bioihbjkbjnl/mcl2 huggingface dataset:
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
Condition: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip
MeSH terms: Osteoarthritis; Joint Diseases; Osteoarthritis, Hip; Necrosis
Study type: Observational

Summary: 
      This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to
      10-years) information regarding the performance and safety of the commercially available 36mm
      CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were
      previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component
      that articulates with a ceramic femoral head in the COC total hip replacement system)
    

Detailed description: 
      Up to five (5) sites will participate. These sites participated in the IDE study and will
      continue subject follow-up.

      Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen
      for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op
      or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years
      (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and
      adverse event information will be collected at each visit.

      If a subject is not willing or able to return for a clinical and radiographic follow-up for
      either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone
      interview may be utilized for the purpose of determining device survivorship.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects from the original IDE study who have already been implanted with a Ceramax 36mm
        ceramic-on-ceramic system and who have given their consent for this study
      
Keywords: Total Hip Replacement; Total Hip Arthroplasty; Hip Joint Replacement; Hip Prosthesis Replacement
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
Condition: Stable Coronary Artery Disease; Percutaneous Coronary Intervention
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV)
      injection, and to evaluate efficacy on the basis of the changes seen in the cardiac
      biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of
      the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be
      explored.
    


Intervention name(s): CMX-2043; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.; Vehicle solution for IV administration single dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients
Condition: Hypertension,Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      SPH3127 tablet is a of renin inhibitor. It is expected to be a new drug for essential
      hypertension. This is a phase IIa trial which designed to evaluate its efficacy and safety on
      treating mild-moderate essential hypertension patients.
    

Detailed description: 
      This is a dose finding trial. Totally 120 mild-moderate essential hypertension patients will
      be enrolled. All the patients will be randomized (1:1:1:1) into four groups (SPH3127 50mg,
      SPH3127 100mg, SPH3127 200mg and placebo).

      The trial has three phases: the screening phase, the leading phase and the treating phase.

      The primary endpoints are the changes of DBP and SBP compared to the baseline after 8 weeks
      of treatment.

      All the adverse events are required to be collected for safety analyzing.
    

Intervention name(s): SPH3127 tablet Dose 1; SPH3127 tablet Dose 2; SPH3127 tablet Dose 3; SPH3127 tablet Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.; Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.; Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.; Oral SPH3127 tablet placebo, once daily for 8 weeks.
Other intervention name(s): renion inhibitor; renion inhibitor; renion inhibitor; renion inhibitor placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mild-moderate essential hypertension; SPH3127 tablet; renin inhibitor; efficacy; safety
Periodized Resistance Training for Persistent Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In this study the feasibility is investigated of a 16-week supervised heavy resistance
      training program with weekly undulating periodization for individuals with persistent
      non-specific low-back pain.
    


Intervention name(s): 16-week supervised heavy resistance training program with weekly undulating periodization
Intervention type(s): Behavioral
Intervention description(s): Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise therapy; Resistance training
The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
Condition: Low HDL Cholesterol
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to
      be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon
      ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the
      heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with
      fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of
      9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.

      patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above
      200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of
      Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the
      capsules is about 1:1.
    


Intervention name(s): Dunaliella
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers
Condition: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic drug interaction between
      Solifenacin and Tamsulosin in healthy male volunteers.
    

Detailed description: 
      A randomized, open-label, single dose, two-way crossover study
    

Intervention name(s): JLP-1207(Fasted); JLP-1207(Fed)
Intervention type(s): Drug; Drug
Intervention description(s): Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.; Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: α1-blockers; antimuscarinic agent
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare renal allograft rejection rates during the first year among high-immunological
      risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
    

Detailed description: 
      The objective of this randomized, multi-center trial is to directly compare the ATG,
      Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal
      transplant population, in order to elucidate whether there is any significant difference in
      the incidence of acute rejection after one year.

      Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day
      7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression
      comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of
      biopsy-proven acute rejection at one year.
    

Intervention name(s): Thymoglobulin (ATG); Daclizumab
Intervention type(s): Drug; Drug
Intervention description(s): Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation; Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
Other intervention name(s): Thymoglobulin, Genzyme; Zenapax, Roche
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplantation; Immunisation; Acute rejection; Induction therapy; Thymoglobulin; Daclizumab; Rejection in sensitized renal transplant recipients
Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to compare the single-dose oral bioavailability of
      Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott
      Laboratories in healthy, adult, human subjects under fasting conditions
    

Detailed description: 
      This was an open label, balanced, and randomized, two-treatment, two-period, two-sequence,
      single-dose, crossover bioavailability study planned on 32 healthy, adult, human subjects
      under fasting conditions. 31 subjects completed both the periods of the study. Both periods
      were separated by a washout of twelve days The study was conducted on 32 healthy, adult,
      human subjects under fasting conditions. 31 subjects completed both the periods of the study
    

Intervention name(s): clarithromycin 250 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence clarithromycin 250mg tablets fasting
Does Melatonin Restore Sleep Architecture in Autistic Children
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Although behavioral disorders origins in autistic children are still unclear, they seem to be
      influenced by sleep disorders. Results of studies performed on sleep quality in autistic
      children showed a high prevalence of sleep disorders in these children, estimated between 50
      and 80% compared to children with typical development and insomnia is one of the sleep
      disorders most frequently reported by autistic children's parents. Others studies showed
      circadian rhythm disorder in autistic children which could be the consequence of genetic
      abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission
      modulation.

      Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of
      sleep proposed for insomnia treatment and circadian rhythm disorders.

      Two major recent studies (not yet published) in the United States and in England seek to show
      the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing
      sleep disorders.

      It is therefore interesting and important to conduct a parallel study to assess the melatonin
      effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…),
      but on sleep quality (number of nocturnal awakenings).

      The strength of this study lies in the combination of several measurement tools to assess the
      melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography),
      biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of
      insomnia severity, rating scale autistic disorder) as well as possible side effects.

      The primary objective is to determine the most effective dose of melatonin to improve sleep
      quality in autistic children.
    


Intervention name(s): melatonin; Melatonin; Melatonin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime; one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime; one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime; one capsule, placebo, oral, once a day, 30 minutes before bedtime
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep,melatonin,autism,children
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Condition: Healthy Adults
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      It has been reported that in the first stages of the pandemic, a significant portion of the
      general population experienced psychological problems such as anxiety, depression and
      post-traumatic disorders. These problems persist today. A balanced diet, physical activity
      participation and relaxation techniques are recommended for preventing such problems. In
      studies conducted before the pandemic, it is reported that breathing exercises have positive
      effects on anxiety, sleep and quality of life in both patients and healthy individuals. Aim
      of this study is to investigate the effects of breathing exercises applied via teleconference
      on fear of COVID-19, anxiety, sleep and quality of life in healthy adult population.
    


Intervention name(s): Breathing Exercises; Information on COVID-19
Intervention type(s): Other; Other
Intervention description(s): Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises; Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of zonisamide for
      anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial
      or partial with secondary generalized seizures.
    


Intervention name(s): Zonisamide; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): Tablet once or twice daily orally for 16 weeks; Tablet once daily orally for 16 weeks
Intervention MeSH terms: Lamotrigine; Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; seizures
IV Cocaine Abuse: A Laboratory Model - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on
      the physiological and subjective effects of cocaine, including cocaine craving in non-opiate
      dependent cocaine users.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: intravenous abuse
Adductor Strength in Roller Hockey Athletes
Condition: Groin Pain
Study type: Observational

Summary: 
      Roller hockey athletes will be recruited along the season and will be examined for adductor
      strength and other potential groin pain risk factors.
    

Detailed description: 
      Roller hockey athletes will be recruited and assess through the season. The assessment
      consist of an adductor, abductor strength measurement, Hip and Groin Outcome Score (HAGOS)
      completion and will be screened for other risk factors which are believed to cause groin pain
      (Age, previous injury)
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Athletes playing in the spanish roller hockey´s third division
      
Keywords: Roller hockey; Groin Pain; Risk factors
Kid STRIDE: Exploring Participation in a Family-based Intervention
Condition: Obesity
Study type: Observational

Summary: 
      The aim of this qualitative study is to explore parental and child perceptions of
      participating in a family-based behavioral intervention targeting healthy behaviors.
    

Detailed description: 
      Children ages 9-14 have been participating in the Kid STRIDE study which is a family-based
      behavioral intervention for obese children. Participants will be divided into 3 groups
      according to their change in weight: 1) children who lost greater than 5% of body weight; 2)
      children who lost less than 5% of body weight or gained less than 1% of body weight; 3)
      children who gained greater than 1% of body weight. We will invite five families from each of
      groups 1 and 3 to participate in an open-ended interview.
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the current Kid STRIDE behavioral intervention study.
      
Keywords: pediatrics, overweight, obese, behavioral intervention
Allopurinol Outcome Study
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the
      safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy
      (ULT) for up to six months. Allopurinol will be dosed according to the local product label,
      at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for
      each patient.
    


Intervention name(s): Allopurinol
Intervention type(s): Drug
Intervention description(s): Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
Intervention MeSH terms: Allopurinol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
      lead over time to cervical cancer in women . This study will evaluate the immune response
      induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): Placebo; HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Other intervention name(s): GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Double-blind; Human Papillomavirus; Phase IIIb; Controlled; Randomized; India
Bioequivalence Study of Cephalexin Suspension 125
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of cephalexin suspension are
      bioequivalent.

      Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product
      Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 28 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Cephalexin 125 mg/5ml; Cephalexin 125 mg/5ml
Intervention type(s): Drug; Drug
Intervention description(s): Reference product 20 ml; Test product 20 ml
Other intervention name(s): Keflex® suspension ELI LILLY Y COMPAÑIA DE MEXICO SA de CV; Ceporex® granulate for suspension GLAXOSMITHKLINE MEXICO SA de CV
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cephalexin; Respiratory infections; Mexico; Bioequivalence
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure, Diastolic
Study type: Interventional

Summary: 
      This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation
      (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients
      will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but
      the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or
      sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation
      (TENS) device with electrodes attached to the tragus of the ear, which is innervated by
      auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of
      LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for
      HRV analysis every 15 minutes of stimulation (total of 4 recordings).
    


Intervention name(s): transcutaneous vagus nerve stimulation
Intervention type(s): Device
Intervention description(s): All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment