bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of the Making Employment Needs
      (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black
      men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with
      housing and employment case management via multiple one-on-one sessions delivered by a peer
      case manager over 60-90 day period. MEN Count was developed and pilot tested using a
      Community-based participatory research (CBPR) approach via funding from a National Institutes
      of Health (NIH) R21, in Boston, Massachusetts. A more larger scale, two-armed
      quasi-experimental controlled trial design will be used to test MEN Count among Black men
      recruited/enrolled from an STD clinic and other community-recruitment methods in Washington,
      DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV
      [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either
      current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN
      Count, a two-armed quasi-experimental design will be conducted in which participants will
      receive either MEN Count or an attention comparison program similar to MEN Count in
      structure. We will assess program impact on reduction in number of unprotected sex episodes
      and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing,
      respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and
      process evaluation efforts will be conducted to ensure high quality program adherence and
      delivery, as well as to support program replication should the model prove effective.
    


Intervention name(s): MEN Count; Comparison
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.; general health intervention for men, not inclusive of HIV or relationship health
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; African American men; evaluation study
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with
      mild to moderate OSAS.
    

Detailed description: 
      Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study
      will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive
      sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen
      saturation, objective sleep parameters and safety information will be collected in this
      study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was
      acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed
      to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 3 mg QD; Placebo tablet
Other intervention name(s): Lunesta; (S)-Zopliclone
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea Syndrome; OSAS
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
Condition: Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention
      should be continued and to which time a patient with schizophrenia is protected enough, so
      that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as
      primary outcome.
    

Detailed description: 
      The main objective of the trial is to evaluate for the first time, how long an antipsychotic
      relapse-prevention should be continued and to which time a patient is protected enough, so
      that a guided withdrawal or reduction of the medication seems appropriate. Relapse is defined
      as primary outcome. We include patients with schizophrenia or schizoaffective disorder in
      remission for at least 3 years under a stable antipsychotic medication.
    

Intervention name(s): Olanzapine; Amisulpride; Risperidone; Haloperidol; Quetiapine; Perphenazine; Sulpiride; bromperidol; Zuclopenthixol; Thioridazine; Paliperidone; Ziprasidone; Benperidol; Fluspirilene; Pimozide; Perazine; Fluphenazine; Flupentixole; Sertindole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Haloperidol; Pimozide; Olanzapine; Risperidone; Quetiapine Fumarate; Paliperidone Palmitate; Ziprasidone; Amisulpride; Perphenazine; Sertindole; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate; Sulpiride; Thioridazine; Clopenthixol; Fluspirilene; Benperidol; Bromperidol; Perazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessment of Patient Use of a New Device: RebiSmart
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the
      nerves in within the brain and the spinal cord. This disease is one of the most common causes
      of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an
      acute attack of disability as a result of an acute attack on the nervous system. There is
      usually some degree of recovery after a relapse.

      Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3
      times a week by injections under the skin. The RebiSmart device is a new injection device
      which has been developed to help patients with injecting their Rebif treatment.

      Currently, all treatments for MS are injectable and require long term patient commitment.
      Patient compliance to treatment is important for the therapy to work effectively and decrease
      the risk of relapse episodes. Using a device that makes it easy for patients to inject may
      potentially improve compliance to treatment and therefore potentially have an impact on the
      number of relapses patients experience. The RebiSmart device has been developed for patients
      to inject conveniently and in comfort. The device allows the patient to control certain
      parameters such as needle depth, needle speed, injection time etc, and also has extra
      features designed to ease the injection process, such as a dose history calendar and an
      on-screen injection guide. The aim of this study is to determine what percentage of patients
      liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study
      will also determine which of the device features were most useful to the patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, who are under regular review by a Multiple Sclerosis nurse, with relapsing
        remitting multiple sclerosis who have been prescribed Rebif and have chosen to use the
        RebiSmart device for drug administration.
      
Keywords: Multiple sclerosis; Rebif; Interferon beta-1a
Oral Cyanocobalamin (Eligen B12) Bioavailability Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess and compare the pharmacokinetics (PK) of
      cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral
      cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered
      intravenously (IV) (also a commercially-available formulation) to healthy male subjects under
      fasting conditions. The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC)
      versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.
    


Intervention name(s): Cyanocobalamin
Intervention type(s): Drug
Other intervention name(s): B12, Eligen® B12, Cobalamin
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
Condition: Schizophrenia; Schizo-affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with
      schizophrenia or schizo-affective disorder who are currently clinically stable and to
      evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite,
      PF-01001252, after multiple doses of PF-02545920 administered orally.
    


Intervention name(s): PF-02545920
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of FES on Children With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately,
      children and young adults with damaged spinal cords may not be able to exercise regularly.
      However, there is an exercise bike specially designed for persons with damaged spinal cords
      that enables them to pedal by directly stimulating the muscles in their legs. Our study is
      designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using
      this bike.
    

Detailed description: 
      The inability to walk due to spinal cord dysfunction has profound effects on patients, both
      physiologically and psychologically. Complications associated with walking upright include
      loss of muscle mass from atrophy, reduction in bone mineral density (osteoporosis),
      compromised cardiovascular endurance, loss of sense of well-being, etc. Functional Electrical
      Stimulation (FES) of the lower extremities has been found to reverse many of these
      complications. We propose to examine the use of FES in children who have suffered from spinal
      cord injury (SCI). We plan to examine the effect of FES bike therapy on bone mineral density
      and psychological well-being.
    

Intervention name(s): RT 300-P FES Cycle
Intervention type(s): Device
Intervention description(s): Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes per session over a 9 month period. The intervention was provided at Children's Specialized Hospital in Mountainside, and families were required to provide their own transportation. During the study, the participants continued to participate in their standard, primary rehabilitation program.
Other intervention name(s): FES (Functional electrical stimulation) cycling using th RT 300-P FES cycle; (Restorative Therapies, Baltimore, MD).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric spinal cord injury; FES cycling; bone mineral density; quality of life
Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old
Condition: Children; Pain; Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the PK parameters of metamizole following a single IV
      administration of metamizole in children less than 6 years of age.
    

Detailed description: 
      This is an open-label pharmacokinetics (PK) study. It aims to assess the PK parameters of
      metamizole and its metabolites following a single IV administration of metamizole (10mg/kg)
      in children less than 6 years of age.

      Thirty-nine children, 3-72 months of age, undergoing elective surgery at the University of
      Basel Children's Hospital, will receive, on the day of surgical procedure, a single dose of
      metamizole 10 mg/kg. After this dose, blood and saliva samples will be obtained at
      predetermined post-dose time points to measure concentrations of metamizole and its
      metabolites. The maximal duration of subject participation will be 24 hours. Plasma PK
      parameters (AUC, Cmax, Tmax, t1/2) of each analyte will be derived using noncompartmental
      methods. A population PK approach will be applied to characterize inter-subject variability
      and quantify the potential influence of age, sex and body weight on the PK parameters.

      There are no published pharmacokinetic studies of metamizole in pediatrics. Furthermore,
      although Swissmedic provides no dose information for IV administration in infants with a body
      weight of less than 9 kg, IV is the most frequently used route of administration for direct
      postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg.
      Due to the absence of data and the lack of any dosing recommendation for infants with a body
      weight less than 9 kg, the IV administration of metamizole in infants is "off-label" and
      inconsistent across hospitals and prescribing paediatricians.
    

Intervention name(s): Metamizole
Intervention type(s): Drug
Intervention description(s): metamizole IV administration
Other intervention name(s): Novalgin
Intervention MeSH terms: Dipyrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets
      (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect
      of food on the bioavailability of vadadustat 450 mg tablet.
    

Detailed description: 
      This is a randomized, open-label, single-dose, three-period crossover study in healthy adults
      to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450
      mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at
      pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48
      hours post-dose. The study will also assess the effect of food on vadadustat bioavailability
      by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.
    

Intervention name(s): vadadustat
Intervention type(s): Drug
Intervention description(s): Vadadustat Tablets
Other intervention name(s): AKB-6548
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, open-label, single-dose, three-period, six- sequence crossover study in healthy adults. A total of 54 eligible subjects will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA). Refer to Treatment Sequences below. Each sequence is comprised of 3 treatments
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vadadustat; healthy volunteers; bioequivalence; pharmacokinetics
Comparison of the Quantity of Distal Movement of the Upper Canine and Molar
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND
      MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS
    

Detailed description: 
      To achieve a Class I canine relationship at the end of the alignment and leveling phase,
      different intraoral devices have been used. These include intermaxillary class II elastics,
      which retract the upper and protract the lower arch, generating extrusive forces at the
      anchorage sites. Its upper distalizing action is exerted to the canine bracket and
      transmitted through the posterior teeth where the upper molar does not receive a direct
      force. The sliding jig is an auxiliary addition that exerts force to the molar by an elastic
      hanged in a jig between the lateral and the canine in class II; such mechanism decreases the
      vertical adverse effects of the elastics wearing while directing the distalizing force to the
      molar.

      A randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which
      were placed sliding jig or stand alone elastics were perform.
    

Intervention name(s): Class II elastics and Sliding Jig; Class II elastic alone
Intervention type(s): Device; Device
Intervention description(s): Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device; Elastics Class II alone, used 24 hours per day for 3 months from the hook of the upper canine to the first lower molar hook
Other intervention name(s): Archwire SS 16X22; Sliding Jig made in SS 17X25; Elastics 3/16 Heavy (6oz) Impala (Ormco); Elastics 3/16 heavy, 6oz. Impala (Ormco)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sliding jig; Class II malocclusion; Distalization mechanics; Intermaxillary elastics
SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to assess effect of SHR6390 combined with anastrozole on
      proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.
    

Detailed description: 
      This is a single-arm, single-center, open-label Phase II clinical study. The purpose of this
      study was to evaluate the effect of SHR6390 combined with anastrozole on the proliferative
      activity of HR-positive HER2-negative breast cancer tumor cells before surgery.
    

Intervention name(s): SHR6390+anatrozole
Intervention type(s): Drug
Intervention description(s): SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blinded dose-finding study evaluates four dose levels of ABY-035, in
      comparison to placebo, in subjects with moderate to severe plaque psoriasis.

      The study consists of 52-week Core study and two optional 52-week periods, Extension and
      Prolongation of Extension.

      The Core study consists of three periods: Induction (placebo-controlled, Week 0-12),
      Optimization (Week 12-24), and Individualization (Week 24-52).
    

Detailed description: 
      The Core study evaluates four doses of ABY-035, in comparison to placebo, in subjects with
      moderate to severe plaque psoriasis. The treatment periods in the Core study are:

        -  Induction (Week 0-12) - four dose levels and placebo (Q2W)

        -  Optimization (Week 12-24) - starting with a possible dose adjustment (all subjects on
           Q2W) depending on PASI score. Subjects on placebo switch to active drug (Q4W).

        -  Individualization (Week 24-52) - starting with a switch to Q4W for all subjects. From
           week 32 dosing interval alters depending on PASI score.

      The study is unblinded after completion of the Core study. During the optional Extension and
      Prolongation of Extension periods, dose levels and intervals alter depending on PASI score.
    

Intervention name(s): ABY-035; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ABY-035 solution for injection; Placebo to ABY-035 solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Deep Brain Stimulation for the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this clinical study is to investigate the safety and efficacy of deep brain
      stimulation (DBS) as a treatment option for obesity.
    

Detailed description: 
      The purpose of this clinical study is to investigate the safety and efficacy of deep brain
      stimulation (DBS) as a treatment option in the management of severe, treatment refractory,
      morbid obesity.
    

Intervention name(s): Deep Brain Stimulation Device
Intervention type(s): Device
Intervention description(s): Deep brain stimulation surgery
Other intervention name(s): Reclaim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Obesity; DBS
Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two
      sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects
    

Detailed description: 
      The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence
      of Biocon Insulin R with Humulin® R in healthy subjects.

      The treatment consists of one single dose of the test or reference product, administered
      during each of the two study periods, separated by 5-7 days between each dosing.

      The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will
      undergo two 12-hour euglycaemic clamp examinations, one after administration of the test
      product and one after administration of the reference product in random order.
    

Intervention name(s): Biocon Insulin R; Humulin®R
Intervention type(s): Biological; Biological
Intervention description(s): Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).; Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Recombinant Human Insulin R (rhi R)