bioihbjkbjnl/mcl2 huggingface dataset:
LOD Before IVF/ICSI in PCOS Patients With High AMH
Condition: Infertility; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Observational

Summary: 
      To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to
      in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes
      in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels
    

Detailed description: 
      Retrospective case-control study of PCOS women with high serum AMH level (≥ 7 ng/ml) who were
      subjected IVF/ICSI. Women underwent LOD in the preceding 3 months prior to IVF/ICSI (study
      group) will be compared with a control group of women who did not underwent LOD (control
      group)
    

Intervention name(s): LOD
Intervention type(s): Procedure
Intervention description(s): Women underwent LOD in the preceding 3 months prior to IVF/ICSI
Other intervention name(s): Laparoscopic ovarian drilling
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Fertility care clinic
      
Keywords: LOD; PCOS; AMH; OHSS
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical
      prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases
      the effectiveness of pectopexy operation. Investigators planned to measure patients' quality
      of life using the female sexual function scale test 3, 6 and 12 months after the surgery and
      to determine how the operation affects the quality of sexual life.
    

Detailed description: 
      In this study, the investigators planned to measure the effectiveness of laparoscopic
      pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to
      pectopexy increases the effectiveness of pectopexy operation. Investigators planned to
      measure patients' quality of life using the female sexual function scale test 3, 6 and 12
      months after the surgery and to determine how the operation affects the quality of sexual
      life.
    

Intervention name(s): pectopexy operation; uterosacral ligaments plication operation.
Intervention type(s): Procedure; Procedure
Intervention description(s): Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.; At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pelvic organ prolapse; pectopexy; laparoscopy; uterosacral ligaments plication
Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI
Condition: Neuropathic Pain; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well
      tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC
      scales.
    

Detailed description: 
      This is a Phase IIa (proof of concept), randomized, double-blind, placebo controlled,
      parallel group, multicentric, clinical trial to evaluate the safety, tolerability and
      efficacy of daily oral treatment with NFX88 in SCI patients who are not receiving opiates or
      cannabinoids and present neuropathic pain with an average pain score ≥ 4 measured with a VAS
      scale during the last week at screening
    

Intervention name(s): NFX88 - 1; NFX88 - 2; NFX88 - 3; PLACEBO - 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 times a day; 3 times a day; 3 times a day; 3 times a day
Other intervention name(s): 2OHOA; 2OHOA; 2OHOA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Screening for Coronary Artery Disease After Mediastinal Irradiation
Condition: Radiation Therapy; Coronary Artery Disease; Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late
      treatment sequelae such as cardiovascular events due to coronary artery disease. At present
      no active screening is performed in these patients since it is not known whether screening
      and subsequent treatment by means of revascularization is effective in reducing the risk of
      cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic
      consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among
      asymptomatic HL survivors will be evaluated.
    

Detailed description: 
      Objectives:

        1. to determine whether MSCT as a screening method of HL survivors treated with mediastinal
           irradiation accurately identifies asymptomatic significant coronary artery disease.

        2. to establish the prevelance of coronary abnormalities in HL survivors treated with
           mediastinal irradiation

        3. to determine the frequency and type of intervention

        4. to evaluate the acceptance of screening and asses quality of life among Hl survivors.

      Study polulation:

      50 long term survivors of HL, previously treatef with mediastinal irradiation without present
      evidence of cardiovascular disease

      Intervention:

      CT-coronary angiography and calcium score, to be performed as a screening method (to indicate
      further diagnostic treatent procedures)
    

Intervention name(s): CT coronary angiography
Intervention type(s): Radiation
Intervention description(s): patient will undergo one CT coronary angiography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: radiation therapy; coronary artery disease; Hodgkin Lymphoma
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral
      activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1
      infected participants. The hypothesis tested in the study is that at a safe and
      well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo
      control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168
      hours postdose.
    


