bioihbjkbjnl/mcl2 huggingface dataset:
Management of Infant Digestive Disorders and Quality of Life
Condition: Infant Nutrition Disorders; Gastrointestinal Dysfunction
MeSH terms: Digestive System Diseases; Nutrition Disorders; Infant Nutrition Disorders
Study type: Observational

Summary: 
      The objective of the study is to measure the evolution of the quality of life in infants
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
    

Detailed description: 
      The objective of the study is to measure the evolution of the quality of life in infants
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic,
      following nutritional management of these disorders by a preparation for thickened infants,
      reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of
      life is assessed using the QUALIN questionnaire
    

Intervention name(s): Management of Infant Digestive Disorders and Quality of Life
Intervention type(s): Other
Intervention description(s): The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        infants between 0 and 5 months
      
Keywords: Quality of life; Infants; Regurgitation; Colic
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Determine the efficacy and tolerability of olanzapine for treatment of acute depression in
      patients with bipolar II or bipolar disorder NOS compared with lithium.
    


Intervention name(s): olanzapine; lithium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a
      potential contributor to the morbidity witnessed in patients with end-stage renal disease
    

Detailed description: 
      The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase
      activity in the setting of renal failure and to evaluate the role of nutritional vitamin D
      deficiency as a potential contributor to monocyte-associated inflammatory pathways in
      patients with end-stage renal disease (ESRD). This study will consist of patients on chronic
      maintenance hemodialysis three times per week who have been identified to have nutritional
      vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week
      washout period of all active vitamin D supplementation. After washout is complete, an blood
      sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by
      flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8
      weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study
      and dosing adjusted as further described in detail within the protocol section. An additional
      blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for
      flow cytometry analysis.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 50,000 Units PO Twice weekly for 8 weeks
Other intervention name(s): Vitamin D, ergocalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Ergocalciferols
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endstage renal disease; Vitamin D; Monocyte function
Third Molar Clinical Trials: Pericoronitis Studies
Condition: Pericoronitis
MeSH terms: Pericoronitis
Study type: Observational

Summary: 
      The purpose of this research study is to find out if the infection around 3rd molars and the
      resulting inflammation around the gum also produces a general systemic inflammation.
    

Detailed description: 
      Relate signs and symptoms of mild pericoronitis, an oral clinical condition characterized by
      intense inflammation and pain around a lower 3rd molar, to indicators of oral and systemic
      inflammation in patients seeking treatment for the condition.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those with mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with
        adjacent 2nd molar with recommended treatment being removal of 3rd molars.
      
Biospecimen description: 
      GCF samples. biofilm samples serum samples
    
Keywords: pericoronitis; periodontal
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center study conducted in two parts. Part 1 will assess the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of
      JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the
      pharmacokinetics of JNJ-38431055.
    

Detailed description: 
      The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized
      (study drug assigned by chance), double-blind (neither the volunteer or investigator knows
      the name of the assigned study drug), placebo-controlled (placebo is a substance that looks
      the same as JNJ-38431055 but contains no JNJ-38431055), single ascending dose study. In Part
      1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on
      Day 1 or three treatment periods. In Part 1, for each volunteer, the study will consist of a
      screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up
      examination. The total study duration for each volunteer will be approximately 9 weeks. Part
      2 is a randomized, open-label, 2-period crossover study to evaluate the effect of
      administering JNJ-38431055 together with food on the pharmacokinetics of JNJ-38431055, as
      compared to administration in the fasting condition. In Part 2, study drug (JNJ-38431055 will
      be administered orally as single doses on Day 1 or two treatment periods. There will be at
      least 7 days between doses. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be
      administered orally as single doses on Day 1 of three treatment periods. In Part 2, study
      drug (JNJ-38431055) will be administered orally as single doses on Day 1 of two treatment
      periods.
    

Intervention name(s): JNJ-38431055
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2
Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery
Condition: Abdominal Surgery
Study type: Observational

Summary: 
      Predictive Value of Various Nutritional Screening and Assesment Tools and a Surgery Scoring
      System (POSSUM Score) for Predicting Postoperative Complications in Patients Scheduled for
      Abdominal Surgery.
    

Detailed description: 
      Preoperative malnutrition in surgical patients is an established risk factor of
      peri-operative morbidity and mortality, post-operative complications, infections and
      increased length of hospital stay. The reported prevalence of malnutrition in
      gastrointestinal (GI) and major abdominal surgery patients ranges from 30% to 50%. For these
      reasons it is important to recognize malnourished patients before surgery in order to provide
      the most appropriate preoperative nutritional therapy which will in turn improve nutritional
      status and reduce postoperative complications and length of hospital stay.

      The aim of the present study was to compare the prognostic power of different screening tools
      for post - op complications. This was a prospective observational cohort study, performed in
      patients scheduled for an abdominal operation in the Second Department of Surgery,
      Evangelismos General Hospital in Athens, Greece. All patients were screened at admission and
      before operation. Data were collected in a special form by the dietician and the surgeon,
      with the use of screening tools and the local Electronic Medical Record System called
      "Emrora". Patients were followed up after surgery until discharge by the surgeon who recorded
      any complication or case of death in a new form.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged at least 18 years who presented with diseases of the digestive tract
        (oesophageal, gastric or intestinal), or with other abdominal diseases requiring elective
        surgery.
      
Keywords: Nutritional assesment; Nutritional screening tools; Abdominal Surgery; Stomach Neoplasms; Colorectal Surgery
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of
      the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine
      dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The
      proportion of participants achieving sustained cocaine abstinence for three consecutive weeks
      at the end of the study will be significantly greater for the combined pharmacotherapies
      group compared to the placebo group.
    

Detailed description: 
      The investigators hypothesize that the combination of an agent that increased baseline
      dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release
      (topiramate) will improve dopamine regulation and be associated with improved cocaine use
      outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and
      all other study inclusion and exclusion criteria will be assigned to the 14-week
      double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive
      either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER
      and topiramate will promote cocaine abstinence. Participants who are randomized to the
      combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks)
      and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the
      trial. During week 14, participants will be tapered off both medications. All participants
      will receive a supportive behavioral treatment that emphasizes study procedure adherence.
      Starting in week one, all patients will receive incentives for compliance with study
      procedures on an escalating reinforcement schedule similar to that developed previously and
      not contingent on urine results. The purpose of the lead-out is to blind patients to the
      exact point of medication discontinuation and to provide naturalistic data on the effects of
      medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what
      happens to cocaine use after treatment discontinuation.
    

Intervention name(s): Adderall-ER; Topiramate; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): MAS-ER 60mg/day; Topiramate 100 mg bid.; Placebo
Other intervention name(s): Adderall extended release (MAS-ER); Topamax
Intervention MeSH terms: Topiramate; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence; adderall; topiramate
A Phase IV Study of Cipro XR in Uncomplicated UTI
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an
      educational brochure. - Women with urinary tract infections were treated with Cipro XR. They
      were also given a brochure with information about urinary tract infections and later tested
      on the information.
    


Intervention name(s): Cipro XR (Ciprofloxacin, BAYQ3939); Cipro XR (Ciprofloxacin, BAYQ3939)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI; Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: UTI
A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another
      beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the
      mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other
      biomarkers.
    


Intervention name(s): Nebivolol; Metoprolol ER (TM)
Intervention type(s): Drug; Drug
Intervention description(s): nebivolol 10mg, 20mg, 40mg daily dosage, oral administration; Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
Other intervention name(s): Bystolic (TM); Toprol XL (TM)
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Blood pressure; Nebivolol; Bystolic (TM); Metoprolol ER (TM)
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's
      Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of
      Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting
      conditions.
    

Detailed description: 
      All study related procedures, restrictions, duration, dates and timings, information on the
      study formulation and confidentiality of subject data were explained clearly to the
      volunteers by clinical personnel at the time of obtaining informed consent. Volunteers who
      signed the consent form and showed"their willingness to participate in the study were
      enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be
      healthy on physical examination with laboratory investigation values within reference limits
      were considered eligible to be admitted into the study.
    

Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): Omeprazole Magnesium DR Capsules 20 mg
Other intervention name(s): Prilosec OTC 20 mg Tablets
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Omeprazole; Crossover
Studding the Implementation of ERAS Protocols in Pediatric Surgery
Condition: ERAS; Pediatric Disorder; Appendicitis; Hydrocele
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols,
      in pediatric surgery and evaluate the feasibility and effectiveness of implementing these
      protocols
    


Intervention name(s): Observational study, non-interventional
Intervention type(s): Other
Intervention description(s): observational study for the ERAS protocols in pediatric surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary
        institution
      
Keywords: Enhanced recovery after surgery (ERAS); enhanced recovery protocol; fast-track surgery; pediatric surgery
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell
      therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple
      sclerosis (RR-MS).
    

Detailed description: 
      A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS.
      Subjects who provide written, informed consent will complete screening and procurement
      assessments and provide blood to be used for vaccine production. Eligible subjects will be
      enrolled to receive either Tovaxin or placebo and will complete baseline assessments.
      Randomization and enrolled subjects will receive study treatment by subcutaneous injections
      at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries,
      urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging
      (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
    

Intervention name(s): Tovaxin Autologous T cell vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24; subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2b Tovaxin; Clinically Isolated Syndrome (CIS); Relapse-Remitting Multiple Sclerosis (RR-MS)
Impact of Art Therapy on Anxiety Identified During Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic
      treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them
      and those around them, stressful, rarely expressed, but noticeable by the care team. In line
      with the recommendations of the High Authority of Health, the multidisciplinary team of
      Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University
      Hospital offers a therapeutic education program tailored to the needs of children with cystic
      fibrosis and their families . The aim is to support children and parents in the acquisition
      of self-care skills (knowledge and skills) and coping skills, such as managing stress and
      emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the
      child, facilitates its expressive capabilities and reduces anxiety.
    


Intervention name(s): Non interventional Study
Intervention type(s): Other
Intervention description(s): Parents and children will be informed at the inclusion visit (V0) that is a normal consultation under the care of the child.
The children included will be followed for 18 months with a maximum of 6 months without meeting art therapy sessions and 12 months with art therapy. The art therapy sessions will be scheduled during the usual consultations conducted as part of the care of children.
At each visit, clinical, paraclinical and external factors of anxiety will be collected and anxiety of parents and children will be measured using specific questionnaires.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        27 children (and their parents) aged 8 to 13 years in 2016 with cystic fibrosis followed at
        CRCM children Nantes.
Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Anemia, Sickle Cell
Study type: Observational

Summary: 
      Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal
      enuresis (bedwetting) compared to the general population. This increased risk has been
      attributed to a decreased ability to concentrate urine caused by sickling-induced
      nephropathy. The sociodemographic, psychosocial, and medical factors associated with
      nocturnal enuresis are not well defined. In addition, the impact of these behaviors on
      emotional and behavioral functioning, along with health-related quality of life are not
      clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very
      few families with a child with sickle cell disease have utilized these methods. The reasons
      for this underutilization of interventions are not clear.
    

Detailed description: 
      PRIMARY OBJECTIVE: To examine differences between those who do and those who do not exhibit
      nocturnal enuresis in regard to health-related quality of life, emotional and behavioral
      functioning, family functioning, stressful life events, sociodemographic factors and medical
      factors.

      SECONDARY OBJECTIVE: To identify barriers to intervention implementation for nocturnal
      enuresis.

      In this study, children and adolescents with sickle cell disease ages 6-18 years and their
      parents/guardians will each complete an interview with questionnaires assessing nocturnal
      enuresis, health-related quality of life, emotional and behavioral functioning, family
      functioning, and stressful life events. Participants who report nocturnal enuresis will
      identify interventions they have used in the past, along with barriers to intervention
      implementation.

      The future goal will be to use this information to develop an effective intervention strategy
      for nocturnal enuresis specific to the needs of children and adolescents with sickle cell
      disease.
    

Intervention name(s): Questionnaire/Interview
Intervention type(s): Other
Intervention description(s): Participants will each complete an interview with questionnaires assessing nocturnal enuresis, health-related quality of life, emotional and behavioral functioning, family functioning, and stressful life events. Participants who report nocturnal enuresis will also be asked to identify interventions they have used in the past, along with barriers to intervention implementation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with sickle cell disease and their parents/guardians
      
Keywords: Nocturnal enuresis; Barriers to treatment