bioihbjkbjnl/mcl2 huggingface dataset:
Gut Hormones After Oral Versus Intravenous Amino Acids
Condition: Normal Non-fluency
Study type: Interventional

Summary: 
      The study hypothesis is that gut hormones are released after oral but not intravenous amino
      acids which result in stimulation of insulin secretion.
    

Detailed description: 
      Amino acid mixture is given orally or intravenously to match total concentrations of amino
      acids in healthy subjects. Samples are taken regularly for 300 min after administrations.
      Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and
      glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and
      glucagon.
    

Intervention name(s): Oral amino acid mixture; Intravenous amino acid administration
Intervention type(s): Other; Other
Intervention description(s): Amino acid mixture 2,93 ml/kg; Amino acid mixture 2,93 ml/kg
Other intervention name(s): Amino acid mixture; Amino acid mixture
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut hormones; Insulin secretion; Normal physiology
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two
      strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and
      bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets
      empagliflozin and metformin under fed conditions (Part II).
    


Intervention name(s): Empagliflozin; Metformin; Empagliflozin; Empagliflozin/Metformin; Metformin; Empagliflozin/Metformin; Empagliflozin; Metformin; Empagliflozin/Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): medium dose oral administration; oral administration; low dose of Empagliflozin oral administration; low dose of Empagliflozin; oral administration; medium dose of Empagliflozin oral administration; medium dose oral administration; oral administration; medium dose of Empagliflozin oral administration
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy
      subjects after administration of one or two oral doses of multiple modified release prototype
      formulations.
    


Intervention name(s): Tolcapone; Tolcapone Modified Release Prototype; Tolcapone Divided Dose; Tolcapone Modified Release Prototype
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Multiple doses of tolcapone tablets in the fasted state; A single dose of tolcapone modified release prototype in the fasted state; Tolcapone (suspension) in equal divided doses in the fasted state; A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
Condition: Malignant Solid Tumour
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to
      multiple solid tumors.
    

Detailed description: 
      By enrolling patients with solid tumors adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using anti-PD-1 and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Pembrolizumab; NK immunotherapy
Intervention type(s): Drug; Biological
Intervention description(s): Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure; Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
Other intervention name(s): Keytruda
Intervention MeSH terms: Pembrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumor; Anti-PD-1; NK immunotherapy
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination
      with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control
      on Metformin Alone.
    

Detailed description: 
      A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic
      Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with
      Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on
      Metformin Alone.
    

Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): Dapagliflozin Tablet
Other intervention name(s): DWP16001
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efﬁcacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.
Condition: Catheter Related Bladder Discomfort
Study type: Interventional

Summary: 
      a prospective, randomized, placebo-controlled study will be conducted to investigate whether
      hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with
      urinary catheters who will undergo elective cesarean sections.
    

Detailed description: 
      The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean
      section may lead to catheter-related bladder discomfort with varying degrees of severity
      during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms
      associated with an indwelling urinary catheter are similar to overactive bladder symptoms
      such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation
      with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a
      drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine
      effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central
      nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD.

      More preventive than therapeutic drugs for CRBD should be investigated to improve patient
      comfort in all surgery patients with a urinary catheter.

      A prospective, randomized, placebo-controlled study will be conducted to investigate whether
      hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with
      urinary catheters who will undergo elective cesarean sections.
    

Intervention name(s): hyoscine-n-butylbromide; control group
Intervention type(s): Drug; Drug
Intervention description(s): one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.; an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.
Other intervention name(s): saline group
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune
      system recover from the side effects of chemotherapy. Giving combination chemotherapy
      together with G-CSF or pegfilgrastim may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and
      trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or
      persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To estimate the antitumor activity of docetaxel plus trabectedin in patients with
           persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity
           cancer primarily through the frequency of objective tumor responses.

        -  To determine the nature and degree of toxicity of docetaxel plus trabectedin in this
           cohort of patients.

      Secondary

        -  To estimate the progression-free survival and overall survival of patients treated with
           docetaxel and trabectedin.

      OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1.
      Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV
      over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts
      recover. Treatment repeats every 3 weeks in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.
    

Intervention name(s): filgrastim; pegfilgrastim; docetaxel; trabectedin
Intervention type(s): Biological; Biological; Drug; Drug
Intervention MeSH terms: Docetaxel; Trabectedin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
The Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of lansoprazole combination with
      domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance
      kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
    

Detailed description: 
      Objectives of the trial to assess the efficacy of lansoprazole in combination with
      domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics
      and gastric emptying in patients with GERD.

      24 hour pH measurement and gastric emptying test will be done at screening visit and after 7
      days of drug treatment. Twelve patients will take one tablet for 7 days.
    

Intervention name(s): Lansoprazole/Domperidone
Intervention type(s): Drug
Intervention description(s): DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Other intervention name(s): Duolans
Intervention MeSH terms: Domperidone; Lansoprazole; Dexlansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
Condition: Fractures, Bone; Patient Fall; Osteoporosis; Physical Activity
MeSH terms: Osteoporosis; Fractures, Bone
Study type: Observational

Summary: 
      The risk for a subsequent fracture is significantly higher in patients presenting with a
      fracture compared to individuals without a previous fracture and is highest within the first
      2 years after the initial fracture. The risk for a subsequent fracture is not dependent of
      BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT
      measurements provide information about bone structure, bone quality and bone strength in
      addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and
      bone strength and fall prediction in the patients at high risk for falls, subsequent fracture
      and mortality such as patients with a recent fracture. Therefore, the investigators conduct a
      prospective observational study in 500 patients aged 50 years and older who present with a
      clinical fracture for evaluation of bone strength, physical activity, falls, subsequent
      fractures and mortality during a follow-up period of 3 years.
    


Intervention name(s): Not applicable. The study is designed as an observational cohort study
Intervention type(s): Other
Intervention description(s): Not applicable. The study is desigend as an observational cohort study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a recent fracture evaluated at the FLS at VieCuri MC Venlo
Pelvic Floor Physical Therapy-Biomarkers Project
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Observational

Summary: 
      This study is collecting serum and urine samples at various time points during pelvic floor
      physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and
      proteomics at various time points.
    

Detailed description: 
      Collection points will be baseline, and at the last PT visit.
    

Intervention name(s): Pelvic floor PT with biomarkers
Intervention type(s): Other
Intervention description(s): Pelvic floor physical therapy and collection of urine for biomarker analysis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic
        floor PT in our center.
      
Biospecimen description: 
      serum and urine
    
Keywords: Pelvic Pain; Pelvic Floor Physical Therapy; Biomarkers
A Study to Evaluate the Safety and Efficacy of SHR-1210, Gemcitabine and Cis-platinum by R/M NPC Subjects
Condition: Nasopharyngeal Carcinoma
MeSH terms: Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single center, non-randomized, phase I trial to evaluate safety and
      efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by
      recurrent and metastatic NPC.
    

Detailed description: 
      This is an open-label, single center, nonrandomized, Phase 1 study to evaluate safety and
      efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by
      recurrent and metastatic NPC.

      The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests,
      Eastern Cooperative Oncology Group (ECOG) performance status, physical examination,
      electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be
      conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory
      events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed
      at baseline, before each study treatment, and throughout the study.Tumor response will be
      assessed by radiographic examination in screening visit and every 2 cycles after first dose.
    

Intervention name(s): SHR-1210; Gemcitabine; cis-platinum
Intervention type(s): Biological; Drug; Drug
Intervention description(s): SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.; gemcitabine; cis-platinum
Other intervention name(s): Gemcitabine Hydrochloride for Injection; Cisplantin Injection
Intervention MeSH terms: Gemcitabine; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One
      dose will be given under fasting . The Other dose will be given with a high fat meal. The
      study will evaluate the effect of a high fat meal on how much of the drug gets into the blood
      stream. Side effects will be documented. This study will last approximately 2weeks not
      including screening.
    

Detailed description: 
      Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a
      total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the
      inclusion criteria and exclusion criteria were enrolled. This clinical study has a
      randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4
      tablets were administered as a single dose in the same individual for 2 periods after fasting
      or a high fat diet, and each period was repeated with an interval of at least 1 week of
      wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned
      schedule
    

Intervention name(s): TEW-7197
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Vactosertib
Intervention MeSH terms: Vactosertib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
Condition: Degenerative Spondylolisthesis G1
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      Spondylolisthesis is a serious health condition that is often treated with surgery or
      pain-relieving lumbar epidural steroids. Patients with persistent and debilitating symptoms
      who have failed to respond to conservative treatment should consider surgery.

      Objectives: The aim of this study was to compare the therapeutic efficacy of three ultrasound
      guided PRP injections of the facet joint capsule to surgical procedures in patients with
      degenerative spondylolisthesis G1 and their effect on neurogenic pain relief and functional
      improvement over a one-year follow-up period.

      Methods:

      A one-year prospective randomised comparative clinical trial was performed on 60 patients
      with degenerative spondylolisthesis G1 who were randomly assigned to one of two groups: Group
      1: thirty patients were injected in the facet joint capsule with a series of three
      ultrasound-guided PRP injections at four-week intervals, and Group 2: thirty patients
      underwent surgery. They were exposed to clinical neuropsychological testing.They were
      assessed for pain and function using clinical neurological assessments, VAS (Visual Analogue
      Scale), FRI (Functional Rating Index), Roland Morris, and ODI.
    


Intervention name(s): PRP injection.; fixation surgical procedure
Intervention type(s): Other; Procedure
Intervention description(s): Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals,; Group 2: thirty patients underwent surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Obesity Control by Astragalus and Notoginseng Extrats
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in
      a randomized double-blind, and crossover human trial.
    

Detailed description: 
      Obesity refers to the body due to physiological or biochemical function of the change caused
      by excessive accumulation of body fat, resulting in weight gain. Hence, the aim of this study
      was to evaluate the effects of the Astragalus and Notoginseng extrats on obesity control by a
      randomized double-blind and crossover human trial. Subjects with simple obesity (body mass
      index (BMI) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19)
      perday for 12 weeks of a stage. Anthropometric measurements (body weight, body fat, blood
      pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total
      cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen
      (BUN), AST, ALT were examined every six weeks.
    

Intervention name(s): InnoSlim; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects ingested 2 capsules (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.; Subjects ingested 2 capsules placebo in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.
Other intervention name(s): Astragalus and Notoginseng extrats
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Astragalus and Notoginseng extrats; Body weight; BMI; Triglyceride; obese