bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies
Condition: Malaria in Pregnancy
MeSH terms: Malaria
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP)
      for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the
      coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo
      (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp
      is distributed as usual in facilities through routine antenatal care (ANC).
    

Detailed description: 
      The specific objectives of this study are to determine the change in the following indicators
      during the course of the TIPTOP project: 1) Proportion of women who have had a pregnancy that
      ended in the past 12 months and have received 1 or more, 2 or more and 3 or more doses of
      IPTp-SP; proportion of women with pregnancy in the past 12 months who attended ANC clinics at
      least once, and who attended at least four times; proportion of pregnant women attending the
      first ANC visit before or at week 14; proportion of women who have had a pregnancy that ended
      in the past 12 months who know about the IPTp service provided by CHWs; and acceptability of
      C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type,
      age, gravidity and distance from facility). To assess these changes, the study will implement
      structured household surveys targeting potential beneficiaries of the project (pregnant
      women) in the intervention and comparison areas, implemented at three time points: baseline,
      mid- and end-points. In each country an initial implementation area (Phase I) and two
      expansion areas (Phase II) have been selected for the project. This study will establish if
      community deliver of IPTp is effective and feasible and whether it influences antenatal care
      service coverage rates. It is expected that the study will provide information to scale up
      the approach the 4 study countries for the prevention of malaria in pregnancy. This
      information is also meant to inform global guidelines on community IPTp delivery and may also
      be used by other countries.
    

Intervention name(s): Community distribution of SP for IPTp
Intervention type(s): Behavioral
Intervention description(s): SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.
Other intervention name(s): C-IPTp-SP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking: None (Open Label)
Primary purpose: Prevention
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to
      ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative
      volunteers.

      ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a
      humoral and cellular response against several antigens. This recombinant construct is based
      on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the
      transmembrane portion of the LAI strain as well as gag and protease.
    

Detailed description: 
      ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a
      humoral and cellular response against several antigens. This recombinant construct is based
      on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the
      transmembrane portion of the LAI strain as well as gag and protease.

      Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or
      both according to varying schedules over 12 months (was 6 months, amended 11/17/95) with a 12
      month follow up. [AS PER AMENDMENT 5/29/98: One additional follow-up visit is required at
      30-36 months.]
    

Intervention name(s): ALVAC-HIV MN120TMG (vCP205); ALVAC-RG Rabies Glycoprotein (vCP65); rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; HIV Preventive Vaccine
A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).
Condition: Chronic Kidney Disease; Congenital Anomalies of Kidney and Urinary Tract
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous
      Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the
      Kidney and Urinary Tract (CAKUT) (REGEN-004)
    

Detailed description: 
      It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy
      (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific
      rationale, based on non-clinical studies, is that the biologically active component of REACT
      (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney
      Disease (CKD) by augmenting renal structure and function. As a result, the more cells that
      can be infused, the greater the potential improvement in renal function.
    

Intervention name(s): Renal Autologous Cell Therapy (REACT)
Intervention type(s): Biological
Intervention description(s): Autologous selected renal cells (SRC)
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Primary purpose: Treatment
Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to analyse the effect of ketoprofen gel in patients presented with
      ankle sprain to the emergency department.
    

Detailed description: 
      Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over
      24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and
      pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of
      2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical
      in colour, form and smelling. After an eligible patient presented to the ED, the drug number
      from an opaque bag is determined by a nurse and then another nurse applies the study drug to
      the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of
      patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the
      administration.
    

Intervention name(s): Ketoprofen gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical ketoprofen as used in gel form.; Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
Other intervention name(s): Fastjel; Placebo gel
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ankle sprain; topical ketoprofen; non-steroidal anti-inflammatory drug; emergency department
Safety and Reactogenicity Trial of Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b
Condition: Haemophilus Influenzae Infection; Vaccines
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial purpose is to evaluate the safety, tolerability and reactogenicity of the Vaccine for
      the prevention of infections caused by Haemophilus Influenzae Type b in volunteers aged
      18-50.
    

Detailed description: 
      The trial includes 2 stages (Stage I and Stage II). The aim of the Stage I is to assess the
      tolerability, reactogenicity and safety of the Hib vaccine in the first 10 volunteers during
      the first 7 days after vaccination.

      The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib
      vaccine during 28 days after vaccination and also to conduct a comparative assessment of the
      safety and reactogenicity of the Hib vaccine and placebo during 28 days after vaccination.
    

Intervention name(s): Vaccine for the prevention of infections caused by Haemophilus influenza type b; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The vaccine is administered into the region of the deltoid muscle; The placebo is administered into the region of the deltoid muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Haemophilus Influenzae; Haeophilus influenza type b; Vaccine; Hib vaccines; Hib; SPbSRIVS
Psychobiology in Inflammatory Bowel Disease(IBD)
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last
      18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress
      questionnaire (PSQ) were randomized to a stress management intervention program or treatment
      as usual and followed up for 18 months.
    

Detailed description: 
      The study includes distressed patients with ulcerous colitis and Crohn's disease with relapse
      or enduring activity last 18 months and an simple activity index ≥4, on stable medication
      last 4 weeks. All patients were followed by a gastroenterologist at baseline, 3, 6, 12 and 18
      months follow up and a psychiatrist or clinical psychologist at 18 months. Half of the
      patients received additional psychosocial intervention (education, relaxation, supportive
      psychotherapy with stress management). Assessments include gastrointestinal assessments;
      blood tests; psychiatric evaluations and psychometric evaluations.
    

Intervention name(s): Psychological behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): 3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
Other intervention name(s): stress management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBD, psychological, stress management
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study seeks to determine the efficacy of single coil defibrillation leads for
      cardioversion of persistent atrial fibrillation.
    

Detailed description: 
      This study seeks to compare the efficacy of single coil defibrillation leads for the internal
      cardioversion of atrial fibrillation as compared with cardioversion by external
      defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion,
      but the presence of the SVC defibrillation coil allows for selection of shock vector that
      more reliably incorporates the majority of atrial tissue compared to a single right
      ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted
      in the majority of patients requiring placement of implantable cardiac defibrillators, and
      many of these patient's will later develop atrial fibrillation and potentially require
      cardioversion. Currently, there is no clear consensus on how to approach cardioversion in
      these patient's and both external and internal methods are used. Internal cardioversion may
      be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion.
      External cardioversion may carry a small risk of damaged to the CIED.

      The investigator's goal is to identify patient's referred for cardioversion for atrial
      fibrillation who also have an implanted cardiac defibrillator with a single coil
      defibrillation lead and randomize them to either external or internal cardioversion.
    

Intervention name(s): Internal Cardioversion; External Cardioversion
Intervention type(s): Procedure; Procedure
Intervention description(s): Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol; External Cardioversion per institutional protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized in block fashion to either internal or external cardioversion
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; implantable cardiac defibrillator; cardioversion
Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of two-way short message service (SMS)
      on glycemic control in low-income, poorly-controlled adult diabetic patients.
    

Detailed description: 
      This multi-center, unblinded, prospective randomized controlled trial will enroll adult
      diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and
      Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum
      hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After
      written informed consent has been obtained, subjects will be randomized to intervention or
      control group (1:1), stratified based on insulin initiation within 1 week of study inclusion.
      Participants randomized to the intervention group will be further divided into subgroups as
      "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The
      content of the message consist of medication reminders, reporting of blood glucose results,
      insulin technique assessment (if applicable), or d) medication adherence assessment.
      Participants will be asked to respond with a simple text within 7 days. The intervention
      group will receive the standard medical appointment reminder via telephone one to two
      business days prior to the appointment at the Health Center PLUS a unidirectional text
      message two business days prior to scheduled health center appointments. Control group
      participants will receive the standard medical appointment reminder via telephone one to two
      business days prior to the appointment at the health center. All participants in the study
      (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the
      determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C
      concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the
      number of texts sent per week and by type, percent of respondents weekly by text or by phone,
      content of participant responses, number of patients unable to be reached via text, total
      investigator time spent per week, and time spent per contact will be recorded. At the three
      month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and
      medication changes will be recorded.
    

Intervention name(s): Texting
Intervention type(s): Other
Intervention description(s): Bidirectional texting once weekly for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes
Efficacy and Tolerability of HAT1 in Patients With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance
      of epidermal-barrier function that results in intensely pruritic subacute and chronic
      eczematous plaques. As the most common cause of chronic inflammatory skin diseases, AD is a
      major cause of morbidity and suffering, affecting upto 30% of children, and increasing in
      prevalence throughout the world. It is estimated that the direct cost of AD in the US alone
      ranged from $0.9 billion to $3.8 billion every year. The current therapy of AD is reactive,
      where the flares are treated through symptomatic management with topical corticosteroids and
      calcineurin inhibitors. Given that these medications have long-term side-effects, and given
      the chronically relapsing immunopathogenic nature of AD, there is an imperative need for
      safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a topical
      treatment for eczema/atopic dermatitis (AD) denoted HAT1, and have demonstrated that HAT1 is
      safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85%
      of patients with AD. This study is aimed to further evaluate the potential of developing HAT1
      as an integral part of AD therapy.
    

Detailed description: 
      This study is a 17 week (119 days) randomized, double-blind, in home use study among 48 male
      and female subjects with moderate to severe active atopic dermatitis (AD). The study will
      include subjects with ages 12 - 65 years old inclusive. Group assignments will be balanced by
      disease severity, age, and body location of AD lesions (listed in order of importance). The
      study will consist of a 1 week washout period, 12 week treatment phase and a 4 week
      regression phase. During the treatment phase, subject will be provided one of the two test
      products to use twice daily on all lesions and non-lesional areas as instructed. No
      additional creams, lotions or soaps other than provided test products will be allowed
      throughout the duration of the study. Measurements, expert visual assessments and
      self-assessments will be taken as described below. Safety and tolerability will be evaluated
      by incidence of AE's (defined per CTCAE), exacerbations, application site
      reactions/infections, and lab evals. There will also be consumption/compliance checks and
      dermatological evaluations at each visit.
    

Intervention name(s): HAT1 topical cream; Vehicle cream
Intervention type(s): Drug; Drug
Other intervention name(s): HAT1; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema; Topical
Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis
Condition: Le Fort; I
Study type: Interventional

Summary: 
      Virtual Surgical planning (VSP) has significantly improved many aspects of oral and
      maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of
      the surgical plan to the operating theatre and reduction of operative time. Conventional
      treatment planning for orthognathic surgery, although proven to be reliable, has many
      drawbacks. Computer guided splintless maxillary orthognathic surgery has been recently
      performed with predictable outcomes. More than one design of PS osteosynthesis has been used
      in recent trials. Nevertheless, which design is more superior to the other is a topic yet to
      be addressed. Either a one-piece fixation device spanning the length of the Le Fort 1
      osteotomy or the fixation can be provided by more than one device placed at the load bearing
      buttresses. The superiority of 4 fixating patients specific plates compared to the other will
      be determined after evaluating many outcomes including accuracy, intra operative time,
      post-operative complications.

      The goal is to take a step towards determining which design is the best for performing
      splintless maxillary orthognathic surgery in terms of accuracy and least complications for
      the correction of prevalent dentofacial deformities.

      Beside the evaluation of accuracy, the two different designs will be compared in terms of
      operative time and post-operative complications.
    


Intervention name(s): Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
Intervention type(s): Procedure
Intervention description(s): Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
Condition: Fatty Liver; Diabetes Mellitus, Type 2
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators want to evaluate the effects and safety of ginger in treatment of
      nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes
      for at least two millennia. It contains several hundred valuable compounds and new
      constituents are still being found. Ginger's high antioxidant value has proved highly
      effective with its ability to scavenge a number of free radicals and protect cell membrane
      lipids from oxidation in a dose-dependent manner.

      In a randomized double-blind placebo-controlled clinical trial, the investigators want to
      investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in
      patients with type 2 diabetes mellitus (T2DM).
    

Intervention name(s): Ginger; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ginger powder capsule 1000 mg twice daily for 3 months; Placebo powder 2 capsules twice daily for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ginger; Medicine, traditional; Herbal medicine