bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene
      (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum
      testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1
      of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit.
      Subjects took their medications orally or by rubbing it onto the skin (depending on the
      treatment assignment) once daily for up to 6 months. Treatment visits occurred at
      approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months
      4, 5, and 6.
    


Intervention name(s): Androxal; Androxal; AndroGel; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 12.5 mg once daily; 25 mg once daily; 5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.; 1 capsule daily
Other intervention name(s): Enclomiphene citrate; Enclomiphene citrate
Intervention MeSH terms: Citric Acid; Sodium Citrate; Enclomiphene; Clomiphene; Zuclomiphene; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Secondary Hypogonadism
Comparison of PRS According to Inhalation Agent During LDLT
Condition: Liver Transplantation; Postreperfusion Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators tried to evaluate the effect of desflurane on the incidence of
      postreperfusion syndrome during living donor liver transplantation surgery. The investigators
      used sevoflurane as a comparison.
    


Intervention name(s): sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study we tested the hypothesis that an increase in protein content of the diet will
      result in an increase in the 24-hour integrated circulating growth hormone (GH) and
      insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in
      people with untreated type 2 diabetes.
    

Detailed description: 
      Subjects with untreated type 2 diabetes were studied using a randomized crossover design. The
      study began with an initial two-week observation period. Subjects then were randomly assigned
      to one arm of the study for 5 weeks. The carbohydrate:protein:fat ratio for the control diet
      is 55:15:30 whereas for the test diet it is 40:30:30. Following a five-week washout period,
      subjects were assigned to the other arm of the study. All meals were provided by the SDTU. A
      six-day rotating meal plan has been devised. At the beginning and end of the 5-week diet
      period, the subject was admitted to the SDTU (Special Diagnostic and Treatment Unit), was
      provided with the meals appropriate for the test or control arm of the study, and had blood
      drawn at various times during a 24-hour period. In addition to measurement of GH and IGF-1,
      IGF-binding proteins 1 and 3, ghrelin, and body composition were determined.
    

Intervention name(s): LoBag Diet - test phase; LoBAG Diet - control phase
Intervention type(s): Other; Other
Intervention description(s): A Low Biologically Available Glucose (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.; A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholesterol; Creatinine Clearance; Diabetes; Glycohemoglobin; High Protein Diet
Tolerability and Safety Study of Recombinant Human Acid Sphingomyelinase in Acid Sphingomyelinase Deficiency Patients
Condition: Human Acid Sphingomyelinase Deficiency
MeSH terms: Niemann-Pick Disease, Type A; Niemann-Pick Diseases; Niemann-Pick Disease, Type C
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM
      in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose
      administration.
    


Intervention name(s): Recombinant human acid sphingomyelinase
Intervention type(s): Drug
Intervention description(s): Administered intravenously every 2 weeks for 26 weeks
Other intervention name(s): GZ402665
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human acid sphingomyelinase deficiency
The PRE-D Trial: Effect of Dapagliflozin, Metformin and Physical Activity in Pre-diabetes
Condition: Prediabetic State; Obesity
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective is to compare the short-term (3 months) effectiveness of three
      glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose
      variability, body composition, and cardiometabolic risk factors in overweight or obese
      individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).
    

Detailed description: 
      Different medical therapies and lifestyle modification for the prevention of type 2 diabetes
      have yet to be compared head-to-head in individuals with pre-diabetes. This research project
      will compare different glucose-lowering interventions in overweight and obese individuals
      with HbA1c levels in the pre-diabetic range.
    

Intervention name(s): Dapagliflozin; Metformin; Exercise
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 10 mg per day as monotherapy for 13 weeks; 2 x 850 mg per day as monotherapy for 13 weeks; Interval training, 5 times per week, 30 min per session
Other intervention name(s): Forxiga, AstraZeneca; Aurobindo, Orion Pharma
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Condition: Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      metastatic germ cell tumors that have relapsed or not responded to treatment.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of sunitinib malate in patients with refractory or relapsed
           metastatic germ cell tumors.

      Secondary

        -  Determine the safety of this drug in these patients.

        -  Determine the time to tumor response and duration of tumor response in patients treated
           with this drug.

      OUTLINE: This is a open-label study.

      Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6
      weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed at 28 days and then periodically
      thereafter.
    

Intervention name(s): sunitinib malate
Intervention type(s): Drug
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian germ cell tumor; stage IV ovarian germ cell tumor; ovarian choriocarcinoma; ovarian immature teratoma; ovarian mature teratoma; recurrent malignant testicular germ cell tumor; testicular choriocarcinoma; testicular seminoma; testicular yolk sac tumor; ovarian dysgerminoma; ovarian embryonal carcinoma; ovarian yolk sac tumor; ovarian monodermal and highly specialized teratoma; ovarian polyembryoma; stage III malignant testicular germ cell tumor; ovarian mixed germ cell tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and seminoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular embryonal carcinoma and seminoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular yolk sac tumor and teratoma with seminoma; testicular yolk sac tumor and teratoma; testicular embryonal carcinoma; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; recurrent extragonadal germ cell tumor; testicular immature teratoma; testicular mature teratoma; adult teratoma
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy
      subjects.
    


Intervention name(s): Insulin 320; insulin glargine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.; As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.; Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
Condition: Gastric Cancer; Gastrostomy
MeSH terms: Stomach Neoplasms; Inflammation
Study type: Interventional

Summary: 
      Many studies have shown that inflammation has an important effect on the development,
      progression, and also response to treatment of tumors. Dexmedetomidine is a potent and
      selective alpha 2 receptor agonist, known to have a sedative, analgesic and
      immune-controlling effect. The purpose of this study is to investigate the effect of
      dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery
      in gastric cancer patients undergoing robot or laparoscopic gastrectomy.
    

Detailed description: 
      -  Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump
           (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after
           induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr

        -  Control group (normal saline group) Continuous IV normal saline using infusion pump
           (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr
    

Intervention name(s): dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.; Saline infusion during same time period.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: gastric cancer; laparoscopic gastrectomy; robotic gastrectomy
Multiple Ascending Dose Phase I Study in Order to Define Lanifibranor (IVA337) Supra-thjerapeutic Dose
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a double-blind, randomized, placebo-controlled, multiple ascending dose
      study with lanifibranor. The study will consist of up to 3 cohorts of 12 subjects each;
      therefore, approximately 36 subjects will be included in this study.
    

Detailed description: 
      All subject will receive first a single dose of 400 mg moxifloxacin, under open-label fasting
      conditions at Day -8 (assay sensitivity).

      Following, all subjects also will receive a dose of placebo under open-label fasting
      conditions at D-1.

      In the morning of Day 1, subjects will be randomized to either the investigational medicinal
      product (IMP) or placebo (3:1). The treatment phase last 14 days and the end of study visit
      will occurs within 5 to 9 days after the last dose of IMP or placebo (or at early
      termination)

      A staggered dose approach will be applied within each subjects cohort with 48 hours of delay
      between subcohorts.

      A sefty review committe (SRC) will review after each cohorts all available safety and PK data
      under blinded conditions and conclude the safety and tolerability of the dose level before
      proceeding to the next dose level.
    

Intervention name(s): Moxifloxacin; Placebo; Lanifibranor; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose at D-8; Single oral dose at D-1; Single daily oral dose during 14 days; Single daily oral dose during 14 days
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Multiple ascending dose study with 3 sequential cohorts of 12 subjects treated by Lanifibranor versus Placebo during 14 days
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy male volunteers; multiple ascending dose; supra-therapeutic dose
Reresveratrol Administered to Healthy Male Subjects
Condition: Healthy Subjects; Heme Oxygenase
Study type: Interventional

Summary: 
      Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to
      evaluate the HO-1 stimulation of resveratrol in healthy humans.
    


Intervention name(s): Resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): 5 g (10 capsules) as single oral dose on day 1
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Reiki Applicatıon on Sleep and Qualıty of Life in Epılepsy Patıents
Condition: Sleep; Life Quality
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      After the general period of positive social adjustments, epilepsy is in a high life cycle to
      control seizures. During seizures in epilepsy, patients' quality of life and antiepileptic
      life span can be seen in daily life such as daily life and daily awakenings.

      Reiki, which has been proven by studies in health problems such as fatigue and pain; an
      energy that can be unblocked or applied in a non-applicable way can benefit from a therapy
      that can be applied by touch or remotely, without negative effects. In the literature, reiki
      applied to epilepsy patients has sleep and quality of life. This thesis is planned to do
      research on sleep and living areas of reiki applied to epilepsy patients.
    

Detailed description: 
      This research; It will be carried out on a voluntary basis with the treatment of 60 patients
      with epilepsy, 30 of which will be tested, 30 of which will be comprehensive, from the
      University of Fır Hospital Neurology Clinic Polyclinic and those over 18 years of age, who
      can communicate adequately, who have psychiatric problems, who are in the last six body mind,
      who can control the phone, who will come to the scale, who will come to sleep. The study will
      be a pretest-posttest controlled group study. Data; Patient Information Form will be
      collected with Pittsburgh Sleep Quality Scale, Quality of Life in Epilepsy Scale. The control
      method will not interfere. If we try, first the application places and the way of doing it
      will be shown. Administration through 4 weeks, first consecutive week; 1 session face-to-face
      30-45 minutes, then 3 sessions of 21 minutes of training, 2 sessions of 21 minutes of
      training in the other 3 training courses, a total of 4 weeks 10. For face-to-face reiki; A
      room will be used inside the hospital. Reiki to 7 different chakras to be taken in the first
      session. For the other sessions, before the application, all will be called and informed
      about the reiki will be sent, and then he will apply reiki from a distance for 21 minutes by
      using the training and reiki symbols. The scales will be reapplied by the researcher, either
      face to face or face to face, during the experiment and 4 weekends to be controlled. Finally,
      there will be a significant difference between the pretest and the son test.
    

Intervention name(s): sleep
Intervention type(s): Behavioral
Intervention description(s): reiki
Other intervention name(s): life quality
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: reiki
Masking: Single (Participant)
Primary purpose: Supportive Care
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes
Condition: Dehydration
MeSH terms: Dehydration
Study type: Observational

Summary: 
      The study will aim to evaluate the correlation between changes in ultrasound velocity and
      measures of hydration status including urine specific gravity, plasma and urine osmolality in
      male and female young adults after undergoing an acute dehydration and rehydration. The study
      will also test the hypothesis that body dehydration is a generalized physiological process
      equally affected all body muscles by comparing the data obtained on calf and biceps muscles.
    


Intervention name(s): Hydration Monitor
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subject pool will be comprised of 100 young, healthy, physically active male and female
        subjects.
      
Keywords: dehydration
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Recent evidence has shown that transcutaneous electrical nerve stimulation (TENS) was
      effective in improving the cognitive function in healthy adult and people with dementia.
      However, lacking of evidence investigated the effect of TENS in improving the cognitive
      function and reversing the occurrence of dementia during the period of mild cognitive
      impairment (MCI), which is the crucial period to prevent the significant loss of cognition
      function. Therefore, the main objective of this study is to investigate the optimal TENS
      treatment protocol in improving the cognitive function in older adults with MCI.
    

Detailed description: 
      This study aims to investigate the effectiveness of 3 intervention protocols (1) In the T1
      TENS group, the subject will receive TENS on T1 spine. (2) In the vagus nerve TENS group, the
      subject will receive TENS on the concha of left outer ear. (3) In the sham stimulation group,
      the subject will receive sham stimulation on the T1 spine, in improving the cognitive
      function in older adults with MCI.
    

Intervention name(s): T1 TENS; Concha TENS; Control
Intervention type(s): Device; Device; Device
Intervention description(s): The subjects in Group A will received TENS (Burst mode, 9 pulses per burst, pulse frequency =160Hz, burst frequency=2Hz, intensity was set to trigger visible muscular twitches). Two 2 x 3 cm electrodes was attached on T1 level with 2 cm from the spine. Previous study has shown that it was effective to improve the cognitive function in subjects with Alzheimer's disease.; The subjects in Group B will received TENS (25Hz, 0.5mA) on the concha of left outer ear. The electrical stimulation was generated by the portable neurostimulator (Nemos®, Cerbomed, Erlangen, Germany) and was delivered by a titanium electrodes positioning on top of a silicon earplug. Previous study has shown that it was effective to improve the Accelerate extinction memory formation and retention in healthy young adults.; The subjects in Group C will receive 30 min sham electrical stimulation on T1 by a placebo-TENS device. The Placebo-TENS was applied by an apparently identical TENS unit. The unit's power indicator light was illuminated, but the unit's electrical circuit had been manually disconnected inside. In order to shape the common mindset, all subjects (except those in the Control group) were informed that they might or might not feel an electrical current, as different stimulation parameters were being applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive function; Transcutaneous electrical nerve stimulation
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086
      vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6
      schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work
      directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086
      vaccine development program. The study will provide descriptive safety and immunogenicity
      data following vaccination of these individuals with bivalent rLP2086 vaccine.
    


Intervention name(s): rLP2086
Intervention type(s): Biological
Intervention description(s): 0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention