bioihbjkbjnl/mcl2 huggingface dataset:
Hemodynamic Changes During Normal Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      Prospective, observational study of the changes in hemodynamic variables such as blood
      pressure, cardiac output, systemic vascular resistance, and of changes in respiratory
      variables such as vital capacity, and functional residual volume.A cohort study of 100
      healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after
      delivery.
    

Detailed description: 
      Healthy pregnant women with the willingness to consent in physiologic tests at 3 different
      time points during, and one time point after pregnancy. Spirometric tests will be performed
      with V-MAX, non-invasive measuring of hemodynamics will be measured by Finometer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healty pregnant women scheduled for delivery at the Birth Clinic, Rikshospitalet University
        Hospital.
      
Keywords: Pregnancy; Blood pressure; Cardiac output
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
Condition: Advanced Malignant Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of
      CM082 tablet.
    

Detailed description: 
      The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of
      CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in
      Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.
    

Intervention name(s): CM082 with fed or fasting
Intervention type(s): Drug
Intervention description(s): The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.
Intervention MeSH terms: Vorolanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
Condition: Bariatric Surgery Candidate; Obesity, Morbid; Vitamin D Deficiency; Calcium Deficiency
MeSH terms: Vitamin D Deficiency; Obesity, Morbid
Study type: Interventional

Summary: 
      Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide,
      a pandemic, and has increased globally in the last 30 years. Developed countries were more
      affected, but developing countries have increasingly contributed to this epidemic as they
      continue to modernize. The national and global burden of obesity, with its public health and
      financial implications, is projected to increase markedly in the next two decades.

      the study aimed to assess the effect of Vit D supplementation on preventing altered levels of
      calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.
    


Intervention name(s): Laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic resection of a part of the stomach to enable the patient to lose weight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
Condition: Anti-Ulcer Agents
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial to investigate the safety, tolerability and pharmacokinetics and
      pharmacodynamics of JP-1366 oral administration in healthy male subjects
    


Intervention name(s): Cohort 1 (JP-1366 A mg); Cohort 2 (JP-1366 B mg); Cohort 3 (JP-1366 C mg); Cohort 4 (JP-1366 D mg); Cohort 5 (JP-1366 E mg); Cohort 6 (JP-1366 F mg); Cohort 7 (JP-1366 G mg); Cohort 8 (JP-1366 H mg); Cohort 9 (JP-1366 I mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg; Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg
Other intervention name(s): SAD; SAD; SAD; SAD; SAD; MAD; MAD; MAD; MAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult Subjects
Condition: Obese
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to provide a description of the pharmacokinetic
      properties of primaquine and metabolites and characterize these in healthy obese Thai
      subjects.

      This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal,
      subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.
    

Detailed description: 
      Subjects will have 1 hospitalization. The visit will require hospitalization for about 24
      hours. After the screening (visit 1), the subject will receive Primaquine (PQ) 30 mg base
      single dose at first admission (visit 2). Assessment of the safety profile will be done after
      admission by the investigating team before proceeding to the regimen.

      The study will enroll 10 healthy obese subjects (Body mass index [BMI] ≥30 kg/m2) both male
      and female, age 18-60 years, from the pharmacokinetic unit at Faculty of Tropical Medicine,
      Mahidol University. Participants will be healthy HIV-1, hepatitis B and C uninfected
      individuals who comprehend the purpose of the study and have provided written consent.
      Participants will be screened and eligibility will be based on inclusion and exclusion
      criteria. If all doses are completed without replacement of subjects, the total number of
      subjects in this study is 10. All subjects will undergo screening assessments within 7 days
      prior to the single dose to determine their eligibility for enrollment into the study.
    

Intervention name(s): Primaquine
Intervention type(s): Drug
Intervention description(s): Primaquine 30 mg taken after meal in the morning.
Intervention MeSH terms: Primaquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Primaquine; Pharmacokinetic
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients
      with mild to moderate Alzheimer's disease.
    


Intervention name(s): SK-PC-B70M
Intervention type(s): Drug
Intervention description(s): for dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to examine the blood flow in acetabulum after periacetabular
      osteotomy by Positron Emission Tomography (PET).
    

Detailed description: 
      As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After
      periacetabular osteotomy has been performed there is fine contact between the osteotomised
      acetabulum and the rest of the pelvis and the potential for healing is good. However, it has
      not been investigated how much the blood flow in acetabulum is changed after surgery. The
      blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the
      blood flow is important in relation to which degree osteoarthritis can be prevented after
      periacetabular osteotomy.

