continued until disease progression, unacceptable toxicity, or over 1 year). The primary endpoint is distant failure-free survival (D-FFS), Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), progression-free survival (PFS) and toxic effects,. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 ys
2. Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 -2
3. Tumor staged as 8th American Joint Committee on Cance (AJCC) T3-4N2M0 or T1-4N3M0 with histologically confirmed
4. Within 12weeks after completion of the curative radiotherapy treatment
5. disease was controlled after radiotherapy
6. with adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min)
7. Patients must be informed and written informed consent was finished.

Exclusion Criteria:

1. allergic to Tegio.
2. Illness may interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
3. Prior malignancy except treated basal cell or in situ cervical cancer.
4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
5. severe comorbidities may bring unacceptable risk or affect the compliance of the trial, including but not limited to unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer

Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
2. Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:

   HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
3. Tumor stage: II-III: Primary tumor size: ≥ 2cm
4. ECOG score 0 \~ 1;
5. Centrally confirmed BRCA1 or BRCA2 germline mutation;
6. Eligible level of organ function

Exclusion Criteria:

1. Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer;
2. Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization;
3. Previously received PARPi therapy;
4. History of another primary malignancy;
5. Confirmed history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia;
6. Female patients who are pregnant or lactating;
7. History of allergy to drugs in this study；
Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients

Tat is a key HIV regulatory protein produced very early after infection, prior to virus integration, and necessary for viral gene expression, cell-to-cell virus transmission and disease progression. Previous studies in natural HIV infection, indicated that the presence of a Tat-specific immune response correlates with a lower incidence and reduced risk of progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune response to Tat may exert a protective role and control the progression to AIDS in vivo.

On the basis of the above mentioned consideration, the present study was directed at investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African patients.

This is an observational, cross-sectional study aimed at assessing the frequency, magnitude and quality of the anti-Tat antibody response in both antiretroviral (ARV)-treated and treatment-naïve HIV-infected South African adults, and at exploring the correlation between the presence of anti-Tat antibody response and the immunological status of participants as well as with the presence of co-infections such as HBV, syphilis and HPV (the latter only for female participants).

The study has involved 531 participants and provided important information for the planning, design and conduction of future therapeutic clinical trials with the Tat-based HIV vaccine in South African individuals.

This study is conducted in the frame of the Government-to-Government cooperation program N. AID 8421, funded by the Italian Ministry of Foreign Affairs-Directorate General for Development Cooperation (MAE-DGCS) and jointly implemented by the Italian Istituto Superiore di Sanita' (ISS) and the South African Department of Health in collaboration with the South African AIDS Vaccine Initiative of the Medical Research Council (MRC-SAAVI)

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals Aged 18-45 years Participants enrolled into the ARV-treated group must have been on treatment for not less than 3 months.

Exclusion Criteria:

* Unwillingness to consent to study inclusion
"EASE" Epicardial Access With the EpiAccess System

Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.

Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained.

As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study.

The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or older
2. Pericardial access is clinically indicated
3. Patient is willing and able to provide written informed consent

Exclusion Criteria:

1. Patient with history of cardiac or pericardial surgery in the past 6 months
2. Patient with history of chronic pericarditis
3. Myocardial infarction within 4 weeks prior to procedure
4. Class IV NYHA (New York Heart Association) heart failure symptoms
5. Cerebrovascular accident within previous 6 months
6. Known carotid artery stenosis greater than 80%
7. Presence of thrombus in the left atrium
8. Coagulopathy
9. Severe Hepatic Dysfunction or Enlargement
10. Life expectancy less than 6 months
11. BMI \> 40
12. Patient is enrolled in another clinical trial
13. Patient is pregnant
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia.
* Willingness to participate in the study
* Capacity to provide informed consent.
* No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations

Exclusion Criteria:

* Patients with transfusion dependent blood loss.
* Patients with severe decompensated liver disease.
* Patients with end stage renal disease.
* Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
* Pregnant or lactating women.
* Patients who have not had a CBC and differential blood draw completed within the last six months.
* Current heavy alcohol use.
Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome

The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.

Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems.

Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome.

The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS.

It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with PCOS according to Rotterdam criteria.
* Being in in vitro fertilization treatment.
* Body mass index less than 30 kg/m2.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Contraindication to perform techniques of assisted reproduction or stimulation of ovulation.
* Advanced state of endometriosis (III or IV).
* Classified as poor responder in fertility treatment.
* Premature ovarian failure.
* Severe male factor (cryptozoospermia).
* Few expectations of compliance and/or collaboration.
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
* Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
* Signed informed consent

Exclusion Criteria:

* Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
* Active bleeding (including Grade 3 or 4 IVH)
* Platelet count \< 100,000
* Coagulopathy
* Suspected NEC
* Suspected perforation
* Creatinine \> 1.5
* Hyperbilirubinemia requiring exchange transfusion
* Hypotension requiring pressor support
* Life-threatening congenital malformation
PHAST: Physical Activity in Substitution Therapy

The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. "street heroin", cocaine, cannabis, alcohol, cigarettes) other than prescribed ST or other prescribed medications; substance craving; blood pressure; lung function; resting pulse; social interaction; self-control capacity; objective and subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are current substitution dose and psychiatric diagnoses.

The investigators aim is to carry out a randomized controlled trial comparing exercise training group and a control group of patients receiving substitution therapy (ST). The specific goals of the study are:

1. To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST.
2. To examine whether a 12-week exercise programme affects the mental health, subjective and objective sleep, quality of life, self-control capacity, substance craving, hair cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung function, resting pulse, and social interaction in patients receiving ST.
3. To compare the effects of the EX and control conditions on the above-mentioned outcome variables.
4. To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables.
5. To explore to what extent objective variables (cardiovascular fitness, pulse, blood pressure, lung function, cortisol, objective sleep-EEG-parameters) and subjective-psychological dimensions (subjective sleep, social interaction, symptoms of depression and anxiety, self-control, substance craving) are interrelated.

Eligibility Criteria:
Inclusion Criteria:

Patient at the Ambulanter Dienst Sucht or Janus clinics in Basel Town (BS); currently under substitution therapy

Exclusion Criteria:

Declared unfit to participate by clinic personnel due to physical disability or severe psychological disturbance or cognitive impairment
Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia

The results of combining infiltrative analgesia applied by orthopedists with epidural analgesia applied by anesthesiologists after knee replacement surgery will be compared.

It aims to compare epidural analgesia with the maximum reduction of postoperative pain in patients, as well as in terms of both analgesic and complications.

The study will include patients who have undergone knee replacement surgery for six months. In the study, we will compare the results of painkillers applied to the patient from the waist or knee after the waist numbing anesthesia, which includes some of the routinely applied protocols of your knee replacement surgery. It is a condition that will be monitored after surgery. The study aims to reduce maximum pain with two painkiller methods applied in small amounts or together. No interventional application will be made to the patient who will undergo surgery other than routine application. After the surgery, you will be asked verbally about your pain level and side effects at certain hours after the surgery and the amount of painkillers used and the amount of painkillers will be determined according to the follow-up hours (1st, 2nd, 6th, 12th, 24th and 48th hours after the surgery). In addition to these, complications will also be monitored. The results of patients who can be fully followed up at the end of 6 months will be presented as a scientific study.


Eligibility Criteria:
Inclusion Criteria:

1. Age range 18-75
2. Those who underwent surgery with combined spinal anesthesia
3. Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia

Exclusion Criteria:

1. Those who do not want to participate in the study
2. Those who underwent surgery under general anesthesia
3. Patients outside the specified age range
4. Patients with inadequate follow-up results (patient, drug and device related)
Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer

Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Age of 40 years or greater
* Diagnosis of advanced prostate cancer (ie: prostate-specific antigen \[PSA\] less than 25 ug/L and undergoing continued treatment with leuteinizing hormone-releasing hormone \[LHRH\] therapy)
* Willing and able to consent

Exclusion Criteria:

* Metastatic disease to bone
* Medications affecting bone turnover (bisphosphonate, steroids, anticonvulsant)
* Renal failure (serum creatinine \> 200 umol/L)
* Co-morbidity factors affecting bone density (ie: Paget's, rheumatoid arthritis)
* Factors affecting ability to perform the bone density tests using femoral head measurements (ie: bilateral hip arthroplasty)
* Cancer other than skin, except when, in the investigators' opinion, it is determined to be appropriate and not adversely affect the outcome of the trial
* Gastrointestinal (GI) pathology (eg. malabsorption syndrome)
* Parathyroid disease
Effectiveness of Neuromuscular Electrical Stimulation in Patients With Subacromial Impingement Syndrome

Subacromial Impingement Syndrome (SIS) is one of the musculoskeletal system problems. SIS, which is the most common cause of shoulder pain, constitutes 44-65% of complaints of shoulder pain. Studies have shown that exercise is effective in treating patients with SIS, but the effectiveness and superiority of Neuromuscular Electrical Stimulation (NMES) to each other is uncertain. NMES is widely applied in physiotherapy. In the SIS, the lower trapezius and serratus anterior muscle are affected. Therefore, our aim is to determine the effects of exercises and NMES used in patients with SIS on pain, range of motion (ROM), muscle strength and functional status, neck pain and sleep quality.

The aim of this study investigate exercise training (ET) and ET combined with Neuromuscular Electrical Stimulation (NMES) on pain, range of motion (ROM), functional capacity, neck pain, sleep quality. The study will be included 48 volunteers with Subacromial Impingement Syndrome (SIS). The study's inclusion criteria are as follows: Having a diagnosis of subacute / chronic extrinsic SIS, 18 to 65 years of age and being volunteer. The exclusion criteria are as follows: Fracture or surgical history in the shoulder region, another diagnosis that can affect shoulder function, having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months, neuromuscular disease, pregnancy, cancer, unstabil angina, communication problems, systemic inflammatory joint disease, situations where electrical stimulation and exercise are contraindicated, orthopedic, rheumatologic or congenital disease of the affected upper extremity. The sociodemographic data of the patients will be questioned. ET will be applied daily and NMES will be applied 2 days a week for 8 weeks. In addition, both groups will apply these exercises as a home program 3 times a day, 10 repetitions of each exercise. Pain intensity with Visual Analog Scale (VAS), range of motion (ROM) with goniometer, muscle strength with Hand-held Dynamometer, upper extremity function evaluation with Quick Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, disability of neck level with Neck Disability Index, sleep quality with Pittsburgh Sleep Quality Index will be evaluated before and after treatment. All parameters will be compared between ET and ET+NMES group.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of subacute / chronic extrinsic SIS
* 18 to 65 years of age
* Being volunteer

Exclusion Criteria:

* Fracture or surgical history in the shoulder region
* Another diagnosis that can affect shoulder function
* Having received local corticosteroid injection / treatment in the shoulder joint within the last 3 months
* Neuromuscular disease
* Pregnancy
* Cancer
* Unstabil angina
* Communication problems
* Systemic inflammatory joint disease
* Situations where electrical stimulation and exercise are contraindicated
* Orthopedic, rheumatologic or congenital disease of the affected upper extremity