bioihbjkbjnl/mcl2 huggingface dataset:
Improving Self-Management in Adolescents With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The objective of this study is to determine the feasibility and acceptability of SCThrive, a
      an innovative, technology-enhanced, group self-management intervention that uses a mixed
      in-person and online format and supported by a tailored mHealth tool, iManage. The study will
      also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in
      adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that
      participants in the SCThrive group will show greater BA (primary outcome) at post-treatment
      than the attention control group, and that participants in the SCThrive group will continue
      to show significantly greater BA at the six week follow-up compared to the attention control
      group. Investigators will also explore whether SCThrive is associated with greater
      improvements in self-management behaviors and quality of life (secondary outcome) compared to
      attention control at the six-week follow-up assessment.
    

Detailed description: 
      The objective of this study is to determine the feasibility and acceptability of SCThrive, a
      an innovative, technology-enhanced, group self-management intervention that uses a mixed
      in-person and online format and supported by a tailored mHealth tool, iManage. The study will
      also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in
      adolescents with Sickle Cell Disease (SCD) ages 13 to 21.
    

Intervention name(s): SCThrive Intervention for Adolescents with SCD
Intervention type(s): Behavioral
Intervention description(s): Chronic Disease Self-Management Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anemia, Sickle Cell; Self Care; Adolescent; Young Adult; Disease Management; Behavioral Activation; Peer Communication
The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes
Condition: Preterm Pregnancy; Antenatal Corticosteroid; Perinatal Problems
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      In this study, the investigators aims to evaluate whether antenatal corticosteroid
      administration to women likely to give birth in the late preterm period will reduce early and
      late neonatal complications and contribute to the literature in this sense.
    

Detailed description: 
      This study is a single-center prospective case-control study investigating the effect of
      antenatal corticosteroids administered in the late preterm period on early and late perinatal
      outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October
      1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were
      included. Patient were divided into two groups antenatal corticosteroid administration
      (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were
      compared between these two groups.
    

Intervention name(s): participants receiving Corticosteroid
Intervention type(s): Other
Intervention description(s): Pregnant women using antenatal corticosteroids for any reason before 34 weeks
Other intervention name(s): betamethasone; dekort
Intervention MeSH terms: Betamethasone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antenatal corticosteroids; Late preterm pregnancy; Late perinatal outcomes
Multistimulation Group Therapy for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Our previous findings support the notion that group activity program, based on cognitive
      stimulation, recreational-occupational activities and physical-psychomotor exercises, can
      lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).

      The purpose of this study is to clarify the efficacy of a rehabilitation program in
      outpatients affected by AD in mild to moderate stages.
    


Intervention name(s): Multidimensional stimulation group therapy
Intervention type(s): Other
Intervention description(s): The MST program involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Safety and Efficacy Study of Plasmodium Falciparum LSA-3 Malaria Vaccine
Condition: Healthy
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Malaria is responsible for over 2 million deaths each year. The development of an efficient
      vaccine would present by far the best solution for solving this disastrous situation.
      Liver-Stage-Antigen-3 (LSA-3) is an antigen that is mainly exhibited by Plasmodium falciparum
      sporozoites and liver-stage parasites. It is characterized by its remarkable antigenicity in
      humans with a wide range and a variety of B and T-lymphocyte epitopes, by its extremely high
      immunogenicity and by an excellent protective efficacy against sporozoite challenge in animal
      models. Therefore, PfLSA-3-rec is a promising candidate vaccine against P. falciparum in
      humans The aim is to screen two different formulations of the recombinant malaria vaccine
      PfLSA-3-rec, one adjuvated with aluminium hydroxide and one with Montanide Isa 720, by
      assessing the safety and immunogenicity (phase I) profile of each formulation in humans, as
      well as its protective efficacy following a sporozoite challenge (phase IIa).
    


Intervention name(s): arm I: PfLSA-3-rec with aluminium hydroxide as adjuvant; arm 2: PfLSA-3-rec with Montanide Isa 720 as adjuvant
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide; Monatide (IMS 3015)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: safety; immunogenicity; efficacy
Mechanical Device for the Relief of Hot Flashes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: A mechanical device when applied to the back of the neck at the onset of a
      menopausal hot flash will attenuate the severity and duration of symptoms providing women
      with a reassuring non-hormonal intervention to improve quality of life in the menopausal
      transition. This pilot study will evaluate the effectiveness of this unit.

      The mechanism of action of the device will not be revealed in advance.
    

Detailed description: 
      This is a pilot study to test logistics and gather information for planning the definite
      trial. We will randomly allocate 40 subjects to receive either the active Menopod device
      (n=20) or a sham device with the mechanism disabled (n=20).

      We will recruit menopausal women with moderate to severe hot flashes (as defined by FDA
      standards this means a minimum of 7 per day).

      The two primary outcome parameters are the hot flash score which is the product of frequency
      x intensity (Sloan 2001), and the average duration (in minutes) of hot flash episodes over
      the course of one day. These outcomes will be self-recorded by subjects in a diary designed
      by our research team on five separate days throughout the course of the study, once during
      the evaluation phase and once per week over the four week treatment phase. The two summary
      measures will be the changes from baseline to the last record collected for hot flash scores
      and average durations. Delta values (assessment phase minus fourth treatment period) will be
      compared between the two treatment groups (active versus sham device) using t tests (IBM SPSS
      Statistics version 21).
    

Intervention name(s): Menopod; Inactive device
Intervention type(s): Device; Device
Intervention description(s): The mechanism of action of the device will not be revealed in advance.
Other intervention name(s): The mechanism of action of the active device is disabled.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopause; hot flash; quality of life
Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Irritable Bowel Syndrome and Healthy Subjects
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      In this observational case-control study investigators aimed to assess the serum levels of
      adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome
      (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the
      possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical
      and psychological disorders.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients were recruited from the outpatient clinic at the Lorestan University of Medical
        Sciences, Khorramabad, Iran, by an attendant gastroenterologist.
REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical
      trial with an optional 12 months open label extension.

      The primary objective of the study is to evaluate the effect of fetal bovine serum
      [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44
      microgram (three times weekly and once weekly) versus placebo on the time to conversion to
      McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical
      demyelinating event at high risk of converting to MS.

      The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three
      times weekly and once weekly) versus placebo on the "Time to conversion to clinically
      definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of
      converting to MS.

      At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS
      and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month
      extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the
      time to conversion to McDonald MS and time to conversion to CDMS.
    


Intervention name(s): RNF; RNF; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months, or 36 months for patients enrolled in the OL extension.; Single dose of RNF administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.; Placebo was supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 mL.
Other intervention name(s): Rebif; Rebif
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rebif New Formulation; Clinical Isolated Syndrome; Multiple Sclerosis
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Detailed description: 
      This was a randomized, double-blind, double-dummy, active comparator-controlled,
      parallel-group, multi-center study with variable treatment duration in approximately 900
      patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study
      for an individual patient was 2.5 years.

      Eligible patients were randomized to receive either experimental ofatumumab subcutaneous
      (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The
      dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day
      7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks
      starting at Week 4. In order to blind for the different formulations, double-dummy masking
      was used i.e. all patients will take injections (containing either active ofatumumab or
      placebo) and oral capsules (containing either active teriflunomide or placebo).
    

Intervention name(s): Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS
Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine the highest dose of BMS-690514 that can be
      safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to
      patients with advanced cancer
    


Intervention name(s): BMS-690514 / FOLFIRI; BMS-690514 / FOLFOX
Intervention type(s): Drug; Drug
Intervention description(s): Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos; Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer (solid tumors)
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the trial is to evaluate safety of a follow on formula supplemented with
      Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was
      carried out. Eighty six months old children were recruited by the department of pediatrics of
      Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a
      follow on formula supplemented or not with the probiotic strain during 6 months. Fecal
      samples were obtained at the recruitment, at 3 months and at the end of the trial. In
      addition revision by the pediatrician was performed once a month and possible adverse effects
      were recorded both by the pediatrician and by parents.
    


Intervention name(s): follow on formula without probiotics; follow on formula with Lactobacillus salivarius CECT5713
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A follow on formula without probiotics; follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: probiotics; safety; fecal microbiota; infections
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
Condition: Type 2 Diabetes; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with Type 2 diabetes and severe insulin resistance with very large insulin
      requirements who have failed all previous insulin regimens using non-concentrated forms of
      insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular
      insulin)infused via insulin pump.
    

Detailed description: 
      Patients with Type 2 diabetes who have severe insulin resistance and very large insulin
      requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent
      poor blood glucose control when standard U-100 insulin formulations are used. This is due in
      part to poor absorption of the large insulin volumes required using these less concentrated
      standard insulin preparations. The hypothesis that using a concentrated form of insulin
      called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the
      volume of insulin required and therefore improve insulin absorption, which will lead to
      improved blood glucose control, will be tested.
    

Intervention name(s): U-500 Insulin delivered by Omnipod (disposable insulin pump)
Intervention type(s): Drug
Intervention description(s): U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Insulin Resistance; Continuous Subcutaneous Insulin Infusion; U-500 Insulin; Omnipod
Clozapine Plasma Levels and the Relationship to the Genetic Polymorphism in Shizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Approximately 30-60% of all schizophrenia patients who fail to respond to typical
      antipsychotics may respond to Clozapine. Clozapine has long been considered the "gold
      standard" within the atypical neuroleptic spectrum, backed by years of clinical experience
      and research, but uncertainties remain in some aspects of this drug. One such question is the
      link between dose, blood levels and patient clinical response. The Clozapine therapeutic
      plasma levels range between 250 - 450 ng/mL creating difficulties in using these results in
      routine clinical practice. Approximately 30% - 51% of "treatment-resistant schizophrenia"
      patients do not fully respond to Clozapine, a poorly understood phenomenon. Factors relevant
      to Clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate
      duration of treatment and inadequate dose/plasma-levels. Pharmacogenetic factors such as
      different polymorphisms in involved genes may play a role. Pharmacodynamic and genetic data
      appear important in determining the clinical response to Clozapine. Clozapine-treated
      patients possessing different 3A4 polymorphisms, may respond differently as compared to other
      patients having normal 3A4 alleles. Recently, the CYP2D6 has also been involved in this drug
      metabolic pathway. Population pharmacokinetics of clozapine evaluated with the nonparametric
      maximum likelihood method. This pharmacogenetic explanation/hypothesis may explain Clozapine-
      resistance in schizophrenics.

      The high variability in plasma levels requires a large study in order to be able to determine
      correlation between clinical efficacy and plasma levels and genotyping. A preliminary study
      will enable power analysis and adequate determination of sample size.
    


Intervention name(s): Clozapine
Intervention type(s): Drug
Intervention description(s): A fixed dose of Clozapine 300 mg/day (150 mg x 2)for 3 month
Other intervention name(s): Leponex
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clozapine; Schizophrenia; Remissia; polymorphism
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with
      diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on
      the patient's level of disability and quality of life was also studied.
    


Intervention name(s): valdecoxib; diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day; diclofenac 75 mg twice daily (BID) for 7 days
Intervention MeSH terms: Diclofenac; Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute low back pain