bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess tolerability and safety of SAR439794 [peanut extract (PE) sublingual immunotherapy
      (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)] after repeated sublingual (SL) daily
      administration in peanut allergic adult and adolescent patients.

      Secondary Objective:

      To assess pharmacodynamics of SAR439794 after repeated SL daily administration in peanut
      allergic adult and adolescent patients.
    

Detailed description: 
      The total study duration per participant is approximately from 15 to 18 weeks (core study)
      from screening until end-of-study visit, and 2 phone calls at Week 26 and Week 52 after the
      last Investigational Medicinal Product (IMP) dose.
    

Intervention name(s): Glucopyranosyl Lipid A (GLA); Sublingual Immuno Therapy (SLIT) Peanut Extract (PE); Placebo for GLA; Placebo for SLIT PE
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual; Pharmaceutical form:Solution Route of administration: Sublingual; Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual; Pharmaceutical form:Solution Route of administration: Sublingual
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The child health and sports center, at the Meir Medical Center, runs for over 10 years an
      intervention program to treat obese children. The program includes physical activity,
      nutritional intervention and behavioral treatment. A similar program exists in the nearby
      city of Hadera. The aim of the programs is to promote weight loss, encourage physical
      activity and modify behavior in order to get long term results. The aim of the present study
      is to try and identify the demographic and behavioral characteristics of children who succeed
      in the program.
    


Intervention name(s): Intervention program for obese children
Intervention type(s): Other
Intervention description(s): The program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle.
Other intervention name(s): exercise, nutrition, behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Adolescence; Predictors; Success; Intervention program
AI Mobile Application Versus HCP for Bodyweight Squats
Condition: Squat Form
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      To assess if an artificial intelligence (AI) mobile application can identify and improve
      bodyweight squat form in adult participants when compared to a Physical Therapist (PT).
    

Detailed description: 
      Artificial intelligence (AI) is changing the way people can address their health needs. One
      such way related to physical exercise is AI-enabled exercise mobile application (digital
      coach), which uses motion tracking technology to monitor and provide real-time audio feedback
      on a person's exercise form. However, this AI technology has yet to be independently tested
      against an in-person evaluator (human coach) for its ability to improve exercise form. This
      study is a blinded randomized controlled trial comparing the ability of the digital coach
      (n=15) and a Physical Therapist (PT) human coach (n=15) to improve bodyweight squat form in
      30 able-bodied volunteers age 20 - 35. Each volunteer performs 10 unassisted control squats,
      then 10 squats with assistive vocal feedback from either coach after each repetition, and
      finally 10 more unassisted test squats, all squats video-recorded. Three independent video
      evaluators count the number of correct squat repetitions completed by volunteers before and
      after intervention by the different coaches. This project is important to validate the
      digital coach compared to a PT human coach in a small population using a bodyweight squat for
      its wide applicability to daily movement patterns.
    

Intervention name(s): Artificial Intelligence Feedback; Physical Therapist Feedback
Intervention type(s): Other; Other
Intervention description(s): AI mobile application provides feedback to participants randomized to artificial intelligence group.; PT provides feedback to participants randomized to physical therapist group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Exercise; Squat; Physical therapist; Artificial Intelligence (AI)
Effects of Therapist Behavior on the Treatment of Depressed Adolescents
Condition: Depression; Depressive Disorder; Dysthymic Disorder
MeSH terms: Depressive Disorder; Dysthymic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to identify and evaluate therapist behaviors that affect how
      well and how long adolescent patients stay in treatment for depression.
    

Detailed description: 
      Early patient drop out, sporadic attendance, and minimal participation have hindered the
      development and administration of effective treatments for adolescent depression. Adolescents
      who do not receive adequate exposure to active treatment are unlikely to benefit from
      experimentally supported treatments. Certain therapist behaviors may influence the
      attendance, drop-out, and overall participation of adolescents with depression. This study
      will evaluate the effect of engagement interventions and alliance on attendance,
      participation, completion, and outcome in depressed adolescents.

      Participants in this study will have 12 weekly sessions of cognitive behavioral therapy (CBT)
      at a school-based health clinic. Audio recordings from the completed CBT sessions will be
      replayed and evaluated to identify therapist engagement interventions, therapy alliance, and
      treatment participation.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent
Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to to evaluate the efficacy and safety of PG201 in
      osteoarthritis patients.

      This clinical study was designated to be non-inferiority test with level of significance:
      95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%.
      Assuming 20% drop-out rate, the number of subjects required for each treatment group was
      estimated to be 154, while the total number of subjects required for the study 308.

      non-inferiority margin: 8mm
    

Detailed description: 
      Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib
      placebo capsule each in the morning and evening per day for 8 weeks.

      Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one
      celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per
      day for 8 weeks.
    

Intervention name(s): PG201 tablet; Celebrex capsule
Intervention type(s): Drug; Drug
Intervention description(s): One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes); One celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes)
Other intervention name(s): botanical drug; chemical drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PG201; Non-inferiority; 100mm pain VAS
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of
      SR1375 in healthy volunteers
    

Detailed description: 
      This study is a phase 1,randomized, double-blind, placebo-controlled, 2-part study to
      evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and
      multiple ascending doses of SR1375 in healthy volunteers. The study is divided into two
      parts, Part A (single ascending dose [SAD]) and Part B (multiple ascending dose [MAD]). In
      Part A, the scheduled dose cohorts include 1, 3, 10, 30, 100, and 200 mg; in Part B, the
      planned dose range will be 5, 15, and 50 mg.
    

Intervention name(s): SR1375; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water; The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
Condition: Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem
MeSH terms: Recurrence
Study type: Observational

Summary: 
      The rationale of this study is to determine if an association exists between WT1 expression
      and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem
      cell transplantation. In particular, we want to studied WT1 expression level on bone marrow
      samples of day +60 in terms of predicting power on relapse incidence so as to determine a
      cut-off value for identify high risk patients.
    

Detailed description: 
      This is a retrospective study which will be held on 50 patients with acute myeloid leukemia
      allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June
      2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after
      transplant. The minimum follow up for surviving patients will be 60 days. Patients will be
      classified according to European Leukemia Net criteria. For each patient a total of 24 ml of
      bone marrow was collected at day +60 post transplant, whereas the same quantity of bone
      marrow was collected from healthy donor during bone marrow harvest procedure.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This is a retrospective study which will be held on 50 patients with acute myeloid leukemia
        allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June
        2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after
        transplant.

        The minimum follow up for surviving patients will be 60 days. Patients will be classified
        according to European Leukemia Net criteria
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Condition: Post Operative Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to assess the efficacy and tolerability of diclofenac potassium soft
      gelatin capsules compared with ibuprofen tablets in patients with moderate to severe
      postoperative dental pain.
    


Intervention name(s): Diclofenac potassium; Ibuprofen; Placebo to ibuprofen; Placebo to diclofenac potassium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of diclofenac 50 mg soft gelatin capsule; Single dose of ibuprofen 400 mg tablet; Single dose of placebo to ibuprofen 400 mg tablet; Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule
Other intervention name(s): diclofenac-K; Ibuprofen acid; Placebo; Placebo
Intervention MeSH terms: Ibuprofen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diclofenac potassium; Post-operative dental pain; Moderate to severe pain
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an investigator-initiated proof of concept study with the purpose to examine the
      safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the
      treatment of adults with Tourette syndrome.
    

Detailed description: 
      The investigators propose a 12-week, investigator-initiated, open-label trial of a
      therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome.
      Participants will receive Dronabinol and PEA in combination for the duration of the trial.
      The goal for this pilot study is to (1) provide initial safety, feasibility and tolerability
      data on both Dronabinol and PEA in a TS population and (2) provide data in order to make a
      more informed decision regarding the appropriate sample size and design of a larger clinical
      trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the
      Dronabinol/PEA combination in TS).
    

Intervention name(s): Dronabinol and Palmitoylethanolamide
Intervention type(s): Drug
Intervention description(s): Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
Other intervention name(s): synthetic Δ9THC; Marinol; C21H30O2; Δ9-Tetrahydracannabinol; PEA; C18H37NO2; PeaPure; N-palmitoylethanolamine; MimyX; Impulsin; Normast
Intervention MeSH terms: Palmidrol; Dronabinol
Intervention model: Single Group Assignment
Intervention model description: Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor tics; Vocal tics; Cannabinoids; Dronabinol; PEA; Palmitoylethanolamide; Tourettes; TS
Gingival Crevicular Fluid Vaspin and Omentin Levels in Obese Patients With Chronic Periodontitis
Condition: Obesity; Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Our objective in this case-control intervention study, therefore, was to explore the effect
      of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with
      chronic periodontitis in order to determine the usefulness of vaspin and omentin as a
      diagnostic and prognostic biomarker of periodontal disease.
    

Detailed description: 
      All individuals underwent a full-mouth periodontal examination, which included probing pocket
      depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI),
      bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c
      and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on
      the periodontal and anthropometric measurements, individuals (n=76) were divided into four
      groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19),
      periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group
      (n=19). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and
      clinical periodontal parameters were assessed before and 6 weeks after therapy. Vaspin,
      omentin, and TNF-α levels were measured by enzyme-linked immunosorbent assay.
    

Intervention name(s): non surgical periodontal treatment; Gingival crevicular fluid collection
Intervention type(s): Other; Other
Intervention description(s): SRP under local anaesthesia, in a total of 2-3 clinical visits.
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.; GCF collection with filter paper (Periopaper) using the intracrevicular method.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: visceral adipose-specific serpin; intelectin 1 (omentin); Tumor Necrosis Factor-alpha
Lipoic Acid Supplementation in IVF
Condition: Women Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the
      success of embryo implantation phase, because it exerts, directly or indirectly, an
      immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that
      facilitate embryo implantation, and to stimulate the production of local mediators useful for
      implantation. This study is a prospective clinical trial and aims to evaluate the
      reproductive outcomes of Italian couples following oocyte donation fresh cycles when
      receiving per os tablets of lipoic acid. Indeed, the control group had only the standard
      treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA
      (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the
      pregnancy test. If the childbearing occurred, treatment continued until the 8th week of
      pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate,
      the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary
      outcomes .
    


Intervention name(s): Oral Lipoic acid; Vaginal Progesterone
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy; 200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy
Intervention MeSH terms: Thioctic Acid; Progesterone
Allocation: Randomized
Keywords: Oocyte donation; IVF; Lipoic acid; Implantation rate; Endometrial receptivity
Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
Condition: Hypoglycemia (Diabetic); Hyperglycaemia (Diabetic); Arrythmia, Cardiac; Type 1 Diabetes; Blood Glucose Fluctuations
MeSH terms: Arrhythmias, Cardiac; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia
Study type: Observational

Summary: 
      The investigators hypothesise that patients with type 1 diabetes have clinically relevant,
      but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or
      clinically significant fluctuations in plasma glucose.
    

Detailed description: 
      30 patients with type 1 diabetes will be recruited for a one-year observational study
      employing CGM (Continuous glucose monitor) and ILR (Implantable loop recorder). Patients will
      be scheduled for a three-week run-in period to ensure that the implanted ILR provides
      reliable data. Patient visits are planned for 0, 3, 6, 9, and 12 months and will include
      clinical examination, blood and urine samples, echocardiography (only first and last visit)
      and implant/explant of CGM. After 12 months, the participants will continue with an extended
      observation period of 2 years employing ILR and clinical examination.

      Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) Implantation of a
      loop-recorder

      Device: Continuous glucose monitoring (Eversense XL, Senseonics, USA) Monitoring with a
      continuous glucose monitor
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 1 Diabetes recrutted in collaboration with Hillerod hospital, Gentofte
        hospital and Steno Diabetes Centre.
Burnout Among Adolescent Population During Covid-19 Lockdown in Pakistan
Condition: Burnout, Psychological; Covid-19 Pandemic
MeSH terms: COVID-19; Burnout, Psychological
Study type: Observational

Summary: 
      The lethal severe acute respiratory syndrome coronavirus 2 (SARS-COV2) which caused the
      COVID-19 pandemic starting at the end of 2019 has affected the lives of children and
      adolescents globally. world adopted the lockdown to prevent spread of the infection and
      protect the population. lockdown suspended out of home activities of almost everyone, along
      with health benefits, yielding some side effects as well including burnout. The burnout
      includes physical and emotional burnout, physical burnout refers to the lack of interest in
      any physical activity to the point of a rebel and the emotional burnout of teenagers refers
      to a syndrome including features such as behavior changes, thinking change, feeling change,
      health change leading to stress and other pathological disturbances. Together the external
      and internal factors lead to overall personality destruction.

      It was an observational study with a sample size of 443 participants.
    

Detailed description: 
      Objective of the study was to analyze the change in behavioral patterns, its impact, and peer
      pressure caused by lockdown during Pandemic COVID-19 among the adolescent population of
      Sialkot Pakistan.

      It was an observational study with a sample size of 443 participants. The study was conducted
      after ethical approval by Institutional Review Board, Sialkot college of Physical Therapy
      wide Reference no. SCPT-IRB-DPT-129-2020 dated 01-09-2020. Data were collected from different
      institutions in Sialkot, Pakistan. The target population of our study was adolescents of age
      13-19 years. Regression analysis was done to find the predictor factors mobile use and
      COVID-19 lockdown on the dependent variable the Burnout score. The correlation was applied
      among mobile phone use, lockdown, and burnout score.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        this study was conducted on adolescent population of students.
      
Keywords: adolescent Population; Covid-19 Pandemic; Burnout; Mental Health