      It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic
      hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is
      quantified by Positron emission tomography based on measurements of O-15 water and F-18
      fluoride.
    

Intervention name(s): Periacetabular osteotomy
Intervention type(s): Procedure
Intervention description(s): osteotomy of the pelvis to increase acetabular coverage
Other intervention name(s): PAO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET; Periacetabular osteotomy
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee
Condition: Chronic Pain; Osteoarthritis
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to see the effects of transcranial direct current stimulation
      (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize
      that there will be a decrease in pain levels with active stimulation, when compared to sham
      stimulation. Before, during and after stimulation, the investigators will measure and assess
      changes intracranial blood flow with transcranial ultrasound.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.
Other intervention name(s): low intensity 1x1 direct current stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; transcranial ultrasound
Likely Use of PrEP for African American YMSM
Condition: HIV
Study type: Observational

Summary: 
      HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has
      been approved by the FDA as a method for reducing HIV transmission rates in the population,
      particularly young men who have sex with men (YMSM). This study will use a qualitative design
      to interview 20-30, HIV-negative, 16-24 year old African American YMSM to: 1) identify and
      understand African American YMSM's, aged 16-24, cognitive and emotional processes in response
      to using PrEP to reduce their risk for HIV and 2) identify what factors (sociocultural,
      individual, experiences in health care, socioeconomic) influence African American YMSM's
      likely use of PrEP as a coping strategy for HIV prevention. Demographic information will be
      collected and analyzed using Statistical Analysis Software version 9.3. Individual interviews
      will be audio recorded and transcribed by a vetted transcription service for analysis. This
      is minimal risk to participants.
    

Detailed description: 
      This study will use an exploratory, naturalistic qualitative design where participants will
      be interviewed to collect data on their emotional and cognitive processes (illness
      representation) in response to the threat of a potential HIV infection, and what factors
      (social, cultural, individual characteristics, and experiences in health care) influence
      their likely use of PrEP. The sample for this study will include 20 to 30 African American
      YMSM, aged 16-24, residing in Durham, Wake, and Orange counties of North Carolina.

      The in-depth interview guide and the 26-item descriptive survey PrEP Knowledge, Sexual
      History, and Demographic Instrument were developed for this study using a combination of the
      concepts from the adapted Common Sense Model of Illness Representation (CSM) and questions
      adapted from the Adolescent Trial Network's (ATN) 082 study's questionnaire. Participants
      will be asked questions relating to African American YMSM's likely use of HIV Pre-Exposure
      Prophylaxis (PrEP) as an HIV risk-reduction strategy. Once informed consent is obtained, the
      interview will commence and study participants will be individually interviewed to discuss
      what factors influence their likely use of PrEP. Each participant will complete the
      descriptive survey and the one-on-one interview.
    

Intervention name(s): No intervention used
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 to 30 African American young men who have sex with men, aged 16-24
      
Keywords: African American YMSM; PrEP; HIV Pre-Exposure Prophylaxis; Common Sense Model; Healthcare; HIV Prevention
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the present study is to demonstrate that the changes in the manufacturing
      process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no
      clinical impact and that the immune responses are non-inferior to the immune responses
      induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
    


Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A (different lots); Infanrix hexa; Infanrix-IPV/Hib; Rotarix
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore; Intramuscular injection, only for Visit 2 in Singapore; Oral, 2 doses
Other intervention name(s): DTPa-combined vaccine; DTPa-combined vaccine; HRV vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Immunogenicity; Primary vaccination; Safety; Pneumococcal disease
Translational Research Evaluating Neurocognitive Memory Processes
Condition: Neurocognition
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the psychometric properties and utility of new,
      computerized, neurocognitive measures in humans with depression, and humans with depression
      undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as
      there is the possibility of developing better computerized neurocognitive measures, and the
      risks are limited to no more than minimal test related fatigue and psychological stress.

      Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with
      Parkinson's disease (age 18-85) will be invited to participate in this study. After providing
      informed consent participants will undergo a clinical psychiatric evaluation to confirm the
      inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will
      complete common and new neurocognitive measures. There will be a total of two testing visits
      (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is
      no more than 2 study visits that can take place over a 4-day period (i.e., the clinical
      evaluation can occur on day 1 and the neuropsychological measures can be administered on day
      2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are able to contact the study team. The depressed ECT cohort will be referred to
        study team.
      
Keywords: Depression; Neurocognition; Electroconvulsive Therapy (ECT); Parkinson's Disease
Safety and Efficacy of Stem Cell Therapy in Patients With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by
      social interaction abnormalities, impaired verbal and non-verbal communication, and
      repetitive, obsessive behavior, while the therapeutic effect of current treatments remains
      limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies
      associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord
      blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune
      response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy.
      In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be
      evaluated in patients with Autism.
    

Detailed description: 
      To investigate the safety and efficacy of human cord blood mononuclear cells and human
      umbilical cord mesenchymal stem cells transplantation in patients of Autism.
    

Intervention name(s): human cord blood mononuclear cells; human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Intervention type(s): Biological; Biological
Intervention description(s): Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.; Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.
Other intervention name(s): Group 1; Group 2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; human cord blood mononuclear cells; human umbilical cord mesenchymal stem cells
Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Condition: Cervical Dystonia; Pain
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Observational

Summary: 
      Dystonia is a chronic neurological condition that impacts the quality of life due to
      decreased mobility, social repercussions caused by others's perception of abnormal
      involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in
      reducing pain in dystonia. However, many patients remain painful despite the injections,
      especially when the decrease in the effect of the latter, performed every 3 months on
      average. Despite frequent use of TENS in pain relief, only a few small studies studying TENS
      in dystonia were published and none of them reported TENS effects on dystonic pain using
      sensory threshold.

      This study aimed to quantify the efficacy and tolerance of TENS in the indication of pain
      related to dystonia, focusing on cervical dystonia which is the most common form of dystonia.
    

Detailed description: 
      TENDYS (TENs use in cervical DYStonia) is an observational, prospective, single arm,
      monocentric study including subjects between September 2019 and July 2020 with cervical
      dystonia treated or not with botulinum neurotoxin (BoNT) type A at the Nancy Regional
      University Hospital.

      All patients who benefited from a simple follow-up or injections of BoNT every 3 or 4 months
      for a painful cervical dystonia were proposed the use of TENS during a neurologic
      consultation with one of two specialist physicians trained to cervical dystonia. Patients who
      accepted had to give informed consent and were re-evaluated about 1 month later to ensure
      that pain persisted and to have a demo of TENS. The electro-stimulator was delivered to
      posterior cervical muscles over or close to the painful site, according to a Conventional or
      High frequency/Low intensity mode (Gate control). Patients were encouraged to use the machine
      daily, as often and long and possible, except for sleeping and driving.

      Follow-up assessments of pain occurred at the consultation toxin injection 3 months later and
      at 4 months for all patients.
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): application on muscles where pain is situated (cervical)
Other intervention name(s): transcutaneous electrical nerve stimulation
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        any patient admitted to a neurology consultation for cervical dystonia treated with
        botulinum toxin.
      
Keywords: cervical dystonia; pain; TENS
Absorption and Elimination of Radiolabeled Daprodustat
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in
      previous clinical trials; however, the elimination routes and metabolic pathways of
      daprodustat have not been fully elucidated in humans. This is an open-label, single-center,
      non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male
      participants. The aim of the study is to assess the excretion balance of daprodustat using
      [14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,
      administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).
      Absolute bioavailability of an oral dose will also be assessed. Each participant will be
      involved in the study for up to 10 weeks which include a screening visit, two treatment
      periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral
      doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The
      primary objective of the study is to gain a better understanding of the compound's excretory
      and metabolic profile. This study will include sampling of duodenal bile to conduct
      qualitative assessment of drug metabolites in this matrix in order to characterize biliary
      elimination pathways.
    


Intervention name(s): [14C]-GSK1278863 solution for IV infusion; [14C]-GSK1278863 oral solution; Daprodustat 6 mg oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It is a clear, colorless solution free from visible particulate matter. Participants will receive 10 mL of 5 µg/mL of [14C]-GSK1278863 IV solution (total dose: 50 µg) by IV infusion over 1 hour.; It is a clear, colorless solution. Participants will receive 125 mL of 200 µg/mL of [14C]-GSK1278863 oral solution (total dose: 25 mg).; It is a 9.0 millimeter (mm) round, white film coated tablet.
Intervention MeSH terms: Pharmaceutical Solutions; Glycine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1278863; pharmacokinetics; mass balance; daprodustat