bioihbjkbjnl/mcl2 huggingface dataset:
Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease
Condition: Cardiovascular Diseases; Diabetes; Gestational Diabetes; Preeclampsia; Gestational Hypertension; Small for Gestational Age at Delivery; Preterm Birth; Overweight and Obesity
MeSH terms: Diabetes, Gestational; Pre-Eclampsia; Premature Birth; Hypertension, Pregnancy-Induced; Cardiovascular Diseases; Diabetes Mellitus; Overweight; Weight Loss
Study type: Interventional

Summary: 
      This study plans to learn more about how to increase postpartum weight loss and how to
      decrease risk factors for postpartum women at increased risk for diabetes and heart disease.
      The program is delivered using a mobile application (app) and a lifestyle coach. This mobile
      application is developed for women who are at higher risk for diabetes and heart disease.
      Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational
      hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in
      the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their
      pregnancies have a higher risk for diabetes and heart disease. This mobile application was
      developed using the latest research studies and using the evidence-based Diabetes Prevention
      and Colorado Weigh programs. The goal of the program is to help women lose weight and
      participate in physical activity after delivery.
    


Intervention name(s): Fit After Baby; Text4Baby Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobile application; Receive free text messages
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Treatment of Hypertension
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether the long-term treatment of essential hypertension without significant
      target organ disease materially influenced mortality and/or cardiovascular renal morbidity.
    

Detailed description: 
      BACKGROUND:

      This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and
      followed a cooperative study of the treatment of renal hypertension initiated in 1960 to
      evaluate the relative efficacy of several recognized drug regimens for reduction of blood
      pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.

      DESIGN NARRATIVE:

      Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were
      assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to
      placebo.

      The study completion date listed in this record was inferred from last publication listed in
      the Citations section of this study record.
    

Intervention name(s): chlorothiazide; Rauwolfia alkaloids
Intervention type(s): Drug; Drug
Intervention MeSH terms: Chlorothiazide
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the
      safety and tolerability of JTT-130 in obese Type 2 diabetic patients.
    


Intervention name(s): JTT-130; JTT-130 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Condition: Corneal Endothelial Cell Loss
MeSH terms: Corneal Endothelial Cell Loss
Study type: Observational

Summary: 
      The primary objective of this clinical study is to collect additional clinical data to
      support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary
      objective is to evaluate any adverse events found during the clinical study.
    


Intervention name(s): Topcon Specular Microscope SP-1P; Konan Specular Microscope CELLCHEK XL
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology Practice
Study of SB681323 and Prednisolone on Biomarkers in COPD (Chronic Obstructive Pulmonary Disease) Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effects of single oral doses of SB681323 and prednisolone on
      biomarkers in induced sputum and blood COPD patients
    


Intervention name(s): SB681323; Prednisolone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg and 2.5 mg tablets - The tablets will be round (9.0 mm in diameter) and white and provided in labelled bottles; 5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous); Tablets matched to SB681323 or prednisolone
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD SB-681323 prednisolone biomarkers
Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients
Condition: Human Papilloma Virus; Hiv; Organ Transplants
MeSH terms: Papilloma
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with immunodeficiencies are at increased risk of developing persistent HPV infection
      and as such HPV-related disease (genital warts and cancer).

      In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety,
      tolerability and immunogenicity will be evaluated up to one month following the 3rd and last
      dose of Gardasil®9.
    

Detailed description: 
      This is a single-center, open-label study on safety, tolerability and immunogenicity of
      Gardasil®9 in 18 to 45 year-old HIV patients, in 18 to 55 year-old solid-organ transplant
      (SOT) patients.

      This study will enrol 140 HIV patients with CD4+ (cluster of differentiation 4) count of
      >200cells/mm² and 170 SOT patients, all of whom have not yet received a prophylactic HPV
      vaccine. The 170 SOT patients will be equally divided over 3 different SOT patient groups,
      namely heart, lung and kidney transplant patients. Therefore the target is to include
      approximately 57 heart transplant patients, 57 lung transplant patients and 57 kidney
      transplant patients. Enrolment in a SOT subgroup will be stopped when 57 patients have been
      included unless recruitment cannot be achieved within one of the other SOT-patient
      population.

      All enrolled subjects will receive a 3-dose regimen (Day 1, Month 2, and Month 6) of
      GARDASIL®9. Serum samples will be collected on Day 1 and Month 7 for anti-HPV 6, 11, 16, 18,
      31, 33, 45, 52, and 58 antibody determination.. The time point for comparison of immune
      responses will be Month 7, or approximately 4 weeks after the administration of the third
      dose. The safety/tolerability profile of the vaccine will be evaluated in all subjects in the
      study. Safety information will be collected on Day 1 through 1 month following the third
      vaccination or for a total of approximately 7 months for each subject.

      The immunogenicity and the safety data will be analyzed per group of patients. More
      specifically a separate analysis of HIV and SOT patients is planned, since it is expected
      that the immunosuppressive therapy of SOT patients might have a more profound effect on
      immunogenicity following vaccination.

      This study will provide a comparison of immunogenicity of Gardasil ®9 in immunocompromised
      patients, with historical controls (15, 18). The number of subjects to be enrolled in the
      study was determined based on the primary immunogenicity objective.
    

Intervention name(s): 9-valent HPV vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination
Other intervention name(s): Gardasil9
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma
Condition: Congenital Cataract; Aphakic Glaucoma
MeSH terms: Glaucoma; Cataract; Glaucoma, Angle-Closure
Study type: Interventional

Summary: 
      This is a retrospective, nonrandomized comparative trial with historical control to
      investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy
      (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following
      congenital cataract surgery.
    

Detailed description: 
      Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and
      serious complication which can be prevented by prophylactic peripheral iridectomy (PPI).
      However, it is difficult to perform routine PPI via scleral tunnel incision especially when
      the pupil is dilated. Here, the investigators designed a novel progressive grasping
      peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy
      position and minimize the complication. The aim of this study is to assess the safety and
      efficacy of the PGPI in preventing AACG following congenital cataract surgery.

      This is a retrospective, nonrandomized comparative trial with historical control. The
      congenital cataract patients performed with cataract extraction combined with PPI (PPI group)
      and the patients performed with cataract extraction alone and leaving the iris intact
      (historical control group) were enrolled and a retrospective medical chart review was
      conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy
      opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO)
      were compared between two groups.
    

Intervention name(s): PPI group; cataract extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.; The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Retrospective,consecutive,nonrandomized comparative trial with historical control
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: congenital cataract; prophylactic peripheral iridectomy; aphakic angle-closure glaucoma; aphakic open-angle glaucoma; iris posterior synechia; visual axis opacity
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and
      female subjects.
    


Intervention name(s): ALXN1007
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; ALXN1007; Healthy Male and Female Subjects
Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to assess the safety and immunogenicity of 4 different doses
      of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be
      enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin
      antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg
      adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects
      will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects
      will be monitored for safety and for antibody response to the vaccine. A data safety
      monitoring board will review and evaluate all the safety data obtained for a dose level
      before allowing administration of the next (higher) dose.
    


Intervention name(s): Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Pandemic influenza
Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA
Condition: Knee Osteoarthritis; Hyaluronic Acid
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating
      pain of knee osteoarthritis (OA).
    

Detailed description: 
      The medical device is a bioabsorbable, extensible, crosslinked, 2% hyaluronic acid gel using
      micro-organism fermentation sourced hyaluronic acid as a major component and add mannitol is
      added which can inhibit the degradation of hyaluronate acid by free radicals to prolong the
      therapeutic effect. The medical device is injected into the articular cavity to protect joint
      tissue, increase joint lubricity, inhibit degradation of cartilage and promote the metabolism
      of cartilage by infiltrating degenerated cartilage. In addition, the medical device can
      penetrate the synovial tissue to inhibit inflammation and degradation. It also inhibits pain
      mediators in the synovium to achieve the pain inhibition. This study is to evaluate the
      effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee OA
      6 months after single injection.
    

Intervention name(s): JETKNEE Synovial Fluid Supplement; Normal saline
Intervention type(s): Device; Device
Intervention description(s): 2mL of JETKNEE Synovial Fluid Supplement; 2mL of normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Condition: Interstitial Lung Disease; Dyspnea; Morphine
MeSH terms: Lung Diseases; Dyspnea; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 4

Summary: 
      36 patients with interstitial lung disease will be randomized to 1 weeks treatment with
      morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4
      times a day, or corresponding doses of placebo.

      VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other
      questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)
    


Intervention name(s): Morphine hydrochloride; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Placebo
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomised; placebo controlled; clinical trial
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild
      cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking
      thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor
      (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to
      Screening and remain on their stable dose throughout the trial. Subjects will receive placebo
      or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the
      pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid
      biomarkers and cognitive and psychological measures.
    


Intervention name(s): E2609; Placebo for E2609
Intervention type(s): Drug; Drug
Intervention description(s): E2609 capsules: 5 mg, 25 mg, 50 mg, and 200 mg
E2609 doses: 5 mg, 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, and 400 mg
According to the randomized study design, participants who are assigned to receive E2609 will each receive a single assigned dose consisting of two capsules of E2609 or in some cases one capsule of E2609 and one of placebo; Placebo capsules
According to the randomized study design, participants who are assigned to receive placebo will each receive a single dose consisting of two capsules of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
First-in-Human Single and Multiple Dose of GLPG1972
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety and tolerability after
      single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also,
      the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy
      subjects daily for 14 days compared to placebo, will be evaluated.

      Furthermore, during the course of the study after single and multiple oral dose
      administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics)
      will be characterized.

      The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential
      of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored
      as well.

      During the course of the study after multiple oral dose administrations, the effect of
      GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.
    


Intervention name(s): GLPG1972 single ascending doses; Placebo single dose; GLPG1972 multiple ascending doses; Placebo multiple doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose, oral solution; single dose, oral solution, matching placebo; multiple doses, daily for 14 days, oral solution; multiple doses, daily for 14 days, oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool
Condition: Contraceptive Adherence and Continuation
Study type: Interventional

Summary: 
      The broad objective of this research is to determine whether a quick, simple intervention
      will increase utilization of contraceptive reminders and adherence to short-term
      contraceptive regimens. Such an intervention could be implemented easily with no additional
      resources into a busy clinical practice.
    

Detailed description: 
      The specific aims of the study are to:

        1. Measure the difference in reminder utilization over three months between patients who
           are assisted with initiating the reminder system during their office visit versus those
           who are encouraged to self-initiate after the visit.

        2. Assess whether provider-assisted enrollment in the online reminder system improves
           adherence to a short-term contraceptive regimen compared to self- initiated enrollment
           after the visit.
    

Intervention name(s): enrollment in online reminder system
Intervention type(s): Other
Intervention description(s): Study personnel enrolled members in the online reminder system during their office visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: contraception, adherence, medication reminder
A Novel Portable Upper Gastrointestinal Endoscopy System
Condition: Digestive System Disease; Diagnoses Disease
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional

Summary: 
      The application of conventional endoscopy in remote and outdoor areas lacking facilities
      remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal
      endoscopy system that has the same functions as conventional endoscopy. A total of 24
      participants from a medical unit on a remote island in China underwent endoscopy with the
      portable system between March and June 2021. The portable system packed into a suitcase is 68
      × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system.
    

Detailed description: 
      The application of conventional endoscopy in remote and outdoor areas lacking facilities
      remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal
      endoscopy system that has the same functions as conventional endoscopy. A total of 24
      participants from a medical unit on a remote island in China underwent endoscopy with the
      portable system between March and June 2021. The portable system packed into a suitcase is 68
      × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system.
      The examination time and any malfunctions in the portable endoscopy system during the
      examination were recorded. After the examination was finished, the disposable sheathed system
      was removed, and a pressure leak test was performed to check the seal of the system. The
      patients were followed up within three days to confirm any adverse events such as nausea,
      vomiting, throat discomfort, bleeding, etc.
    

Intervention name(s): a novel portable upper gastrointestinal endoscopy system
Intervention type(s): Device
Intervention description(s): Patients arrived at the hospital in the morning after an overnight fast (>6 hours). The patients took oral dyclonine glue 15 mins before their examination. The doctors prepared the portable endoscopy system so that it was in working status and the disposable sheathed system was placed on the endoscope optical probe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic