bioihbjkbjnl/mcl2 huggingface dataset:
Bandebereho Father Groups Randomized Control Trial in Rwanda
Condition: Gender Relations; Prenatal Care; Partner Communication; Contraception; Violence
Study type: Interventional

Summary: 
      This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group
      education intervention on men's attitudes towards, and participation in, sexual and
      reproductive health, maternal, newborn and child health, and equitable and non-violent
      relationships with their children and partners.
    

Detailed description: 
      This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group
      education intervention on men's attitudes towards, and participation in, sexual and
      reproductive health, maternal, newborn and child health, and equitable and non-violent
      relationships with their children and partners. The MenCare+/ Bandebereho program is a
      multi-component comprehensive intervention being implemented by the Rwanda Men's Resource
      Center (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and
      local authorities in Karongi, Musanze, Nyaruguru and Rwamagana districts. The proposed study
      will evaluate one component of the program, a 15-session group education intervention
      targeting young fathers and mothers. The impact of the fathers' group education will be
      assessed through a randomized control trial design with an intervention arm of men and women
      participating in the father groups and a control arm of men and women who do not participate
      in the intervention. The study will collect quantitative and qualitative data over a period
      of approximately three years.
    

Intervention name(s): MenCare+/Bandebereho fathers'/couples' group education
Intervention type(s): Behavioral
Intervention description(s): MenCare+/Bandebereho is a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants are first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engages men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
Other intervention name(s): Program P
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gender, caregiving, MNCH, violence, sexual and reproductive health, parenting
Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      the study aim to protect patients received anthracyclines containing chemotherapy from
      cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for
      protection the heart from anthracyclines toxicities, and in addition its a comparitive study
      between L-carnitine and Silymarin.
    

Detailed description: 
      Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in
      treatment of various types of cancer. This study aimed to investigate benefits from adding
      L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with
      cancer.

      Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University,
      Egypt, then prospectively randomized to receive their anthracycline containing therapeutic
      regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or
      anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at
      begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin
      and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA
      and paired t test. P <0.05 was statistically significant.
    

Intervention name(s): L-Carnitine 500Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study
without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months.
Other intervention name(s): Silymarin
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: anthracycline-containg chemotherapy; cardiotoxicity; breast cancer patients; slymarin; l-carnitine
The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and Fecal Compounds in Healthy Adults
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      High consumption of red meat is related to cardiovascular diseases. Red meat containing more
      unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty
      acid profile in humans. Furthermore, consumption of red meat and especially processed red
      meat is considered harmful to colon health. However, consumption of fruit and berries rich in
      antioxidants and flavonoids may provide protection when red meat is consumed.

      The study aims to answer whether the fatty acid profile of pork when modified towards more
      unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects of
      pork with a modified fatty acid content is compared with conventional pork with lower
      unsaturated fat content. Fatty acid composition of pork is modified by altering the
      composition of animal feed.

      The other arm of the study investigates the effects of consuming berries together with red
      meat on gut metabolism. The study focuses on how berries affect the formation of fecal
      compounds known to be related to high red meat consumption, such as N-nitroso compounds.
    


Intervention name(s): Modified pork; Pork; Pork and berries
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Pork with modified fatty acid composition; Pork with normal fat composition; Pork with normal fat composition and Finnish berries
Other intervention name(s): Pork with modified fatty acid composition and berries; Pork; Pork and Finnish berries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fatty acids; Lipids; Nitroso compounds; Lipid metabolism; Gut metabolism
Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Children with autism spectrum disorders (ASDs) have unique social-communication and behavior
      impairments that complicate their medical management. This study aimed to evaluate the
      effectiveness of using a picture schedule paired with a reinforcement system during the
      medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with
      ASD and below average adaptive communication impairment were asked to participate. Following
      participation in an overview of autism diagnostic symptoms training, two teams (comprised of
      one chief medical resident and one nurse), blind to the study aim, conducted the study exams.
    

Detailed description: 
      Objective: This pilot study aimed to evaluate the effects of a picture-schedule reinforcement
      system on reducing problem behaviors in children with Autism Spectrum Disorder (ASD) during a
      physical exam.

      Design, setting, patients, intervention: Fifteen study participants, aged 5-10 years, with
      autism and identified by caregivers as typically uncooperative with physical exams were
      randomized to one of two physical exam groups (treatment and control) based on their adaptive
      communication score. The treatment group exam included use of a picture
      schedule-reinforcement book and the control group exam did not introduce the book. Caregivers
      rated participants' irritability/stereotypy behaviors before and during study exams. Exam
      teams blinded to study aims, recorded participants' total exam items completed and caregivers
      rated participants' level of cooperation.
    

Intervention name(s): Treatment: Physical Exam with Visual Pedagogy and Structure; Control: Physical Exam without Visual Pedagogy and Structure
Intervention type(s): Other; Other
Intervention description(s): Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).; Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: visual pedagogy
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine
      in the most severe form of ulcerative colitis.

      The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the
      colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine
      (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and
      patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon
      in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.
    

Detailed description: 
      Design: prospective, randomized, double-blind, dose-finding study with retarded
      phosphatidylcholine.

      Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to
      historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic
      active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at
      least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.

      Exclusion criteria: Pregnancy & fulminant course
    

Intervention name(s): retarded release phosphatidylcholine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Dose Finding; Phosphatidylcholine
Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the
      Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic
      Steatohepatitis (NASH)
    

Detailed description: 
      This is a phase II, randomized, double blind placebo-controlled, three-arm, parallel-group,
      intervention clinical trial evaluating anti-oxidant activity of Heptex; a herbal medicinal
      product of Aerial Parts of Phyllanthus niruri (Dukung Anak) and Fruits of Silybum marianum
      (Milk Thistle) in patients with apparent risk factors of NASH.
    

Intervention name(s): Heptex; Rice bran
Intervention type(s): Drug; Other
Intervention description(s): Dukung Anak 200 mg + Milk thistle 100 mg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: NASH
A Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of a new tablet formulation of lanabecestat
      gets into the blood stream and how long it takes the body to get rid of it, compared to the
      current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the
      body absorbs the new tablet formulation will also be evaluated. In addition any side effects
      of the study drug using both the new and current tablet formulations will be evaluated. The
      study will last about 22 days, with screening required within 30 days prior to the start of
      the study.
    


Intervention name(s): Lanabecestat
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY3314814; AZD3293
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy
      participants
    


Intervention name(s): rosuvastatin; BMS-963272
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of LY900010 in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to
      tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED)
      who incompletely respond to tadalafil alone.
    


Intervention name(s): LY2452473; tadalafil; placebo (tadalafil); placebo (LY2452473)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Female Sexual Wellness
Condition: Sexuality; Sexual Dysfunction; Sexual Desire Disorder; Hypoactive Sexual Desire Disorder; Orgasmic Disorder; Pelvic Organ Prolapse; Urinary Incontinence; Interstitial Cystitis; Pelvic Floor Disorders; Female Sexual Dysfunction
MeSH terms: Hypokinesia; Urinary Incontinence; Enuresis; Cystitis; Cystitis, Interstitial; Pelvic Floor Disorders; Prolapse; Pelvic Organ Prolapse; Sexual Dysfunctions, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of commercially available genital vibrator
      use on sexual health, female pelvic floor disorders, and overall quality of life among a
      diverse population of women.
    


Intervention name(s): Vibrator
Intervention type(s): Behavioral
Intervention description(s): Clitoral stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sexuality; Sexual Dysfunction; Sexual Desire Disorder; Hypoactive Sexual Desire Disorder; Orgasmic Disorder; Pelvic Organ Prolapse; Urinary Incontinence; Interstitial Cystitis; Pelvic Floor Disorders; Wellness; Female Sexual Dysfunction
Oral Functions and Malocclusions
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Observational

Summary: 
      The aim of our research is to establish a link between malocclusions and oral dysfunctions.
      The clinical examination includes: caries screening (DMFT and dft scores), a quantification
      of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute
      Autorité de Santé HAS). The functional examination includes improper mouth breathing,
      abnormal deglutition and incorrect position of tongue at rest.
    


Intervention name(s): oral examination
Intervention type(s): Other
Intervention description(s): examination done by dentist
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes
        Maritimes, France
Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
Condition: Cancer
Study type: Interventional

Summary: 
      In order to gain a greater understanding of the full experience of children with
      life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years
      olds in active treatment for cancer, and instruct them to make video illness narratives over
      the course of 1-3 months. The narratives will be studied as an intervention; each of the
      participants will be administered a measure of physical symptoms (the Memorial Symptom
      Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The
      video narratives will also be analyzed for content by theme in order to understand the
      participants' experiences in their own words. Our hypothesis is that these narratives will
      provide insight into the lives of children with cancer, increase their self-esteem, and
      decrease symptom distress, and improve communication between patients and their doctors.
    

Detailed description: 
      In addition to the above outcome measures:

      The video narratives will also be analyzed for content by theme in order to understand the
      participants' experiences in their own words.
    

Intervention name(s): Video Illness Narrative
Intervention type(s): Behavioral
Intervention description(s): video
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Intermittent vs. Continuous Walking in MS
Condition: Multiple Sclerosis, Endurance
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Objective: To compare effects of an intermittent and continuous walking program on walking
      endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover
      prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week
      for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The
      intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week
      detraining period, participants performed the second training condition.
    


Intervention name(s): type of walking
Intervention type(s): Other
Intervention description(s): Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence
      between two formulations of Mixtard® 30 in healthy subjects.
    


Intervention name(s): biphasic human insulin 30
Intervention type(s): Drug
Intervention description(s): Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lung Function of Asthmatic Children by Nebulized MgSO4
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a common chronic respiratory illness which results in frequent wheezing,
      cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy,
      β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although
      inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma
      exacerbation, there are still some asthmatic children unresponsive to this management. The
      Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate
      (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous
      MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g
      relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB
      provides greater benefit in severe asthma exacerbation.
    


Intervention name(s): Magnesium Sulfate & albuterol; albuterol; magnesium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Magnesium Sulfate; Albuterol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnesium sulfate; nebulization; lung function