bioihbjkbjnl/mcl2 huggingface dataset:
Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana
Condition: Inflammation; Growth Retardation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      REACCTING (Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern
      Ghana) is an interdisciplinary randomized cookstove intervention study in the Kassena-Nankana
      District of Northern Ghana. The study tests two types of biomass burning stoves that have the
      potential to meet local cooking needs and represent different "rungs" in the cookstove
      technology ladder: a locally-made, low-tech Gyapa rocket stove and the imported, highly
      efficient Philips gasifier stove. Intervention households were randomized into four different
      groups, three of which received different combinations of two improved stoves, while the
      fourth group serves as a control for the duration of the study. Diverse measurements assess
      different points along the causal chain linking the intervention to final outcomes of
      interest. The investigators assess stove use and cooking behavior, cooking emissions,
      household air pollution and personal exposure, health burden, and local to regional air
      quality. Integrated analysis and modeling will tackle a range of interdisciplinary science
      questions, including examining ambient exposures among the regional population, assessing how
      those exposures might change with different technologies and behaviors, and estimating the
      comparative impact of local behavior and technological changes versus regional climate
      variability and change on local air quality and health outcomes.
    


Intervention name(s): Philips stove; Gyapa stove
Intervention type(s): Device; Device
Intervention description(s): Philips Smokeless stove HD4012LS; Wood stove made in Ghana
Other intervention name(s): Gasifier stove; Rocket stove
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were 4 groups, 3 intervention and 1 control, all operating over the same period.
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment of Overweight in General Practice
Condition: Overweight and Obesity; Nutritional and Metabolic Diseases
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      In this study the investigators want to explore the feasibility and effect of a simple
      intervention provided by primary care physicians on treatment for overweight in general
      practice. Regular patients visiting their ordinary family physician will be asked for
      participation if they comply with the inclusion criteria. If so, they will follow a detailed
      food list for 12 months with regular visits to the doctor. At each visit, the participating
      patients will be asked about their progress on weight loss and all measurements will be made.
      Simultaneously a control group of primary care physicians will also recruit patients that
      fulfill the inclusion criteria. These patients will also provide data that will serve as
      Control to the intervention group.
    

Detailed description: 
      The number of patients with overweight is increasing and a daily issue in general practice.
      Many patients wish to discuss their weight problem with their family physician but many of
      these feel helpless to guide their patients in how to reduce weight. Providing useful and
      correct information should not be so difficult but many doctors choose to refer their
      patients to dietary courses or follow-up in specialist health care.In this study the
      investigators wish to implement a simple tool for treatment of overweight in primary care by
      providing the patients a detailed list for all meals that will ensure a weight loss. The
      patients will be given a close follow-up by their doctor, and the motivating conversation and
      list of meals will be the only treatment given.

      The study is a cluster randomised controlled trial where all general practices in the area of
      Moss city in Norway will be asked to participate. Half of the physicians will constitute the
      intervention group while the other half will serve as control group. Each participating
      doctor in both groups will recruit patients according to the eligibility criteria. The
      doctors in the intervention group will be provided with a course to learn the intervention
      and have a manual to follow for each patient. All participating patients of both groups will
      be asked to meet regularly for data collection.

      According to the power calculation, a number of 12 physicians in each group will be
      sufficient if they recruit 10 patients each.

      The intervention will be conducted for 12 months and thereafter data will be continued to be
      collected at 6 and 12 months after.
    

Intervention name(s): Intervention group
Intervention type(s): Behavioral
Intervention description(s): Please see the preceding section
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: overweight, general practice
Secondhand Smoke Exposure Reduction Study
Condition: Secondhand Smoking
Study type: Interventional

Summary: 
      The high prevalence of smoking in adults in many developing countries (e.g. in China, 61%
      among men and 7% among women) results in many children being exposed to secondhand smoke
      (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of
      proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and
      children), similar recommendations in many developing countries are either scarce or
      non-existent. We hypothesize that implementation of a package of smoking hygiene intervention
      measures delivered by community health workers (CHWs) will reduce Chinese children's exposure
      to SHS and improve their respiratory health.
    


Intervention name(s): smoking hygiene intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention, SHI, will address SHS and quitting. It will include behavioral counseling to address health hazards of SHS for children, brief advice to quit and to adopt a no smoking policy around children and self-help materials (related to second hand smoking).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: SHS
Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury
Condition: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture
MeSH terms: Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite
      completion of formal rehabilitation and clearance to return to physical activity (PA).
      Focused exercises and targeted health education may improve these negative outcomes and
      increase quality of life. The purpose of this study is determine the effects of an 8-week
      rehabilitation program on strength, sensorimotor function, functional performance and
      patient-reported outcomes in patients with a history of ACLR. A secondary aim will be to
      identify baseline PA levels and dietary intake patterns in these individuals. Participants
      will complete standard knee radiographs and all baseline measures, and resume normal
      activities of daily living for one-week while wearing an accelerometer to quantify PA levels
      and complete two, 24-hour dietary recalls to examine dietary patterns. After one-week,
      participants will come back to the laboratory and complete the pre-intervention assessments
      prior to randomization to the exercise or control group. After 8-weeks, participants will
      complete all outcome assessments 24-48 hours, 1-month and 3-months post exercise completion.
      The investigators hypothesize the intervention group will have significantly better outcomes
      post-intervention compared to the control group. In addition, the investigators hypothesize
      areas of educational and behavioral intervention related to PA engagement and dietary
      strategies to support weight management will be needed.
    


Intervention name(s): Exercise Group
Intervention type(s): Other
Intervention description(s): An 8-week home exercise program will be given to the participants. The program is designed to have four phases, progressed every two weeks. The participants will receive and email from study personnel every two weeks with new videos detailing the progression of exercises. The participants will be given all of the equipment to complete the exercises. The exercises will include balance and strength training exercises for the core and lower extremity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation
Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide
      two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a
      topical barrier repair cream designed to deliver special epidermal lipids to the top layers
      of the skin in order to correct skin barrier abnormalities found in atopic dermatitis.
      Epiceram does not contain corticosteroids or other conventional anti-inflammatory components
      and represents a novel class of skin barrier repair therapy for inflammatory skin disease.

      The objective of this study is to determine whether Epiceram is a safe and effective therapy
      for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel
      therapy.
    

Detailed description: 
      Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide
      two- to threefold over the last 50 years. Current standard of care for atopic dermatitis
      includes topical corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The
      chronic use of topical corticosteroids is limited by side effects including skin atrophy,
      striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with
      calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer
      exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.

      Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to
      deliver special epidermal lipids to the top layers of the skin in order to correct skin
      barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids
      or other conventional anti-inflammatory components and represents a novel class of skin
      barrier repair therapy for inflammatory skin disease. The objective of this study is to
      determine whether Epiceram is a safe and effective therapy for mild to moderate atopic
      dermatitis and whether it may serve as an alternative to Elidel therapy.
    

Intervention name(s): Elidel(R) (pimecrolimus 1%); EpiCeram(R) -ceramide based barrier repair cream
Intervention type(s): Drug; Device
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; eczema; dermatitis; skin barrier; barrier repair; ceramide; physiologic lipid; pruritus; Elidel; Epiceram; topical steroid
Enhancing PrEP in Community Settings (EPIC)
Condition: HIV
Study type: Interventional

Summary: 
      To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for
      pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men
      (MSM).
    


Intervention name(s): Prepmate
Intervention type(s): Behavioral
Intervention description(s): A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adherence; prevention
Healthy Eating Education for Latinos
Condition: Diet, Healthy; Diet Habit; Obesity; Blood Pressure; Psychological
Study type: Interventional

Summary: 
      This intervention aims to evaluate the efficacy of a pilot educational intervention with
      deep-structure cultural tailoring for Latino ethnic groups on diet quality compared to
      general, surface-level healthy-eating messages.
    


Intervention name(s): Culturally tailored healthy eating advice; Standard healthy eating advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Culturally-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.; Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy
Condition: Menopausal Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO)
      transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein
      (CRP), and cardiovascular risk factors in postmenopausal women.
    

Detailed description: 
      In this open label study, 27 postmenopausal women, with no clinical evidence of
      cardiovascular disease, were randomly divided in two groups.

      During 12 weeks,

      15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5
      mg/day + progesterone 100 mg/day).

      and

      14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day +
      progesterone 100mg/day).

      After 12 weeks of treatment patients were evaluated.

      Baseline and Post-THT measures were determined: Insulin, body mass index, waist
      circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.
    

Intervention name(s): Micronized estradiol + progesterone; Nanoparticulate estradiol + progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.; Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other intervention name(s): Mic Group; NANO Group
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of
      EDP-305 in subjects with primary biliary cholangitis
    


Intervention name(s): EDP-305 1 mg; EDP-305 2.5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two tablets daily for 12 weeks; Two tablets daily for 12 weeks; Two tablets daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PBC; Primary Biliary Cholangitis (PBC)
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and
      positive-controlled, single-site, 4-way crossover study to investigate the effects of single
      therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in
      healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4
      treatment periods with a minimum 5-day washout between treatments. Subjects will receive each
      of the study treatments over the course of the study. Randomized subjects will receive the
      assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each
      treatment period.
    


Intervention name(s): CR845 0.5 mcg/kg IV; CR845 3 mcg/kg IV; Moxifloxacin 400 mg Oral Tablet; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 0.5 mcg/kg IV CR845; 3 mcg/kg IV CR845; 400 mg Oral Moxifloxacin; IV Placebo as a bolus injection
Other intervention name(s): Difelikefalin 0.5 mcg/kg; Difelikefalin 3 mcg/kg; Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Difelikefalin; CR845; QTc; TQT
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
Condition: Polymorphic Light Eruption (PLE)
MeSH terms: Exanthema; Dermatitis, Contact
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is
      effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients
      with a well documented history of the disease. The study also aims to determine whether
      treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.
    

Detailed description: 
      Polymorphic Light Eruption (PLE) is a prevalent photosensitivity disorder, occurring in up to
      20% of the European and US populations and up to 5% of the Australian population. The disease
      is characterised by a rash that is intensely itchy with blisters, bumps and patches
      presenting on areas of the skin that have been exposed to the sun. There is a lack of
      effective treatment available for the condition but the most common available forms of
      therapy include sun avoidance and the use of the use of steroids and/or phototherapy.
    

Intervention name(s): Afamelanotide (CUV1647)
Intervention type(s): Drug
Intervention description(s): 16mg implant
Intervention MeSH terms: Afamelanotide
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate/severe polymorphic light eruption (PLE)
      
Keywords: Polymorphic Light Eruption (PLE); Afamelanotide; CUV1647; photoprotection; sun poisoning
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a treatment with 4 cycles anthracycline +
      cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than
      therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
    


Intervention name(s): Cyclophosphamide, Epirubicin, Paclitaxel; Epirubicin, Paclitaxel, Filgrastim
Intervention type(s): Drug; Drug
Intervention description(s): 4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d; cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer with 1-3 afflicted axillary lymph nodes
Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes
Condition: Dyslipidemia/Glucose Metabolism Disorder
MeSH terms: Dyslipidemias; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective was to assess the effect of 3-month treatment of low and standard doses
      of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels
      in patients with type 2 diabetes and dyslipidemia.
    


Intervention name(s): fenofibrate and metformin combination (drug)
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
The Effects of Core Stability Training in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to assess effects of core stability training on functional
      ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic
      stroke patients.
    

Detailed description: 
      After being informed about the study all the patients giving written informed consent were
      assessed. At the beginning the eligible patients were randomized into two groups: core
      stability and conventional therapy group. The therapy programs were performed 5 times a week
      for 45 min over a period of 3 weeks. Patients were assessed twice: before and after
      treatment.
    

Intervention name(s): Core stability training; Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): The core stability training were performed 5 days a week for 15 min over a period of 3 weeks. The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks. Duration of each session was 45 min.; The conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks. Duration of each session was 45 min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Prediction of Pain After Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Despite improvements in treatment, a significant part of patients have severe pain following
      knee arthroplasty. Preoperative identification of high-risk patients would allow for an
      intensive individualized analgesic treatment pre- and postoperatively and thus potentially in
      reduced pain acute and chronically.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with knee osteoarthritis referred for total knee arthroplasty.