bioihbjkbjnl/mcl2 huggingface dataset:
Combined Package of Interventions for Environmental Enteropathy
Condition: Environmental Enteropathy
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,
      albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian
      children.
    


Intervention name(s): Albendazole; Zinc; Multiple Micronutrient Supplement; Placebo
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention MeSH terms: Micronutrients; Trace Elements; Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Condition: Parkinson's Disease; Apathy
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Use lay language.

      Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of
      Parkinson's disease. Depending on methodological approach of the study, its prevalence is
      estimated to be between 16 and 51%.

      Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which
      seems to play a central role in the control of mood and motivation. The subcortical
      components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and
      the constituents of the limbic system (particularly the hippocampus and amygdala), all of
      which are located deep inside the brain (18). The hypothesis is that depletion of striatal
      dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical
      circuits results in hypofunction of these circuits and the loss of frontal cortical activity,
      particularly within in the frontal orbital cortex, the anterior cingulate cortex and the
      prefrontal cortex

      The objective of this study is to explore, using diffusion weighted MRI, the regions of the
      brain which are proposed to play a role in motivation in apathetic Parkinson's disease
      patients and to define more precisely the relation between dopaminergic fibres and the
      meso-cortico-limbic system with the help of tractography methods
    

Detailed description: 
      3 groups :

        -  20 apathetic patients with Parkinson's disease

        -  20 non apathetic paired patients)

        -  20 healthy paired control

      Description of the protocol for patients :

      J0 : Inclusion visit (duration : 4h):

        -  motor assessment (UPDRS)

        -  neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental
           State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille
           apathy rating scale (LARS) ; Starkstein scale.

      Depression assessment : Montgomery et Alsberg depression rating scale (MADRS)

      J0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI
      examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional
      (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T.
    

Intervention name(s): Diffusion tensor imaging and fibres tracking
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Parkinson's disease; Apathy; diffusion tensor imaging; tractography
Intervention With a GABA Supplement in Prediabetics
Condition: Prediabetes; Hypertension
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      In this double-blind parallel placebo controlled intervention study the effects of 3 times
      daily 500 mg gamma-aminobutyric acid (GABA) supplementation on glucose tolerance and
      cardiovascular health will be assessed in prediabetics.
    


Intervention name(s): GABA; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The dietary supplement GABA will be taken orally 3 times daily, before each main meal; Gelatin capsule containing powdered cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled double blind parallel study design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin
      production, albeit at low levels. Finding means to increase this production would be of
      tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been
      shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of
      ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late
      complications. Liraglutide may through its incretin effect directly potentiate beta-cell
      function, but also holds the potential to be mitogenic for these cells.

      The hypothesis of the present trial is that treatment with liraglutide will not only have a
      direct effect on beta-cell function, which is more or less immediately observed, but also
      progressively improve C-peptide concentrations over time.
    


Intervention name(s): Liraglutide; Placebo for liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with liraglutide for 52 weeks; Placebo for liraglutide. Treatment once daily for 52 weeks
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
Condition: Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study will be a randomized clinical trial to evaluate the surgical performance and
      outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy
      ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University
      Hospital in order to reach the optimum technique for our locality
    

Detailed description: 
      Hysterectomy is the surgical removal of the uterus. It is the commonest major gynecological
      surgery, next to caesarean section, with millions of procedures performed annually throughout
      the world.Approximately 90% of hysterectomies are performed for benign conditions.

      Although there are many approaches to hysterectomy, which depend on clinical criteria,
      certain patients may be eligible to be operated in any of the several available approaches.
      The optimal route of hysterectomy for a patient will depend on the pathological nature, size
      and shape of the vagina and uterus, uterine descent, endometriosis and the likelihood of
      pelvic adhesions, adnexal masses, previous pelvic surgery, available hospital technology,
      devices and the surgeon's preference.

      Approaches to hysterectomy may be broadly categorized into four options: abdominal
      hysterectomy (AH); vaginal hysterectomy (VH); laparoscopic hysterectomy (LH) where at least
      some of the operation is conducted laparoscopically and robotic-assisted hysterectomy
      (RH).Vaginal and laparoscopic procedures are considered "minimally invasive" surgical
      approaches because they do not require a large abdominal incision and, thus, typically are
      associated with shortened hospitalization and postoperative recovery times compared with open
      abdominal hysterectomy.

      This study will be a randomized clinical trial to evaluate the surgical performance and
      outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy,
      using bipolar vessel sealer, in cases of abnormal uterine bleeding in order to reach the
      optimum technique with lower cost to be easily applied to low resource settings.
    

Intervention name(s): Vaginal hysterectomy; Laparoscopic hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse; Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginal hysterectomy; Laparoscopic hysterectomy
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is
      non-inferior to that of standard therapy CTX through analyzing overall remission rate after
      treatment.
    


Intervention name(s): Mizoribine (MZR); Cyclophosphamide (CTX)
Intervention type(s): Drug; Drug
Other intervention name(s): HE-69
Intervention MeSH terms: Mizoribine; Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
Condition: Chronic Hepatitis C Genotype-1 Relapse
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study designed to identify a dose of NIM811 that has a good safety profile, is well
      tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral
      load reduction compared to SOC alone. This information will be used to support doses selected
      for future studies.
    


Intervention name(s): NIM811; Placebo BID + SOC
Intervention type(s): Drug; Drug
Intervention description(s): BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV); Placebo BID + SOC (PEG IFN and RBV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NIM811; chronic hepatitis; chronic hepatitis C; chronic hepatitis C genotype-1; HCV; HCV-1; relapser
Vitamin D to Prevent Autism in Newborn Siblings
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether by administering vitamin D to mothers who
      already have at least one child with autism and who are pregnant, that the vitamin D will
      prevent the recurrence of autism in the newborn sibling.
    

Detailed description: 
      The incidence of autism is increasing. Also, women of childbearing age are increasingly found
      to be insufficient/deficient in vitamin D. Vitamin D is a neurohormone which is important for
      development of the child, especially of the child's brain. The primary source of vitamin D is
      from the sun through one's skin. People have been avoiding the sun because of skin cancer,
      because of increasing Television watching, computer viewing and wearing clothes that cover
      most of the body. This approach will study whether making the pregnant mother, whose child is
      at risk for autism because of a previous child with autism, replete with vitamin D will
      prevent that recurrence of autism in the newborn sibling.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age.
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Autism; Pregnancy; Newborn siblings
Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of different crystalloid coload
      volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing
      postspinal anesthesia hypotension during cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Coload has been highly demonstrated for
      prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some
      evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence
      of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose
      of this study is to investigate the effect of different crystalloid coload volumes on the 90%
      effective dose of norepinephrine infusion prophylaxis for hypotension during spinal
      anesthesia for cesarean section.
    

Intervention name(s): Crystalloid - 0 ml/kg; Crystalloid - 5 ml/kg; Crystalloid - 10 ml/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.; 5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.; 10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Other intervention name(s): Crystalloid; Crystalloid; Crystalloid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Norepinephrine; Postspinal anesthesia hypotension; Coload; Cesarean section
ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
Condition: Vitamin d Deficiency; Vitamin B 12 Deficiency; Protein Deficiency
MeSH terms: Vitamin D Deficiency; Vitamin B 12 Deficiency; Protein Deficiency
Study type: Interventional

Summary: 
      The aim of this pilot study is to conduct a study on geriatric population in Slovenia
      (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and
      assess deficiency of selected nutrients, and to investigate the efficiency of the innovative
      food supplement prototype in improving nutritional status of elderly adults.
    

Detailed description: 
      The main objective is to show that in the geriatric population regular use of investigation
      food supplement would improve nutritional status. The study should provide answers to the
      following main questions: (1) Is regular use of investigated product beneficial for improving
      serum vitamin D levels in elderly population? (2) Is regular use of investigated product
      beneficial for increasing daily protein intake in elderly population? (3) Is regular use of
      investigated product beneficial for improving vitamin B12 status in elderly population?
    

Intervention name(s): Use of food supplement; Use of placebo food supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute).
In the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day).
Intervention end on day 56 ±3 (fasted condition):
Measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight & height Collecting data regarding the palatability of the product; On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age > 65 years) who tested study products. On screening visit, participants underwent measuring of body weight & height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mobile Mindfulness Training for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training
      smartphone application on smoking cessation in smokers ages 18 to 65 years.
    

Detailed description: 
      In this study, a pilot phase will be carried out first to test feasibility and engagement of
      the tested intervention. Then in the randomized control trial, subjects will be randomly
      assigned to receive one of two treatments: (1) a standard smartphone application to support
      smokers working to become quit-free, or (2) the tested intervention, an app that trains
      mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point
      prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
    

Intervention name(s): Active Comparator App/Training; Experimental App/Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones; It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; Cessation
Sodium Oxybate in the Treatment of Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this research study is to study the effectiveness, tolerability and safety of
      sodium oxybate in outpatients with binge eating disorder.
    


Intervention name(s): Sodium Oxybate
Intervention type(s): Drug
Intervention description(s): 4.5 g/night - 9 g/night, liquid taken twice per night
Intervention MeSH terms: Sodium Oxybate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of HPV in the School Health Service
Condition: Human Papillomavirus; Cervix Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The last ten years sexually transmitted infections (STI) have substantially increased among
      adolescents. STI can lead to individual suffering and have a negative effect on the future
      reproductive health and also increase the need for health care, thus it is important to
      reduce the number of STIs. HPV vaccination is included in the school-based vaccination
      program since 2012, a catch-up vaccination is offered to older girls and young women aged
      13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and the
      school-based vaccination program has a substantial higher coverage rate. Knowledge is an
      important factor associated with attitude to preventive methods against HPV. In previous
      studies the results indicate that young people have low awareness of HPV and the HPV vaccine.
      Interventions can decrease sexual risk taking and influence the intention to receive HPV
      vaccination and increase the use of condom.

      The aim of this study is to increase primary prevention of human papillomavirus (HPV) by
      promoting HPV vaccination and increase condom use among upper secondary students. The aim is
      also to increase the knowledge about HPV, risk and prevention.
    


Intervention name(s): Education about HPV by school nurse
Intervention type(s): Behavioral
Intervention description(s): Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Attitude; Condom; Human Papillomavirus Vaccines; Primary prevention; School Health