bioihbjkbjnl/mcl2 huggingface dataset:
A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an
      already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It
      is expected that the combination will further improve the blood sugar control compared to
      semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in
      people with various degrees of reduced kidney function to the blood levels in people with
      normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants
      will only get the study medicine as two injections into a skinfold of participants belly
      (subcutaneous).

      The study will last for about 65 days including a screening phase of up to 28 days prior to
      dosing.

      If participants are eligible for the study, participants will have 11 visits to the study
      centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory
      visits (Visit 3 to Visit 11).

      Participants' vital signs (heart rate, blood pressure, body temperature) will be measured,
      participants will have blood drawn, urine will be collected and electrocardiograms (ECGs)
      will be recorded.If participants are women and can get pregnant they cannot take part in the
      study. A hormone test will be done to check if participants may be post-menopausal.
    


Intervention name(s): NNC0480-0389
Intervention type(s): Drug
Intervention description(s): A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin).
Total duration of study participation for each participant is 38 to 66 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare the pharmacokinetics of four products used for treatment of
      acute diarrhea.
    

Detailed description: 
      The study will be a single dose, randomized, four -way, four-sequence crossover study in 24
      healthy subjects, with equal numbers of males and females (minimum of 10 of either gender).
      Subjects who drop out will not be replaced. The four doses of medication given in the study
      (a single dose in each of the four study periods) will be separated by a washout period of at
      least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis
      will be taken over 12 hours. Blood samples will be centrifuged and concentrations of
      thiorphan (the active metabolite) in plasma will be measured using a validated
      chromatographic assay. Pharmacokinetic parameters will be calculated from plasma
      concentration data.
    

Intervention name(s): Racecadotril; Racecadotril; Racecadotril; Racecadotril
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Racecadotril Powder Blend; Marketed Capsule; Marketed Film-coated Tablet
Other intervention name(s): Not yet marketed; Not yet marketed; Tiorfast®; Tiorfanor®
Intervention MeSH terms: Racecadotril; Thiorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Antidiarrheals
Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery
Condition: Educational Videos; Maternal Anxiety; Surgery; Congenital Heart Disease in Children; Maternal Depression
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      To examine if educational digital video disk can reduce maternal anxiety and depression if
      their children undergo congenital heart disease surgery and when surgical or post-surgical
      complications occur. Compared to only routine education, adding digital video disk could
      decrease mothers' anxiety more after education, and until the day of discharge. Compared to
      only routine education, adding digital video disk could decrease mothers' anxiety more on the
      discharge day if their child had surgical or post-surgical complications.
    

Detailed description: 
      Aims and objectives: To examine if educational digital video disk can reduce maternal anxiety
      and depression if their children undergo congenital heart disease surgery and when surgical
      or post-surgical complications occur.

      Background: Mothers experience anxiety and depression if their children undergo conditions
      mentioned above.

      Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used.

      Methods: In a teaching hospital, 120 mothers whose children underwent first elective surgery
      for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine
      education plus digital video disk before surgery; and group 2: 60 mothers receiving routine
      education. Between groups, mothers' anxiety and depression levels were compared (1) before
      education, (2) after education (before surgery) and (3) on the discharge day. Among mothers
      whose children had surgical or post-surgical complications, the effect of watching the
      digital video disk on anxiety and depression at discharge day was evaluated.
    

Intervention name(s): Preoperative educational videos plus routine education; Preoperative routine education
Intervention type(s): Other; Other
Intervention description(s): Mothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.; Mothers receiving routine education before their children receiving congenital heart disease surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Effects of Varenicline on Brain Activity During Nicotine Abstinence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This project aims to define mechanisms through which varenicline might be an effective
      smoking cessation medication.
    

Detailed description: 
      Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject
      (cross-over), double-blind study that will assess effects of varenicline on brain activation
      while performing certain tasks. Prior to beginning the study, participants will complete an
      health and physical screening to determine final eligibility. Following a medication run-up
      and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan
      while performing attention, working memory and emotion tasks). After a 14 to 21-day washout
      period the study procedures will be repeated with placebo (order of study medication
      counterbalanced). After completion of both study periods, all participants will be offered a
      13-week quit smoking program with varenicline.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily; Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Varenicline, Imaging, fMRI
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This pilot trial will test feasibility and acceptability of a primary care-based intervention
      that aims to increase the portion of patients who enter evidence-based behavioral weight loss
      treatment.
    

Detailed description: 
      This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics
      to determine intervention acceptability and the feasibility of proposed study protocol.
    

Intervention name(s): Motivational Intervention; Comparator Intervention
Intervention type(s): Behavioral; Other
Intervention description(s): Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.; Participants informed that they have access to weight loss treatment.
Other intervention name(s): Your Wellness Prescription
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the lipid-lowering effect and safety of colesevelam therapy
      administered to heterozygous familial pediatric patients 10 through 17 years of age who are
      on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin,
      simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.
    


Intervention name(s): colesevelam HCl; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Matching Tablets
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric; hypercholesterolemia; colesevelam
Hydrotherapy CP and Lying Down to Sitting Position
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a very specific hydrotherapy
      programm on the movement from lying down to sitting position for children with CP
    

Detailed description: 
      40 children aged 5-11 years with cerebral palsy and difficulty in the transfer activity from
      lying down to sitting position were randomly divided into 2 groups of 20 children, a land
      group and a water group. The children of the land attended a neurodevelopmental treatment
      program and the water group a very specific program in hydrotherapy on combined rotation at
      all levels. The water program was implemented by specialized physiotherapists in
      hydrotherapy. The duration of the program for both groups was 3 months. On the first and last
      day of the intervention, an evaluation of all children was performed using the GMFM and PBS
      evaluation tests of the evaluation parameters of the transfer from the lying position to the
      sitting position.
    

Intervention name(s): Hydrotherapy programm
Intervention type(s): Other
Intervention description(s): Treatment
Other intervention name(s): Neurodevelomental treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 equal groups
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Cerebral palsy; hydrotherapy; Neurodevelopmental treatment; Lying down; Sitting
A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to evaluate the efficacy and safety of two different doses of
      QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses
      (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic
      participants as determined by pulmonary function testing, and effects on asthma control
    


Intervention name(s): Indacaterol acetate/Mometasone furoate; Mometasone furoate; Salmeterol xinafoate/fluticasone propionate
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): QMF149
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QMF149, Mometasone furoate (MF), asthma
Antipsychotic Response in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a
      specific disease process, as in negative schizophrenia or depression or it can be the result
      of medications used to treat forms of mental illness. Prior research has lead to a novel
      instrumental approach for distinguishing subtypes of motor slowing - one type related to
      cognitive processes and another related to parkinsonism. The purpose of this study is to test
      whether new medications used to treat schizophrenia improve the cognitive or parkinsonian
      components of motor slowing. Patients will be studied in the laboratory before and 8-weeks
      after starting a new antipsychotic. The n of this study = 60 patients. The results of this
      study will improve our understanding of the complex interactions between cognitive processing
      and motor behavior in patients with psychotic illnesses and how drugs work to treat these
      problems.
    


Intervention name(s): Risperidone; Olanzapine; Quetiapine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antipsychotics; schizophrenia; motor retardation; bradykinesia
A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A two-phase study design will be used for this pilot study. In the first phase, a 2×2
      crossover study will be used to evaluate the safety, tolerability and PK characteristic of
      APL-1202 and APL-1501 ER Tablets 3. Twelve healthy subjects will be in ratio 1:1 randomly
      assigned to two groups, randomization will be stratified by gender (male, female) in ratio
      1:1. Each group will be dosed with APL-1202, APL-1501 ER Tablets 3 in a cross-over way. A
      7-day (±1 day) washout will be required before next period of drug administration. The
      samples in first phase will be sent to bioanalysis lab for PK research at the end of first
      phase. The initiate of second phase will depend on the results of first phase within 30 days
      and not less than 7 days after the first phase.
    


Intervention name(s): APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2; APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2
Intervention type(s): Drug; Drug
Intervention description(s): Phase1: Period 1 drug administration( APL-1202 50 mg, 3 tablets, orally );Washout( 7± 1 day) ; Period 2 drug administration(1501 ER Tablets 3 382 mg ASN-1324, 1 tablet); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet); Phase1: Period 1 drug administration( 1501 ER Tablets 3 382 mg ASN-1324, 1 tablet );Washout( 7± 1 day) ; Period 2 drug administration(APL-1202 50 mg, 3 tablets, orally); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Condition: Major Depressive Disorder; Psychotic Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called
      cortisol. Under normal conditions, cortisol and other hormones are created by the body in
      response to physical and emotional stress, triggering a healthy stress response. People who
      suffer from psychotic major depression may have unusually high levels of cortisol circulating
      within them or abnormal patterns of cortisol levels, overloading the stress response
      mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If
      Corlux can keep the body's cortisol receptors from being overloaded, the stress response
      system may return to normal function, which may result in improvement of symptoms. The
      purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients
      who have been diagnosed with psychotic major depression (PMD).
    


Intervention name(s): mifepristone; mifepristone matched placebo; mifepristone 600 mg; mifepristone 1200 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): mifepristone 300 mg daily for 7 dats; daily for 7 days; mifepristone 600 mg daily for 7 days; mifepristone 1200 mg daily for 7 days
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PMD; Psychotic Depression; Psychosis; Major Depression; Depression; Psychotic Major Depression
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being performed as a Phase IV FDA commitment study and is being powered
      adequately to assess changes in sperm concentration, FSH and testosterone in healthy male
      subjects treated with pregabalin as compared to placebo, in addition to confirming lack of
      effects on sperm motility.
    

Detailed description: 
      This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects
      of pregabalin as compared to placebo on sperm concentration in healthy male subjects
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin 600 mg given twice a day; Placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial was to determine the effective doses and treatment period
      of PDC-1421 Capsule in subjects with ADHD.

      The secondary objective was to evaluate the safety of PDC-1421 Capsule in subjects receiving
      PDC-1421 at various dose levels.
    

Detailed description: 
      This study was a Part I of Phase II study designed to evaluate the safety and efficacy in
      adult patients with ADHD. The Screening phase is intended for diagnosing and assessing the
      patient for possible inclusion in the study and for providing an adequate washout period. The
      targeted population of this Part I study is six subjects who met the intent-to-treat
      per-protocol basis.

      Part I study is an open-label study, single-center, and dose escalation evaluation in six
      patients.

        1. Low dose: Six subjects will be initially evaluated for safety and efficacy assessments
           at low-dose (1 PDC-1421capsule TID) for 28 days. The subject will return for visit once
           a week during the treatment period.

        2. Checkpoint #1: There will be an evaluation with all safety assessments data to decide
           whether subjects pass the checkpoint to enter high-dose treatment or continue to receive
           a low-dose treatment by the investigator.

        3. High dose: The subjects who pass Checkpoint #1 will be initially evaluated for safety
           and efficacy assessments at high-dose (2 PDC-1421 capsules TID) for 28 days. Subjects
           will return for visit biweekly during the treatment period.

        4. Checkpoint #2: There will be an evaluation with all safety assessments data to decide
           whether this study passes the checkpoint to enter Part II by the investigators.
    

Intervention name(s): PDC-1421 Capsule
Intervention type(s): Drug
Intervention description(s): PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD
Non Invasive Ventilation During Physical Training in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Patients with cystic fibrosis older than 18 years will performance a Bruce test with non
      invasive ventilation (once) after 30 minutes they perform the same test with oxygen
      supplementation.

      Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.
    

Detailed description: 
      measurements before and after the test: transcutaneous level off carbon dioxide, saturation,
      respiratory rate, dyspnea scale.
    

Intervention name(s): Non invasive ventilation; Oxygen
Intervention type(s): Device; Device
Intervention description(s): Training on treadmill with Non invasive ventilation; Training on treadmill with oxygen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment