bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Study the Effect of CVL-231 on 24-Hour Ambulatory Blood Pressure in Participants With Schizophrenia
Condition: Blood Pressure; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to characterize the effects of 2 oral doses (over 8 weeks total)
      of CVL-231 on ambulatory blood pressure and heart rate in patients with stable schizophrenia.
    


Intervention name(s): CVL-231
Intervention type(s): Drug
Intervention description(s): CVL-231 is a brain penetrant mAChR activator that selectively binds to the M4 mAChR subtype while sparing other muscarinic receptor subtypes (M1, M2, M3, and M5). CVL-231 is being developed for treatment of psychosis in schizophrenia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Quality of Diet in Preschool Population
Condition: Feeding and Eating Disorders of Childhood
MeSH terms: Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
Study type: Interventional

Summary: 
      Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is
      mostly due to inadequate life habits, modifiable through preventive strategies. The objective
      was to evaluate in the medium term the effectiveness of an intervention on adherence to the
      Mediterranean diet pattern in preschoolers.

      Method: Community trial with two groups, in children between 3-5 years. The experimental
      group conducted a school garden and the usual contents on human body and health were taught
      in the control. Two schools were selected by cluster sampling, whose first unit of
      randomization were the educational areas followed by schools. The adaptation to the
      Mediterranean diet pattern was evaluated using the KIDMED questionnaire and weight, height,
      BMI and sociodemographic variables were controlled.
    


Intervention name(s): Education food
Intervention type(s): Device
Intervention description(s): The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information from children's books that dealt with the topic of food and were available in the public library.
The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center.
All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutritional Status; Child Nutrition Sciences; Nutrition Therapy; Nutrition Assessment; Diet, Food, and Nutrition
Sagittal Balance Through Ages
Condition: Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary
      according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These
      parameters have been described as a function of age in previous scientific work without
      taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This
      work, carried out within the framework of a round table of the French Society of Spinal
      Surgery (SFCR), would make it possible to provide a more detailed repository of existing
      radiographic parameters.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back
        pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in
        spinal surgery consultation
      
Keywords: Spinal Deformity; Low back pain; Sciatica; Cervico brachial neuralgia
Long-Duration Ultrasound for Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms
      of knee arthritis pain.
    


Intervention name(s): Long duration ultrasound
Intervention type(s): Device
Intervention description(s): Low-intensity long duration ultrasound treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assessed the efficiency of treatment based on the objective
      response rate (RECIST 1.1)
    


Intervention name(s): Bevacizumab; Capecitabine; Irinotecan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1; Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4; Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)
Intervention MeSH terms: Bevacizumab; Capecitabine; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Condition: Autism; Fragile-X Syndrome (FXS); Healthy Volunteers
MeSH terms: Fragile X Syndrome; Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in
      autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers
    


Intervention name(s): [18F]FPEB PET imaging; Biological samples; MRI
Intervention type(s): Drug; Other; Other
Intervention description(s): PET exam; blood sample and urine sample; MRI exam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: autism; fragile X syndrome (FXS); PET (Positron Emission Tomography); glutamate
Ganaxolone in Posttraumatic Stress Disorder (PTSD)
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,
      15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress
      Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either
      ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants
      will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of
      ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment
      using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to
      evaluate the safety and tolerability of ganaxolone in the PTSD population.
    


Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200-600 mg bid, capsules, up to 12 weeks; capsules, bid, up to 12 weeks
Other intervention name(s): GNX; PBO
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Posttraumatic Stress Disorder; pharmacotherapy; ganaxolone
The Various Effects of Gaseous Albuterol on Serum Lactate
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Empirical data from physician observation indicates an increase in serum lactate in acute
      asthmatic patients being treated with inhaled albuterol therapy.

      It is not clear if this increased serum lactate is in response to a physiological response to
      the asthmatic process or from the albuterol treatment.

      This study is designed to determine if administration of inhaled albuterol increases serum
      lactate in healthy subjects.
    

Detailed description: 
      Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered
      our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be
      greater than 1.0 mmol/L.

      All volunteer subjects will sign a written consent, approved by the Institutional Review
      Board. The intended pool of volunteers will be from residents, attendings, and medical
      students in the hospital. The consent form will clearly specify that their participation in
      the study will not impact their academic status or employment.

      The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous
      Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline
      nebulizer treatment. The chief pharmacist for the study will randomly assign a number between
      one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.

      Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every
      15 minutes.
    

Intervention name(s): Normal Saline; Albuterol
Intervention type(s): Drug; Drug
Intervention description(s): One hour inhaled normal saline; One hour inhaled ten milligrams of albuterol
Other intervention name(s): NS; Saline; Ventilin; Proventil
Intervention MeSH terms: Albuterol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Albuterol; Serum Lactate; Lactic Acidosis; Asthma
Chronic Pain and Opioid Dependence Assessment and Treatment
Condition: Chronic Pain; Opioid Dependency
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional

Summary: 
      This study involves the development of an integrated psychotherapy that addresses both
      chronic pain and opioid dependence(POD).
    

Detailed description: 
      To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and
      potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by
      urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain
      intensity and pain interference on self-report measures from baseline throughout treatment)
      for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of
      sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative
      feedback from individual exit interviews, and c) develop and modify initial therapist
      training and process rating measures. Products will include a) a manual for integrated CBT
      for POD to be used in opioid treatment programs and primary care settings with POD patients,
      b) therapist training materials, and c) process rating instruments.
    

Intervention name(s): Integrated Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; opioid dependence; Cognitive Behavioral Therapy (CBT)
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Observational

Summary: 
      The purpose of this study is to contribute to the validation of an electronic daily diary to
      assess symptoms in patients with varicose veins.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Varicose veins
SGA-induced Metabolic Syndrome in Bipolar Youth
Condition: Bipolar Youth Treated With Second-generation Antipsychotics
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid
      supplementation will attenuate the adverse cardiometabolic effects of second-generation
      antipsychotics exposure in first-episode adolescent manic patients.
    

Detailed description: 
      Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic
      patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with
      long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective
      effects on the of adverse cardiometabolic events and weight gain during quetiapine
      maintenance therapy. They will have 6 visits over a 24-week period.
    

Intervention name(s): Omega; Placebo; Quetiapine fumarate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omega-3 supplements; Similar in shape and color to Omega supplements; Prior to randomization to Omega/placebo, patients were started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
Other intervention name(s): EPA+DHA supplements (OmegaRx); Placebo supplements (corn oil) provided by the Inflammation Research Foundation; Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Second-generation antipsychotics; Obesity; Cardiometabolic risk
The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction
Condition: Retinitis Pigmentosa; Cataract
MeSH terms: Cataract; Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients
      with Retinitis Pigmentosa
    

Detailed description: 
      Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior
      sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of
      capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication
      following cataract surgery. The rate of which is higher in RP patients due to the weak
      zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of
      contraction.

      Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the
      other 20 would not receive CTR. The percentage of anterior capsular contraction would be
      evaluated using EPCO software.
    

Intervention name(s): IOL surgery; IOL surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): IOL surgery using capsular tension ring (AURORING); IOL surgery without CTR
Other intervention name(s): AURORING; Phacoemulsification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Retinitis Pigmentosa; Cataract
Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS
Condition: Walking
Study type: Interventional

Summary: 
      Investigators investigate the patterns of cortical activation using the NIRST in patients
      with peripheral neurological injury caused by lower extremity burns.
    

Detailed description: 
      Understanding the mechanisms associated with locomotor networks may be of benefit for
      rehabilitation of burn victims with neurological locomotor deficits. However, the effects of
      peripheral neurological injury on locomotor network remains unknown. A wearable functional
      near-infrared spectroscopy (fNIRS) device has been developed for studying cortical
      hemodynamics. Changes in cortical activity has not previously been documented in patients
      with burn injury.

      Investigators assessed 15 patients with lower extremity burns and 11 healthy controls.

      Investigators measured walking-related cortical activity using an fNIRS device at baseline
      and during usual walking.

      Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The
      NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.
    

Intervention name(s): Functional near-infrared spectroscopy (fNIRS)
Intervention type(s): Diagnostic Test
Intervention description(s): Functional near-infrared spectroscopy (fNIRS) measurement
Intervention model: Single Group Assignment
Intervention model description: patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Burn; Near-infrared spectroscopy (NIRS)
Effect of Erythropoietin on Preterm Brain Injury
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      EPO has been safely used for prevent preterm anemia and recent studies have shown the
      neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The
      aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg
      higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on
      neurodevelopment in preterm infants; to detect biological indicators and explore the
      neuroprotective mechanism of EPO.
    

Detailed description: 
      Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in
      preterm infants, which is related with the development of cerebral palsy. The current therapy
      is only supportive to maintain the live sign stable. There is no effective therapeutic
      strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective
      against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and
      clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo
      (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity
      during the past decade. It has been considered to be safe and well tolerated in preterm
      infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm
      brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm
      infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day
      for2 week possesses neuroprotective properties. Very preterm infants with gestational age of
      < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is
      obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary
      short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and
      periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very
      preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.
    

Intervention name(s): recombinant human erythropoietin
Intervention type(s): Drug
Intervention description(s): rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.
Other intervention name(s): EPO
Intervention MeSH terms: Epoetin Alfa
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: erythropoietin; preterm; brain injury; cerebral palsy; PVL
A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-742457 is a 5HT6 receptor antagonist that is in development for the symptomatic treatment
      of mild to moderate Alzheimer's disease . To date, all clinical trials have been conducted
      using a capsule formulation of SB-742457. However, it is intended to conduct all futures
      studies with a tablet formulation. The aim of this study is to assess the pharmacokinetic
      profile of SB-742457 and its major metabolites following single doses of both the capsule and
      tablet formulations.
    


Intervention name(s): SB-742457
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bio-availability, healthy elderly volunteers
The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site
      study in subjects with at least two sensitive teeth to compare the efficacy of a test
      dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
    


Intervention name(s): Stannous Fluoride; Sodium Monofluorophosphate
Intervention type(s): Drug; Drug
Intervention description(s): Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.; Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment