bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema
Condition: Lymphedema; Edema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      To investigate whether addition of the Biobridge scaffold to the standard surgery for
      vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema
      of the upper arm.
    

Detailed description: 
      The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year
      following surgery to determine the success of the surgery. In addition, the volume of the
      operated arm will be monitored by repeated measurement with a tape measure. The investigators
      will also track bioimpedance, a painless technique to detect fluid in the tissues. The
      investigators will obtain small skin biopsies and blood samples to detect the biological
      changes that may occur as a result of successful surgery.
    

Intervention name(s): Biobridge and lymph node transfer
Intervention type(s): Device
Intervention description(s): Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphedema; edema
Effect of Ticagrelor on Fractional Flow Reserve
Condition: Fractional Flow Reserve
Study type: Interventional
Phase: Phase 4

Summary: 
      Fractional flow reserve (FFR) is an established invasive method for assessing the
      physiological significance of coronary artery stenosis. Adenosine, an important endogenous
      regulator of coronary blood flow during both stress and ischemia, is widely used to achieve
      conditions of stable hyperemia required for measurement of FFR.

      Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post
      percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential
      coronary blood flow velocity response during increasing doses of adenosine compared to
      placebo or prasugrel treated subjects, respectively. It has also been demonstrated that
      patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has
      been hypothesized that the degree of hyperemia obtained with adenosine infusion may be
      greater in patients on ticagrelor than that obtained in patients taking clopidogrel or
      prasugrel. If this proves to be true, it would lead to a lower FFR value with possible
      important clinical implications in ticagrelor receiving patients in need for FFR measurement.

      This is a prospective, single center, randomized study of parallel design. Consecutive
      ticagrelor naive patients who are referred for coronary angiography and have an
      angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual
      assessment) in at least one major epicardial coronary artery amenable to PCI are candidates
      for this study. Patients after informed consent will be randomized (hour 0) to receive
      immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute
      period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose
      (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.
    


Intervention name(s): Ticagrelor; Prasugrel or Clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: FFR; adenosine; Ticagrelor
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg
      doses of mifepristone against a placebo in women with laparoscopic diagnostic of
      endometriosis.

      The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and
      should be used in future studies on medical treatment of endometriosis.
    

Detailed description: 
      This is double-blind randomized clinical trial.

      Examinations undertaken Thorough gynecological examination, pelvic ultrasound examination,
      diagnostic laparoscopy before starting treatment in order to determine the localization,
      extent and degree of severity of the endometrial lesions and a score was assigned in
      accordance with the revised American Fertility Society (AFS) classification.19 Blood samples
      were taken for hematological tests and hepatic function. Endometrial biopsy was performed if
      endometrial thickness as calibrated by ultrasound was >8 mm or if there had been abnormal
      bleeding in the past 3 months. After 90 and 180 days of treatment an ultrasound examination
      of the pelvis was carried out and then followed by diagnostic-therapeutic laparoscopy and
      endometrial biopsy.

      Subjects Women with laparoscopic confirmed diagnosis of endometriosis who volunteered to take
      part in the study. Inclusion criteria: a) age between 18 and 45, b) certain diagnosis of
      endometriosis of any degree corresponding to the American Fertility Society (AFS); c)
      patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to
      other gynecological illness and d) acceptance of the use of barrier contraceptive methods
      during the study. Exclusion criteria: a) breastfeeding, b) hormonal or surgical treatment for
      the endometriosis less than 4 months previous to study, c) diabetes, d) severe arterial
      hypertension, e) hepatopathy, f) renal malfunction, g) endocrinopathy, and f) any other
      contraindication regarding the use of antiprogestins.
    

Intervention name(s): Mifepristone; PLACEBO
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mifepristone; Endometriosis
A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      A prospective randomized, double-blinded, comparative within-person study to evaluate the use
      of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.
    

Detailed description: 
      Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting
      technique. Once harvested, the SV will be divided into segments and these vein segments from
      each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed
      saline. The patients will then be randomized and SVG segment allocations will be defined and
      grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be
      completed 4-6 weeks and 3 months post surgery (CABG) procedure.
    

Intervention name(s): SOMVC001 Vascular Conduit Solution; Standard of care Heparin-dosed saline
Intervention type(s): Device; Other
Intervention description(s): SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.; SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
Other intervention name(s): active comparator
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
Condition: Malignant Pleural Effusion
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment
      for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
    


Intervention name(s): Bevacizumab; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week; Cisplatin 30mg,intrapleural administration,each 2 week
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bevacizumab;; non-small cell lung cancer;; malignant pleural effusion;; intrapleural administration
Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa
Condition: Placenta Previa Without Hemorrhage
MeSH terms: Placenta Previa; Hemorrhage
Study type: Interventional

Summary: 
      This trial will address the effect of uterine artery ligation during Cesarean section in
      cases with placenta previa to decrease blood loss.
    

Detailed description: 
      This Study will address the effect of uterine artery ligation prior to fetal delivery during
      Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage
      and to minimize blood loss.
    

Intervention name(s): Uterine artery ligation
Intervention type(s): Procedure
Intervention description(s): Uterine artery ligation during cesarean section before delivery of the baby
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: placenta previa, uterine artery ligation
Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore the pharmacological mechanism of Danhong injection in
      the treatment of acute ischemic stroke.
    


Intervention name(s): Danhong injection; Standard medical care; placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion; Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.; 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
Other intervention name(s): A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acute Ischemic Stroke; Randomized Controlled Trial; Traditional Chinese Medicine; Proteomics
Prospective Metabolic Indicator Study
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study was to assess the impact of a physician-supervised non-surgical medical
      weight management program on prevalence of metabolic syndrome and to examine the relationship
      between program retention and levels of key indicators of metabolic syndrome among
      participants that self-enrolled to the program. A total of 479 overweight or obese
      participants aged 19 years or older were observed. The revised National Cholesterol Education
      Program Adult Treatment Panel III (NCEP ATP III) criteria were used to define metabolic
      syndrome.
    

Detailed description: 
      Each individual self-enrolled to a physician-supervised non-surgical weight management
      program, hereafter referred to as the Program. They received a weight loss intervention as a
      part of routine medical care in the Program. At the end of their first consultation, each
      individual that met the inclusion criteria and failed to meet the exclusion criteria was
      asked if he or she would like to join the study. Each individual was informed that the study
      would not change the type or level of care that he or she would receive while enrolled to the
      program; however, researchers would be studying the effects of their care through additional
      screenings. Individuals who thereafter signed an informed consent form were monitored for
      changes in health outcomes without change to the Program.

      This study was observational. Health outcomes were assessed in individuals that predefined
      their program status (i.e., enrolled or not enrolled). Each participant received routine
      medical care, and the investigators studied the effects of the intervention. No new
      intervention or intervention specific to participants only was assigned.
    

Intervention name(s): Physician-supervised nonsurgical weight management program
Intervention type(s): Behavioral
Intervention description(s): Participants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        New patients of the Medi-Weightloss franchise, a physician-supervised nonsurgical weight
        management program
      
Keywords: Metabolic Syndrome
Effects of Glucagon Administration on Energy Expenditure
Condition: Hyperglucagonemia; Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to collect data to help researchers better understand the
      effects of glucagon on the amount of calories burned.
    

Detailed description: 
      1. To compare the effect of prolonged hyperglucagonemia to that of acute hyperglucagonemia
           on energy expenditure in healthy subjects using room indirect calorimetry in the setting
           of octreotide-mediated prevention of plasma insulin excursions.

        2. To compare the effects of prolonged hyperglucagonemia to acute hyperglucagonemia on EGP
           in healthy subjects in the setting of octreotide-mediated prevention of plasma insulin
           excursions.

        3. To determine the effects of prolonged hyperglucagonemia to acute hyperglucagonemia on
           rates of substrate oxidation, fibroblast growth factor21 and metabolites of interest.
    

Intervention name(s): Glucagon; Octreotide; Placebo; Insulin
Intervention type(s): Drug; Drug; Behavioral; Drug
Other intervention name(s): Sandostatin; Saline; Hypoglycemic agent
Intervention MeSH terms: Hypoglycemic Agents; Octreotide; Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Energy expenditure; Glucagon; Octreotide; Weight loss
Vildagliptin vs Sitagliptin add-on to Insulin - Impact on Glycemic Profile and Correlation of Hypoglycemic Episodes and Heart Function
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in
      their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50
      mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding
      postprandial blood-glucose normalization as well as protective properties regarding
      hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic
      patients a correlation has been described between hypoglycemia and abnormal heart function
      (QTc-elongation), which can have severe consequences for the patients. This study aims for
      the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in
      insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of
      hypoglycemic episodes with changes in heart-function measured by Holter-ECG.

      The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than
      sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function
      caused by undetected hypoglycemic episodes.
    


Intervention name(s): Vildagliptin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): vildagliptin 50mg BID for 8 weeks; sitagliptin 100mg QD for 8 weeks
Other intervention name(s): Vildagliptin (Galvus) LAF237; sitagliptin, Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vildagliptin; sitagliptin; continuous glucose monitoring (CGM); glycemic fluctuations; MAGE; impact of hypoglycemia on heart function (cardiac dysfuction measured via ECG); difference in glycemic profile of vildagliptin compared to sitagliptin
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific
      evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and
      exercise in the treatment of obese subjects with one or more obesity-related comorbid
      conditions.
    


Intervention name(s): ReShape Duo balloon; Diet counseling; Exercise counseling
Intervention type(s): Device; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; weight loss
Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, double-blind, randomized, active control, single dose escalation
      study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)
      profiles of P1101 in 48 healthy volunteers.
    

Detailed description: 
      The primary objectives were to determine the safety and tolerability of single ascending
      subcutaneous doses of P1101 and to determine the pharmacokinetics of P1101 in single
      ascending subcutaneous doses of P1101 in healthy male subjects.

      The secondary objectives were to evaluate the occurrence of side effects in healthy subjects
      receiving either P1101 or PEGASYS; to compare the pharmacokinetic parameters for P1101 and
      PEGASYS; and to assess the effect of P1101 on the biomarkers 2',5' oligoadenylate synthetase
      and neopterin.

      A total of 48 subjects were enrolled to receive subcutaneous injection of P1101 in the dose
      level of 24 , 48 , 90 , 180 , 225 , or 270 mcg or to receive subcutaneous injection of 180
      mcg Pegasys.
    

Intervention name(s): P1101 (24 mcg); P1101 (48 mcg); P1101 (90 mcg); P1101 (180 mcg); P1101 (225 mcg); P1101 (270 mcg); Pegasys
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 24 mcg subcutaneously.; P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 48 mcg subcutaneously.; P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 90 mcg subcutaneously.; P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 180 mcg subcutaneously.; P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 225 mcg subcutaneously.; P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 270 mcg subcutaneously.; Pegasys for injection, 180 mcg/mL, 1.0 mL/vial, Dose/subject: 180 mcg subcutaneously.
Other intervention name(s): peginterferon alfa-2a
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This was a single center, double-blind, randomized, active control, single dose escalation study, with P1101 (24, 48, 90, 180, 225, 270 mcg) as the test drug and Pegasys (180 ug) as the control drug.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: P1101, phase 1, healthy volunteers
Evaluation of TTP399 in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1
      diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different
      TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and
      efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.
    


Intervention name(s): TTP399; TTP399; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days; Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks; Phase 2: Participants will receive Placebo oral tablets for 12 weeks
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment