bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics
      (the exposure of the trial drug in the body), pharmacodynamics (the effect of the
      investigated drug on the body), and the safety and tolerability of semaglutide in healthy
      male Japanese and Caucasian subjects.
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule; Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      This research is being done to see how effective high-dose rate endorectal brachytherapy
      (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want
      to try to decrease side effects and shorten the course of radiation treatment for patients
      with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This
      is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation
      is given through an applicator placed into the bowel next to the tumor. The radiation is
      directed at the tumor and a small area around it.
    

Detailed description: 
      This study is a pilot study open to patients with clinical stage T2N1 or T3N0-1 resectable
      rectal cancer. The investigational tool being evaluated is high-dose endorectal brachytherapy
      (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal
      cancer. This study assumes that the rate of pathological response to HDRBT will be similar to
      historical controls (conventional neoadjuvant chemoradiation). All patients will receive
      postoperative standard 5-fluorouracil (FU) based chemotherapy (at the discretion of the
      medical oncologist). The clinical response will be assessed with endoscopic/ultrasound,
      pelvic MRI and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT. In addition,
      tissue and serum will be collected to evaluate for biological predictors of response to
      therapy. The endpoints of this study include adverse events (gastrointestinal toxicity),
      quality of life as measured by the quality of life questionnaire (QLQ)-C30, and tumor
      regression/response.
    

Intervention name(s): High-dose endorectal brachytherapy (HDRBT)
Intervention type(s): Radiation
Intervention description(s): The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
Other intervention name(s): HDRBT
Intervention model: Single Group Assignment
Intervention model description: High-Dose-Rate Endorectal Brachytherapy (HDRBT)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal cancer; high dose endorectal brachytherapy
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
Condition: Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare visual acuity, safety, predictability, corneal
      biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule
      extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after
      ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
    


Intervention name(s): Carl Zeiss Meditech VisuMax laser
Intervention type(s): Device
Intervention description(s): Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Other intervention name(s): Refractive lenticule extraction, ReLEx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Myopia; refractive surgery; all femtosecond laser; ReLEx flex; ReLEx smile
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
Condition: Peripheral Arterial Disease; Critical Limb Ischemia
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an MRI technique called Blood Oxygen Level
      Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment
      with standard endovascular therapy in patients with chronic lower limb ischemia.
    

Detailed description: 
      This study is a prospective single arm, open label registry to evaluate the feasibility of
      blood oxygen level dependent (BOLD) magnetic resonance imaging for the assessment of a
      potentially new functional surrogate of altered lower limb skeletal muscle oxygenation after
      a successful percutaneous endovascular intervention. Baseline MRI assessment using the BOLD
      technique will be performed on qualified subjects prior to undergoing a standard of care
      endovascular therapy. Post-procedure BOLD-MRI assessment will also be performed at 30 days
      and either 90 or 180 days post-procedure. Post-MR image acquisition processing and analysis
      will be performed, using pre-determined algorithms, by a core laboratory.
    

Intervention name(s): BOLD-MRI
Intervention type(s): Other
Intervention description(s): A fixed air cuff will be placed on the index limb at the level of the calf and will be inflated to a level which induces the loss of the pedal Doppler signal. Inflation will be maintained for 180 seconds, then will be rapidly deflated and BOLD MR imaging will be initiated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Time Point of Carboprost Methylate Administration and Perioperative Complications
Condition: Artificial Abortion, PONV(Post Operative Nausea and Vomiting)
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Artificial abortion is the most widely used procedure in termination of first-trimester
      pregnancy. Cervical ripening before the operation guarantees operative convenience and
      decreases complications. An overstrained cervical dilation associates with uterine
      perforation, cervical laceration and cervical incompetence. To address the issue, various
      mechanical and pharmaceutical methods have been applied to prepare the cervix before
      transvaginal procedures. Prostaglandin analogues (PGs) play an important role in ripening the
      cervix or promoting uterine contraction in gynecology and obstetrics. As most tissues express
      prostaglandin receptors, vomiting, nausea, fever, diarrhea and abdominal pain can hardly be
      avoided with PGs administration. Longer PGs action contributes to better cervical ripening,
      but more uncomfortableness at the same time. These annoying symptoms may affect the
      participants' satisfaction and increase perioperative risks. To balance the safety and
      effectiveness of the surgery as well as patients' feeling, a proper timing for cervical
      ripening should be investigated. However, the administration timing of PGs has not reached a
      broad consensus, ranging from 16 hours to 2 hours before surgery. Carboprost methylate (CM),
      a PG-F2α analogue, has been used nationwide for cervical ripening in China. To minimize the
      side effects of PGs without affecting cervical ripening, the investigators intended to
      explore shortening the action time of CM in cervical preparation before artificial abortion.
      Thus, the investigators conducted this prospective cohort study and aimed to examine the
      efficacy of early and delayed vaginal administration of CM before surgery, and optimized both
      the perioperative safety and participants' convenience. The investigators hypothesize that
      early vaginal administration of CM would not affect the cervical ripening status, but will
      greatly reduce the unpleasant complications among the participants.
    


Intervention name(s): early vaginal administration of carboprost methylate; delayed vaginal administration of carboprost methylate
Intervention type(s): Drug; Drug
Intervention description(s): In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.; In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.
Intervention MeSH terms: Carboprost; Carboprost tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose
      of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
    


Intervention name(s): Lorcaserin hydrochloride
Intervention type(s): Drug
Intervention description(s): A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water.
Other intervention name(s): APD356
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Lorcaserin hydrochloride; APD356; Pediatric; Pharmacokinetics
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Condition: Obstetric Labor Complications; Hemorrhage
MeSH terms: Obstetric Labor Complications; Hemorrhage
Study type: Interventional

Summary: 
      This is a prospective, randomized and controlled study to find out if a rotational
      thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions
      in major obstetric haemorrhage compared to standard care of clinical decision making,
      conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out
      if ROTEM can predict the incidence of thromboembolic events in this patient group.
    

Detailed description: 
      A comparison of two different treatment protocols is made in patients suffering major
      obstetric haemorrhage: those who after a normal delivery are bleeding more than 1000 ml and
      are in need of surgical intervention to control the bleeding and those in cesarean section
      with ongoing bleeding of more than 1000 ml. Patients are randomized in to two groups: the
      control group(n=30) will be treated according to a protocol based on clinical decision
      making, standard coagulation tests and massive transfusion packages of blood products(1:1:1),
      if needed. This is referred as 'Standard care' in this hospital. The intervention group(n=30)
      will be treated according to a rotational thromboelastometry guided protocol, and massive
      transfusion packages, if needed. The study is powered to detect a reduction of one unit in
      red blood cell transfusion. Blood product, fibrinogen concentrate, prothrombin complex
      concentrate usage and total amount of blood loss will be compared, and the number of
      transfusion related side effects and thromboembolic events 30 days after the bleeding will be
      recorded.
    

Intervention name(s): Rotational Thromboelastometry (ROTEM)
Intervention type(s): Device
Intervention description(s): A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thromboelastometry; Obstetric Hemorrhage; Blood Component Transfusion
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.
    


Intervention name(s): PNU-100480; PNU-100480; Placebo; PNU-100480; PNU-100480; Placebo; PNU-100480; PNU-100480; Placebo; PNU-100480; PNU-100480; PNU-100480; Placebo; PNU-100480; PNU-100480; PNU-100480; Placebo; PNU-100480; PNU-100480; PNU-100480; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg oral suspension given once; 300 mg oral suspension given once; placebo to match oral suspension given once; 300 mg oral suspension given once; 35 mg oral suspension given once; placebo to match oral suspension given once; 100 mg oral suspension given once; 35 mg oral suspension given once; placebo to match oral suspension given once; 1000 mg oral suspension given once; 1500 mg oral suspension given once; Fed conditions, 600 mg oral suspension given once; placebo to match oral suspension given once; 1500 mg oral suspension given once; 600 mg oral suspension given once; Fed conditions, 600 mg oral suspension given once; placebo to match oral suspension given once; 1000 mg oral suspension given once; 600 mg oral suspension given once; Fed conditions, 600 mg oral suspension given once; placebo to match oral suspension given once
Other intervention name(s): Period 2; Period 3; Period 1; Period 3; Period 1; Period 2; Period 2; Period 1; Period 3; Period 2; Period 3; Period 4 (Fed); Period 1; Period 3; Period 1; Period 4 (Fed); Period 2; Period 2; Period 1; Period 4 (Fed); Period 3
Intervention MeSH terms: Oxazolidinones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety tolerability pharmacokinetics PK first in human FIH
Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
Condition: Early-Onset Scoliosis Deformity of Spine
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      The investigators are conducting research to compare serum and urine titanium levels in
      children with early onset scoliosis who are being treated with certain types of metal spinal
      rods. These rods include traditional growing rods (TGR), magnetically-controlled growing rods
      (MCGR), and Vertical Expandable Prosthetic Titanium Rib (VEPTR). Children with metal rods may
      have elevated serum and urine titanium levels. These levels may remain elevated over time.
      The investigators will collect serum titanium levels from children with metal rods and
      children without metal rods to see if there are differences in their titanium levels. The
      investigators will then collect a second serum titanium level from children with metal rods
      at least 6 months later to see if the participants titanium levels remain elevated over time.
      The investigators will also collect urine titanium levels from children with metal rods to
      see if titanium is excreted in the urine.
    