Intervention name(s): Ulonivirine
Intervention type(s): Drug
Intervention description(s): MK-8507 administered as a single oral dose
Other intervention name(s): MK-8507
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses
      of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability,
      and pharmacokinetics in healthy subjects.
    


Intervention name(s): SAGE-718; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-718 in combination with Ketamine; Placebo in combination with Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers
Condition: MRSA, SSTI
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending
      multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally
      administered EDP-322 in healthy adult volunteers.
    

Detailed description: 
      Fifty-two subjects were enrolled into 6 cohorts. Six subjects of each cohort were randomized
      to received EDP-322 and 2 subjects of each cohort received placebo. Each cohort received the
      study drug once daily (QD) for 7 days under fed conditions. Multiple oral doses of EDP 322
      ranging from 200 to 800 mg were safe and generally well tolerated by the healthy male and
      female subjects in this study.
    

Intervention name(s): EDP-322
Intervention type(s): Drug
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160.
Condition: Pain, Inflammatory
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-time-in-human study. The overall purpose of the study is to assess whether
      the drug is safe and well tolerated after single, increasing doses. At different doses, we
      will look to see how much of the drug gets into the bloodstream, how the drug is broken down
      and excreted and whether this is affected by the presence of food.
    

Detailed description: 
      GSK1482160 is a new drug to be developed for treating inflammatory pain (for example,
      arthritis). It acts on structures on inflammatory cells, known as P2X7 receptors. Blocking
      these receptors reduces the release of important inflammatory chemicals which exists within
      the body and are thought to play an important role in promoting inflammatory pain.

      This study will start with a very low dose of study drug, which will then be gradually
      increased in subsequent doses. This is known as dose-rising and is the way to assess safety
      and tolerability (any side effects that make taking the drug unpleasant). Effects will be
      compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy
      male or female volunteers will be enrolled into the study. In addition, part of the study
      will be used to check if there is a difference in the blood levels of the study drug when
      taken with or without a high fat meal.
    

Intervention name(s): GSK1482160 or placebo
Intervention type(s): Drug
Intervention description(s): GSK1482160 is a P2X7 receptor antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: First-Time-in-Human; Tolerability; Pharmacodynamics; Safety; Food Effect; Pharmacokinetics; Healthy Volunteers
Allogeneic ABCB5-positive Stem Cells for Treatment of CVU
Condition: Skin Ulcer Venous Stasis Chronic
MeSH terms: Varicose Ulcer; Skin Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size
      reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the
      medicinal product to be studied after two applications on the wound surface in patients with
      Chronic Venous Ulcers.
    

Detailed description: 
      This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
      and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in
      patients with chronic venous ulcer (CVU). Allogeneic MSCs will be isolated ex vivo and will
      be expanded in vitro. The IMP incorporating the ABCB5-positive MSCs will then be applied on
      the wound surface of CVU under local anesthesia (on Day 0 and Week 6.1).

      Wound measurements from Visit (V) 2 and V9 will be used to determine the cell amount for the
      IMP treatments on V3 and V10, respectively.

      Patients are followed up for efficacy for 3 months which allows to distinguish actual wound
      healing from transient wound coverage.

      The wound healing process will be documented by standardized photography. The wound size
      evaluation will start on the day of the first change of wound dressing. The quality of the
      wound healing process will be assessed on the basis of formation of granulation tissue,
      epithelialization and wound exudation.

      Pain will be assessed using a numerical rating scale and quality of life will be investigated
      with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-CVU
      three follow-up visits at Months 6, 9 and 12 after the first IMP applications are included.
    

Intervention name(s): allo-APZ2-CVU
Intervention type(s): Biological
Intervention description(s): Suspension of ABCB5-positive mesenchymal stem cells
Intervention model: Single Group Assignment
Intervention model description: Interventional, single arm, multicenter, phase I/IIa clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Venous Ulcer; ABCB5; Allogeneic; Mesenchymal stem cells; varicose ulcer; skin ulcer; advanced therapy medicinal product; somatic cell therapy; phase I/IIa
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the safety and immunogenicity of 2 different formulations of the candidate
      HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to
      that of Engerix™-B in healthy adolescents aged 11 to 15
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): HBV-MPL vaccine Formulation A; HBV-MPL vaccine Formulation B; Engerix™-B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection; 2-dose intramuscular injection; Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Recombinant hepatitis B vaccine; Adjuvant
Immunogenicity After COVID-19 Vaccines in Adapted Schedules
Condition: Coronavirus Disease 2019; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this clinical trial is to compare different Coronavirus Disease 2019 (COVID-19)
      vaccination schedules in healthy adults that have not yet been exposed to SARS-CoV-2, the
      virus causing COVID-19. The main questions it aims to answer are:

        1. Is it possible to adapt COVID-19 vaccination schedules while maintaining an adequate
           humoral immune response?

        2. Is it possible to adapt COVID-19 vaccination schedules while maintaining an acceptable
           safety profile?

      Participants will be vaccinated twice with a COVID-19 vaccine (on day 0, and on day 28 or
      84). After each vaccination, they will collect information about adverse events in a diary
      for 14 days. Information about the occurrence of events such as hospitalizations and
      infections with SARS-CoV-2 will be collected by the investigator for up to 364 days after the
      first vaccination. Blood samples will be taken on different timepoints and used to assess
      immunity against SARS-CoV-2.

      Researchers will compare 8 vaccination schedules to see if the immune response and safety
      profile is similar. Each participant will receive 1 of the following 8 vaccine schedules:

        -  BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 28

        -  BNT162b2 (20µg) on day 0, followed by BNT162b2 (20µg) on day 28

        -  BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 84

        -  BNT162b2 (30µg) on day 0, followed by mRNA-1273 (100µg) on day 28

        -  BNT162b2 (30µg) on day 0, followed by ChAdOx1-S [recombinant] on day 28

        -  BNT162b2 (6µg, intradermal administration) on day 0, followed by BNT162b2 (6µg,
           intradermal administration) on day 28

        -  mRNA-1273 (100µg) on day 0, followed by mRNA-1273 (100µg) on day 28

        -  mRNA-1273 (50µg) on day 0, followed by mRNA-1273 (50µg) on day 28
    


Intervention name(s): BNT162b2 30µg; BNT162b2 20µg; BNT162b2 6µg; mRNA-1273 100µg; mRNA-1273 50µg; ChAdOx1-S [Recombinant]
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): intramuscular administration of 30µg; intramuscular administration of 20µg; intradermal administration of 6µg; intramuscular administration of 100µg; intramuscular administration of 50µg; intramuscular administration of not less than 2.5 x 10^8 infectious units
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to characterize the pharmacokinetics and
      pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16
      years inclusive. The secondary objectives are to characterize the safety and efficacy of
      hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
    

Detailed description: 
      Hydromorphone is an opioid analgesic that has been used for decades as an alternative to
      morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small
      number of analgesics have been studied in children. The benefits to the subjects include
      contribution of knowledge that will provide for appropriate dosing regimen recommendations
      for future pediatric subjects.

      Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately
      following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the
      oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects
      were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator
      determined the timing of the first dose based on each subject's clinical condition.

      The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral
      Treatment Period and up to 54 hours for the Oral Treatment Period).

      Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for
      both the oral and parenteral treatments.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Other intervention name(s): Infants and todlers;; Young child;; Older child;; Adolescent.
Intervention MeSH terms: Hydromorphone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative pain; Hydromorphone oral solution; opioid; pharmacokinetics; pharmacodynamics
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy
Condition: Sedation or Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical
      Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio
      to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of
      HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing
      fiberoptic bronchoscopy.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Subjects < 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects < 65 years old.; Subjects < 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects < 65 years old.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sedation anesthesia fiberoptic bronchoscopy