bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Barley Based Food Products on Metabolism and Gut Microflora
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The main objective is to investigate gut microflora composition in relation to
      cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a
      barley kernel based product on these variables.
    

Detailed description: 
      100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen
      based on their gut microflora composition to participate in the Barley intervention.
    

Intervention name(s): Barley kernel bread; white wheat bread
Intervention type(s): Other; Other
Intervention description(s): 3 days intervention with barley kernel bread; 3 days intervention with white wheat bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic
      drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
    

Detailed description: 
      A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
    

Intervention name(s): Rosuvastatin; Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days; Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other intervention name(s): Crestor; Twynsta; Crestor and Twynsta
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke
Condition: Dysphagia Following Cerebral Infarction
MeSH terms: Deglutition Disorders; Cerebral Infarction; Infarction
Study type: Interventional

Summary: 
      This is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to
      assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal
      dysphagia following a stroke.
    

Detailed description: 
      Randomization will be stratified at each site in a 1:1 fashion. All patients will have the
      Phagenyx® Catheter placed prior to randomization, and will receive either an active treatment
      of Pharyngeal Electrical Stimulation (PES) or a sham treatment performed by a health care
      professional (HCP) that is un-blinded to treatment assignment. All other speech pathology
      standard dysphagia care will be provided by a speech language pathologist (SLP) that is
      blinded to treatment assignment. Administration of all protocol-specific assessments will be
      conducted by personnel blinded to treatment assignment.

      The study will follow an adaptive group sequential design with unblinded sample size
      re-assessment. To ensure 180 evaluable patients with 7-day data and assuming a 20% dropout
      rate, 225 patients will be enrolled initially. An interim analysis for futility will occur
      after the first 60 patients complete their 7-day visits and another interim analysis will be
      performed for efficacy and futility after 120 patients complete their 7-day visits. The total
      sample size may be increased up to 338 patients after the second interim analysis to ensure
      up to 270 evaluable patients. Up to 15 investigational centers across the US and possibly
      Europe will participate in this study. The enrollment period is expected to be approximately
      24 months and patient participation will last for approximately 11 weeks. Patients will be
      assessed at the following intervals: baseline, 48 hours, 7 days, 14 days or at discharge,
      whichever is first, and 11 weeks after completion of the study treatments.
    

Intervention name(s): PES
Intervention type(s): Device
Intervention description(s): The PES system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Phagenyx® Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation.
Other intervention name(s): Pharyngeal Electrical Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Condition: Measles; Rubella; Mumps; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)
      Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy
      children in their second year of life.
    

Detailed description: 
      This study included an active control group who received the licensed Priorix (measles,
      mumps, rubella [MMR] vaccine).
    

Intervention name(s): Measles, Mumps, Rubella and Chickenpox (live vaccine)
Intervention type(s): Biological
Other intervention name(s): Measles; Mumps; Rubella and Chickenpox (live vaccine)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis measles, mumps, rubella and chickenpox
Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome
Condition: IVF; Pregnancy
Study type: Observational

Summary: 
      Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014-
      2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All
      factors that might impact the embryo transfer will be analyzed. We want to see which factors
      that influence the success rate are not related to the subjectivity of the operator and could
      be adjusted through different approaches.
    

Detailed description: 
      Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve
      pregnancy and live birth. Many reasons have been proposed to explain these results. Among
      them, the factor Embryo Transfer Procedure gained less of the attention since few papers have
      been published and most of them had a lot of biases. In order to eliminate possible biases,
      we wanted to analyze our Embryo transfer data, prospectively collected during the last 6
      years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers
      since 1984. All factors that might impact the embryo transfer will be analyzed. We want to
      see which factors that influence the success rate are not related to the subjectivity of the
      operator and could be adjusted through different approaches.

      Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth
      rate.

      Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of
      catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard
      catheter to pass through the cervix and the orifice, the site of the uterine cavity that the
      embryo was released, single or double transfer due to blocked embryo in the catheter.

      In addition for each embryo transfer variables that may influence the pregnancy rates will be
      collected: age of the woman, number of oocytes harvested, sperm characteristics,
      fertilization rate, stage and grade of the embryos the day of transfer
    

Intervention name(s): embryo transfer catheter
Intervention type(s): Device
Intervention description(s): undergoing embryo transfer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing embryo transfer after IVF
The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Condition: Diabetes Mellitus, Type 2; Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical trial is to assess and compare the effect of insulin detemir in
      combination with liraglutide and metformin versus insulin detemir in combination with insulin
      aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).
    

Detailed description: 
      The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment
      regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled
      (HbA1c>10%) type 2 diabetes. The investigators will compare the two regimens with respect to
      efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on
      patient quality of life, treatment burden, physician time, as well as healthcare related
      cost. The investigators hypothesize that at 26 weeks from randomization the two treatment
      regimens will have similar percentage of patients reaching A1c levels <7.0%, while more
      patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c
      levels <7.0% without severe hypoglycemia or significant weight gain.
    

