bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety and Tolerability of MBF-118 in Healthy Volunteers
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomised, double blind, placebo controlled clinical study to
      assess the safety and tolerability of MBF-118 in healthy volunteers.This clinical phase I
      trial is divided in two stages and involves, first, a single ascending dose (SAD) study in
      healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young
      men and woman. MBF-118 is developed for the treatment of cancer.
    

Detailed description: 
      This clinical phase I trial is divided in two stages. The first stage will be a dose
      escalation study without therapeutic benefit, in which MBF-118 will be administered as single
      oral ascending dose to healthy young male volunteers. Up to four different rising doses will
      be tested (100 mg, 200 mg, 400 mg and 600 mg) in groups/cohorts of 8 participants. Thus, four
      groups/cohorts will participate. For each dose level/group, the participants will be
      randomized to active or placebo with 2 participants being randomly assigned to placebo and 6
      to the active drug. First, one volunteer will receive active drug (subgroup 1); after at
      least 72h of safety and tolerability assessment a second subgroup of 3 volunteers will
      receive 2 active drug and 1 placebo; after at least another 72h of safety and tolerability
      parameters assessment a third subgroup of 4 volunteers will receive 3 active drug and 1
      placebo. After evaluation of safety parameters of corresponding dose level, the process will
      replicate one week afterwards in the following dosages.

      The second stage will be a dose escalation study without therapeutic benefit, in which
      MBF-118 will be administered as single oral daily dose, during 5 days to young male and
      female healthy volunteers. Up to three different rising dose levels will be tested (100 mg,
      200 mg, and 400 mg) in cohorts of 8 subjects that are randomised to active treatment and
      placebo (6:2) and divided into three subsequent treatment blocks, as described above in the
      first stage.

      The pharmacokinetics profile of MBF-118 will be also assessed at each dose level tested of
      the Single ascending dose study and the multiple ascending dose study.
    

Intervention name(s): MBF-118 oral capsules; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): MBF-118 oral capsules PPAR gamma receptor partial agonist; Placebo oral capsule solid microcrystalline cellulose
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single center, randomized, double-blind, placebo-controlled clinical study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PPAR gamma partial agonist; anti-inflammatory; Cancer
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Condition: Osteoporosis Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the dose-response on the percent change from baseline
      in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when
      odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52
      weeks to Japanese involutional osteoporosis participants. The study will also assess safety
      and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

      The study will enroll approximately 280 participants and randomly assign them to 3 different
      doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium
      carbonate. The primary efficacy hypothesis is that a dose-response relationship on the
      percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50
      mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis
      participants. The primary safety hypothesis is that odanacatib will be safe and well
      tolerated over 52 weeks to involutional osteoporosis participants.
    


Intervention name(s): Odanacatib; Vitamin D3; Calcium carbonate; Placebo
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.; Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.; Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.; Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
Other intervention name(s): MK-0822; cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Telepsychiatry and In-person Outcomes
Condition: Psychiatric Disorders
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes
      and be less costly when provided via videoconferencing (telepsychiatry) than when provided
      in-person.
    

Detailed description: 
      We predict that patients referred by their family physician for a psychiatric consultation
      and, if needed, short-term follow-up will have equivalent clinical outcomes when seen via
      telepsychiatry as compared to those patients seen in-person. We also predicted that
      telepsychiatry will be cheaper than in-person care.Study Design: a single-centre equivalence
      trial.We will use a sample size calculation and analytical methods that are specifically
      tailored for equivalence trials.
    

Intervention name(s): Videoconference equipment (telepsychiatry)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telepsychiatry; Videoconference; Psychiatric consultation; Equivalence trial
Crossover Trial of AD109 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of AD109 versus its individual components or placebo in
      patients with obstructive sleep apnea.
    

Detailed description: 
      The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep
      apnea. The study is a four-period single-dose randomized crossover design in which patients
      will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4
      treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks
      after their final crossover PSG for an end of study (EOS) visit.
    

Intervention name(s): AD109; Atomoxetine; R-oxybutynin; Placebo; Digit System Substitution Test
Intervention type(s): Drug; Drug; Drug; Drug; Diagnostic Test
Intervention description(s): Oral administration before bed; Oral administration before bed; Oral administration before bed; Oral administration before bed; a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Other intervention name(s): DSST
Intervention MeSH terms: Oxybutynin; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in
      reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed
      menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might
      become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed
      that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in
      the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on
      carbohydrate and lipid metabolism.

      The present clinical trial intends to compare the effects of metformin and oral
      contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and
      menstrual cycle etc. The investigators also aim to study the effects of metformin on serum
      adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS
      patients.
    


Intervention name(s): Metformin; Ethinylestradiol and Cyproterone Acetate
Intervention type(s): Drug; Drug
Intervention description(s): 425mg bid for morning and evening after meals, one week after treatment, increase the dosage to 850 mg bid. If the patients have side effects such as nausea, diarrhea and other gastrointestinal symptoms, the dose would be reduced to 425mg bid for 1 week, and try the dosage to 425mg tid again, until the maximum tolerated dose.; from the first day of bleeding of the menstrual cycle, daily oral administration of one pill for 21 days consecutively, then stopped taking the pill for seven days, and on the eighth day to start taking the pill again.
Other intervention name(s): Glucophage; Diane-35
Intervention MeSH terms: Metformin; Cyproterone Acetate; Ethinyl Estradiol; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; insulin resistance
Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
Condition: Respiratory Distress Score
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV)
      is very common in infants under two years old. It is usually benign. However, the dyspnea it
      causes is a big concern for parents and this disease can take a severe form on certain
      particular ground thus constituting a frequent reason for hospitalization in pediatrics.
      Nebulized epinephrine showed more efficacy than nebulized salbutamol.
    

Detailed description: 
      The objective of this study is to determine if nebulized epinephrine is more efficacious than
      nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of
      bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics
      department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included
      in the study.

      Children who meet the inclusion criteria will be alternately distributed in two groups:

      Group 1:

      Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

      Group 2:

      Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted
      patients will receive aerosol every 20 minutes three times and after, depending on the
      clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at
      the admission if oxygen saturation is below 94% till the normalization of the oxygen
      saturation.

      Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart
      rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24
      hours until they are discharged.
    

Intervention name(s): Salbutamol; Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status; At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
Intervention MeSH terms: Epinephrine; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Occupational Therapy in Complex Patients: a Pilot Study
Condition: Complex Patients in Rehabilitation Phase
Study type: Interventional

Summary: 
      To date, there are no studies that demonstrate that the intervention of Occupational Therapy
      (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical
      and functional outcome for the patient. For this reason, the investigators propose one
      randomized controlled trial that will compare the group receiving the intervention of OT and
      the control group, to quantify the level of performance and satisfaction in the activities of
      interest of the patient, identified through the COPM. The hypothesis is that the benefit may
      be higher, as clinically relevant, in the group of complex patients treated with the proposed
      intervention of OT compared to those receiving the usual rehabilitation therapy.
    

Detailed description: 
      The investigators already implemented an observational pilot study, aimed at defining the
      characteristics and needs of the population in question and the OT intervention
      characteristics. These information will now be used to implement this randomized controlled
      trial, designed to demonstrate the effectiveness of the OT intervention on the basis of
      clinically relevant outcome measures.

      This study will be set with exploratory purposes, with appropriate high number, which will
      allow the investigators to quantify the difference between the two groups in terms of
      performance scores derived from the COPM (COPM_p). From the results of this part it will then
      depend on the planning for the subsequent study with the correct sample size.
    

Intervention name(s): occupational therapy; Usual care
Intervention type(s): Other; Other
Intervention description(s): an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Occupational Therapy; Complex patients; Randomized controlled trial; Occupational performance problem; Rehabilitation Complexity Scale
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
Condition: Astigmatism; Myopia
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The principal hypothesis is to be tested in this work is that vision stability (the primary
      outcome measure) with a spherical contact lens correction vs. a toric contact lens correction
      will be the same.
    

Detailed description: 
      This will be a randomised, subject-masked, crossover, bilateral non-dispensing study,
      controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in
      random sequence.
    

Intervention name(s): Test Contact lens; Control Contact lens
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.; Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Other intervention name(s): Soft comfilcon A toric contact lenses; Soft comfilcon A sphere contact lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder
Condition: Bipolar Disorder; Schizophrenia; Attention Deficit Disorder With Hyperactivity
MeSH terms: Schizophrenia; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The purpose of this study is to study the predictive value of SensoDetect-BERA as a
      diagnostic tool in clinical practice for schizophrenia and bipolar disorder.
    

Detailed description: 
      Background:

      Within the daily clinical work of all medical specialties, objective diagnostic tools are
      paramount. However, in the psychiatric field such measures are lacking. Since 1983 the method
      of psychoacoustics has been under development in hope to serve this purpose. A recent
      development of auditory brainstem response (ABR/SD-BERA), has been proposed as a potential
      diagnostic tool within psychiatry.

      The ABR is a diagnostic tool used primarily to diagnose sensorineural hearing loss. It
      detects evoked potentials, generated by neuronal activity in the auditory pathways in the
      brainstem, within the first 10 ms following acoustic stimulation. The potentials are recorded
      by surface electrodes placed on the forehead and on the mastoid processes. The wave pattern
      recorded consists of seven peaks, which are interpreted with respect to latencies and
      amplitudes.

      Previous studies have aimed to associate the peaks with specific anatomical structures. The
      method SD-BERA is a further development of the standard ABR. It uses a wider array of
      acoustic stimuli, including complex sounds, for instance masking noises. The measuring
      procedure will roughly take 25 minutes. Previous studies using these complex sounds to
      compare mentally healthy subjects with patients suffering from schizophrenia, ADHD and
      bipolar disorder have shown that the different psychiatric groups exhibit specific wave
      patterns.

      Aims

      The aim of the first study is to validate previous results and identify five (n=5) patients
      with diagnosed ADHD, schizophrenia and bipolar disorder, and to compare these patients (n=15)
      with healthy, age-matched controls.

      The aim of the second study is to present a blinded study where 12 patients with
      schizophrenia and 12 patients with bipolar disorder (total n=24) are compared to each other
      and to healthy controls (n=12) in order to evaluate the method as a diagnostic tool in
      clinical healthcare practice.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients recruited from the University Hospital of North Norway and the General Practice
        Clinic in Balsfjord, Troms, Norway. Healthy controls from North Norway.
      
Keywords: Auditory Brainstem Response; ABR; SD-BERA
Database Surveillance Safety Study of PENTACEL® Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Observational

Summary: 
      The objective for this study is to characterize the safety profile of PENTACEL® vaccine for
      identification of potential vaccine-related adverse events not currently associated with
      PENTACEL® vaccine administration.
    

Detailed description: 
      The study will be conducted at Kaiser Permanente Northern California and will commence with
      first use of licensed PENTACEL® vaccine within that organization.

      Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with
      acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency
      room, hospitalization, laboratory, state death reporting, and related databases will be
      reviewed to identify medical care events.
    

Intervention name(s): DTaP-IPV/Hib; Other DTap Vaccines
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): PENTACEL®; DAPTACEL®; INFANRIX®; PEDIARIX®; TRIPEDIA®
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
      
Keywords: DAPTACEL®; PENTACEL®; Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type b
Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
Condition: Postpartum Hemorrhage; Pain
MeSH terms: Postpartum Hemorrhage; Hemorrhage; Pain, Postoperative
Study type: Interventional

Summary: 
      This is a pilot study investigating the use of abdominal binders after cesarean sections. The
      researchers are testing whether elastic abdominal binders improve postoperative pain control
      and reduce postoperative blood loss. Blood loss and pain control are both concerns after
      giving birth. It is hoped that the use of an abdominal binder after giving birth will provide
      a non-pharmacologic way to to reduce blood loss and manage pain.
    


Intervention name(s): Procare abdominal binder; Standard of Care
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MyDiaText Text Messaging Intervention for Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To test a text messaging intervention using MyDiaText and financial incentives to determine
      whether such an intervention will improve self-reported self-care behaviors in children 12 to
      18 years old. The intervention will consist of daily text messages sent to the subject's
      personal mobile device. Subjects will be incentivized to respond to text messages via a
      lottery financial incentive. Previously developed text messages based on the American
      Diabetes Association (ADA) behavior goals will be used for this intervention.
    


Intervention name(s): MyDiaText
Intervention type(s): Other
Intervention description(s): The intervention will consist of daily text messages sent to the subject's personal mobile device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other