bioihbjkbjnl/mcl2 huggingface dataset:
Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events
Condition: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Observational [Patient Registry]

Summary: 
      The protocol is a large registry to describe acute, sub-acute and extended duration of
      anticoagulation management, clinical and economic duration of anticoagulation management,
      clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the
      real-world setting.

      Main objectives are to clarify the:

        -  treatment related details for acute VTE (either conventional anticoagulation therapy,
           treatment with a direct oral anti-coagulant or other modalities of treatment)

        -  Rate of early and late symptomatic VTE recurrence

        -  Rate and nature of complications of VTE including post thrombotic syndrome and chronic
           thromboembolic pulmonary hypertension

        -  Rate of bleeding complications

        -  Rate of all-cause mortality at six months
    

Detailed description: 
      Other objectives are to clarify the additional outcomes of:

        -  Stroke (Measured by number of incidences)

        -  Transient Ischemic Attack (TIA) (Measured by number on incidences)

        -  ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences)

        -  Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences)

        -  Unstable Angina (Measured by number of incidences)

        -  Quality of life and patient reported outcomes and costs associated with the management
           of VTE.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sites will be selected at random from a representative list reflecting treatment patterns
        in each country. Consecutive male and female VTE patients at the randomly selected sited
        will be included in the registry if they meet the eligibility criteria.
      
Keywords: venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis
Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess safety of and explore glycemic outcomes with
      Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.
    

Detailed description: 
      This feasibility study is a prospective, randomized, two-period crossover multi-center study
      of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing
      (AID) system will be evaluated in multiple age groups over 4 weeks of use.
    

Intervention name(s): t:slim X2 insulin pump with Control-IQ technology 2.0
Intervention type(s): Device
Intervention description(s): t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Control-IQ technology; type 1 diabetes
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate
      the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic
      NASH patients.
    


Intervention name(s): TERN-101; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Farnesoid X receptor; NASH; Nonalcoholic Steatohepatitis; NAFLD; Nonalcoholic Fatty Liver Disease; FXR
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      pharmacodynamics of SLV337 in patients with type 2 diabetes
    


Intervention name(s): Placebo; SLV337; SLV337; SLV337
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; SLV337 400 mg/day; SLV337 800 mg/day; SLV337 1400 mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; interventional; placebo; controlled; PK; PD; safety
A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal
      repair is feasible in the Philippine setting. It will result in a comparable recurrence rate
      as published for the traditional Lichtenstein approach.
    

Detailed description: 
      The specific aim of this study is to assess the feasibility of using a self fixating
      lightweight mesh in open inguinal hernia under both under regional and local anesthesia in
      the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years
      (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather
      data with regards to postoperative pain, post operative surgical complications, wound healing
      complications, operating factors (mesh deployment time, total operating time), hernia factors
      (type and size of inguinal hernia).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Potential study subjects will be patients who are:

        18 - 80 years old; Has confirmed with the informed consent; Has a primary inguinal hernia
        (either unilateral or bilateral) which is reducible and amenable to local or regional
        hernia repair
      
Keywords: Inguinal Hernia; Self-fixating mesh; Progrip; Hernia Recurrence; Mesh, Surgical; Recurrence
Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage
Condition: Mechanical Ventilation
MeSH terms: Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients mechanically ventilated using an endotracheal tube with a subglottic secretion
      drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than
      using a conventional endotracheal tube
    

Detailed description: 
      Subglottic secretions accumulated above the endotracheal cuff may progress, descending along
      the channels within folds of the cuff wall, to the lower respiratory tract causing VAP.
      Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by
      reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the
      hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion
      drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from
      the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.
    

Intervention name(s): tube with subglottic drainage and polyurethane cuff
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ventilator-associated pneumonia; endotracheal tube; polyurethane cuff; polyvinyl cuff; subglottic secretion drainage
Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.
Condition: Pneumocystis Jirovecii Pneumonia; Solid Organ Transplantation
MeSH terms: Pneumonia; Pneumonia, Pneumocystis
Study type: Observational [Patient Registry]

Summary: 
      PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated
      immunodeficiency.With the increasing number of solid organ transplantation, how to
      effectively treat severe PCP after solid organ transplantation has become an urgent problem
      to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as
      second-line alternatives when TMP-SMX fails to treat HIV-PCP. Therefore, the objective of
      this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX
      combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ
      transplantation.
    

Detailed description: 
      PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated
      immunodeficiency.With the increasing number of solid organ transplantation, how to
      effectively treat severe PCP after solid organ transplantation has become an urgent problem
      to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as
      second-line alternatives when TMP-SMX fails to treat HIV-PCP. More and more studies suggest
      that clindamycin-based alternatives play an increasingly important role in treating of PCP.
      Therefore, the objective of this study is to preliminarily investigate the safety and
      efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of
      severe PCP after solid organ transplantation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A. the clinical manifestations are fever, shortness of breath, dry cough ,respiratory
        distress B. Chest CT showed manifested by fine, bilateral, perihilar, diffuse infiltrates ,
        an interstitial alveolar butterfly pattern C. Bronchoalveolar lavage was sent for next
        generation sequencing (NGS)
      
Keywords: TMP-SMX; clindamycin; oxygenation index; adverse reactions
The Stork OTC: Collection, Placement & Delivery
Condition: Safety and Usability
Study type: Interventional

Summary: 
      This is a clinical study designed to validate the usability and safety of the
      over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease
      of use of The Stork™ Conception System and the instructions for use. In addition to
      usability, results for safety, including vaginal
    

Detailed description: 
      Female participants will undergo a baseline pelvic examination. Participating couples will be
      given The Stork™ Conception System (OTC), including Instructions for Use, the questionnaire
      and two ziplock bags. The device will be used in accordance with the instructions for use.
      Participants will use the Conceptacle as a collection condom during sexual intercourse.
      Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the
      Sheath. Participants will then load the Cervical Cap into the Applicator for insertion,
      placement and deployment of the device. Participants will wash the applicator with soap and
      water and place it in the double zip lock bags. During the time the cervical cap is inserted,
      normal activity will be recommended with the exception of having intercourse. The female
      participants will leave the conception cap inserted for a period of time between 4 and 12
      hours, return to the investigator's office for examination, remove the Cervical Cap, and
      undergo a follow up pelvic examination. Participants will be asked to complete the study and
      the questionnaire within 3 days of receiving the study packet. As a result, this study could
      take up to 4 days to complete per enrolled couple.
    

Intervention name(s): The Stork - Conception Aid
Intervention type(s): Device
Other intervention name(s): The Stork
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: OTC Home Use Conception Aid Cervical Cap Insemination
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Condition: Breastfeeding; Post Partum
Study type: Interventional
Phase: Phase 4

Summary: 
      To study and compare acceptability and tolerance between breast-feeding post-partum woman,
      who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving
      birth, using either Levonorgestrel or Etonogestrel contraceptive implant.
    

Detailed description: 
      -  To study and compare acceptability and tolerance between breast-feeding post-partum
           woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks
           after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.

        -  Participants who wish to attend the study will be invited to choose between
           Levonorgestrel and Etonogestrel contraceptive implant, then they will be randomized into
           immediate postpartum or delay postpartum group. They will be follow-up at 6 and 12 weeks
           after receive contraceptive implant.

        -  Information about side effects, breastfeeding status, child growth, acceptability and
           tolerance will be noted using medical records and interviewing, gathering on paper case
           record forms.

        -  Sample size N = 60 (30 in each group (Immediate and delay postpartum group, 15 in each
           subgroup (Levonogestrel and Etonogestrel group)) This number of sample size is already
           counted with 10% data loss
    

Intervention name(s): Etonogestrel Drug Implant; Levonorgestrel Drug Implant
Intervention type(s): Drug; Drug
Intervention description(s): Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.; Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
Other intervention name(s): Implanon; Jadelle
Intervention MeSH terms: Levonorgestrel; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immediate postpartum implant; postpartum implant; implant contraception; Etonogestrel; Levonorgestrel
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Condition: Influenza; Orthomyxoviridae Infections
MeSH terms: Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2008-2009 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study.

      Observational Objectives:

      To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,
      administered in a one- or two-dose schedule in accordance with Advisory Committee on
      Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

      To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,
      administered in a one- or two-dose schedule in accordance with ACIP recommendations, in
      children ≥ 6 months to < 5 years of age.
    

Detailed description: 
      The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that
      all healthy children aged 6 through 59 months receive influenza vaccine. Because of the
      growing emphasis on influenza immunization of infants and young children, Center for
      Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from
      children who have been vaccinated with the current formulation of Fluzone® vaccine. These
      sera will be tested to evaluate each individual's immune response to the current formulation
      of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order
      to support formulation recommendations for the subsequent year (particularly for influenza B
      strains, which predominantly affect the young).
    

Intervention name(s): Influenza Virus Vaccine No Preservative: Pediatric Dose; Influenza Virus Vaccine No Preservative: Pediatric Dose
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months); 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Orthomyxoviridae Infections; Influenza vaccine
A Self-Guided Intervention to Promote Condom Use Among African American Males
Condition: Correct Consistent Condom Use
Study type: Interventional

Summary: 
      The Centers for Disease Control and Prevention has declared that AIDS is a "state of
      emergency" in the US for African Americans - young African American men are especially
      vulnerable in this epidemic. Thus, the development of effective interventions tailored to
      this population is a national priority. The investigators previous preliminary studies
      suggest that a brief, clinic-initiated, home-based, self-guided condom use program may
      effectively promote the acceptance of condom use and increase the quality and consistency of
      condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility
      of this program (Homework Intervention Strategy, HIS) for young African American men
      attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the
      program. The HIS has the potential to be readily translated into widespread practice, while
      requiring only minimal resources. Unlike previously tested interventions, the HIS can be
      applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI
      status. To develop the HIS to meet the needs of these high-risk men, the proposed study will
      include a formative phase during which the basic intervention "instructions" which will be
      delivered by DVD will be refined and tailored for this population.

      One hundred young African American men recruited from an urban STD clinic will be randomized
      to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5
      assessment periods over the course of 6 months. Assessments will compare the groups on
      frequency of unprotected sex, quality of the condom use experience, experience of condom use
      errors and problems, attitudes regarding condom use, condom use acceptability, and condom use
      self-efficacy and confidence.
    


Intervention name(s): Homework Intervention Strategy
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants
Condition: Cushing Syndrome; Neoplasms
MeSH terms: Cushing Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the effect of relacorilant on the pharmacokinetics (PK)
      of the sensitive P-glycoprotein (P-gp) substrate dabigatran etexilate.
    

Detailed description: 
      The investigational medicinal product (IMP), relacorilant, and the non-investigational
      medicinal product (NIMP), dabigatran etexilate, will be used to evaluate the effect of
      relacorilant on the PK of the sensitive P-gp substrate, dabigatran etexilate in healthy
      participants. Participants will receive a single dose of dabigatran etexilate before and
      after administration of daily (QD) doses of relacorilant for 11 days. As all participants
      will receive the same treatments, the study will be open-label and no randomization is
      required.
    

Intervention name(s): Dabigatran Etexilate; Relacorilant
Intervention type(s): Drug; Drug
Intervention description(s): Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12.; Relacorilant will be administered orally as 4 X 100 mg capsules (400 mg) on Days 3 through 13.
Other intervention name(s): Pradaxa®
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function
Condition: Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the influence of severe renal impairment on the pharmacokinetics (PK),
      safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by
      inhalation with the Respimat® Inhaler)
    


Intervention name(s): BI 1774 CL
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
Condition: Coronary Artery Disease; Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The research will study the differences between interval training and continuous training
      among cardiac patients in a cardiac rehabilitation facility.

      The main objectives are:

        1. Functional capacity measures (VO2 max).

        2. Cardiac risk factors

        3. Quality of life assessments.

      Study hypothesis:

      Interval training will be more effective in improving functional capacity, cardiac risk
      factors and quality of life, compared to continuous training.
    


Intervention name(s): Interval exercise training; Continuous exercise training
Intervention type(s): Other; Other
Intervention description(s): Exercise bouts in low and high intensities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care