bioihbjkbjnl/mcl2 huggingface dataset:
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Condition: Uterine Fibroids; Fertility Disorders
MeSH terms: Leiomyoma; Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the
      prevention of adhesions in gynaecologic surgery, and to assess post-operative complications
      related to adhesions and pregnancy rate after myomectomy by open surgery.
    

Detailed description: 
      This study was addressed to patients having an immediate or differed pregnancy desire and
      presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.

        -  The primary end point was the assessment of adhesion rate to the uterine surgical sites
           during a laparoscopic second look performed 10 to 20 weeks post-surgery.

        -  The secondary end points were the assessment, throughout a 3 years follow-up period, of:

             -  pregnancy rate,

             -  adverse events related to adhesions,

             -  adnexal adhesions according to American Fertility Society score,

             -  abdomino-pelvic adhesions according to the modified American Fertility Society
                score.
    

Intervention name(s): Ringer lactate solution; Prevadh film
Intervention type(s): Other; Device
Intervention description(s): Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.; Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
Other intervention name(s): Myomectomy by Laparotomy; Myomectomy by Laparotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myomectomy; adhesion prevention; pregnancy rate
A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
Condition: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in
      the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers
    


Intervention name(s): BL-8040; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Pilot Study of Growth Hormon to Treat SMA Typ II and III
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Growth hormon can increase strength in
      spinal muscular atrophy type II and III.
    

Detailed description: 
      This pilot study is planned as a placebo-controlled cross-over trial in a limited number of
      patients. It is the aim to investigate the effect of GH on the short-term changes of strength
      and to investigate the tolerability of the treatment. If the results of the study are
      positive, further studies of longer duration addressing the development of motor function and
      quality of life could follow
    

Intervention name(s): somatotropin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening; 0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
Other intervention name(s): Penfill®; Penfill®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: growth hormone; strength; Spinal muscular atrophy type II and III
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray
      following a single dose in epileptic patients experiencing a seizure episode.
    


Intervention name(s): Diazepam
Intervention type(s): Drug
Intervention description(s): single-dose; dosage in mg, based on patient body weight
Intervention MeSH terms: Diazepam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potential Association of a Common L-FABP Polymorphism With Lipid-induced Hepatic Insulin Resistance
Condition: Wildtype; Polymorphism Liver FABP
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The investigators hypothesise that a common A277G polymorphism of the liver fatty acid
      binding protein (L-FABP) gene, which leads to an amino acid exchange, may be associated with
      alterations of lipid-induced hepatic insulin resistance. In the present study the
      investigators will investigate potential differences in lipid-induced hepatic insulin
      resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy
      subjects with the A277G polymorphism vs. subjects carrying the wildtype.
    

Detailed description: 
      Liver fatty acid binding protein (L-FABP) is an abundant cytosolic lipid-binding protein that
      regulates lipid transport and metabolism. Only one common non-synonymous polymorphism (A227G)
      leading to an amino-acid exchange in the exonic region of the L-FABP gene has been previously
      identified. Experimental elevations of free fatty acids (FFAs) have been shown to impair
      insulin mediated suppression of endogenous glucose production (EGP). Deletion of the L-FABP
      gene shows no obvious phenotype in mice receiving a low fat chow diet, but leads to decreased
      hepatic triglyceride accumulation in the prolonged fasted state, which exposes mice to an
      increased fatty acid flux to the liver. The function of the L-FABP gene may be altered by
      polymorphisms in coding regions of the gene, probably leading to modifications in hepatic
      triglyceride accumulation and hepatic insulin resistance.We hypothesize that carriers of the
      A277G SNP, when compared to matched wild-type subjects, may show altered responses of hepatic
      glucose production upon exposure to increased peripheral fatty acid concentrations, as
      achieved by lipid / heparin infusions. Because it is known that free fatty acids potently
      increase insulin secretion, we use somatostatin clamps in our experiments, followed by
      replacement of postabsorptive insulin and glucagon concentrations.
    

Intervention name(s): measurement of lipid-induced hepatic insulin resistance
Intervention type(s): Procedure
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: lipid induced hepatic insulin resistance; polymorphisms liver fatty-acid-binding-protein; gluconeogenesis; glycogenolysis; endogenous glucose production
A Food Effect Study of KC1036 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The primary objective of the study was to assess the effect of High Fat Diet on the
      pharmacokinetics of KC1036 in Chinese adult healthy subjects.
    

Detailed description: 
      This is an open-label, randomized, two cycle self crossover experimental design study to
      assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of
      KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.

      Group A：In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat
      diet state, KC1036 po only once (60mg QD).

      Group B：In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the
      fasting state, KC1036 po only once (60mg QD).
    

Intervention name(s): KC1036
Intervention type(s): Drug
Intervention description(s): 60mg QD
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double cycle, self crossover
Masking: None (Open Label)
Primary purpose: Other
Transitional Rehabilitation in CABG Patients
Condition: Coronary Artery Disease; Coronary Artery Bypass Graft Surgery
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The goal of this research study is to understand whether an at-home exercise program started
      soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital,
      can preserve or improve physical function.
    

Detailed description: 
      Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important
      treatment option for coronary artery disease. The post-surgery period of rest and recovery is
      associated with cardiorespiratory and skeletal muscle deconditioning. The goal of this
      research study is to understand whether an at-home exercise program started soon after CABG
      surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a
      bridge between surgery and the start of cardiac rehabilitation to preserve or improve
      physical function. Volunteers will be randomly assigned to receive neuromuscular electrical
      stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group).
      Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery.
      Assessments will include measurements of physical function by the Short Physical Performance
      Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective
      physical functional capacity and quality of life using the Medical Outcomes Short form 36.
      Additionally, accelerometry will be used to monitor weight-bearing physical activity during
      the 4 week treatment phase.
    

Intervention name(s): neuromuscular electrical stimulation
Intervention type(s): Device
Intervention description(s): bilateral quadriceps exercise with neuromuscular electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
This Study Will Examine the Effects of GSK256066 to Protect Mild Steroid-naive Asthmatics Against an Antigen Challenge
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a single centre, randomised, double-blind, placebo-controlled, 2-period
      crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066
      on bronchial hyper-reactivity to adenosine monophosphate.
    


Intervention name(s): GSK256066
Intervention type(s): Drug
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GSK256066,; allergen,; challenge,; repeat dose,; AMP,; mild asthmatics
The Effect of Scapular Exercises in Patients With Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      There is a paucity of research on the correlation between postural control and upper
      extremity function. Analyzing the mechanisms of postural deficits and related problems is
      believed to give idea for any conceivable advance in future rehabilitation strategies in
      patients with stroke.

      The purpose of this study was to examine the effect of scapular exercises on the scapular
      stability and trunk control. We hypothesized that scapular exercises correct the scapular
      position and improve postural control. Hence the reaching out movement can be applied in a
      controlled and fluent manner at the end of the treatment.
    


Intervention name(s): Bobath Approach; Isometric scapular exercises
Intervention type(s): Other; Other
Intervention description(s): The patients in both groups were treated with the exercise program according to the Bobath concept was planned taking the functional needs of the survivors into account, including stretching and facilitation of latissimus dorsi muscle, facilitation of abdominal muscles, placing exercises, training of lumbar spine stabilizers, functional reach of shoulder in different directions. Five sessions of about an hour each were provided to the patients; Isometric scapular exercises were performed to the patients included to the study group in a sitting position and at 900 of the shoulder flexion and 900 of the shoulder abduction. The patients were exercised by a physiotherapist using isometric contraction in protraction and retraction by a physiotherapist. Isometric contractions lasted 5 seconds and each exercise was repeated 2x15 times. One minute rest period was given between sets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group
      comparative trial to be conducted in nocturia patients. The trial is designed to characterize
      the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct
      dose recommendations in the target patient population. In particular, the trial is designed
      to link the duration of action to the clinical endpoint. Furthermore, the trial is designed
      to describe the safety of four different dose levels of desmopressin.
    


Intervention name(s): Desmopressin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration; Placebo melt tablet for sublingual administration
Other intervention name(s): FE992026; Minirin Melt
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nocturia; bladder function
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      The aim of the study is to evaluate whether fluid responsiveness of the critically ill
      patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood
      pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left
      ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test).
      The chances are compared to increase of CI after volume expansion (gold standard). In
      clinical practise, it would be especially relevant if PEEP-induced changes in arterial
      pressure variations could be used in evaluation of volume status and fluid responsiveness.
      However, as ECHO-derived variables are used in greater extent to guide the treatment with
      inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic
      measurements is essential in the study design.
    


Intervention name(s): Volume expansion with gelofusine
Intervention type(s): Other
Intervention MeSH terms: Polygeline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: norepinephrine infusion; under 48 hours in ICU
STorz Against Glidescope Effectiveness
Condition: Difficult Airway
Study type: Interventional

Summary: 
      This study evaluates success rates of tracheal intubation (passing a breathing tube)for
      patients who may be more challenging to intubate while utilizing one of two devices that
      facilitate placement of the tube with video technology.
    


Intervention name(s): C-MAC; Glidescope
Intervention type(s): Device; Device
Intervention description(s): C-MAC arm; Glidescope arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: difficult airway; video laryngoscopy
Migraine Study in Adolescent Patients
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine how well the combination medication, sumatriptan and
      naproxen sodium, treats migraine headache in adolescents 12-17 years old
    

Detailed description: 
      The purpose of this study is to determine whether the combination product, sumatriptan and
      naproxen sodium, is effective compared to placebo in the treatment of acute migraine in
      adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week
      period.
    

Intervention name(s): Sumatriptan and Naproxen Sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan succinate and naproxen sodium; Placebo to match
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine with or without aura; Migraine efficacy; Migraine; Migraine headache; Adolescent migraine; TREXIMET; Sumatriptan succinate; Naproxen sodium; Migraine, acute
Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
Condition: Schizophrenia; Hallucinations
MeSH terms: Hallucinations; Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the changes in various aspects of auditory verbal
      hallucinations during 24-week antipsychotic treatment in naturalistic condition.
    

Detailed description: 
      Auditory verbal hallucinations (AVH), meaning the experience of hearing voices, occur in
      60-75% of patients with schizophrenia. Patients experiencing persistent AVH tend to be
      interrupted in their daily routines and have trouble keeping regular jobs due to the
      intrusiveness or abusive contents of voices. In addition, auditory hallucinations are
      reported to remain even after disappearance of other psychotic symptoms in many patients with
      schizophrenia spectrum disorders after treatment with typical antipsychotics.

      The study involves detailed phenomenological assessments of AVH and other psychotic symptoms,
      as well as side effects of atypical antipsychotics.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        voice-hearing patients with schizophrenia
      
Biospecimen description: 
      routine lab tests for changes in medical condition
    
Keywords: schizophrenia; auditory verbal hallucination; antipsychotic treatment
Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of
      insulin degludec and liraglutide, when administered either combined or as separate
      administrations.
    


Intervention name(s): insulin degludec; insulin degludec/liraglutide; liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.; Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.; Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions
Condition: Depression
MeSH terms: Malnutrition; Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine
      Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.
    


Intervention name(s): Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.); Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.); Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment