cyrilzakka/clinical-trials huggingface dataset:
Hepatobiliary Tumors Tissue Samples Acquisition

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. Moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. However, these drugs are expensive and can cause treatment-related adverse events. Therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets.

Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.

OBJECTIVES:

1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);
2. Observe the evolution of tumors and discover specific diagnostic markers as a control group.
3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;
4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets

Eligibility Criteria:
Inclusion Criteria:

1. Be older than 18 years old;
2. ECOG 0-2 points;
3. May have received treatment;
4. Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants;
5. Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;
6. Patients understand and are willing to sign written informed consent documents.

Exclusion Criteria:

1. The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.)
2. Pregnant women;
3. Active or uncontrollable infections (fungi, bacteria, etc.);
4. Estimated survival time \<12 weeks;
5. If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days;
6. In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.
Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

It is questionable whether elective appendectomy can effectively reduce pain in persistent or recurrent lower abdominal quadrant pain due to chronic appendicitis.

A single centre randomised double-blind sham surgery controlled clinical trial studied the effects of elective laparoscopic appendectomy on postoperative pain perception in patients with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months postoperatively. Secondary outcome was the relation between clinical response and the appendix' histopathology. The analysis was performed on an intention-to-treat basis. Pain scores were compared using a Fisher's exact test.

Forty patients were randomised, 18 patients had a laparoscopic appendectomy and 22 patients had a laparoscopic inspection only. The postoperative pain scores were significantly different favouring appendix removal (p \< 0.01). Relative risk calculations indicated a 2.4 fold (95% CI: 1.3 - 4.0) greater chance of improving or becoming pain free after laparoscopic appendectomy. The number needed to treat was 2.2 patients (95% CI: 1.5 - 6.5). There was no significant relation between postoperative pain scores and histopathology findings.

Conclusions Chronic or recurrent appendicitis is a realistic clinical entity that can be treated successfully by elective appendectomy leading to significant pain reduction in properly selected cases. Histopathology of the removed appendix does not contribute to the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion.

Exclusion Criteria:

* Exclusion criteria consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, exclusion was possible when diagnostic laparoscopy revealed abnormalities (see below).
Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.

The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic HIV-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor.

It is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin with pravastatin.

Statins are administered from D0, with a single daily dose in the morning, for 45 consecutive days.

The duration of the study for each patient will be 45 days not including the preselection period (maximum 15 days).

The primary end-point compares the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted Protease Inhibitor.

Secondary end-points compares changes in triglycerides and HDL cholesterol; percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45; clinical safety and laboratory safety parameters of rosuvastatin and pravastatin; distribution profile of the diameter of LDL cholesterol particles.

Cmin of rosuvastatin, pravastatin and protease inhibitors (PI) are controlled at D15 for statins and PI.

Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l)
* Blood triglycerides over 8.8 mmol/L (8 g/l)
* HIV-1 infection
* Viral load above or equal to 10.000 copies/ml
* Stable antiretroviral regimen for past two months

Exclusion Criteria:

* Coronary disease
* Genetic muscular disease
* CPK over 5N
* Hepatic or renal insufficiency
* Alcohol intake more than 40g/d
* Hypothyroidism
* Pregnancy and breast feeding
Turkish Reliability and Validity of FOPQC-SF

The aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with JIA according to the ILAR classification
* 7-18 years old
* Agree to participate in the study

Exclusion Criteria:

* Psychiatric illness that may affect cooperation,
* Those with heart failure and lung pathology at a level that will affect their daily life activities
Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score

The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.

The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .

In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.

In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.

Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.

Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.

Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma without operation or recurrence after operation or metastasis
* diagnosed within three months
* KPS score≥60
* expected survival time was above 3 months
* HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
* normal function with heart 、kidney and liver

Exclusion Criteria:

* not gastric adenocarcinoma
* simultaneous diagnosis with other malignant tumor
* participate in clinical trials of new drugs not listed in China
* combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
Tolerance of Early Exercise in Intensive Care Unit

Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Over 18 years old
* Hospitalized in intensive care unit
* Patients whose clinical condition allows initiating an early exercise program from critical care physician inclusion

Exclusion Criteria:

* Less than 18 years old or disabled adult
* Head or spinal severe trauma
* Severe trauma of the lower limbs or pelvis
* Musculoskeletal and neurological conditions which do not permit to realise the exercise program
* Patient for whom the reason for hospitalization does not justify early physical therapy
Metformin in Assisted Reproduction-MET-AR-study

Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.

PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease.

These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling Rotterdam criteria for PCOS
* Infertility more than 1 year
* First or second cycle of IVF/ICSI treatment
* Age below 38 years at inclusion
* BMI below 28 kg/m3 at inclusion
* Willing to be randomised to 4 months metformin or placebo
* Signed written informed consent

Exclusion Criteria:

* Not suitable for starting dose 112.5 IE
* Basal FSH above 10 IU/L
* Known renal disease or s-creatinine above 110 umol/L
* Known liver disease or s-ALAT above 80 IU/L
* Known alcoholism or drug abuse
* Known diabetes mellitus or fasting plasma glucose above 7 mmol/L
* Corticosteroid treatment (oral)
* Treatment with cimetidine, anticoagulants, erythromycin or other macrolides
* Hyperprolactinemia (PRL above 700 mIU/L)
* Abnormal thyroid function tests
* Known congenital adrenal hyperplasia
* Androgen secreting tumours
* Cushing syndrome
* Metformin treatment within the last one month prior to screening
* Unfit to participate for any other reason
Impact of Mothers Touch Program on Women's Psychological Functioning

The study investigates the effect of the Mothers Touch program on the psychological well-being of new mothers following 5 weeks of child birth. Mothers Touch Program is designed based on traditional Indian post-partum care given by trained carer in the family.

Study was designed as cohort, including a randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women giving birth for first time (primiparous)
* Given informed consent
* Accepts traditional home care

Exclusion Criteria:

* Previous history of mental health condition
* History drug or substance abuse
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer


Eligibility Criteria:
Inclusion criteria:

* Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
* Site of disease that can be safely biopsied

Exclusion criteria:

* Patients received prior anti-HER3 antibody treatment
* Patients with impaired cardiac function
* Brain metastases that have not been adequately treated
* Malignant disease other than that being treated in this study
* Pregnant or nursing (lactating) women
* Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
Cardiac Output Monitoring in Burn Patients

The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.

Appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. Currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. The NICOM has been used in the resuscitation of patients with sepsis. The NICOM will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

Eligibility Criteria:
Inclusion Criteria:

1) Burn greater than 20% TBSA (total body surface area)

Exclusion Criteria:

1) Burn less than 20% TBSA (total body surface area)
Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

For patients undergoing colorectal surgery, post-operative pulmonary complications (PPCs) are common. PPCs are associated with increased morbidity and mortality, as well as prolonged hospital stays and healthcare costs. Pulmonary exercise in the pre-operative setting is thought to improve pulmonary fitness and decrease incidence of PPCs. Use of an oscillating positive expiratory pressure (OPEP) device sees patients improve their respiratory fitness through prescribed usage of a handheld instrument that exercises pulmonary muscles while breathing. Here, the investigators propose a pilot randomized-controlled trial (RCT) to evaluate the feasibility of a large scale study that would examine the effect of preoperative OPEP device exercises in preventing PPCs for patients undergoing elective colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older, and scheduled for an elective colorectal procedure at London Health Science Center (LHSC). Informed consent must be obtained.

Exclusion Criteria:

* Patients unable to perform written consent will be excluded. The investigators will not include colorectal procedures performed for urgent or emergent indications. Patients with advanced pulmonary disease necessitating home oxygen pre-operatively will be excluded. Patients that are pregnant will be excluded.
PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare ROC, BWL, ROC+BWL combined and an active comparator (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.

Eligibility Criteria:
1. All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45.
2. Participants will provide written informed consent for study participation.
3. Participants will possess English language skills at the 5th grade reading level.
4. Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.
5. Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
6. Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months).
7. Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating.
8. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
9. Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
10. Participants cannot have a history of bariatric surgery
11. Participants cannot currently be enrolled in an organized weight control program.
Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally advanced NPC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition）
* No evidence of distant metastasis (M0)
* Male and no pregnant female
* Age between 18-65
* WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3
* With normal liver function test (ALT、AST ≤ 2.5×ULN)
* With normal renal function test (Creatinine ≤ 1.5×ULN)
* Satisfactory performance status: Karnofsky scale (KPS)\> 70
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent

Exclusion Criteria:

* Patients have evidence of relapse or distant metastasis
* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Receiving radiotherapy or chemotherapy
* Pregnancy or lactation