bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of LTB4 in HIV-1 Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study to assess the safety and antiretroviral activity of a naturally
      occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the
      effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2
      additional weeks after the end of active treatment for safety follow-up. 40 patients in seven
      clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4
      or placebo. Study drug is administered intravenously once daily. LTB4 can activate and
      stimulate various white blood cells and by the activation release natural substances in the
      body and this process is an important part of the body's defense against infections.
    

Detailed description: 
      The objective of this pilot study is to investigate whether LTB4, administered at a dose that
      provides an increase in alfa-defensin release from neutrophils, can affect HIV viral load in
      HIV-1 infected individuals. The safety, tolerability and effect will be assessed of 28 days
      of daily intravenous dosing of LTB4 on HIV viral load. Safety and tolerability will also be
      assessed.

      The study is randomized, double-blind, placebo controlled. All subjects will be randomly
      assigned to one of three treamtent groups, LTB4 at two different dose levels or corresponding
      placebo. Treatment duration is 4 weeks and follow-up period is 2 weeks. Subjects will visit
      the clinic on a daily basis during the treatment period to receive a daily intravenous
      injection of the study drug. 40 subjects will be enrolled, seven clinics in Canada will
      participate in the study.

      Primary endpoint: Change in viral load over the treatment period of 28 days. Secondary
      endpoint: CD4, CD8 and neutrophil counts, alfa-defensins and CC-che, mokine release in blood.
    

Intervention name(s): LTB4
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pilot study; Randomized; Placebo-controlled; Double-blind; Effect on viral load; LTB4; HIV-1 infection
A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial investigates the effects of several doses of FE 999049 in Japanese women
      undergoing IVF/ICSI treatment.
    


Intervention name(s): FE 999049; follitropin beta
Intervention type(s): Drug; Drug
Other intervention name(s): FOLLISTIM
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Condition: Healthy
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The objective of this pilot trial is to demonstrate the safety and the performance of the
      Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes
      patients.
    

Detailed description: 
      1. Safety: To evaluate safety issues related to implantation and use of the Hyposafe
           hypoglycaemia alarm device.

        2. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.

        3. Usability: To obtain information about the subjects use and acceptance of the Hyposafe
           Hypoglycaemia alarm device.
    

Intervention name(s): Hyposafe device
Intervention type(s): Device
Intervention description(s): Subcutaneous EEG recorder for EEG measurements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Evaluation of subcutaneous EEG recording
Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
Condition: Intracranial Thrombosis
MeSH terms: Intracranial Thrombosis; Thrombosis
Study type: Interventional

Summary: 
      Our overall aim is to examine if ultrasound is as accurate as MRI and/or CT in the evaluation
      of dural venous sinuses. We hypothesize that sonography will be accurate (accuracy >80%) for
      diagnosing specific anatomic findings of dural venous sinuses.
    

Detailed description: 
      Cranial ultrasound is an established technique for evaluation of the neonatal brain. However
      its role in the evaluation of cerebral dural venous sinuses in neonates has not been
      established. It is very important to evaluate the cerebral dural venous sinuses, as cerebral
      sinovenous thrombosis (CSVT) is an increasingly recognized condition in neonates.

      There is an obvious clinical need for systematically evaluating the role of ultrasound with
      doppler in the evaluation of cerebral venous sinuses. Advances in diagnostic imaging have led
      to rapid clinical implementation of newer technologies like MR and CT for evaluation of
      venous sinuses. However technological advances in older imaging methods like ultrasound which
      have advantages of being non-invasive and being performed at the bedside have not been
      evaluated.
    

Intervention name(s): Ultrasound
Intervention type(s): Procedure
Intervention description(s): All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Intracranial Thrombosis; Cerebral Sinovenous Thrombosis; Pediatrics; Cranial Ultrasound
Comparison of Analgesic Effect of Volatile Anesthetics
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical trial is to compare analgesic effect of sevoflurane and
      desflurane at equal minimum alveolar concentrations using surgical pleth index.
    

Detailed description: 
      Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated
      that equi-minimum alveolar concentration of various volatile anesthetic agents may produce
      different bispectral index values. However, the difference between analgesic effects of
      volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to
      compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar
      concentrations using surgical pleth index-guided remifentanil infusion.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.; End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other intervention name(s): SEVO; DES
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the mass balance of PD 0200390
    


Intervention name(s): PD 0200390
Intervention type(s): Drug
Intervention description(s): Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-restorative; sleep
Safety and Tolerability of CFTX-1554 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will consist of 2 parts, i.e. a single ascending dose part with integrated food
      effect assessment and assessment of relative bioavailability (Part A), and a multiple
      ascending dose part (Part B).

      Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive
      single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition)
      in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted
      conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under
      fasted conditions (Period 1) (1 single dose level only) will be assessed.

      Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple
      ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.
    


Intervention name(s): CFTX-1554; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).; CFTX-1554 matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether individual cognitive functional therapy
      (CFT), when compared to group exercise classes is effective in reducing pain and disability
      in patients with non-specific chronic low back pain.
    

Detailed description: 
      A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used.
      Patient with non- specific chronic low back pain will be assessed for eligibility. The
      patients fitting the inclusion criteria will be randomised to receive either the individual
      CFT or the group classes consisting of education and exercise. Participants' pain,
      disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general
      health, stress levels, as well as number and cost of treatments will be evaluated using a
      range of outcome measures at the start and on completion of the treatment. Patients will
      receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months
      after treatment to reassess clinical outcomes. If a participant does not respond to
      follow-up, they will be telephoned to ask if they wish to complete the questionnaires.
    

Intervention name(s): Individual Cognitive Functional Therapy; Group Exercise Classes
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.; Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-specific chronic low back pain; Cognitive functional therapy; Exercise classes
Selenium in the Prevention of Cancer
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. Selenium may be effective in preventing cancer. It is not yet known
      which dose of selenium may be most effective in preventing cancer.

      PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing
      cancer in healthy people.
    

Detailed description: 
      OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces
      total cancer incidence and site-specific cancer incidence in the general population. II.
      Determine whether this regimen has a beneficial effect on mood.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
      Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are
      randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II:
      Participants receive low-dose oral selenium once daily. Arm III: Participants receive
      moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium
      once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable
      side effects or diagnosis of cancer.

      PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study
      within 9-12 months.
    

Intervention name(s): selenium
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific
Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health
Condition: Sleep; Pain; Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      A randomized, blinded, placebo-controlled study of health and wellness product formulations
      and their effects on overall health
    

Detailed description: 
      This is a randomized, blinded, placebo-controlled study conducted with adult participants,
      age 21 and older and residing in the United States.

      Eligible participants will (1) endorse a desire for better health during screening; (2)
      indicate an interest in taking a health and wellness product to potentially help improve
      their health, and (3) express acceptance in taking a product and not knowing its formulation
      until the end of the study.

      Participants with known liver or kidney disease, heavy drinkers, and those who report they
      are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking
      certain medications will be excluded.

      Self-reported data will be collected electronically from eligible participants over 5 weeks.
      Participant reports of health indicators will be collected during baseline, throughout the
      active period of study product use, and in a final survey. All study assessments will be
      electronic; there are no in-person visits or assessments for this real-world evidence study.
    

Intervention name(s): Placebo Control Form 1 Capsules; Health Active Study Product 1.1 Capsules; Health Active Study Product 1.2 Capsules; Health Active Study Product 1.3 Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.; Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.; Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.; Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arm
Masking: Double (Participant, Investigator)
Primary purpose: Other
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Condition: Schizophrenia, Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a
      randomized, prospective manner.
    

Detailed description: 
      Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent
      problem of clinical psychiatry. Current problems are treatment resistant positive and/or
      negative symptoms, as well as side effects. Therefore, different strategies of augmentations
      have been applied. Based on successful experiences in case reports and results of other work
      groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a
      randomized, prospective manner.
    

Intervention name(s): ziprasidone; risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia,; schizoaffective disorder,; treatment resistancy; clozapine,; ziprasidone; risperidone; combination
Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
Condition: Lower Limb Surgery
Study type: Interventional

Summary: 
      This study aims to determine the minimum effective dose of bupivacaine 0.5% in 90% of
      patients undergoing lower limb surgery with ultrasound-guided spinal anesthesia using
      Taylor's approach. A biased coin design up-and-down sequential method is applied. The initial
      dose is 15 mg of bupivacaine 0.5%. After 45 successful spinal anesthesia, the ED90 of
      bupivacaine 0.5% will be calculated.
    

Detailed description: 
      The minimum effective dose of local anesthetics for spinal anesthesia using Taylor's approach
      is not known. This study aims to determine the minimum effective dose of bupivacaine 0.5%
      using a biased coin design up-and-down sequential method. Patients will receive real-time
      ultrasound guided spinal anesthesia using Taylor's approach. The initial dose is chosen as 15
      mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block,
      the bupivacaine dose is increased by 2 mg in the next subject. If a patient has a successful
      block, the next subject is randomized to receive either a lower dose (with a decrement of 2
      mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89.
      Forty five successful blocks will be accomplished. MED90 will be calculated by isotonic
      regression.
    

Intervention name(s): spinal anesthesia
Intervention type(s): Procedure
Intervention description(s): Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. Various doses of bupivacaine 0.5% (Bupivacaine hydrochloride injection, Harvest Pharmaceutical CO., LTD., Shanghai, China) will be administered.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known if carboplatin is more effective with or without liposomal doxorubicin in treating
      recurrent ovarian epithelial or primary peritoneal cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or
      without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or
      primary peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare overall survival of patients with platinum-sensitive recurrent ovarian
           epithelial or primary peritoneal cancer treated with carboplatin with or without
           pegylated doxorubicin HCl liposome.

        -  Compare progression-free survival, confirmed complete response rates, and time to
           treatment failure in patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without
      elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more),
      and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl
           liposome IV over 1 hour on day 1.

        -  Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats
           every 4 weeks for a total of 15 courses in the absence of disease progression or
           unacceptable toxicity.

      Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.

      PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 4 years.
    

Intervention name(s): carboplatin; pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): intravenous q 4 weeks; intravenous q 4 weeks
Intervention MeSH terms: Carboplatin; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal cavity cancer; recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This initial clinical study in the US will be a randomized, double-blind, placebo-controlled,
      single-dose, dose-escalation, and sequential cohort study to evaluate the safety,
      tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).

      In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label
      manner; once in the fasted state and once in the fed state.
    


Intervention name(s): D-0120
Intervention type(s): Drug
Intervention description(s): oral, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment