bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces
      high risk behavior in cocaine dependent subjects.
    

Detailed description: 
      The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB
      in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an
      8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in
      conjunction with Cognitive Behavioral Therapy (CBT).
    

Intervention name(s): Modafinil; placebo; Cognitive Behavioral Therapy (CBT)
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 300mg a day for 8 weeks; placebo pills for 8 weeks; Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence; hiv prevention
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Condition: Hearing Loss, Conductive; Bone Conduction Deafness
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive
Study type: Interventional

Summary: 
      The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to
      randomize patients to receive either the Bonebridge or a conventional bone conducting hearing
      device. The investigators will then compare the surgical and audiological outcomes of the two
      groups.
    

Detailed description: 
      The new Bonebridge fully implanted, except for an external sound processor. It does not have
      any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that
      this may improve wound healing and reduce problems with wound infection and skin overgrowth
      seen in Bone Anchored Hearing Aids.

      There may also be audiological improvements by the use of the Bonebridge as the physical
      separation of the vibrating part from the sound processor should reduce feedback. The company
      also claims other audiological improvements in the Bonebridge.

      The investigators wish to demonstrate whether this is actually the case by performing a study
      directly comparing the outcomes of the two groups.
    

Intervention name(s): Bonebridge; Bone Anchored Hearing Aid
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing Loss, Conductive; Bone Conduction; bone conduction thresholds better than 45 dBHL
Can Postpartum Depression Be Prevented With Care
Condition: Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study was designed to eliminate postpartum insomnia and fatigue and reduce the risk of
      postpartum depression through the maintenance of structural, personal, and social integrity
      with holistic care under the guidance of Levine's conservation model for primiparous
      puerperal women who experience fatigue and are at risk of developing depression. : A
      single-blind pretest-posttest randomized controlled study. Women were called to the hospital
      on the 7th postpartum day and randomly assigned by a computer program to either the
      intervention group (n=56) or the control group (n=56). Participants did not know which group
      they were in.
    

Detailed description: 
      A nursing care program was prepared for the intervention group under the guidance of Levine's
      conservation model. This program was applied with 7 home visits between the 8th and 80th
      postpartum days. Face-to-face training and training booklets were provided in home visits. As
      of the fourth home visit, Pilates exercises were performed. The women in the control group
      received routine care. Pretest and posttest data were collected with a personal data sheet,
      visual analogue scale for fatigue, Postpartum Physical Symptom Severity Scale, Postpartum
      Sleep Quality Scale, Edinburgh Postpartum Depression Scale, and Postpartum Support Scale.

      Sleep quality improved for the primiparous puerperal women of the intervention group. They
      had reduced postpartum fatigue and increased energy; maintained their structural, personal,
      and social integrity; and had decreased risk of developing postpartum depression with the
      holistic care provided (all p<0.001). A negative correlation was detected between the support
      subscale posttest total score from the Postpartum Support Scale and the posttest scores of
      the Edinburgh Postpartum Depression Scale for the women of the intervention group (r=-0.303;
      p<0.05)
    

Intervention name(s): A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
Intervention type(s): Behavioral
Intervention description(s): Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the
      effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing
      ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected
      with human immunodeficiency virus (HIV) is important in the prevention of unplanned
      pregnancies. The study will consist of a screening period of 28 days, check-in (Day -4), a
      run-in period and a treatment period. During the run-in period, subjects will be administered
      Portia® (0.03 milligrams [mg] EE/0.15 mg LNG) once daily on Days -3 to -1. Subjects will then
      be administered Portia once daily on Days 1 to 10 of treatment period A followed by
      administration of Portia once daily along with GSK3640254 200 mg on Days 11 to 21 of
      treatment period B. The duration of the study is approximately 8 weeks, including Screening
      and Run-in. Portia is a registered trademark of Teva Pharmaceuticals USA.
    


Intervention name(s): GSK3640254; Portia
Intervention type(s): Drug; Drug
Intervention description(s): GSK3640254 will be available as a 100 mg capsule. Subjects will be administered 200 mg GSK3640254 once daily via the oral route on Days 11 to 21.; Portia will be available in the form of tablets containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK3640254; ethinyl estradiol; levonorgestrel; oral contraceptive; drug-drug interaction
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial evaluated folic acid supplementation after oral administration of the ethinyl
      estradiol + levonorgestrel + folic acid (0.02 mg + 0.10 mg + 0.4 mg) coated tablet
      (Level-Fol® Biolab Sanus Farmacêutica, São Paulo, Brazil) in healthy female volunteers, based
      on statistical comparisons of folate levels in erythrocytes. Its safety and tolerability was
      also evaluated.
    

Detailed description: 
      This Phase III trial was performed as a monocentric, open label, randomized design, with 1
      treatment regimen, in 3 cycles (12 weeks), with administration in multiple doses, in which
      the healthy volunteers received one coated tablet of the test product - ethinyl estradiol +
      levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg (Level-Fol® Biolab Sanus
      Farmaceutica, Brazil) for 21 days and a placebo coated tablet containing folic acid 0.4 mg
      only (Biolab Sanus Farmaceutica, Brazil) on the last 7 days of the cycle.

      The subjects were required to present to the Clinical Unit for every drug administration,
      which was assisted by a member of the research team. Blood samples of 15 mL were collected
      via direct venepuncture into tubes containing 50 µL of ethylenediaminetetraacetic acid (EDTA)
      at pre-dose, 1st, 21st, 28th, 29th, 49th, 56th, 57th, 77th and 84th day of treatment.

      Te safety assessment was based on recording adverse events throughout the study duration as
      well as through the monitoring of vital signs and evaluation of laboratory tests and ECG.
    

Intervention name(s): ethinyl estradiol + levonorgestrel + folic acid; Folic Acid
Intervention type(s): Drug; Drug
Intervention description(s): One coated tablet of ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg for 21 days in 3 cycles (12 weeks).; One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Folic acid; Supplementation; Ethinyl estradiol; Levonorgestrel; Oral contraceptive
A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about the side effects of LY3437943 when given to
      Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to
      investigate how the body processes the study drug and how the study drug affects the body.
      Each enrolled participant will receive injections of LY3437943 or placebo given just under
      the skin. For each participant, the study will last up to 5 months, inclusive of screening
      and will include 16 visits to the study center.
    


Intervention name(s): LY3437943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Condition: Knee Arthroplasty, Total; Osteoarthritis; Radiologic Tibiofemoral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and
      functional status in non-surgical patients with knee osteoarthritis as well as the high
      prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed
      to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic
      postoperative pain as well as functional status in patients undergoing TKA. Patients will be
      randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group
      (RFA needles placed in proper location without effective neurotomy).
    

Detailed description: 
      Total knee arthroplasty (TKA) is a common and effective treatment for severe knee
      osteoarthritis. As the average age of the population increases in developed countries, the
      number of TKAs performed is projected to increase to 3.48 million procedures per year by
      2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of
      treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and
      postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical
      patients with chronic knee osteoarthritis with significant post procedure improvement in pain
      and functional status. This study is designed to determine the efficacy of preoperative
      genicular nerve RFA in improving acute and chronic postoperative pain as well as functional
      status in patients undergoing TKA.
    

Intervention name(s): Genicular Nerve RFA; Sham Genicular Nerve RFA
Intervention type(s): Procedure; Procedure
Intervention description(s): Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.; Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiofrequency ablation
Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Pioglitazone decreases oxidative load, inflammatory end points and improves vascular
      reactivity in obese patients in a dose dependent manner and that this effect is independent
      of its glucose lowering effects.
    

Detailed description: 
      This is a single center, open labeled study. A total of 24 obese patients will be recruited
      to participate in this study. The study will have three groups of 8 patients each. Subjects
      will be enrolled into each group by alternate recruitment. Subjects in group one will receive
      15mg of pioglitazone; subjects in group two will receive 30 mg of pioglitazone; subjects in
      group three will receive placebo. All subjects will receive Pioglitazone or placebo for 6
      weeks, followed by a 6-week observation period off Pioglitazone/placebo.

