bioihbjkbjnl/mcl2 huggingface dataset:
Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to determine whether universal salt iodization (USI) meets the
      iodine requirements of pregnant women, lactating women and infants.
    

Detailed description: 
      Because pregnant women, lactating women and infants are the groups most vulnerable to iodine
      deficiency and its irreversible consequences, programs should focus on these groups. But like
      other mass fortification strategies, it is uncertain whether USI can meet the increased
      dietary requirements of pregnant women, lactating women and infants. Objective of this study
      to test whether USI can meet the dietary requirements of iodine in women of reproductive age,
      pregnant women, lactating women and infants up to 2 years of age without causing excess
      iodine intake in school children and non-pregnant non-lactating women. The study hypothesis
      is that USI, when fortified at adequate levels and applied to all salt consumed, including
      both household salt and salt used for processed foods, provides adequate dietary iodine for
      all population groups, except for weaning infants; while not posing any risk of excessive
      iodine intakes in other age groups.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        In each of the four study countries, six population groups will be studied:

          -  women of reproductive age

          -  pregnant women

          -  lactating women

          -  young infants

          -  toddlers

          -  school-aged children
      
Biospecimen description: 
      Urine, dried blood spots, breast milk
    
Keywords: Iodine deficiency
A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache
Condition: Migraine Disorders; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Observational

Summary: 
      This study is a retrospective chart review in patients diagnosed with headache or migraine to
      evaluate treatment patterns and diagnosis.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): There is no intervention in this study.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with
      Attention-Deficit/Hyperactivity Disorder (ADHD)
    


Intervention name(s): ABT-894; atomoxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.; Subjects will take 40 mg BID or placebo for up to four weeks.; Subjects will take BID for up to four weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Yoga for Smoking Cessation Feasibility Study
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this study is to test whether it is feasible to provide a smoking cessation
      program together with a yoga program to help women quit smoking. We anticipate that women
      will be enthusiastic about the program and that we will be able to recruit and treat women
      for smoking cessation within the designated time frame.
    

Detailed description: 
      Cigarette smoking is the leading preventable cause of morbidity and mortality among adults in
      the United States. Smoking, and quitting smoking may be especially problematic for women. Our
      prior research has demonstrated that traditional aerobic exercise (e.g., brisk walking,
      bicycling) improves cessation outcomes among women. Exercise appears to reduce the effects of
      nicotine withdrawal and improves cessation outcomes by improving mood and reducing weight
      gain. yoga that shares many of the same properties of the traditional aerobic exercise that
      has been shown to be an efficacious adjunct to smoking cessation treatment. Moreover, some
      features of yoga, including a focus on breathing, meditation, stress reduction and enhanced
      mood are likely to have special relevance to smokers who are trying to quit. Thus, yoga may
      prove to be a more efficacious complimentary treatment for smoking cessation than traditional
      aerobic exercise.

      The goal of this proposal is to conduct an initial investigation of the efficacy of providing
      Yoga as an adjunct to cognitive behavioral treatment (CBT) for smoking cessation. Adult women
      smokers (n=72) will be recruited through newspaper advertisements and will be randomly
      assigned to either: (1) CBT plus Yoga , or (2) CBT plus contact control. All study
      participants will be given a sub-maximal exercise stress test to ensure that they are safe to
      exercise. Yoga sessions will be conducted twice weekly for 12 weeks, and will be lead by
      certified instructors in yoga. Smoking cessation sessions will be conducted once per week for
      12 weeks and will be lead by Masters or PhD level specialists in smoking cessation.
      Differences in post-treatment (12 week) cessation rates (7-day point prevalence abstinence)
      will provide data for estimates of effect size between conditions. This effect size estimate
      is necessary in order to calculate power estimates for a major clinical trial.
    

Intervention name(s): Yoga; Wellness; Smoking cessation therapy
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Yoga twice weekly; Health and wellness classes twice weekly; Smoking cessation therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Yoga; Wellness; Feasibility; Smoking Cessation Therapy
Qigong and Exercise Therapy for Low Back Pain in Adults
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of qigong for the treatment of low
      back pain compared to a stabilizing exercise therapy.
    


Intervention name(s): qigong; exercise therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): one therapy session once a week during three months, that is 12 therapy sessions altogether; one therapy session once a week during three months, that is 12 therapy sessions altogether
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: qigong; traditional chinese medicine; exercise therapy; low back pain
Effects of Salvinorin A in Healthy Controls
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the
      plant Salvia divinorum that is known to have been used by Mexican Indians as part of
      religious rituals. The purpose of this project is to understand what people experience when
      they consume Salvinorin A.
    


Intervention name(s): Salvinorin A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg; Control or Placebo SA (30 % ethanolic solution)
Other intervention name(s): SA; Salvia; Salvia Divinorim
Intervention MeSH terms: Salvinorin A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Salvia; SA; Salvinorin; Psychotomimetic Effects
Abnormal Plantar Pressure in Patients With Diabetes
Condition: Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Study type: Observational

Summary: 
      The prevalence of abnormal plantar pressure distribution (APD) and its connection with
      various factors among patients with diabetes is not known. The purpose of this study was to
      evaluate the prevalence of the APD and its connection with selected factors among patients
      with diabetes.
    

Detailed description: 
      The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar
      calluses which are responsible for diabetic foot ulcer.

      The knowledge of APD is necessary to plan proper prevention in the group of patients with
      diabetes mellitus (DM).

      Medical records from previous patients' visits of non-ulcer patients with diabetes were
      retrospectively analysed. The relationship between APD, obtained during a pedobarographic
      test as a semi-quantitative assessment with colourful print analysis, and neuropathy, gender,
      age and BMI was searched.
    

Intervention name(s): retrospective observational study with no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be
        examined despite the absence of diabetic foot signs or symptoms
      
Keywords: diabetic foot; pedobarography; diabetic neuropathy; plantar pressure
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Condition: Postmenopausal Symptoms
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is intended to establish the lowest effective dose of EstroGel® for the treatment
      of vasomotor symptoms associated with menopause.
    

Detailed description: 
      The primary objective of this study was to establish the lowest effective dose of EstroGel®
      for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy
      of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and
      vaginal atrophy were assessed as secondary efficacy parameters.
    

Intervention name(s): Estrogel; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post menopausal vasomotor symptoms
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to follow and collect additional medical and developmental
      information on children after histrelin subcutaneous implant therapy is discontinued.
    

Detailed description: 
      Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia
      deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3
      patients per site. It is anticipated that half the patients will be receiving GnRH analog
      treatment and the other half will be treatment naïve. All patients will undergo selective PK
      sampling post-implantation to assess histrelin profile. At 12 months, provided that the
      patient continues to meet the safety and efficacy parameters, the original implant will be
      removed and the patient can receive a new implant. At 13 months, patients who receive new
      implants will be evaluated at the study site and administratively transferred to the initial
      extension study. At Month 24), the implants inserted at Month 12 will be removed. At this
      time, patients who have completed the initial extension study and who wish to continue
      therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and
      to enter an additional 12-month extended access phase at the discretion of the investigator.
      At Month 36, the implants inserted at Month 24 for the Extended Access Phase will be removed.
      At this time, patients who have completed the Extended Access Phase and who wish to continue
      therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and
      to enter the Long Term Extended Access Phase (referred to as the Implant Treatment Phase) at
      the discretion of the investigator. The purpose of this phase is to provide patients with the
      opportunity to continue to receive a new implant at the end of each 12-month period until the
      patient no longer requires hormone suppression. Once implant therapy is discontinued, all
      patients are eligible to enter the Long Term Follow Up Phase (Post Implant Phase) of the
      study.
    

Intervention name(s): Histrelin Subcutaneous Implant
Intervention type(s): Drug
Intervention description(s): histrelin subcutaneous 50 mg implant
Other intervention name(s): Supprelin LA; implant therapy; histrelin implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: puberty; precocious puberty; early puberty; early onset puberty; histrelin; histrelin subcutaneous implant; implant therapy
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Condition: Hyperlipidemia; Diabetes Mellitus; Metabolic Syndrome; Arterial Hypertension; Obesity
MeSH terms: Metabolic Syndrome; Hyperlipidemias; Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of the present study is to conduct a thorough and relevant physiology study of
      carriers and non-carriers of the gene variant X in order to determine the effect of the
      genetic variant on various metabolic parameters.
    


Intervention name(s): first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
Intervention type(s): Other
Intervention description(s): FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes.
HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes
Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes.
Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes.
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted to

        1. assess whether SLM0807 alters pharmacodynamics of HKB0701

        2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and
           multiple co-administration of HKB0701/SLM0807 in healthy subject
    


Intervention name(s): Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001; Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701; Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis
Condition: Cirrhosis; Liver Fibrosis; Portal Hypertension; Cystic Fibrosis; Cholestasis of Parenteral Nutrition
MeSH terms: Cystic Fibrosis; Liver Cirrhosis; Hypertension, Portal; Cholestasis; Fibrosis
Study type: Interventional

Summary: 
      Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver
      disease. At present, the unique validated method to evaluate the liver fibrosis in children,
      is the liver biopsy which is an invasive method. If the elastometry method is proved to be a
      good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.
    

Detailed description: 
      The elastometry method is proved to be efficient for the evaluation of liver fibrosis in
      adults. But the inter-costal space is too thin in children, and the adult probe could not be
      used. Recently a special probe adapted to the children have been TECHNICATED. We want to test
      this specific probe in children. Five French Paediatrics centres will participate to the
      study. We need 200 children inclusions in 2 years to have a statistically power analysis.
      Inclusion of each child will be in order to the need of a liver biopsy. Each children
      included will have an elastometry measure in the same time than the liver biopsy. The
      fibrosis will be staged by a trained pathologist and scored by METAVIR score witch is the
      reference. The elastometry measure will be realised by physician with 3 sequential measures
      in each child. The statistical analysis will be performed by statistician. If elastometry is
      proved to be an efficient method to evaluate the liver fibrosis in children, a numerous of
      liver biopsy could be avoided. Because elastometry is a non invasive method it could also be
      used as follow-up in different categories of children who needs sequential liver biopsy.
    

Intervention name(s): Elastometry
Intervention type(s): Other
Intervention description(s): Fibrosis detection with FIBROSCANN
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Liver; Fibrosis; Elastometry; FIBROSCANN; Children
The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the effect of treatment of traumatized refugees
      with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point
      towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy
      being the most effective treatments of PTSD, but very little evidence of treatment effects
      exist for the group of multitraumatized refugees. This study therefore seeks to investigate
      the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or
      Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual
      will undergo treatment. They will be randomized to 4 different groups: antidepressants,
      psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures
      include symptoms, life quality and function. Patients with a diagnosis of drug abuse or
      psychosis will not be included. The hypothesis is that a combination of antidepressants and
      psychotherapy will be more effective than either of the two treatment regimes on their own.
    


Intervention name(s): Sertraline; trauma-focused cognitive behavioural therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): varies; once a week
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatized refugee; treatment; antidepressants; psychotherapy; PTSD in traumatized refugees
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
Condition: Rhinitis, Allergic, Perennial; Hay Fever
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the safety of three dose levels of
      ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once
      daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure
      serum concentrations of ciclesonide and its active metabolite under steady state conditions
      at three time points corresponding to the presumed peak and trough exposure after six weeks
      of administration.

      In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of
      treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were
      summarized.
    


Intervention name(s): Ciclesonide nasal; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): safety of Ciclesonide (200µg, 100µg, 25µg); placebo
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Perennial Allergic Rhinitis; Ciclesonide; Hay Fever; PAR