bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
Condition: Hepatic Impairment; Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in
      subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh
      system, who will be matched with normal healthy subjects as controls.
    

Detailed description: 
      This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in
      subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh
      system, who will be matched with normal healthy subjects as controls. The study will be
      conducted in two phases: Pretreatment and Treatment. The Pretreatment Phase will have two
      periods: Screening and Baseline. The study will enroll a sufficient number of subjects so
      that at least 24 subjects complete the study. This will include six subjects with mild
      hepatic impairment (Group 1), six subjects with moderate hepatic impairment (Group 2), four
      to six subjects with severe hepatic impairment (Group 3), and eight subjects with normal
      hepatic function (Group 4). Potential study subjects with hepatic impairment (Groups 1, 2,
      and 3) and those with normal hepatic function (Group 4) will first be screened for study
      entry. Group 1, 2, and 3 subjects will be enrolled sequentially into the study first. The
      Group 4 normal healthy subjects will be enrolled following enrollment of all of the hepatic
      impairment subjects. Subjects determined to be eligible for the protocol will receive either
      a 5- or 10-mg single oral dose of lenvatinib on Day 1, depending on their hepatic status.
      Subjects will be discharged from the unit on Day 17 (+/- 2 days) after all study discharge
      procedures have been completed.
    

Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): 5- or 10-mg single oral dose of E7080, depending on their hepatic status [Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)].
Other intervention name(s): E7080
Intervention MeSH terms: Lenvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Hepatic Function
Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
Condition: Tinnitus; Depression
MeSH terms: Tinnitus; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The investigators combined transcranial direct current stimulation (tDCS) and transcranial
      magnetic stimulation (TMS) to increase the effective response of a single session of
      neuromodulation in subjective tinnitus.
    

Detailed description: 
      To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and
      transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators
      combined these two types of neuromodulation techniques to increase the effective response of
      a single session of neuromodulation in subjective tinnitus. Experimental groups with 80
      tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham
      TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal
      area and TMS stimulated contralateral single side of the temporoparietal cortex with 200
      pulses at 1herz (Hz) stimulation.
    

Intervention name(s): transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tinnitus, tDCS, TMS
Psychobiological Evaluation of the Army Resilience Training
Condition: Psychological Stress; Psychological Adaptation
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study evaluates the influence of a resilience training on psychobiological factors which
      are related to stress and resilience in young healthy male cadets. Half of participants will
      join in the resilience training, while the other half take part in a control-training
      (diversity management training).
    

Detailed description: 
      The resilience training (Army Resilience Training / ART) is a stress prevention program based
      on well established methods from Cognitive Behavioral Therapy (CBT) and Positive Psychology
      adapted for the needs of Swiss Armed Forces. ART is designed for healthy subjects to learn
      how to get over strain.

      Diversity management training (DMT) aims to promote social skills and acts as control
      condition. DMT is part of the military training but not mandatory for the study population.
    

Intervention name(s): Army Resilience Training; Diversity Management Training
Intervention type(s): Behavioral; Other
Intervention description(s): The Army Resilience Training consists four training sessions of 90 minutes each. Participants learn to reflect their stress management (including thinking, emotions, behavioral consequences; coping strategies) and build resilience using specific strategies.; Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.
Other intervention name(s): Resilience Training; Diversity Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status
      I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1
      received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From
      the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation
      Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and
      separation-score was noted. If intranasal sedation failed, an intravenous canula was placed
      and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to
      receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.
    

Detailed description: 
      OBJECTIVES OF STUDY Anesthetic agents used for MRI in paediatrics should have few adverse
      effects, allow fast induction and recovery. The administration route is also important and
      should be minimally invasive. In this study the investigators aimed to compare two different
      doses of intranasal dexmedetomidine applied to children for MRI sedation.

      MATERIALS AND METHODS Sixty patients aged between 1-10 years, ASA I-II scheduled for MRI were
      allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2
      received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10
      minutes HR, SpO2 and RSS were recorded. Induction time was time interval to receive RSS 5.
      MRI began and separation-score was noted. If intranasal sedation failed, an intravenous
      canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was
      time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient
      was discharged.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Drug: dexmedetomidine 100 mcg/mL was applied in 3 mcg/kg and 4 mcg/kg doses in 1 mL preperates, 0.5 mL for each nostril
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: dexmedetomidine; sedation; MRI
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      This study examines the effect of soluble fiber dextrin on food intake, appetite, and
      physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this
      study. Participants were given two doses of SFD in the morning and appetite, food intake and
      physiological markers of appetite were measured over 10 years.
    

Detailed description: 
      Overweight and obesity are leading health problems. The study investigates the effect of a
      food ingredient from two different sources at two different doses on food intake and appetite
      markers over a 10 hour period. All participants reported to the laboratory first thing in the
      morning and remained in the laboratory until after their evening meal. A fixed breakfast was
      served but the participants were free to eat as much as they liked at lunch and dinner. Blood
      was taken at regular intervals during the day and assayed for glucose and several hormones
      related to appetite. Subjective measures of appetite were also collected over the 10 hour
      test session.
    

Intervention name(s): Soluble Fiber Dextrin
Intervention type(s): Other
Intervention description(s): Ingredient based on resistant starch
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Human subjects
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising
      doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
    

Detailed description: 
      The primary objective of the single rising dose part under fasting and under fed conditions
      is to investigate safety and tolerability of BI 705564 in healthy male subjects following
      oral administration of single rising doses.

      Secondary objectives are the exploration of pharmacokinetics (PK) including dose
      proportionality, and pharmacodynamics (PD) of BI 705564 after single rising doses.

      The objective of the food effect part is to explore the relative bioavailability of BI 705564
      tablets under fed and fasted conditions following the oral administration of single doses.
    

Intervention name(s): Placebo; BI 705564 (Test); BI 705564 (Reference)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet and solution formulation; Fed state; Fasting state
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Insulin and Polycystic Ovary Syndrome
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the
      kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating
      DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin
      directly by inhibition of islet insulin release with diazoxide in obese women with PCOS
      1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.
    


Intervention name(s): diazoxide
Intervention type(s): Drug
Intervention description(s): 100mg orally three times per day for 10 days
Intervention MeSH terms: Diazoxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Condition: Pain, Postoperative; Major Abdominal Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous
      Epidural Analgesia With Bupivacaine
    

Detailed description: 
      The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal
      bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major
      lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to
      continuous epidural analgesia on pain management, defined as noninferior for both pain
      control and total opioid consumption for 72 hours, in patients who had major lower abdominal
      surgery.
    

Intervention name(s): TAP block; Epidural analgesia; EXPAREL; Bupivacaine
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.; Epidural catheters will be inserted preoperatively.; Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.; Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.
Other intervention name(s): Liposomal Bupivacaine; Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
      product to the reference product as measured by increases in FEV1.
    

Detailed description: 
      A single center, open label, single dose study to demonstrate the pharmacodynamic
      bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate
      or albuterol sulfate/ipratropium in adult patients with COPD.
    

Intervention name(s): Albuterol Sulfate and Ipratropium Bromide; Albuterol Sulfate
Intervention type(s): Combination Product; Combination Product
Intervention MeSH terms: Bromides; Albuterol; Ipratropium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Condition: Depersonalization Disorder
MeSH terms: Depersonalization
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic
      stimulation in the treatment of Depersonalization Disorder (DPD).
    

Detailed description: 
      This study is a research trial of an outpatient, non-medication, non-invasive investigational
      treatment called Transcranial Magnetic Stimulation (TMS). TMS applies a magnetic field to the
      brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily
      sessions every weekday for a series of weeks. The investigators are testing whether TMS can
      treat Depersonalization Disorder (DPD).

      This is an open-label study. All patients will receive active treatment. DPD symptoms will be
      monitored through weekly self-report questionnaires as well clinical ratings with a doctor.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
Other intervention name(s): Magstim, Magstim Rapid, Magstim Rapid2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dissociative; Dissociation; Depersonalization; Depersonalization Disorder; Transcranial Magnetic Stimulation; TMS; Depersonalization Disorder (DPD); rTMS
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Condition: Attention Deficit Hyperactivity Disorder; Substance Use Disorders
MeSH terms: Hyperkinesis; Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if cognitive behavioral therapy is effective in
      treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder(ADHD) is an important comorbid condition in patients
      with substance use disorders (SUD). The prevalence of ADHD in patients with SUD is estimated
      23%, and ADHD is associated with an untoward prognosis of SUD. However, adequate treatment
      programs for patients with ADHD and SUD are not available. Results of medication trials for
      patients with ADHD and SUD are disappointing, and cognitive behavioral therapy (CBT) has not
      yet been investigated in this population. In patients with ADHD without comorbid SUD, the
      results of CBT in randomized trials are positive. The purpose of this study is to investigate
      if CBT is effective in treating ADHD symptoms in patients with ADHD and SUD.
    

Intervention name(s): cognitive behavioral therapy for treating ADHD symptoms
Intervention type(s): Behavioral
Intervention description(s): 5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; SUD; cognitive behavioral therapy
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if giving study drugs before a meal may lower blood
      sugars after the meal. An improvement in blood sugar control may prevent long-term problems
      of diabetes.
    

Detailed description: 
      A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped
      or delayed the occurrence of health problems. As a result of the study, treatment should try
      to control blood sugars as near to normal as safely possible.

      In people without diabetes, the "after meal" blood sugar level is very carefully controlled
      by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that
      raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2
      new substances made by the body called amylin and GLP-1 that also help with this careful
      balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin
      and GLP-1 are abnormal in people with diabetes.

      There are two medicines that may help to control after meal blood sugars from going too high.
      The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like
      amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work
      to control blood sugars.

      Both medicines help to keep glucagon lower after a meal. They both also help the stomach to
      digest food more slowly so the blood sugar does not go up too fast after eating. They also
      help to control how much hunger a person may have before meals. This may help a person to eat
      less and possibly lose weight. Byetta also seems to help islet cells (cells that make
      insulin) make more insulin.

      Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs
      in children with T2DM.
    

Intervention name(s): Byetta (exenatide); Symlin (pramlintide)
Intervention type(s): Drug; Drug
Intervention description(s): exenatide 5 mcg subcutaneously; pramlintide 60 mcg subcutaneously
Intervention MeSH terms: Exenatide; Pramlintide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes; pramlintide; Symlin; exenatide; byetta; glucagon; gastric emptying
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
Condition: Spider Veins
MeSH terms: Telangiectasis
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of the Excel V system for the treatment of lower
      extremity spider veins on the ankles.
    

Detailed description: 
      The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064
      nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider
      veins, specifically on the ankles, within a clinic setting.
    

Intervention name(s): Nd:YAG laser
Intervention type(s): Device
Intervention description(s): Treatment of lower extremity spider veins
Other intervention name(s): Cutera Excel V
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Condition: Epigastric Hernia; Women With Epigastric Hernias
MeSH terms: Hernia; Hernia, Abdominal
Study type: Observational

Summary: 
      The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide
      basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for
      complication, risk factors for recurrence, and readmittance.
    

Detailed description: 
      Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore,
      women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.

      The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in
      women on a nationwide basis.

      Methods Nationwide database cohort study using prospectively recorded data from the Danish
      Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year
      period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data
      from the National Civil Register (NRC). The primary outcome was operation for recurrence,
      secondary outcomes were readmission and operation for complications. We compared open vs.
      laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all patients undergoing ventral hernia repair in Denmark.