bioihbjkbjnl/mcl2 huggingface dataset:
Validation of a Test System for Development of Medications for Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      Using theTEMA (test system for development of medications for alcoholism) it can be shown,
      that naltrexone administration reduces the willingness to perform work for alcohol infusion
      in a laboratory experiment.
    

Detailed description: 
      Objective of this study is to show that a laboratory alcohol self-administration method can
      predict the therapeutic potential of new compounds to reduce relapse in alcohol-dependent
      patients.

      The 'TEMA" translates several animal behavioral paradigms of alcohol self-administration into
      corresponding human experiments.

      We will investigate the opiate antagonist Naltrexone, whose anti-relapse effect is well
      documented, as a reference drug for validation.

      Main objective:

      With TEMA (test system for development of medications for alcoholism ) it can be shown, that
      naltrexone administration reduces the willingness to perform work for alcohol infusion in a
      laboratory experiment.

      Secondary objectives:

        -  administration of naltrexone in comparison to placebo leads to a reduction of alcohol
           craving and real-life drinking

        -  administration of naltrexone in comparison to placebo leads to reduction of the
           CDT-Level

        -  administration of naltrexone in comparison to placebo leads to a change in perception of
           subjective alcohol effects

        -  the effectiveness of naltrexone can be predicted by the A118G polymorphism of the OPRM1

        -  administration of naltrexone changes the baseline and alcohol-induced ability of motor
           inhibition

        -  administration of naltrexone changes the baseline and alcohol-induced regional cerebral
           perfusion

        -  administration of naltrexone changes the baseline and alcohol-induced cerebral resting
           state activity

        -  changes of alcohol effects to the brain activity induced by naltrexone in comparison to
           placebo correlate with effects of naltrexone on the willingness to work for alcohol
           self-administration
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule
Other intervention name(s): Adepend
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Alcoholism; alcohol self-administration
Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults
Condition: Digestive Health
Study type: Interventional

Summary: 
      This is a randomized crossover intervention designed to evaluate effects of daily intake of
      beverages containing orange or apple Pomace on gastrointestinal function as measured by stool
      frequency. Additional outcomes will include aspects of digestive health and self-reported GI
      symptoms and dietary intake as well as analysis of gut microbiota.
    


Intervention name(s): Orange juice + Orange Pomace; Orange Juice; Apple Juice and Apple Pomace; Apple Juice
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 16 oz. orange juice + orange Pomace per day for 4 weeks; 16 oz. orange juice per day for 4 weeks; 16 oz. apple juice and apple Pomace per day for 4 weeks; 16 oz. apple juice per day for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance
Condition: Postprandial Hyperglycemia
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional

Summary: 
      Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and
      insulin responses and hence promote well-being. It has previously been observed that
      consumption of a bilberry drink decreases the postprandial insulin demand. In the present
      study, the impact of probiotic fruit beverages with different polyphenol profiles on the
      postprandial levels of glucose and insulin, were investigated.
    


Intervention name(s): Bilberry; Blackcurrant; Mango; Beetroot; Rose hip; Glucose drink
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Fruit beverage with bilberry and fermented oatmeal; Fruit beverage with blackcurrant and fermented oatmeal; Fruit beverage with mango and fermented oatmeal; Fruit beverage with beetroot and fermented oatmeal; Fruit beverage with rose hip and fermented oatmeal; A reference glucose drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss
Condition: Female Pattern Hair Loss; Androgenetic Alopecia (AGA); Ludwig Type 1; Ludwig Type 2
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Pantovigar - a high effective product designed primarily for the treatment of diffuse hair
      loss in women as well as for the treatment of damaged hair, in the combined therapy can be
      successfully applied in other types of alopecia.

      The purpose of this study is to evaluate efficacy and tolerability of combination therapy
      Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined
      treatment Pantovigar plus 2% Minoxidil course therapy.
    


Intervention name(s): Pantovigar; Minoxidil 2% only
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.; 1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity
Condition: Disorders, Temporomandibular Joint; Range of Motion, Articular
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established.
      Pre-intervention measurements and intermediate and end-of-treatment measurements are taken.
      Range of movement, algometry and muscle balance are assessed.
    


Intervention name(s): Physiotherapy treatment
Intervention type(s): Other
Intervention description(s): A treatment plan is carried out which aims to improve pain, muscle balance and range of motion of the temporomandibular joint.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: range of motion, articular; disorders, temporomandibular joint
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Condition: Diabetes; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether individuals with diabetic peripheral
      neuropathy can learn to change the way they walk in order to reduce the pressures underneath
      the feet, which may lead to a reduced risk of foot ulceration.
    

Detailed description: 
      This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak
      plantar pressure in individuals who are susceptible to plantar ulcerations. It has not,
      however, been studied whether these changes would be maintained long-term or if they had any
      effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback
      necessary to elicit the desired motor pattern was discussed. It has been suggested that
      proprioception plays an integral role in the use of feedback to develop error-detection
      mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic
      peripheral neuropathy subject population, proprioception and kinesthesia may be compromised.
      This may have effects on the ability of this population to maintain changes in inappropriate
      movement patterns. A significant portion of patients continue to develop plantar ulcers even
      with prescriptive footwear compliance, so gait training to change inappropriate patterns
      which result in the high plantar pressures may be critical to prevent ulceration.

      Comparisons: Two groups of subjects will receive gait training, one group will receive
      feedback of performance while the other will only receive training, and one control group.
      Comparisons will include whether plantar pressures are decreased in the training groups, and
      if those changes are maintained long-term.
    

Intervention name(s): Gait Training with Feedback; Gait Training with no feedback
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Peripheral Neuropathy; Walking
Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.
    

Detailed description: 
      Evaluation of safety and pharmacokinetics
    

Intervention name(s): PF-04802540; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data; Placebo capsules q12 hours for 10 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: PF-04802540 multiple dose safety study
School Based Malaria Control in Ugandan Schoolchildren
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that schoolchildren treated with IPT using DP over one year of
      follow-up will have a different risk of clinical malaria compared to those treated with
      placebo.
    


Intervention name(s): Four monthly IPT with dihydroartemisinin Piperaquine (DP); Monthly IPT using DP; Placebo given every month
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given every 4 months (once a school term); Given every month; No active ingredient
Other intervention name(s): Duocortexin; Duocortexin; Placebo
Intervention MeSH terms: Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      Assess the antibody response to influenza vaccine in patients with relapsing form of multiple
      sclerosis (RMS) treated with teriflunomide compared to a reference population.

      Secondary Objectives:

        -  Assess the effect of teriflunomide on immunoglobulin levels;

        -  Assess the safety of influenza vaccination in patients with RMS treated with
           teriflunomide.

      The reference population was defined as multiple sclerosis (MS) patients with a stable
      treatment with interferon-β-1. Antibody response was measured using hemagglutination
      inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1,
      and B as present in the influenza vaccine used.
    

Detailed description: 
      The maximum duration of the study period for a participant was approximatively 49 days broken
      down as follows:

        -  Screening period of up to 21 days;

        -  Influenza vaccination at Day 1;

        -  Follow-up period of 28 days (±2 days).

      MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the
      study.
    

Intervention name(s): teriflunomide; Interferon-β-1; Influenza vaccine
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Film-coated tablet
Oral administration; Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection; Inactivated, split-virion influenza vaccine 2011-2012
One administration by intramuscular or intradermal route as per product specification
Other intervention name(s): HMR1726; Rebif®; Avonex®; Betaseron®; Betaferon®; Extavia®; Genfaxone®
Intervention MeSH terms: Interferons; Interferon-beta; Teriflunomide; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Healthy Living in Pregnancy
Condition: Lifestyle; Weight Gain; Pregnancy
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal
      state of Germany, targeting maternal and fetal health. The objective of this trial is to
      evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity
      and weight monitoring during pregnancy. The intervention comprises 4 individual counseling
      sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary
      outcomes are pregnancy and obstetric complications like gestational diabetes and rate of
      caesarean sections as well as offspring health.

      The lifestyle intervention program is adapted to the German health care system to allow an
      immediate implementation after successful evaluation.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention program consists of four individual counseling modules focusing on diet, physical activity and weight monitoring (12th-16th, 16th-20th, 30th-34th week of gestation and 6th-8th week postpartum). The counseling sessions are given by carefully trained midwives or medical staff in combination with prenatal visits and follow a standardized curriculum. Women are provided with brochures including a list of adequate prenatal exercise programs and a pedometer. Furthermore, they receive a chart personalized according to their baseline BMI category to monitor weight development.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Quest Sound Recover (SR2) vs. Venture SR2
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Goal of this study is to determine the benefit of an improved feature on a new hearing aid
      platform.

      To investigate the improvements of this feature is compared on a new and older hearing aid
      platform. The obtained results will be used for future improvement for this feature. This
      feature should improve the speech understanding and speech recognition of the hearing aid
      user.
    


Intervention name(s): hearing aid
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effect of Dried Fruit on Cardiometabolic Risk Factors
Condition: Cardiovascular Diseases; Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      This is a 2-period randomized crossover study with free-living subjects on self-selected
      diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried
      plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack
      food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who
      are representative of the U.S. population and at risk for cardiovascular disease
      (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).

      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood
      pressure and LDL-cholesterol, and improve artery function (assessed by standard blood
      pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial
      stiffness) compared to the control group and baseline.
    


Intervention name(s): Dried Fruit; High Carbohydrate Snack
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.; Calorie-matched carbohydrate-rich snack.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Aerobic Interval Training in Cardiac Rehabilitation
Condition: Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of the study is to compare home-based aerobic interval training with supervised
      interval training performed in groups or on a treadmill at the hospital.
    

Detailed description: 
      Cardiac rehabilitation is usually first offered in hospitals, but there are several studies
      that show that home-based rehabilitation is equally efficient. How this comes out when
      exercise is organized as aerobic interval training is not known.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation outcome; cardiac patients; exercise intensity
A Photodynamic Therapy for Treatment of Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of photodynamic therapy with
      5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.
    

Detailed description: 
      This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid
      and intense pulsed light vs. absence of treatment for actinic keratoses
    

Intervention name(s): Photodynamic therapy
Intervention type(s): Procedure
Intervention description(s): Photodynamic therapy applied to actinic keratoses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Nxstan: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the
      Colville reservation through a community-based, culturally informed intervention, the study
      specifically aims to: 1. conduct focus groups and interviews with adult members of Colville
      tribe to inform the adaptation, manualization and implementation of a culturally informed
      diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness
      of a community-based, culturally informed diabetes prevention intervention by assessing
      between group changes.
    

Detailed description: 
      To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the
      Colville reservation through a community-based, culturally informed intervention, the study
      specifically aims to: 1. conduct focus groups and interviews with adult members of Colville
      tribe to inform the adaptation, manualization and implementation of a culturally informed
      diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness
      of a community-based, culturally informed diabetes prevention intervention by assessing
      between group changes in: Primary Outcomes: weight, dietary fat and caloric intake, vegetable
      consumption, and physical activity; Secondary Outcomes: physical fitness, blood pressure,
      lipids, self-reported quality of life; and, 3. evaluate the sustainability of the diabetes
      prevention intervention by assessing participant perceptions of program component fit through
      focus group discussions with participants in the intervention and telephone interviews with
      those who left the program.
    

Intervention name(s): Diabetes Prevention Program
Intervention type(s): Behavioral
Intervention description(s): Culturally adapted diabetes prevention program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
Condition: Mucositis; Gingivitis
MeSH terms: Gingivitis; Mucositis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a
      chemical adjuvant for the treatment of peri-implant mucositis in single implants compared
      with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month
      follow-up.
    

Detailed description: 
      The following clinical parameters were evaluated in both test and control groups; visible
      plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and
      ISG) and for each implant and teeth (VPI implant; VPI teeth; GBI implant; GBI teeth). For
      statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and
      implants were calculated. These parameters were evaluated at baseline and at one, three and
      six months post-therapy.

      Probing depth (PD implant; PD teeth) and bleeding on probing (BOP implant; BOP teeth) were
      collected for all implants and teeth with a North Carolina periodontal probe at six sites.
      After data collection, an arithmetic averages of the sites with bleeding on probing and
      probing depths were calculated at baseline, three and six months. The peri-implant and
      periodontal biotype for each implant and teeth was rated as thin or thick, according to probe
      transparency during probing depth.
    

Intervention name(s): Chlorhexidine gluconate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
Other intervention name(s): Chlorhexidine; placebo solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental Implantation; Chlorhexidine gluconate