cyrilzakka/clinical-trials huggingface dataset:
Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy

Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.

Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .

Inclusion criterion :

1. The sex does not limit, age:18-70 years old .
2. The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 %
3. The patients have failure in surgical intervention or resection operation recidivist
4. Hepatic function Child-pugh A、B
5. All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results
6. The patient's prediction of live time\>6 months, who can tolerant of TACE and has quality of life ECOG score\<3
7. The patients participate the clinical trial voluntarily and have already signed informed consent

Exclusion criterion :

1. Main portal vein was obstructed completely.
2. The occupation of tumor are 70 % or more than 70 % in the whole liver
3. The patient has TACE or other antineoplaston
4. After carcinosectomy the patient has the prophylactic
5. The patient is with renal inadequacy: Cr≥133 umol/L
6. Severe cardiovascular disease
7. The patient is with other diseases to influence the proposal

Eligibility Criteria:
Inclusion Criteria:

1. The sex does not limit, age:18-70 years old ;
2. The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 %;
3. The patients have failure in surgical intervention or resection operation recidivist;
4. Hepatic function Child-pugh A、B;
5. All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
6. The patient's prediction of live time\>6 months, who can tolerant of TACE and has quality of life ECOG score\<3;
7. The patients participate the clinical trial voluntarily and have already signed informed consent.

Exclusion Criteria:

1. Main portal vein was obstructed completely;
2. The occupation of tumour are 70 % or more than 70 % in the whole liver;
3. The patient has recepted TACE or other antineoplaston;
4. After carcinosectomy the patient has the prophylactic;
5. The patient is with renal inadequacy: Cr≥133 umol/L
6. Severe cardiovascular disease;
7. The patient is with other diseases to influence the proposal;
8. All over the body generally have metabasis or be with other malignant neoplastic disease;
9. In the process of participation of other medicinal trial;
10. Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck

Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder area.

The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain.

The two sub-hypotheses are

1. Alleviation of pain is independent of training frequency
2. Alleviation of pain is higher following supervised training vs training with initial instruction only

Recent studies have shown a positive effect of work site physical exercise intervention, however, there is a lack of evidence regarding: 1) extend of instruction and supervision, and 2) frequency of training session during the wek.

Questionnaires will be send to around 2000 office workers inviting them to participate in work site training for 1 hr per week for 20 weeks. Those accepting the invitation will be randomized into 5 different groups:

1. training 1 hr one time per week supervized 50% of the time
2. training 3 x 20 min per week supervised 50 % of the time
3. training 3 x 20 min per week supervised only initially with careful instructions
4. training 10 x 6 min per week supervised 50 % of the time
5. no training serving as reference control group At termination of the training period there will be a follow-up questionnaire survey

Eligibility Criteria:
Inclusion Criteria:

* office workers
* employed

Exclusion Criteria:

* physically heavy work
* trauma
* leif threatening disease, e.g. cancer,
* pregnancy
The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome

The aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of Carpal Tunnel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years;
2. Presence of sensory abnormalities and motor dysfunction in the median nerve distribution area;
3. Positive Tinel's sign or Phalen's test;
4. Neurophysiological examination consistent with mild to moderate Carpal Tunnel Syndrome.-

Exclusion Criteria:

1. Severe Carpal Tunnel Syndrome;
2. Concurrent rheumatic, metabolic, systemic, or other systemic diseases;
3. Concurrent cervical spondylosis or other peripheral neuropathies;
4. Wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions;
5. Concurrent malignant tumors or severe cardiopulmonary diseases;
6. History of previous wrist surgery or injections;
7. Pregnancy;
8. Allergy to corticosteroids or local anesthetics.-
Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.

OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest. Treatment continues in the absence of disease progression until complete response or 90 days is reached. Upon achieving complete response, treatment is discontinued for 30 days. Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy. Patients are followed monthly.

PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory acute leukemia (myeloid or lymphoid), blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma of all FAB subtypes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (except for leukemic infiltration dysfunction) Alkaline phosphatase less than 2 times upper limit of normal (except for leukemic infiltration dysfunction) Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection Not pregnant Fertile patients must use effective contraception No history of seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior chemotherapy (except hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents Concurrent antibiotic therapy allowed for stable patients
Eslicarbazepine Acetate Monotherapy Long Term Study

This is a long term, open-label, safety extension study in subjects with partial onset seizures.

This is a long term, multicenter, open-label, safety extension study in subjects with partial onset seizures who have just completed, discontinued, or exited the 18-week treatment phase of Protocols 093-045 or 093-046. The initial study duration is 1 year with the option of continuing study drug treatment post 1 year until a subject discontinues study, the study drug becomes clinically available in the subject's locale, or the sponsor terminates the study drug clinical development program.

This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Subject Inclusion/Exclusion Criteria:

* Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
* Subject must give written informed consent prior to participation in the study. For subjects \<18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the "Women of Childbearing Potential" Addendum.
* Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
* If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
* Criterion for Continuation into the Post 1 year Part of Study:

For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)

Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.

Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of a renal allograft, male and female patients age \>18
* The eGF\>20 ml/min/1.73 m2,
* Renal biopsy Criteria: chronic active ABMR.
* Written informed consent, compliant with local regulations.

Exclusion Criteria:

* Recipients of multiple organs.
* Pregnant women.
* Malignant disease in last 5 years
* Active autoimmune disease
* Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
* Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months.
* Evidence of liver disease
* Inadequate compliance to treatment.
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective outpatient arthroscopic knee surgery expected to last \<= 90 minutes using general anesthesia
* Patients must experience moderate to severe pain following surgery
* Patient must be in general good health as judged by the primary investigator

Exclusion Criteria:

* Osteoarthritis; rheumatoid arthritis
* Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
* Asthma associated with nasal polyps
* Any arthroscopic knee surgery in the past 6 months
Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery

Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.

Eligibility Criteria:
Inclusion criteria

* Patients undergoing abdominal laparoscopic surgery (digestive, urologic, gynecologic surgery) with general anesthesia
* BMI \<= 30 kg/m2
* Assessed with ASA 1-3
* Willing to participate in this study

Exclusion Criteria:

* Allergy to dexmedetomidine
* Heart rate \< 60 or systolic blood pressure \<100 mmHg
* Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder
* Sepsis
* Pregnancy
* Difficult airway

Drop out Criteria:

* Intraoperative emergency
* Convert to open laparatomy
* Decided to withdraw from the study
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients with Advanced Ovarian Cancer (SUNNY)

The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?

OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery.

OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy.

Patients are followed every 3 months within the first 5 years, and then every 6 months.

PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥ 18 years.
2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration\*). Laparoscopic biopsy with pictures is recommended.

   \* If fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum CA125/CEA ratio\>25. If serum CA125/CEA ratio\<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer.
3. ECOG performance status of 0 to 2.
4. ASA score of 1 to 2.
5. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:

   1. white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
   2. serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
   3. serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
6. Comply with the study protocol and follow-up.
7. Written informed consent.

Exclusion Criteria:

1. Patients with non-epithelial tumors as well as borderline tumors.
2. Mucinous ovarian cancer.
3. Low grade ovarian cancer.
4. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
5. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
6. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)

The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.

Eligibility Criteria:
Inclusion Criteria :

* Age \>= 6 years
* Genetically proven Duchenne muscular dystrophy
* Affiliation to French medical insurance
* Informed consent provided

Exclusion Criteria :

* Age \<6 years
* Left ventricular ejection fraction \<30%
* Tracheostomy of hospitalisation for acute respiratory failure \<1 year
* Contraindication to MRI: claustrophobia, Gadolinum allergy
NHF in Acute Hypercapnic Acute Exacerbation of COPD

Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH \< 7,38 and pCO2 \> 45 mm Hg. Patients were treated if pH \>7,38 or refusal of therapy.


Eligibility Criteria:
Inclusion Criteria:

* pH \< 7,38
* hypercapnic AECOPD

Exclusion Criteria:

* Need of intubation
Sacubitril/Valsartan Versus Valsartan in Heart Failure

The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.

Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HF were enrolled if aged \> 35 years,
* Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) \< 35%,
* NYHA class II-III,
* Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.

Exclusion Criteria:

* Patients with acute decompensation,
* Cerebrovascular events during the previous 6 months,
* Pregnancy, breastfeeding,
* Any valve dysfunction/abnormality,
* Active myocarditis,
* Second-degree and third-degree atrioventricular block,
* Sick sinus syndrome.
Dairy Intervention in People With Obesity

Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):

* Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d,
* Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d
* Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥30 kg/m²
* Age of ≥18 and \<60 years
* Written informed consent before study entry
* Willingness to introduce a dietary change to lose weight

Exclusion Criteria:

* Serum calcium ≥2.7 mmol/l
* Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products
* Pregnancy or lactating women
* Having given birth in the last year or planning a pregnancy in the next 6 months
* Menopause (as defined by FSH levels ≥30 IU/l)
* Disorders associated with androgen excess and/or menstrual irregularities except PCOS (overt thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
* Malabsorption syndrome
* Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, ...), obesity pharmacotherapeutic agents, or calcium supplements in the last 3 months before study entry
* Regular intake of calcium supplements in the last 3 months before study entry
* Lifestyle changes (changes in physical activity) or weight reduction (≥10% of body weight) in the last 3 months before study entry