bioihbjkbjnl/mcl2 huggingface dataset:
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
Condition: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty
      adolescents. Subjects who complete this trial may enter a 3 month extension study
      (UMD-01-090E).
    


Intervention name(s): Testosterone Gel (1%)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism
Performance of Junctional Tourniquets in Normal Human Volunteers
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Normal human adult volunteers wereused to investigate the performance of medical devices
      intended to stop junctional bleeding on the battlefield.
    

Detailed description: 
      Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and
      Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional
      Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity
      pulses were measured in 10 volunteers before and after junctional tourniquet application
      aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied
      in a randomized fashion, with 5 min rest periods between each application. Each tourniquet
      was applied to each subject, such that the subjects acted as their own controls.
    

Intervention name(s): CRoC; AAJT; JETT; SJT
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Use of Combat Ready Clamp (CRoC); Use of Abdominal Aortic and Junctional Tourniquet (AAJT); Use of Junctional Emergency Treatment Tool (JETT); Use of SAM Junctional Tourniquet (SJT)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control
      system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic
      excursions than insulin mono-therapy.

      Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition
      of Liraglutide compared to insulin mono-therapy.

      Study Design: This is a randomized open labeled crossover design trial comparing adjuvant
      Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for
      insulin delivery.
    

Detailed description: 
      After the screening visit, subjects will be randomized to come for two overnight visits.
      Study A- the subjects will be on the closed loop device with Novolog rapid acting insulin. In
      Study B- in addition to insulin the subjects will take a one time sub cutaneous injection of
      1.2 mg of Victoza before dinner on Day 1. Both visits will last for approximately 30 hours
      and the subjects will be managed by the closed loop device for approximately 25 hours.
    

Intervention name(s): Closed loop with sensor and Insulin; Closed loop with sensor, Insulin and Liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.; In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1.
Other intervention name(s): Novolog; Victoza
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; closed loop; artificial pancreas; insulin; victoza; liraglutide
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
Condition: Complicated Urinary Tract Infection; Cuti
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics
      and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal
      Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based
      on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in
      Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI
      (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)
    


Intervention name(s): benapenem; benapenem; benapenem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single-dose Benapenem 1.0mg(iv), 60min infusion; single-dose Benapenem 1.0mg(iv), 60min infusion; single-dose Benapenem 1.0mg(iv), 60min infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Egg Protein Hydrolysate and Vascular Function
Condition: Arterial Stiffness; Dietary Modification; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are
      at increased risk of developing long term micro- and macrovascular complications. Subjects
      with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral
      glucose load. These subjects have a markedly increased risk of later T2DM development.

      T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle
      changes and reduce the risk of T2DM development, foods containing functional ingredients are
      being developed. An interesting functional ingredient is protein hydrolysate. An egg protein
      hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma
      angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein
      hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction
      associated with T2DM. In the present study, the effects of egg protein hydrolysate will be
      evaluated in subjects with overweight or moderate obesity and IGT or T2DM.
    


Intervention name(s): protein hydrolysate capsules and placebo capsules
Intervention type(s): Dietary Supplement
Intervention description(s): Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over.
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: egg protein hydrolysate
Is Hemodialysis Associated With Cardiac Markers Change?
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the
      heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic
      tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with
      routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I
      (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
    


Intervention name(s): Hypothermic dialysis followed with routine dialysis; Routine dialysis followed with hypothermic dialysis
Intervention type(s): Procedure; Procedure
Intervention description(s): Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate); Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: End-Stage Kidney Disease; Hypothermic hemodialysis; Cardiovascular events; Troponin T; Brain natriuretic peptide
Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      The study investigates whether endurance training breathing 100% oxygen gives a additional
      improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training
      without extra oxygen supplementation. In addition work economy, stroke volume and cardiac
      perfusion is measured.

      The hypothesis of the study is that increased oxygenation of the air increases performance,
      stroke volume, work economy and cardiac perfusion.
    


Intervention name(s): Hypoxic interval training; Normoxic interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max; 4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: angina pectoris; hyperoxia; endurance training; stroke volume; cardiac perfusion
An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate
      (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune
      disease that causes pain, swelling, stiffness and loss of function in joints) in participants
      with moderate disease versus participants with severe disease and to compare the efficacy and
      safety of the MTX subgroups.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-center (study
      conducted in more than 1 center), prospective (study following participants forward in time)
      study comparing the American College of Rheumatology (ACR) scores of participants with
      moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease
      Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score
      greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX.
      DAS evaluates RA activity by several parameters including the number of swollen and tender
      joints and the participant's own assessment of their pain. Participants will receive
      infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein)
      (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of
      7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22
      Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be
      assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week
      26. Participants' safety will be assessed throughout the study.
    

Intervention name(s): Infliximab; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.; MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
Intervention MeSH terms: Infliximab; Methotrexate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis, Rheumatoid; Infliximab; Methotrexate
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 764198
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety and tolerability of BI 764198 in healthy male subjects following oral
      administration of multiple rising doses per day over 14 days and to explore the
      pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing. In addition, the
      effect of BI 764198 on the pharmacokinetics of midazolam, given as an oral microdose, will be
      explored after multiple oral dosing.
    


Intervention name(s): BI 764198; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules; Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Remediation and Functional Skills Training in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This randomized trial is examining whether a treatment called cognitive remediation is more
      effective when it is paired with a social and functional skills training component.
    


Intervention name(s): Cognitive Remediation; FAST
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer-based, therapist-lead cognitive remediation; Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Psychosis; Schizoaffective Disorder
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions
      in Chinese Healthy Volunteers.
    

Detailed description: 
      A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to
      Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference
      Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.
    

Intervention name(s): Empagliflozin Tablets; Empagliflozin Tab 25 MG
Intervention type(s): Drug; Drug
Intervention description(s): Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.; Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating
      acute pain after an abdominoplasty.
    


Intervention name(s): VX-548; HB/APAP; Placebo (matched to VX-548); Placebo (matched to HB/APAP)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Placebo matched to VX-548 for oral administration.; Placebo matched to HB/APAP for oral administration.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Peritoneal Closure Versus Non Closure During Open Appendectomy
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      There has been no consensus over closure versus non closure of peritoneum during abdominal
      operations. The aim of this study is to compare the effect of peritoneal closure versus non
      closure over postoperative pain, early complications and life quality.
    

Detailed description: 
      There has been no consensus over closure versus non closure of peritoneum during abdominal
      operations. in literature, few reports suggested that peritoneal closure may prolong the
      operation time, may increase the costs and has a probable aggravating effect on postoperative
      pain. In addition, there have been some reports that suggest non closure of peritoneum may
      not increase the postoperative complications. The need of further studies to clarify the
      effect of peritoneal closure versus non closure on postoperative pain and life quality
      especially has been specified in some literature. The aim of this study is to compare the
      effect of peritoneal closure versus non closure over postoperative pain, early complications
      and life quality.
    

Intervention name(s): open appendectomy with peritoneal closure; open appendectomy without peritoneal closure
Intervention type(s): Procedure; Procedure
Intervention description(s): open appendectomy with peritoneal closure under general anesthesia for acute appendicitis; open appendectomy without peritoneal closure under general anesthesia for acute appendicitis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peritoneal closure; appendectomy; postoperative pain; life quality
Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy
Condition: Metastatic Colorectal Cancer; Skin Rash; Skin Toxicities; Colon Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms; Exanthema
Study type: Interventional
Phase: Phase 2

Summary: 
      A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in
      patients with metastatic colorectal cancer (mCRC) who are receiving second-line
      irinotecan-based chemotherapy concomitantly with panitumumab.
    


Intervention name(s): Panitumumab; Irinotecan; FOLFIRI; Pre-emptive Skin Treatment; Reactive Skin Treatment
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): Administered by intravenous infusion; Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines.; Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.; Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).; Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)
Other intervention name(s): Vectibix
Intervention MeSH terms: Irinotecan; Panitumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STEPP; STEP; STEEP; mCRC; Skin Toxicities; Skin Rash; Metastatic Colorectal Cancer; Anti-EGFr Skin Rash; colon cancer; colorectal cancer; rectal cancer
Anti-Inflammatory Effects of Pioglitazone
Condition: Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Atherosclerosis
MeSH terms: Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      There is increasing evidence that inflammation plays a role in progression and
      destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity
      of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque
      inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.
    

Detailed description: 
      Atherosclerotic patients with impaired glucose tolerance and type 2 diabetes will undergo the
      FDG-PET/CT imaging at baseline and again following 4 months after treatment. Patients who
      meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone or 4
      mg/day glimepiride. Physical examinations will be done at baseline, 4 months, and 12 months.
      During study, subjects will have body weight, and vital signs (HR, BP, etc) assessed as well
      as waist circumference. Laboratory assessments will be done at each baseline, 4 month.
    

Intervention name(s): Pioglitazone; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.; Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.
Other intervention name(s): CAS number: 111025-46-8, ATC code: A10BG03; CAS number: 93479-97-1, ATC code: A10BB12
Intervention MeSH terms: Pioglitazone; Glimepiride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the change in weight from baseline to study week 52
      in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal
      Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
    


Intervention name(s): insulin glulisine; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.; POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment