cyrilzakka/clinical-trials huggingface dataset:
A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.

  * Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible.
  * For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be documented.
* Premenopausal woman with a uterus.
* ECOG performance status of 0-2.
* At least 18 years of age and no more than 45 years of age.
* Interested in uterine preservation and/or fertility-sparing treatment.
* BMI ≥ 30 kg/m\^2.
* Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Current, active treatment for any malignant neoplasm with chemotherapy or radiation.
* Pregnant and/or breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.
* Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.
Effects of Monosodium Glutamate on Energy Balance and Eating Behavior

This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss.

The proposed study enables us to assess the long term effects of consuming MSG on body weight regain following weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 19-45
* BMI 27-35
* Blood pressure \<140/90
* Non-smoking

Exclusion Criteria:

* Anemic: hgb \< 11.5 mg/dL
* Sensitivity to MSG (self reported)
* Pregnant or planning to get pregnant
* Taking medication for hypertension, depression, or weight loss
* Diabetic
* Vegetarian
* MRI Contraindications: internal metal, braces on teeth, history of metal in the eye, claustrophobia
* blindness or heavily corrected vision
* not fluent in English
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.


Eligibility Criteria:
Inclusion criteria:

* Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.
* Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.

  * LVEF \< 40% (measured within the last 6 months).
  * Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
* Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
* Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).

Exclusion Criteria:

* Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
* Concomitant use of ACEI and ARB at randomization.
* Right heart failure due to pulmonary disease.
* Diagnosis of postpartum cardiomyopathy.
* Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
* Patients with a history of heart transplant or who are on a transplant list.
* Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.

Other protocol-defined inclusion/exclusion criteria applied.
Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)

New effective non-surgical treatments are needed for patients whose obesity and type 2 diabetes (T2DM) do not respond to current medical therapies. We propose a randomised controlled trial of Endobarrier, an implantable intestinal device that separates ingested food from contacting the first 60cm of intestine where sited and that mimics some of the clinical effects of bariatric surgery (improved metabolic control with weight loss) with or without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal glycaemic control despite current conventional diabetes treatment, in an NHS setting.

Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA therapy will be studied over 24 months and randomised to receive Endobarrier with continued Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg without Endobarrier.

We will investigate potential mechanisms of action and their time course as part of the study by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and permeability measures.

The data will inform clinical use of the device and development of new treatments for T2DM and obesity.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes with latest HbA1c ≥7.5% (≥58mmol/mol)
* obesity with latest BMI ≥35 Kg/m2 (≥30 Kg/m2 for those of South Asian origin)
* liraglutide therapy for at least 6 months - HbA1c and weight trend data should be available
* stable weight and HbA1c in preceding 3 months (\<3 Kg reduction in weight and \<0.3% reduction in HbA1c)

Exclusion Criteria:

* \<18 years of age
* abnormal intestinal anatomy e.g. Crohn's disease
* contraindication to oesophago-gastroduodenoscopy
* previous bariatric surgery or bowel surgery
* active infection
* anticoagulation therapy which cannot be discontinued/ coagulopathy INR \>1.3
* eGFR \<30
* known portal hypertension
* previous pancreatitis or amylase \> 3 times the upper limit of normal
* uncontrolled cardiovascular disease
* lactating or pregnant females
* patients taking aspirin in whom it should continue (e.g. active ischaemic heart disease or cerebrovascular disease)
* excess anaesthetic risk as identified by the anaesthetist or investigator (e.g. uncontrolled obstructive sleep apnoea)
Autologous Cell Therapy for Ischemic Heart Failure

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 but less than 80 years
* Prior myocardial infarction
* Depressed left ventricular ejection fraction (LVEF) ≤ 35%
* NYHA functional classification of II to IV

Exclusion Criteria:

* Not under stable optimal medical management
* Cardiac surgery or percutaneous coronary intervention within 3 months
* Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
* Prior cell, gene, or transmyocardial laser revascularization therapy
* Ventricular wall thickness in target region ≤ 5 mm
* Moderate to severe aortic valve stenosis or mechanical valve replacement
* Left ventricular aneurysm or thrombus
* Left ventricular dysfunction associated with a reversible cause
* Vascular disease preventing percutaneous vascular access
* History of myopathic disease
* History of neoplasia within 5 years, except for basal cell carcinoma
* Receiving or planning to receive anti-cancer medications
* Serum creatinine \> 3.0 mg/dl
* Pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months
* Life expectancy of less than 1 year
* Morbid obesity (defined as BMI \> 35)
* History of bleeding diathesis or coagulopathy
* Positive for HIV, Hepatitis B, or Hepatitis C
* Known hypersensitivity or contraindication to study product or treatment procedure
* Enrolled in another research project at the time of enrollment
* Unable to provide informed consent
* Unable or unwilling to commit to the follow-up clinical procedures
International Prospective Registry of Disseminated Intravascular Coagulation

Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry.

Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis.

Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days.

Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.


Eligibility Criteria:
Inclusion Criteria:

* admission to the intensive care unit
* 18 years or older

AND one of the following conditions:

* sepsis/severe infection
* solid tumor
* hematological malignancy
* trauma
* obstetric complications
* acute pancreatitis

Exclusion Criteria:

-\<18 years
Proprioception and BRACE Training in Knee Osteoarthritis

Knee osteoarthritis is common joint disorder in older adults. The prevalence of osteoarthritis is increasing in the elderly population and due to obesity.The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis

Knee osteoarthritis is common joint disorder in older adults. The prevalence of osteoarthritis is increasing in the elderly population and due to obesity. Balance disorder generally disturbed equilibrium and increase risk of fall. There is lack of proprioceptive sensation in patients with knee osteoarthritis. The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis. Randomized control trial study of 8 week follows up. Sample size will be 22. The patients will be divided into 2 groups BRACE and proprioceptive training. The patients will get training section for 3 days per week for 8 weeks. The measurement will be taken at base line, after 8 weeks. Study duration will be 6 months. Individuals of age 50-70 year, Mini-mental state examination (MMSE) 20 or higher, Berg Balance Scale (BBS) 30-45 points, Experience of at least one fall during the previous 12 months, both Males and Females will be include. Patients will be excluded if they exhibited history of cardiovascular or musculoskeletal diseases, previously used medication for the central nervous system, occurrence of lower limbs lesions or fractures in last six months. Assessment tools will be MMSE, Berg balance scale, TUG, CTSIB, 6 minute walk test. Data will be analyzed through SPSS 20. Data will be check for its normality, within groups comparison paired sample T-test, between groups independent sample T-test will be used

Eligibility Criteria:
Inclusion Criteria:

* Age 50-70 years.
* Both Males and Females
* Knee osteoarthritis unilateral and bilateral (12).
* American College of Rheumatology (ACR) criteria for diagnosing osteoarthritis of knee joint is presence of pain in knee joint plus any three of six factors listed below (13).
* Age more than 50 y
* Presence of crepitus on active motion
* Less than 30 min of morning stiffness
* Bony tenderness
* Bony overgrowth
* No palpable warmth of synovium
* Mini-mental state examination (MMSE) 23 or higher (14).
* Berg Balance Scale (BBS) 30-45 points (4)

Exclusion Criteria:

* History of stroke during the previous 12 months
* History of cardiovascular or musculoskeletal diseases,

  * Previously used medication for the central nervous system.
* Presence of lower limb lesions or fractures in the last six months
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.

The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.

Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.

Eligibility Criteria:
Inclusion Criteria:

* Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder.
* Failed one or two mobilization attempts.
* ECOG performance status of 0, 1, or 2.

Exclusion Criteria:

* Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension
* Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease.
* Renal disease: serum creatinine \> 2 mg/dl
* Hepatic disease: SGOT or SGPT \> 3x normal; serum bilirubin \> 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
* Calcium \> 10.5
* Phosphate \< 1.6
* Uncontrolled infection
* Pregnancy or breast feeding mother
Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients

This study aims to evaluate the effectiveness of far-infrared radiation (FIR) emitting socks in improving neuropathic pain, nerve conduction, and quality of life in patients with diabetic peripheral neuropathy (DPN). It is the first comprehensive study in Turkey investigating FIR technology for DPN treatment and offers an alternative approach to traditional methods.The study will be conducted at Erciyes University Gevher Nesibe Hospital between February 2025 and June 2026 as a randomized controlled trial (RCT) with a triple-blind design. Participants will be assigned to either the FIR socks group or the placebo group, with both groups receiving two pairs of socks to wear daily. Assessments will include the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale, the Neuropathic Pain Impact on Quality of Life (NePIQoL) questionnaire, and the Visual Analog Scale (VAS) for patient-reported outcomes. Electroneuromyography (ENMG) testing will also be performed before and after the intervention to assess nerve function.

This research is expected to provide clinical evidence on FIR socks as a non-pharmacological treatment for neuropathic pain, contributing to improved patient care and the development of innovative medical technologies in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetic peripheral neuropathy (DPN) with mild to moderate severity based on clinical evaluation.
* Oriented to person, place, and time (cognitively intact).
* Residing in Kayseri and receiving treatment in the city.
* HbA1C level below 8.5% during the study period.
* Non-smoker for at least 6 months.
* Not using neuropathic pain medication for at least 3 months before enrollment.
* Body Mass Index (BMI) between 25 - 35.
* Able to be contacted by phone for follow-up.
* Willing to participate and provide informed consent.

Exclusion Criteria:

* Presence of diabetic foot ulcers.
* Non-mobilized individuals (unable to walk independently).
* Severe peripheral artery disease (Ankle Brachial Index (ABI) \< 0.4).
* Liver failure or renal failure (dialysis patients).
* Coronary artery disease.
* Candidates for surgery during the intervention period.
* Lower extremity arthroplasty or orthosis indication during the intervention period.
* Neurological or cognitive impairments (e.g., dementia, Alzheimer's disease).
* Receiving non-pharmacological treatment for diabetic peripheral neuropathy (DPN).
* Chronic alcohol or substance use.
* Severe anemia, vitamin B12 deficiency, or iron deficiency anemia.
* Recent changes in diabetes medication or newly diagnosed with diabetes.
* Neurological, cardiovascular, or orthopedic damage affecting the lower extremities.
* Use of cytotoxic or immunosuppressive agents or history of radiation therapy.
* Pregnant, breastfeeding, or attempting to conceive.
* Receiving physiotherapy at any point during the study period.
GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven unresectable pancreatic carcinoma
2. There must be measurable lesions with multislice CT
3. ECOG Performance status 0-2
4. No other active cancer
5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
7. No serious complications
8. Be able to eat food
9. Life expectancy of more than 8 weeks duration
10. Informed consent is obtained-

Exclusion Criteria:

1. Interstitial pneumonia
2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
3. Serious infection
4. Pregnant or lactating females
5. History of serious drug allergy
6. Serious other complications
7. Uncontrolled mental disorders -
Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma

The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a single arm trial of tandem HDCT/ASCT will be carried out.

Although the outcome of high-risk neuroblastoma has improved after the introduction of HDCT/ASCT, the outcome was still unsatisfactory with 30-40% of survival. We previously reported the results of a single arm prospective trial (SMC NB-2004 study) using tandem HDCT/auto-SCT for high-risk neuroblastoma. In the NB-2004 trial, total body irradiation (TBI) was incorporated in second transplantation. Survival rates were very encouraging; however, short- and long-term toxicities associated with tandem HDCT/auto-SCT, particularly TBI, were also very significant. For this reason, we designed a new prospective trial (SMC NB-2009 study), in which only TBI in the second HDCT/auto-SCT of NB-2004 study was substituted with high-dose 131I-MIBG treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high-risk neuroblastoma

Exclusion Criteria:

* Patients with progressive disease before high-dose chemotherapy
* Patients whose parents want to stop or change the planned treatment
* Patients with organ toxicities of NCI grade \>2 before high-dose chemotherapy