bioihbjkbjnl/mcl2 huggingface dataset:
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
Condition: Multiple Sclerosis (MS); Relapsing-Remitting MS; Primary Progressive MS; Secondary Progressive MS; Clinically Isolated Syndrome (CIS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV
      transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients.
      The study will be conducted over one year in four cohorts of patients with different forms of
      MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and
      secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who
      have suffered a single clinical event but do not comply with diagnosis criteria for definite
      MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution
      of patients and with the reverse transcriptase activity, inflammatory markers assessed by
      cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003,
      is performed in parallel and is part of another dedicated protocol).
    


Intervention name(s): No study treatments administered - blood draws only
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients coming to the Hospital for regular visits.
      
Biospecimen description: 
      Plasma, serum and PBMC
    
Keywords: Multiple sclerosis (MS); Relapsing-Remitting MS; Primary progressive MS; Secondary progressive MS; Clinically Isolated Syndrome (CIS); Multiple Sclerosis associated RetroVirus (MSRV); MSRV envelop protein (MSRV-Env); Temelimab
Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED)
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this project is to evaluate the effectiveness and tolerability of the novel
      weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle
      modification counseling in the treatment of binge eating disorder (BED) in overweight or
      obese individuals.
    

Detailed description: 
      This is an exploratory open-label trial of PHEN/TPM ER (Qsymia®) in BED. It is hypothesized
      that PHEN/TPM ER (Qsymia®) will be an effective, safe, and well tolerated treatment for BED
      and propose to conduct a 1-site, 12-week, open-label, flexible dose study of PHEN/TPM ER
      (Qsymia®) in 10 outpatients, ages 18 through 65 years, with BED. It is also hypothesized that
      PHEN/TPM ER (Qsymia®) will reduce weight and binge eating behavior, and will be well
      tolerated. The primary objective is to show that PHEN/TPM ER (Qsymia®) along with nutritional
      and lifestyle modification counseling is effective in reducing weight in overweight or obese
      patients with BED. Secondary objectives are to show that PHEN/TPM ER (Qsymia®) is effective
      in reducing frequency of binge eating episodes and associated eating psychopathology and is
      safe and well tolerated in patients with BED.
    

Intervention name(s): PHEN/TPM ER (Qsymia®)
Intervention type(s): Drug
Intervention description(s): PHEN/TPM ER (Qsymia®)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
Condition: Breast Milk Collection
Study type: Observational

Summary: 
      The study will collect human milk from 100 mother of term infants 2-3m after delivery and
      from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be
      analysed and statistical analysis will look at correlation between demographics, dietary
      habits and milk composition.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        General healthy lactating mothers
      
Biospecimen description: 
      Human milk
Impact of Contraceptives on Cervico-Vaginal Mucosa
Condition: Mucosal Inflammation; Contraceptive; Complications, Intrauterine
MeSH terms: Mucositis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      UMPALA is a research study to look at the effect of four different, approved contraceptives
      on the cervical and vaginal tissues as well as on factors in the blood. Participants will
      have a baseline examination then receive one of four approved, marketed contraceptive
      products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation
      and 3 months after to assess changes in mucosal safety after use of various contraceptive
      products in young, healthy, HIV uninfected women.
    

Detailed description: 
      This clinical study will complete approximately 12 healthy, non-pregnant, HIV-uninfected
      women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted
      infections (STIs) at two clinical sites, for a total of approximately 96 completed
      participants. The study will examine changes from baseline, pre-contraceptive dosing to post
      contraceptive dosing of cervico-vaginal mucosal safety and adverse events.

      Participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved
      contraceptive dosing forms: Levonorgestrel (LNG) 52 mg. Intrauterine System (IUS), Copper
      Intrauterine Device (IUD), etonogestrel (ETG, Nexplanon, Implanon) contraceptive implant, or
      DMPA SC contraceptive injection.

      Enrollment is expected to take approximately 8 months and each participant is expected to
      complete the study within 4 months.
    

Intervention name(s): Copper IUD; Etonogestrel implant; Levonorgestrel IUS; DMPA Sub-cutaneous
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.; Participants randomized to ETG implant will receive the implant at Visit 2.; Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.; Participants randomized to DMPA SC will receive the injection at Visit 2.
Other intervention name(s): Paragard; Nexplanon; Implanon; Mirena; Liletta; Subcutaneous depot medroxyprogesterone acetate
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Levonorgestrel; Medroxyprogesterone; Etonogestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Contraception; Reproductive health; Copper IUD; Etonogestrel implant; DMPA sub-cutaneous; Levonorgestrel IUS
Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder
Condition: Adult Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Non-interventional study to gain further information about the therapy progression in routine
      treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be
      on the improvement of the clinical global impression (CGI) in comparison to the outcome of
      randomized, controlled studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with newly diagnosed ADHD who shall be treated with Medikinet(R) adult.
      
Keywords: Non-interventional study; Attention Deficit/Hyperactivity Disorder; ADHD
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Condition: Impetigo; Folliculitis; Secondarily Infected Eczema; Minor Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Impetigo; Eczema; Folliculitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to document the clinical and bacteriological efficacy of
      retapamulin in the treatment of subjects with bacterial infections, including impetigo,
      folliculitis, and minor soft tissue infections including secondarily infected eczema presumed
      to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to
      98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound
      cultures will be collected, and then subjects will apply topical retapamulin twice daily for
      five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus
      aureus (MRSA) infection based on clinical presentation and physical exam, as well as
      bacteriological efficacy based on culture results. It is anticipated that approximately 75
      patients will be enrolled, with expectation that approximately 50 of these patients will have
      MRSA infections.
    


Intervention name(s): Retapamulin (Altabax)
Intervention type(s): Drug
Intervention description(s): Retapamulin ointment, applied topically twice daily for five days
Other intervention name(s): Altabax
Intervention MeSH terms: Retapamulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eczema; Atopic dermatitis; Infection; Impetigo; Folliculitis
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Condition: Dystonia-Parkinsonism, Adult-Onset; Parkinson Disease
MeSH terms: Parkinson Disease; Dystonia; Dystonic Disorders; Parkinsonian Disorders
Study type: Interventional

Summary: 
      This study occurs during five visits that are already scheduled as part of "Biomarkers to
      Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688).
      If participants have dystonia associated with Parkinson's disease, the investigators will
      consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale)
      to assess the severity of dystonia.
    

Detailed description: 
      To measure the effects of DBS on dystonia, the investigators will measure the change in the
      Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus
      preoperative baseline. This will allow them to contrast the effects of omnidirectional versus
      directional STN DBS on dystonia symptoms in patients with PD.
    

Intervention name(s): Boston Scientific Vercise PC IPG with directional DBS lead
Intervention type(s): Device
Intervention description(s): We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Intervention model: Single Group Assignment
Intervention model description: To measure the effects of directional DBS on dystonia, we will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dystonia; Parkinson's Disease
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
Condition: Wheezing; Reactive Airway Disease; Mild Asthma
MeSH terms: Asthma; Respiratory Aspiration; Bronchial Hyperreactivity; Respiratory Sounds
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate budesonide levels in the blood following
      inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive
      airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary
      objectives include the evaluation of the safety and tolerability of VR647 Inhalation
      Suspension administered using the VR647 Inhalation System.

      The study consists of four visits; a screening visit (Visit 1), two dosing days (Visits 2 and
      3) and a follow-up visit (Visit 4). On each dosing day a single dose of treatment will be
      administered. Treatment allocation at Visits 2 and 3 is determined by a balanced incomplete
      block design.
    


Intervention name(s): VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System; 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.; Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open label, randomized, balanced, incomplete block design trial. Eligible subjects will be randomized to 1 of 12 treatment sequences (A,B), (A,C), (A,D), (B,A), (B,C), (B,D), (C,A), (C,B), (C,D), (D,A), (D,B) or (D,C), corresponding to the following treatment regimens:
(A) 5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
(B) 10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
(C) 20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
(D) 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty
The treatment period comprises 2 dosing visits. Each subject will receive their first treatment regimen during Visit 2 and their second treatment regimen during Visit 3.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mild asthma; budesonide; nebulizer; pediatric; pharmacokinetics
A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to measure the whole-body distribution and radiation
      dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography
      (PET) (Part A); and to measure the uptake, binding, distribution, and washout of
      [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue
      specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF)
      (Part B).
    


Intervention name(s): [18F]JNJ-64511070
Intervention type(s): Drug
Intervention description(s): An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Epidemiologic Analysis of Change in Eyelash Characteristics With Age in Healthy Women
Condition: Health
Study type: Observational

Summary: 
      This study will asses epidemiologic changes in eyelash characteristics with increasing age.
    


Intervention name(s): No treatment
Intervention type(s): Other
Intervention description(s): No treatment will be provided
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Females
Transdiagnostic REBT Prevention Program for Adolescents
Condition: Social Anxiety; Major Depression Mild; Panic Disorder; Specific Phobia; Generalized Anxiety Disorder
MeSH terms: Depression; Anxiety Disorders; Panic Disorder
Study type: Interventional

Summary: 
      Anxiety and depressive disorders are common in adolescents, however they are often
      unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral
      therapy (CBT) is efficient for children and adolescents. School settings are appropriate
      environments to deliver such interventions for vulnerable youths. Given youth's access and
      predilection to use technology, a video-based prevention program was developed. The present
      study aims to investigate the efficacy of a transdiagnostic REBT prevention program for
      internalizing symptoms in adolescents, implemented in a school setting.

      Classes from different Romanian public schools will be randomized in either intervention or
      wait list group.
    

Detailed description: 
      The prevention program will be group-based, delivered in 6 sessions, over 3 weeks.

      Each of the six modules aimed a different component: Psychoeducation, Relaxation,
      Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive
      restructuring, Exposure/ behavioral activation and problem solving, Maintenance of gainings.
      Despite specific activities, for each session a video cartoon on that subject will be viewed
      and discussed. Homework would be given at every session.

      REBT prevention programs delivered in school settings represent ecological modalities to
      target vulnerable groups. Technology components added to traditional programs may lead to
      greater motivation and satisfaction with treatment.

      Adolescents will complete assessments at four time-points: T1 (baseline), T2
      (post-intervention), T3 (3 months follow-up) and T4 (12 months follow-up).
    

Intervention name(s): video-based transdiagnostic REBT; Wait list
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.; Delayed intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: anxiety symptoms; depression symptoms; internalizing symptoms
Effectiveness of the Cytokine Hemadsorption on Sepsis
Condition: Interleukin-6
MeSH terms: Sepsis
Study type: Observational

Summary: 
      In this prospective study, we aimed to compare the laboratory and clinical results of
      cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis
      or septic shock.
    


Intervention name(s): cytokine hemadsorption
Intervention type(s): Procedure
Intervention description(s): the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In this one-centered study, we prospectively analyzed the outcomes and laboratory findings
        of 39 patients diagnosed with sepsis from 01 Jan 2020 to 30 December 2020 hospitalized in
        ICU.
Butyrate in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The first prospective randomised placebo-controlled study in the IBD pediatric population was
      conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.
    

Detailed description: 
      Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel
      disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium
      butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed
      IBD.

      This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18
      years with colonic Crohn's disease or ulcerative colitis, who received standard therapy
      depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice
      a day (group A) or placebo (group B). The primary outcome was the difference in disease
      activity and fecal calprotectin concentration between the two study groups measured at 12
      weeks of the study.
    

Intervention name(s): sodium butyrate; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): add-on therapy irrespective of standard treatment depending on severity (according to the guidelines); placebo
Intervention MeSH terms: Butyric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Crohn's disease; ulcerative colitis; sodium butyrate
Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along
      with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in
      the treatment of intrabony defects (IBDs).

      Materials and methods: Study was conducted on subjects reporting to the Department of
      Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90
      periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone
      (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each
      subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm
      in at least three teeth.
    


Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with Titanium Platelet rich fibrin (TPRF)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Oral prophylaxis followed by Open flap debridement (OFD); Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect; Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontal regeneration; Growth factors