Intervention name(s): Metformin; Detemir; Liraglutide; Insulin Aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day); Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.; Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached; Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180
Other intervention name(s): Metformin tablets; Insulin Detemir subcutaneous once or twice daily; Liraglutide 6 mg/mL Subcutaneously; Insulin Aspart Subcutaneous injection one to three times daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Liraglutide; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Insulin; Insulin, Long-Acting; Insulin, Short Acting; Detemir; Liraglutide; GLP-1; Glucagon Like Peptide; Metformin; Uncontrolled Diabetes; Elevated A1c; Incretins
Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving
Condition: Methamphetamine Dependence
Study type: Interventional

Summary: 
      Specific Primary Aims include:

      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the
      cortical excitability and to inhibit meth cue craving in meth dependent population. The
      investigators anticipate that meth elevates cortical excitability measured by motor
      threshold, causes changes of cortical silent period, and RC. The investigators also
      anticipate that paired pulse measures (short-interval intracortical inhibition,
      short-interval intracortical facilitation and long-interval intracortical inhibition) will be
      different from healthy control, which are more directly linked to glutamatergic cortical
      facilitation and GABAergic inhibition, respectively.

      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will
      use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to
      reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving
      in meth dependent population compared with sham rTMS.
    


Intervention name(s): Transcranial Magnetic Stimulation; Sham Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.; The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
Other intervention name(s): Magstim Rapid; Epix VT Transcutaneous Electrical Nerve Stimulation Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: methamphetamine, craving, TMS, cortical excitability, prefrontal cortex
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      the aim of our study is to identify independent predictors of quality of life in AIS.
    

Detailed description: 
      Adolescent idiopathic scoliosis (AIS) is the lateral and horizontal deformity of the columna
      vertebralis which occurs idiopathically in adolescence ages. The aim of this study is to
      identify independent predictors of quality of life in AIS
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        volunteered for the study participants were diagnosed with adolescent idiopathic scoliosis,
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
Condition: Advanced Primary Liver Cancer; Advanced Biliary Tract Carcinoma
MeSH terms: Carcinoma; Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of
      SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects
      with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior
      systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC
      or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus
      FOLFOX4 or GEMOX regimen.
    


Intervention name(s): SHR-1210; Apatinib; FOLFOX4; GEMOX
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks; Subjects receive Apatinib orally every day with a dose escalation; Subjects receive FOLFOX4 treatment every 2 weeks; Subjects receive GEMOX treatment every 2 weeks
Intervention MeSH terms: Apatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
Condition: Ureter Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in
      intraoperative ureter structure delineation. Stage A of the study will determine the safe
      optimal dose and Stage B will determine expanded safety and efficacy for intraoperative
      ureter structure delineation for the identified optimal dose in study participants.
    

Detailed description: 
      Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a
      well-known and serious complication of pelvic and abdominal surgery that frequently goes
      unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of
      intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted
      surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a
      dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an
      expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug
      safety control to evaluate the effects of surgery alone on the safety parameters of the
      study.
    

Intervention name(s): IS-001; No treatment
Intervention type(s): Drug; Drug
Intervention description(s): intravenous injection of IS-001 investigational drug; no drug injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: robotic-assisted surgery; minimally invasive surgery
Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of insulin resistance on brain function
      in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior
      to and following 4-month treatment with Metformin. Additionally, brain function in women with
      PCOS will be compared to the brain activity in normal control subjects with regular menstrual
      cycles.
    

Detailed description: 
      The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder,
      is associated with insulin resistance. The effects of insulin resistance on cognition, mood,
      opioid system and reproductive function in PCOS affected women are investigated in the
      current study. The identification of reversible changes in brain function and reproductive
      measures in insulin resistant PCOS patients would likely significantly influence treatment
      protocols for these young women.

        1. Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to
           normal controls.

        2. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women
           with insulin resistant PCOS.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times daily (TID), adding a 500 mg tablet after supper. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia.
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Insulin resistance; Metformin; Brain function
Quality of Life After Rectal Cancer Surgery
Condition: Rectal Cancer; Quality of Life
MeSH terms: Rectal Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Following colorectal surgery, many patients face a combination of physical and emotional
      problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and
      sexual function, as well as problems in social and role functioning, inevitably affect the
      patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is
      becoming increasingly important in clinical trials. The investigators aimed to compare long
      term health related life quality (HRQoL) results of laparoscopic approach with open approach
      in patients with sphincter preserving resections for rectal cancer at a single-center.
    

Detailed description: 
      This study is planned prospectively. All patients scheduled for operation due to rectal
      cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability
      for the study. During the preoperative examination, patients will be informed about the study
      and their written consent will be obtained. Patients will be randomized between open and
      laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of
      patients will be analyzed from the hospital database programme.

      The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for
      Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after
      the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients'
      daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the
      first year after surgery.

      In this way, it will be aimed to compare the early and long-term quality of life (HRQoL)
      results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.
    

Intervention name(s): Open Rectal cancer surgery; Laparoscopic Rectal cancer surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Open sphincter preserving surgery for rectal cancer; Laparoscopic sphincter preserving surgery for rectal cancer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients who underwent surgery (laparoscopic or open) for rectal cancer in our
        department.
      
Keywords: rectal cancer surgery; life quality; questionnaire
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and
      Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will
      be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time
      on study treatment is 3-12 months.
    


Intervention name(s): bevacizumab [Avastin]; docetaxel; capecitabine [Xeloda]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles; 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles; 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
Intervention MeSH terms: Bevacizumab; Docetaxel; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment