cyrilzakka/clinical-trials huggingface dataset:
Multicentric Randomised Trial for Resectable Gastric Cancer

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts:

* Preoperative treatment is associated with better patient compliance than postoperative regimens
* Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections
* Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens


Eligibility Criteria:
Inclusion Criteria:

* TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction
* WHO \< 2
* Age ≥ 18 yrs
* Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
* No prior abdominal radiotherapy
* Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l
* Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN
* At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative
* Written informed consent
* Expected adequacy of follow-up
* Caloric intake≥1500 kcal/day, verified by a dietician before registration.
* if caloric intake is \< 1500 kcal/day or if bodyweight has decreased \> 10% over the last 6 months or \> 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory

Exclusion Criteria:

* T1N0 disease (assessed by endoscopic ultrasound)
* Distant metastases
* Inoperable patients; due to technical surgery-related factors or general condition
* Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri; in case of a previous other malignancy with a disease-free period≥5 years, inclusion can be accepted after consultation of the principal investigator
* Solitary functioning kidney that will be within the radiation field
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
* Uncontrolled (bacterial) infections
* Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
* Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
* Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednison
* Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
* Neurotoxicity \> CTC grade 1
* Pregnancy or breast feeding
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
* Gastric or gastro-esophageal stent within radiation field
Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

The investigators plan to conduct this multicentered, sham-controlled randomized clinical trial to evaluate the efficacy and safety of acupuncture for clinical symptomatic improvement of hand OA.

Symptomatic hand osteoarthritis (HOA) is estimated to affect 15.9% of women and 8.2% of men in the general population. Since no therapy can completely cure HOA at present, alternative effective therapies are needed. Acupuncture has been an effective treatment to alleviate pain and improve joint motion for patients with knee osteoarthritis according to a considerable amount of research. It is not surprised that acupuncture is effective in treating HOA in clinical practice considering the similar pathogenesis HOA shared with knee osteoarthritis. However, the research on the effects of acupuncture in patients with HOA is very limited. The present study aims to evaluate the efficacy and safety of acupuncture for HOA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as hand OA according to the American College of Rheumatology (ACR) clinical classification criteria
* History of hand OA for at least 3 months before enrollment and history of taking nonsteroidal anti-inflammatory drugs (NSAIDs) to treat hand OA
* Aged 18-80 years
* At least 40 mm in visual analog scale (VAS) on the average pain intensity of the dominant hand over the last 48 hours (patients applying NSAIDs at the screening have to have an increase in pain in the dominant hand of ≥ 20 mm after 1-week washout)
* Posterior-anterior radiographs of the dominant hand shows Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints
* Negative results in both rheumatoid factor and anticyclonic citrullinated peptide
* Able to comply with the study protocol and understand the medical information forms
* Voluntarily sign the informed consent

Exclusion Criteria:

* History or current evidence of secondary OA (due to causes other than a solely degenerative joint disease) or symptomatic OA at additional locations besides the hand(s) requiring treatment, or any painful syndrome of the upper limb which may interfere with evaluation of hand pain;
* History of inflammatory arthritis (such as rheumatoid arthritis (RA) or psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;
* History of trauma, dislocation or operation to the hand or arm in the previous 3 months;
* Hand pain and stiffness due to tissue scarring or tendinitis;
* Skin damage or serious skin disorders in the hands;
* Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study;
* Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment;
* Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder;
* Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
An Applied Study on the Use of Stone Needles Therapy to Assist the Rehabilitation of Maternal Diastasis Rectus Abdominis Based on the Theory of Belt Channel

This clinical trial aims to find out whether stone needles therapy can effectively assist in the treatment of maternal diastasis rectus abdominis (DRA) based on the Belt channel theory, it will also validate whether the Ben-Tovim Walker body attitude questionnaire (BAQ) can be used as a tool to measure body image satisfaction in Chinese patients with postpartum DRA. The main questions it aims to answer are: Can stone needles therapy promote the recovery of maternal DRA? Whether the Chinese version of the Body attitude questionnaire (BAQ-C) can be used as a body image satisfaction measurement tool for patients with postpartum DRA. The researchers will add stone needles therapy to neuromuscular electrical stimulation (NMES) and massage therapy to see if stone needles therapy can promote the recovery of postpartum DRA.

Participants will: Receive NMES combined with massage therapy or the addition of stone needles therapy on a sub-basis every day for 10 days.

Abdominal circumference, inner rectus distance will be measured and recorded after each treatment Body imagery satisfaction, low back pain and dysfunction scores, anxiety, depression scores, and quality of life scores will be measured after all treatments are completed.

Eligibility Criteria:
Inclusion Criteria:

1. patients who meet the diagnostic criteria of postpartum rectus abdominis muscle separation, and the distance of rectus abdominis muscle separation is ≥3.0cm with postpartum low back pain.
2. Patients who are \>42d postpartum and have cleaned up their discharge;
3. Women who are 42day-3 mouths after normal delivery;
4. Postpartum women who have not received any other treatment before treatment in our hospital;

Exclusion Criteria:

1. With severe parenchymal organ diseases such as renal, cardiac, or hepatic diseases or due to comorbid cognitive impairment, Alzheimer's disease or psychological or psychiatric diseases can not complete the cooperation, etc;
2. Those with contraindications to stone therapy;
3. Those with contraindications to bioelectric stimulation therapy.
4. Combined with puerperal infection and gastrointestinal adhesion;
5. Patients with postpartum back pain due to other reasons such as lumbar disc herniation or kidney stones;
6. Patients who cannot tolerate the program;
Brain Activity Under the Influence of JWH

The goal of this placebo-controlled study is to learn about the neural mechanisms underlying the acute effects of the synthetical cannabinoid JWH-018 in healthy, occasional cannabis users. It aims to assess neural underpinnings of neurocognitive impairments and psychotomimetic symptoms expected during the intoxication. Neuronal changes similar to those seen in cannabis intoxication are expected, such as altered neurotransmission and loss of functional connectivity within the mesocorticolimbic circuit. MRS, fMRI and blood parameters will be used for assessment. Participants will be asked to complete cognitive tasks and subjective questionnaires related to the subjective experience of the drug.


Eligibility Criteria:
Inclusion Criteria:

* sufficient experience with cannabis
* Age between 18 and 40 years
* Free from psychotropic medication
* Good physical health
* Absence of any major medical, endocrine and neurological condition
* Normal weight, body mass index (weight/height\^2) between 18 and 28 kg/m\^2
* Written Informed Consent
* Good knowledge and understanding of the English language
* refrain from taking illicit psychoactive substances during the study
* willing to drink only alcohol-free liquids and no caffeinated beverages from 24 hours prior to dosing day, as well as during the study day
* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.

Exclusion Criteria:

* History of drug addiction
* Pregnancy or lactation or pregnancy planned during study participation
* Hypertension (diastolic \> 90 mmHg; systolic \> 140 mmHg)
* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
* Any chronic or acute medical condition
* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,...)
* For women: no use of a reliable contraceptive
* Tobacco smoking (\>20 per day)
* Excessive drinking (\>20 alcoholic consumptions per week)
* Simultaneous participation in another clinical trial
* fMRI contraindications
Time-Restricted Eating With Exercise

The purpose of the study is to determine if body composition differs between early time restricted eating (8-hour feeding period from 7 am to 3 pm) with exercise and late time restricted eating (8-hour feeding period from 3 pm to 11 pm) with exercise in overweight adults.

Time-restricted eating (TRE) is a hot trend in weight-loss diets. TRE can reduce cardio-metabolic risks, thereby lowering body weight, blood pressure, lipid profile, glucose, and inflammation. The most effective way for the overweight population to improve body composition is to incorporate TRE with exercise. However, there were only two TRE interventions in humans that included exercise, suggesting that the additive effect of TRE to exercise may be dependent on dietary timing. TRE can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window. However, whether different TRE schedules with exercise can improve cardio-metabolic health is questionable. There have been no interventions of different TRE schedules with exercise. This study will be beneficial for determining which TRE schedule with exercise is efficacious to prevent cardio-metabolic disease.

Eligibility Criteria:
Lists of inclusion criteria: the participants will be allowed to participate in this study if they

1. are adults, aged between 18-30 years
2. are apparently healthy and physically inactive (defined as any form of physical activity performed \< 2 days per week)
3. are overweight (BMI 25-\<30 kg/m2)
4. are non-smokers
5. are free from the following chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV)
6. are free from the orthopedic conditions that would hinder physical activity
7. have not taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinological (e.g, thyroid, insulin, etc), emotional/psychotropic (e.g,Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications(anabolic steroids)
8. have low risk for cardiovascular disease and with no contraindications to exercise as outlined by the American College of Sports Medicine (ACSM) will be included.

Lists of exclusion criteria: the participants will not be allowed to participate in this study if they

1. are younger than 18 years and older than 30 years.
2. have consumed any medication for chronic medical condition.
3. are participating in weight management programs.
4. have constrictions to exercise.
5. are currently exercising regularly (at least 2 days per week).
An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County

Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level approaches to prevent and control childhood obesity. Our Choice is translating evidence-based approaches for modifying behaviors, policies, systems, and environments to promote fruit and vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate goal is to assist Children's Health Insurance Program-eligible children between 2-12 years old attain a healthy weight. In addition to site-specific intervention and evaluation activities, Our Choice is working with the University of Houston Evaluation Center to conduct a cross-site evaluation on a set of shared measures.

Our Choice is a partnership between a university-affiliated research institute, a federally qualified health center, and a county public health department. We used formative research, advisory committee members' recommendations, and previous research to inform the development of the Our Choice project. Our theory-informed multi-sector, multi-level intervention targets improvements in four health behaviors: fruit, vegetable, and water consumption, physical activity, and sleep. Intervention partners include 1200 families, a federally qualified health center (including three clinics), 26 early care and education centers, two elementary school districts (and 20 elementary schools), three community recreation centers, and three restaurants. Intervention components in all sectors target changes in behaviors, policies, systems, and the social and physical environment. Evaluation activities include assessment of the primary outcome, BMI z-score, at baseline, 12- and 18-months post-baseline, and sector evaluations at baseline, 12, and 24-months.

Eligibility Criteria:
Inclusion Criteria:

* If family had school-age child, child must attend one of the designated Our Choice schools located in one of three designated cities.
* If family had preschool-age child, family must reside in one of three designated cities.
* Children ages 2-11 years old
* Maximum two children per household
* Children above the 5th percentile body mass index
* Family agrees to remain in the area throughout the duration of the study
* Participating parent had to understand English or Spanish

Exclusion Criteria:

* Child has any condition that significantly limits eating or physical activity in a way that interventions would be impacted
Pilot Study Using Propranolol To Promote Prenylation Of Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients

This is a an ancillary study designed to explore whether an additional cell signaling pathway (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may be affected by beta-blocker use.

This is a proof of concept randomized controlled pilot study assessing whether prenylation and membrane localization of Rap1 in PBMCs can be altered in individuals undergoing autologous Hematopoietic Cell Transplant (HCT) for Multiple Myeloma by administering a daily beta-blocker (propranolol) to 20 participants. Outcomes of patients on this clinical trial will be compared to 20 participants in a control arm.

Eligibility Criteria:
Inclusion Criteria:

Patients with multiple myeloma receiving an autologous HCT are eligible when the following criteria are met:

1. 18-75 years of age
2. ≤ 1 year since initiation of systemic anti-myeloma therapy
3. Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront therapy for their multiple myeloma
4. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the study
5. All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.

Exclusion Criteria:

1. Prior autologous HCT
2. Non secretory multiple myeloma
3. Concurrent beta-blocker therapy at or within 3 weeks of study entry.
4. Previous intolerance to beta-blocker therapy
5. Any medical contraindications to beta-blocker therapy including, but not limited to, symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker; uncompensated heart failure; or uncontrolled asthma
6. Active, untreated depression screened for by the HCT physician (Patients who screen positive will be offered a referral to the MCW Psycho-Oncology program for further evaluation and treatment)
7. Concurrent use of medications as specified in the protocol throughout the study or within one week of study entry.
8. Pregnant or lactating women
Neovascularization Embolisation for Knee Osteoarthritis.(NEO)

In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.

Rationale:

Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.

A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction

Objective:

The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.

The investigators hypothesize that novel transcatheter arterial embolization of neovessels is a feasible, effective, and safe treatment for patients with symptomatic radiographic knee OA, resulting in significant improvement of pain symptoms in a period of 4 months follow-up compared to sham embolization.

Secondary objectives are

1. to assess whether reduction of neovessels is related to pain relief,
2. to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief,
3. to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and
4. to assess whether transcatheter arterial embolization improve the outcome at 1, 4, 8 and 12 months compared to placebo of the: ICOAP, painDETECT, EQ-5D-5L questionnaires and NRS for pain.

Eligibility Criteria:
Inclusion Criteria:

* Age.≥18 years
* Knee pain for a duration of ≥ 6 months
* Knee pain (numeric rating scale ≥4 - ≤8) on at least half of the days in the preceding month at time of inclusion.
* There is insufficient response of conservative treatment for at least 6 months
* Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)

Exlusion criteria:

* Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
* Contra-indications for angiography
* Renal insufficiency, checked with blood sample test (GFR \< 30 ml/min/1, 73 m2);
* Known allergy to contrast agents;
* Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
* Women who are pregnant or lactating
* Intermittent claudication of affected limb
* Intra articular injections in the ipsilateral knee less than 6 months ago
* On the waiting list for joint replacement surgery
* Amitriptyline usage.
* Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene.
* Insufficient command of the Dutch or English language.
* Legally incompetent adults.
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)


Eligibility Criteria:
Inclusion Criteria:

* Patients willing and capable of providing written informed consent for study participation.
* Adults 18 to 70 years of age.
* Liver allograft from a deceased or living donor.
* Treated with a CNI containing immunosuppressive regimen.
* Liver transplant 6 to 24 months prior to screening.
* Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min \< eGFR \< CKD II/60 mL/min with deteriorating renal function.
* Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion Criteria:

* Multiple solid organ transplant recipients
* Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
* Malignant diseases other than neoplasms of the skin.
* Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
* Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
* HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.