Intervention name(s): Growth-sparing instrumentation and titanium levels
Intervention type(s): Combination Product
Intervention description(s): Patients with growth-sparing instrumentation as treatment for early onset scoliosis, will have their titanium (serum and urine) levels tested, to evaluated if they have elevated titanium levels compared to a control group.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be patients treated by the Pediatric Orthopaedic Surgery
        department at Michigan Medicine.
      
Keywords: Titanium Levels
[C-11]NOP-1A and Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use
      disorders and controls
    

Detailed description: 
      This will allow for understanding brain stress and antistress mechanisms that underlie abuse
      of alcohol in humans
    

Intervention name(s): [C-11]; NOP-1A
Intervention type(s): Radiation; Drug
Intervention description(s): Radiolabel; Tracer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: [C-11]NOP-1A
Masking: None (Open Label)
Primary purpose: Basic Science
Asthma and Obesity: Observational
Condition: Asthma; Obesity
MeSH terms: Asthma; Obesity
Study type: Observational

Summary: 
      Obesity is associated with poor asthma control and greater healthcare utilization and costs.
      In this study the researchers will examine the biologic and behavioral interrelationships
      between these conditions and their impact on outcomes. Towards this end, the researchers will
      conduct an observational prospective cohort study of 400 obese asthmatic patients treated at
      institutions in New York City and Denver, and develop and pilot test educational and
      counseling modules that take an integrated approach to asthma and obesity self-management
      support.
    

Detailed description: 
      The objective of this study is to examine novel biological and behavioral pathways that may
      explain the association of obesity with asthma morbidity, and develop and pilot test
      educational and counseling modules, based on self-regulation theory, that take an integrated
      approach to asthma and obesity self-management support.

      The Specific Aims are to:

        1. Compare the longitudinal relationship between L-arginine/ADMA balance and morbidity
           (lung function, asthma control, acute resource utilization, and quality of life) between
           obese adults with late onset asthma vs. (a) obese adults with early onset asthma and
           non-obese asthmatics with early (b) or late (c) onset disease. Age of asthma onset is as
           categorized as early when developed ≤12 years of age or late when developed >12 years of
           age.

        2. Evaluate the interrelationship between obesity- and asthma-related illness beliefs, and
           the impact of cognitive function, on patients' management of these conditions over time
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A description of the population from which the groups or cohorts will be selected (for
        example, primary care clinic, community sample, residents of a certain town).
      
Biospecimen description: 
      Serum and plasma
    
Keywords: Asthma; Obesity; Observational Study
A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof of concept study will be a placebo controlled, randomised, double blind, parallel
      study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of
      osteoarthritis (OA) pain in the knee.
    


Intervention name(s): AKR 202; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and safety of a single oral
      administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg
      famotidine and a single oral administration of placebo (comparator without an active
      substance) in treating the symptoms of acute heartburn episodes. The study is designed to
      collect more efficacy data on Talcid® in patients using self-medication to relief the
      symptoms of acute heartburn.
    


Intervention name(s): Talcid (Hydrotalcite, BAY4516H); Famotidine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine; 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg; 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine
Intervention MeSH terms: Famotidine; Hydrotalcite
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute heartburn episodes