      At baseline, and at week 1, week 2, week 4, week 6 and month 3 all patients will have blood
      drawn for TBARS, ortho and meta-tyrosine, 9-HODE and 13-HODE, NF, Ikb, TNF-a, ICAM-1, VCAM-1,
      PAI-1, AP-1, EGR-1, MMP-2, MMP-9, TIMP, CRP-1, E-Selectin, P-Selectin, Asymmetric
      dimethylarginine (ADMA), PAPP-A, SAA, MCP-1, IL-6, ROS generation, insulin levels, and CRP.

      Post-ischemic dilation of the brachial artery will be used as an index of
      endothelium-mediated vasodilation. All subjects will have an oral glucose tolerance test
      (GTT) with 75gm of glucose at Day 0 and at Day 42. Vascular reactivity will be assessed at 0,
      6, and at 12 weeks.
    

Intervention name(s): Pioglitazone 15mg; pioglitazone 30mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Condition: Temporomandibular Joint Dysfunction; Pain; Arthrocentesis
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the administration of hyaluronic acid or
      corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain
      relief and improved function.

      The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the
      mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
    

Detailed description: 
      This study will enroll patients with temporomandibular joint dysfunction who are deemed
      appropriate candidates for irrigation of their jaw joints secondary to pain or limited
      opening. At the completion of the joint irrigation subjects will be injected by one of three
      different products to determine if the additional injection results in a further decrease in
      jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not
      show improvement may be candidates for additional treatment.
    

Intervention name(s): Hyaluronic acid; Corticosteroid; Lactated Ringers
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 cc hyalgan to be injected into superior joint space; 1cc celestone (6 mg/cc) will be injected into the joint space; 1 cc lactated ringers solution will be injected into the joint space
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, participants with Type 1 diabetes received insulin through an infusion into a
      vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for
      injection under the skin, and their blood glucose was measured for 3 hours.

      The main objective of this study was to evaluate the safety and efficacy of intranasal and
      subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with
      type 1 diabetes.
    

Detailed description: 
      In the study, up to four (4) treatments were administered as a single dose either
      intranasally or subcutaneously to eighteen (18) male or female participants under fasting
      conditions and following the use of insulin to lower blood glucose. The participants were
      assigned at random to a group that received one treatment for each of the 3 study periods.
      The glucagon administrations were separated by approximately 7 calendar days. For 2
      participants, a single dose of 3 mg NG was administered at the 4th period that was separated
      by at least 21 calendar days from the 3rd period.
    

Intervention name(s): Nasal Glucagon 1 mg; Nasal Glucagon 2 mg; SC Glucagon; Nasal Glucagon 3 mg
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Dry Powder Nasal Glucagon; AMG504-1; LY900018; Dry Powder Nasal Glucagon; AMG504-1; LY900018; Glucagon; Glucagon for injection (rDNA origin); Dry Powder Nasal Glucagon; AMG504-1; LY900018
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoglycemia; Diabetes mellitus
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric lower limb spasticity.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Biological
Intervention description(s): Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Other intervention name(s): BOTOX®; OnabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
Condition: Chemotherapy-induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the
      optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter
      randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of
      Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11
      (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240
      cancer patients undergoing chemotherapy.
    

Detailed description: 
      The investigators recently developed a mutant form of rhIL-11 with improved stability. In in
      vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more
      effectively, while retaining the biological activity of the original rhIL-11. The improved
      stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of
      subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its
      improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is
      well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose
      of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is
      a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate
      optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable
      chemotherapeutic regimen for treating cancer.
    

Intervention name(s): NL201; NL201; NL201; rhIL-11
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；; mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；; The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.; rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other intervention name(s): mIL-11; mIL-11; mIL-11; Recombinant Human Interleukin-11 for Injection
Intervention MeSH terms: Oprelvekin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Chemotherapy; Thrombocytopenia; Interleukin-11; Platelet