bioihbjkbjnl/mcl2 huggingface dataset:
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Condition: Endometriosis Related Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams
      (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate
      (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
    

Detailed description: 
      This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy
      and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered
      with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo.

      Approximately 600 women with endometriosis-associated pain were enrolled and randomized 1:1:1
      to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix
      monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back
      therapy, or Group C - placebo (N = 200 per group).

      Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the
      double-blind period.

      Eligible participants, including those randomized to placebo, were offered the opportunity to
      enroll in an 80-week open label extension study where participants received relugolix
      co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension
      study had a Follow-Up visit approximately 30 days after the participant's last dose of study
      drug.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Relugolix 40-mg tablet administered orally once daily.; Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.; E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Other intervention name(s): TAK-385; MVT-601; E2/NETA
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Relugolix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Endometriosis; Pain; Dysmenorrhea
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK
      Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine
      comparators in children 6 to 35 months of age. Recruitment will encompass at least 4
      independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort
      in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a
      fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and
      subtropical countries (beginning 2014).
    


Intervention name(s): Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A; Havrix Junior; Prevenar 13; Varivax/ProVarivax; Varilrix
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection administered to subjects aged 12 months or older; Intramuscular injection administered to subjects less than 12 months of age; Intramuscular injection administered to subjects more than 12 months of age; Subcutaneous injection administered to subjects more than 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Seasonal Flu; Efficacy; Children
An Evaluation of the Effects of a Non-Caffeinated Energy Dietary Supplement
Condition: Health Behavior
Study type: Interventional

Summary: 
      This study tested the effects of a botanical blend to a caffeine and a placebo condition on
      1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3)
      physical performance and 4) stress biomarkers.
    

Detailed description: 
      This study aimed to build on this work by investigating the possibility that a specific
      botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora
      methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could
      improve cognitive and physical performance. To this end, this study was a randomized,
      double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study
      compared the effects of the botanical blend at baseline to a caffeine and a placebo condition
      on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3)
      physical performance and 4) stress biomarkers.
    

Intervention name(s): Phytovive; Placebo; Caffeine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins); Natural Flavors [Chocolate, Caramel, Vanilla Cream], Silica, Inulin, Sucralose); Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caf-feine])
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized Double-Blind Placebo-Controlled Study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
AZD7268 Safety and Tolerability Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to prove the principle that treatment with AZD7268 reduces
      depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
    


Intervention name(s): AZD7268; Escitalopram; Placebo capsules; Placebo tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 mg, oral, twice daily (BID); 20 mg, oral, once daily (QD); Placebo capsules to match AZD7268; Placebo tablets to match encapsulated escitalopram
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression
An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups.
      Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic
      collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations
      have been analyzed, doses of GSK2212836 will be selected for further study in Part B.
      Subjects from Part A will participate in Part B.

      Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week
      repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836.
      Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day
      -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be
      released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day
      6, they will also have a brief outpatient visit. Subjects will check into the clinic again on
      the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles
      collected. Subjects will be released from the clinical research unit on Day 14, following a
      test meal, triglyceride sampling and check-out assessments, and will be released from the
      study 5-10 days later after completing a follow up visit.
    


Intervention name(s): GSK2212836; GSK2212836
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.; Treatment D - low dose of GSK2212836 test formulation, Treatment E - medium dose of GSK2212836 test formulation, Treatment F - high dose of GSK2212836 test formulation, Treatment G - GSK2212836 marketed formulation, or Placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hypertriglyceridemia; GSK2212836; relative bioavailability
Pilot Study of Diet and Behavior in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      We hypothesize that in children with autism dietary antigens can change the intestine, making
      it "leaky" and then affecting the brain changing their behavior.
    

Detailed description: 
      Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in
      intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).
    

Intervention name(s): Gluten and dry milk; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk; Rice flour 1.0 g/kg/day
Other intervention name(s): Gluten and dairy group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: intestinal permeability; diet; gluten; dairy
A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and
      therefore we investigate here the contributions of UsD in early recovery.
    


Intervention name(s): Minilaparotomy vs laparoscopy
Intervention type(s): Procedure
Intervention description(s): MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of
      GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes
      mellitus (T2DM) patients.
    


Intervention name(s): GW823093 15mg; GW823093 placebo capsule; GW823093 30mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): White opaque capsule containing 15mg of GW823093 as free base; Matching placebo of GW823093 capsule or 15mg capsule; White opaque capsule containing 15mg of GW823093 as free base
Other intervention name(s): GW823093
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: pharmacodynamics; Diabetes; pharmacokinetics
Dasotraline SEP360-105 Pediatric PK/PD Study
Condition: Pediatric Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Pediatric PK study of SEP-225289 (Dasotraline)
    

Detailed description: 
      To characterize the pharmacokinetics (PK) and assess safety and tolerability of a range of
      single oral doses of SEP-225289 in subjects 6 to 17 years old with ADHD
    

Intervention name(s): Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily
Intervention type(s): Drug
Intervention description(s): Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Birth Environment of the Future
Condition: Pregnancy
Study type: Interventional

Summary: 
      The main purpose of this study is to explore the impact of the birth environment on women's
      birth experience and relevant birth outcomes in the experimental Labour room compared to a
      standard Labour room.
    

Detailed description: 
      In the last decade, there has been an increased interest in exploring the impact of the birth
      environment on midwifery practice and the women's birth experiences. Results from these
      studies show that a home-like birth environment has positive effects on both midwifery
      practice and the birth experience. The hormone oxytocin that causes contractions during
      labour may play an important role in this context. The hormone is released when being in a
      safe, secure and confident environment. Therefore, it is a reasonable assumption that the
      birth environment also has an impact on birth outcomes.

      To investigate this assumption one traditional labour room was transformed to an experimental
      labour room. The design of the room is inspired by knowledge from evidence-based healthcare
      design, which describes bringing nature into the room. Furthermore, it is possible for the
      parents to design their own birth setting by choosing atmosphere through sound, light and
      nature scenes.
    

Intervention name(s): Supportive care in a specially designed labour room
Intervention type(s): Other
Intervention description(s): Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Birth environment; oxytocin; epidural; analgesia; home-like
Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic
      pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and
      physiologic assessment at baseline. Subjects will be monitored off treatment for three months
      for changes in symptoms and physiology. Subjects will then be randomized to six months of
      treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is
      change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment.
      Secondary endpoints are progression free survival, change in dyspnea, change in quality of
      life, and change in physiology.
    


Intervention name(s): zileuton; azathioprine/prednisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prednisone; Zileuton; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal; Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess
      the safety, PK, and efficacy of single postsurgical application of TLC590 compared with
      Naropin®
    

Detailed description: 
      A Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to
      assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared
      with Naropin® via a single infiltrative local administration in adult subjects following
      inguinal hernia repair surgery.

      Approximately 64 evaluable subjects across 4 cohorts. Dose escalation of a single
      postsurgical administration of TLC590 or Naropin® will be performed. Dose escalation will be
      determined by review of treatment-related adverse events and all serious adverse events (AEs)
      by a safety monitoring committee.
    

Intervention name(s): TLC590; Naropin
Intervention type(s): Drug; Drug
Intervention description(s): TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension; Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL
Other intervention name(s): TLC590 (Ropivacaine Liposome Injectable Suspension); Naropin, 0.5% Injectable Solution
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects will be enrolled to each cohort in a 3:1 ratio. Each cohort will comprise subjects receiving a dose of TLC590 and active comparator drug (Naropin® 150 mg) in accordance with the randomization schedule and dose-escalation scheme.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Postsurgical Pain Management
NEURESCUE Device as an Adjunct to Cardiac Arrest
Condition: Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Arrest
Study type: Interventional

Summary: 
      The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, an
      emergency technique that supercharges blood flow to the heart and brain within one minute
      from deployment.

      The catheter-based device is delivered via the femoral artery, temporarily inflating a soft
      balloon in the descending to redirect blood flow towards the upper body.

      The objective of the study is to investigate the safety and performance of the NEURESCUE
      device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.
    


Intervention name(s): NEURESCUE device
Intervention type(s): Device
Intervention description(s): The balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breast Ultrasonography and Polycystic Ovary Syndrome
Condition: Breast Diseases; Polycystic Ovary
MeSH terms: Polycystic Ovary Syndrome; Breast Diseases
Study type: Observational [Patient Registry]

Summary: 
      The results of the evaluation of breast ultrasonography results of patients with polycystic
      ovary syndrome diagnosis over 30 years of age will be evaluated.

      Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory
      data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day
      after the end of menstrual breast ultrasonography. The aim of this study is to show the
      association of polycystic ovary syndrome and fibrocystic breast.
    


Intervention name(s): Breast ultrasonography findings
Intervention type(s): Procedure
Intervention description(s): Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients over 30 years of age diagnosed with polycystic ovary syndrome breast
        ultrasonography findings in these patients
      
Keywords: breast diseases; fibrocystic breast; polycystic ovari syndrome; fibroadenoma
Effect of Leg Pedalling Exercise From Inclined Position
Condition: Cerebral Palsy Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Statement of the problem:- Does the lower limb pedalling exercise from inclined position
      improve functional ability and trunk control in children with diplegic cerebral palsy? Null
      Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position
      on functional ability and trunk control in children with diplegic cerebral palsy
    

Detailed description: 
      Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP)
      from both sexes will be recruited based on a pilot study according to the inclusion and
      exclusion criteria. They will be selected from the out-patient private clinics in Giza and
      Tenth of Ramadan City.

      Study design:

      Randomized controlled clinical trial. Children will receive intervention type randomly, 15
      child received the designed physical therapy program and the pedaling exercise from inclined
      position and the other 15 child receieved the designed physical therapy program only.
      Children will be assessed by measuring functional ability with Gross Motor Functional
      measures and trunk control with trunk control measurement scale
    

Intervention name(s): Leg pedalling exercise; The designed physical therapy program
Intervention type(s): Device; Other
Intervention description(s): Each child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher; It applied for all participated children in both groups. It includes;
Flexibility exercises
Static and dynamic balance
Functional training exercises
Other intervention name(s): Leg ergometer; Traditional physical therapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Leg Pedalling