bioihbjkbjnl/mcl2 huggingface dataset:
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous
      system, and may be beneficial in the treatment of patients with schizophrenia. Our recent
      8-week, randomized, double-blind trial among patients with chronic schizophrenia and
      schizoaffective disorders, in which PREG versus placebo and DHEA have been added to
      conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG
      (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of
      the present study is to evaluate the potential role of PREG's augmentation compared to
      placebo in the treatment of young patients with newly diagnosed schizophrenia or
      schizophreniform or schizoaffective disorders.

      In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo
      capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with
      recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants
      will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of
      research instruments will be used for assessment of psychopathology, cognitive functions,
      side effects, general functioning and quality of life. In addition blood PREG levels will be
      monitored at baseline and during the study. The study is powered to detect moderate
      between-group effects on persistent positive, negative and cognitive symptoms.
    


Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50 mg, caps.; caps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Neurosteroids; Pregnenolone; Augmentation
Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
Condition: Allergic Rhinoconjunctivitis to Birch Pollen; With a Positive Skin Prick Test to Birch Pollen
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      Several studies have reported a deficit and/or a defect in regulatory T cells in allergic
      subjects, which can be correlated with the allergic responses, especially for respiratory
      allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells
      (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2
      would control allergic responses.

      This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on
      the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch
      allergen exposure.
    

Detailed description: 
      Primary objective To evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on
      nasal response on day 40

      Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms, on
      inflammatory mediators, allergic specific immune responses and safety.

      Experimental design This is a monocentric, randomized, placebo controlled, double-blind trial
      in parallel-groups, evaluating a treatment by ILT-101/placebo, 1 MIU daily for 5 days and 1
      MIU every week, until day 36.

      Population involved Male or female, aged between 18 and 55 years, with allergic rhinitis to
      birch pollen.

      Number of subjects: 24

      Duration of patient participation: 3 months (treatment period: 36 days months, follow-up
      period: 34 days)
    

Intervention name(s): ILT-101 ld-(IL2)
Intervention type(s): Drug
Intervention description(s): Subcutaneous injections of ILT-101 or Placebo starting with once-daily administration for 5 consecutive days followed by once every two weeks administration during five months
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Safety/Efficacy
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
Condition: Class II Malocclusion, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The study was directed to compare the treatment outcomes of subjects with Class II
      malocclusion who were treated with Herbst appliance before and after puberty.
    

Detailed description: 
      Thirty-six Class II patients were randomly selected and divided into two groups based on
      their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5
      years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were
      treated with metallic splint supported Herbst IV appliance.

      Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both
      groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.
    

Intervention name(s): Herbst appliance
Intervention type(s): Device
Intervention description(s): The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Class II malocclusion.; prepubertal patients.; postpubertal patients.; Herbst appliance.
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Condition: Chronic Kidney Disease; Chronic Renal Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira
      compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose
      requirements in patients treated for anemia associated with chronic renal failure and on
      hemodialysis.
    


Intervention name(s): Epoetin Hospira; Epogen (Amgen)
Intervention type(s): Biological; Biological
Intervention description(s): Variable dose; Variable dose
Other intervention name(s): Epoetin Alfa
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months
Condition: Cervical Cancer; Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as
      monotherapy, and the next logical step is to evaluate rational therapeutic associations. The
      aim of the NiCOL study is to assess the safety of nivolumab in association with
      chemoradiation therapy and to gain initial insight into its efficacy in association with the
      current standard of care, including chemoradiation.
    


Intervention name(s): Nivolumab Injection; Cisplatin; radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 2 possible doses : flat dose 240 mg q2 weeks or 1mg/kg q2 weeks; 40 mg/m2, once a week during radiotherapy; Intensity-modulated radiation therapy (including volumetric-modulated arc therapy and tomography) will be used. A dose of 45 Gy will be delivered to the pelvis in 25 fractions of 1.8 Gy using a 6-MV photon energy.
An additional dose of 54 Gy in 25 fractions of 2.16 Gy may be delivered to invaded lymph nodes using SIB-IMRT.
An additional lateral pelvic dose may be delivered if coverage of the target volumes is judged insufficient. The volumes, doses and techniques will be those usually used in each center.
Intervention MeSH terms: Nivolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical cancer; nivolumab; cisplatin; radiotherapy
TSHβX1 and D2 THR92ALA in Pregnancy
Condition: Pregnancy Related; Hypothyroidism; Hyperthyroidism
MeSH terms: Hypothyroidism; Hyperthyroidism
Study type: Observational

Summary: 
      Thyroid diseases are pathologies that frequently affect pregnant women causing serious
      complications. This current research aims to find out whether the expression of TSHβX1 splice
      variant and D2 Thr92Ala polymorphism in the DIO2 gene are associated with thyroid disease in
      Mexican pregnant women.
    

Detailed description: 
      Deiodinase 2 (DIO2) is a selenoenzyme responsible for the deiodination of T4 to T3, which
      makes it crucial for the proper functioning of thyroid hormones. Polymorphisms of DIO2 alters
      the enzymatic function. In addition, the Ala92Ala genotype was reported to be related with a
      reduction in the placental activity of D2, which could worsen gestational complications.

      In the other hand, the TSHβ gene (NC_000001.11) located on chromosome 1 at position 38p12,
      codes for the beta unit of the thyroid stimulating hormone (TSH). It is admitted that genetic
      variants can show a different spectrum of actions.

      This was a clinical, comparative, prospective and transversal study. Pregnant women aged
      18-44 years old, were invited to identify it they had a DIO2 polymorphism or the TSHβX1
      splice variant.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are
        mainly of low socioeconomical status.
      
Keywords: Hyperthyroidism; Polymorphism; TSHβX1; D2 THR92ALA; Hypothyroidism
The Effect of Consuming on Body Composition and Blood Biochemistry Index
Condition: Gut Microbiota
Study type: Interventional

Summary: 
      To assess the effect of consuming on body composition and blood biochemistry index
    


Intervention name(s): Fruit and vegetable solid drink
Intervention type(s): Dietary Supplement
Intervention description(s): weight loss program supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anthropometric index; Biochemical items
Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
Condition: Pain
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve
      gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.
    

Detailed description: 
      Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized
      by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by
      structural or biochemical abnormalities. IBS is the most common functional gastrointestinal
      disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary
      care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not
      completely understood and currently available drug treatments for IBS are very limited (1-2).
      The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together
      with the greater understanding of the role of inflammation and intestinal microflora in the
      pathophysiology of IBS has led to increased interest in use of probiotics in patients with
      IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies
      show encouraging results and suggests some symptomatic response and parallel improvement in
      quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to
      L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain
      and tended to normalize stool frequency in constipated patients (5). On the other hand,
      Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and
      diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3
      improved abdominal bloating in patients with diarrhea-predominant IBS. However, no
      differences in gastrointestinal transit measurement, bowel function scores or satisfactory
      global symptom relief were shown (7). The inconsistent findings of these clinical studies may
      be accounted to the differences in probiotics composition and the heterogeneous and
      multifactorial nature of the disorder. However, these studies indicate a potential
      relationship between probiotics therapy and functional abdominal symptoms and suggesting that
      the possible role of probiotics in the treatment of IBS deserves further study.
    

Intervention name(s): Probiotics - Lactobacillus and bifidobacterium; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotics administered bid for 6 weeks.; Placebo administered bid for 6 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; Functional Gastrointestinal Symptoms
Community-based Program to Treat Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a comprehensive community based program on
      reducing excess weight in children and teens. This study will recruit 150 participants
      between the ages of 6-12 and 13-17.
    

Detailed description: 
      This study will evaluate the effectiveness of a comprehensive community based program on
      reducing excess weight. Overweight and obese study participants will be grouped with peers of
      similar ages and their parent/guardians. The participants will be divided into 2 groups,
      child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their
      parent/guardian. 150 participants will be recruited for this study.

      This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the
      best components of current evidence for individual treatment and places them in a
      comprehensive community based program. These include:

        -  Parental involvement

        -  Reduction in consumption of sugar sweetened beverages

        -  Reduction of screen time

        -  Self-monitoring

        -  Physical activity

        -  Stimulus control
    

Intervention name(s): JOIN Intervention
Intervention type(s): Behavioral
Intervention description(s): Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood Obesity; Group Treatment; Community-based Programs
A Comparison of External Mechanical Work Between Different Prosthetic Feet
Condition: Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are
      at risk of functional decline, joint degeneration, skin breakdown and further limb loss due
      to the forces placed on the contralateral limb through prosthetic ambulation. If specialized
      prosthetic gait training and proper use of the appropriate prosthetic foot can decrease
      forces on the intact limb, the long term health and quality of life of veterans with
      amputations could be substantially improved. We will address two key questions:

      Key Question 1: After receiving specialized gait training and a new prosthetic socket, will
      subjects demonstrate differences in gait symmetry and external mechanical work between the
      bionic and conventional prosthetic feet, while performing various functional activities.

      Key Question 2: Can external mechanical work be used as a clinically friendly measure to
      differentiate between prosthetic feet?
    

Detailed description: 
      The study examined the application of outcome measures to determine changes in function of
      unilateral transtibial amputees (TTAs) caused by specialized functional prosthetic training
      (training) and the use of four different prosthetic feet. Two self-report measures i.e. the
      Prosthetic Evaluation Questionnaire (PEQ-13) and Locomotor Capability Index (LCI-5), and
      three performance-based measures i.e. the Amputee Mobility Predictor (AMPPRO), Six-minute
      Walk Test (6MWT), and Step Activity Monitor (SAM) were utilized. Healthy unilateral
      Transtibial Amputees between the age of 40-65 will participate in the study. Subjects were
      tested at baseline, after receiving training with their existing prosthesis, and with the
      study socket and four prosthetic feet i.e. SACH, SAFE, Talux and PROPRIO FOOT over an 8-10
      week period. Training was administered between testing sessions.
    

Intervention name(s): Specialized Functional Prosthetic Training
Intervention type(s): Other
Intervention description(s): Each subject receives specialized functional prosthetic training
Other intervention name(s): Proshetic Feet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The purpose of this study is to compare an technology-based weight maintenance intervention
      using action plans, videos discussion boards and health behavior tracking (weight, calories
      in and out, pedometer steps) with a technology-based standard advice group to facilitate
      health management, resourcefulness and health status for rural middle-aged women.
    

Detailed description: 
      The purpose of this research project is to evaluate the influence of a theory-based
      intervention using the Health Effects of Life Transitions for Women Model to promote
      maintenance of initial weight loss. The intervention will be designed to promote physical
      activity to prevent weight regain among an underserved and vulnerable population of rural,
      mid-life women. The intervention delivered through action plans, videos, discussion boards
      and health behavior tracking (weight, calories in and out, pedometer steps) to facilitate
      health management, resourcefulness and health status will be compared with the standard
      advice group who receives newsletters and health behavior tracking (weight) to initiate,
      increase, or sustain physical activity for weight maintenance.
    

Intervention name(s): Videos; Action Plans; Discussion Boards; Health behavior tracking
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.; Online action plans will be used by subjects to set and evaluate physical activity goals; forum to exchange information and experiences; online tracking of weight for both intervention and standard advice group. In addition, the intervention group will also track their calories in and out and their pedometer steps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide 1 mg by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares semaglutide in two different injection tools called "PDS290" and
      "DV3372". The study aims to show similar levels of semaglutide in the blood when using either
      of the two injection tools. The researchers also want to look at how well the injection tools
      work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection
      tool. This is decided by chance, like flipping a coin. This is called randomisation.
      Semaglutide is an approved medicine (thus available on the market) for people with type 2
      diabetes. Semaglutide will be injected subcutaneously (injection under the skin).
      Participants will get a total of 5 injections with semaglutide. The study will last for a
      maximum of 86 days. Participants will have 17 scheduled site visits with the study physician
      or study staff at the study centre. For one of the visits participants will stay at the
      research unit for 4 days and 3 nights. Participants cannot take part in this study if
      participants have any disorder that the doctor thinks is a health problem. Only healthy men
      and women are allowed to take part. Women cannot take part if pregnant, breast-feeding or
      plan to become pregnant during the study period.
    


Intervention name(s): Semaglutide, 0.25 mg; Semaglutide, 0.5 mg; Semaglutide, 1.0 mg; DV3372; PDS290 pen-injector
Intervention type(s): Drug; Drug; Drug; Device; Device
Intervention description(s): Semaglutide will be administered subcutaneously (s.c., under the skin) on day 1 and 8 in the morning after an overnight fast of at least 8 hours; Semaglutide will be administered s.c. (under the skin) on day 15 and 22 in the morning after an overnight fast of at least 8 hours; Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours; DV3372 device will be used for administration of semaglutide; PDS290 pen-injector will be used for administration of semaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment