bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Chronic tinnitus affects about 10-15% of the population in industrialized countries.
      Investigations of the brain activity by using electroencephalography (EEG) showed that in
      localized regions of the hearing system brain activity was decreased. This reduction of
      activity is thought to be one of the reasons that keep the perception of the tinnitus going.
      Recent studies have shown that neurofeedback is a viable option for treatment of chronic
      tinnitus. By using neurofeedback it is possible to train brain functions by the simple
      principle of rewarding wanted changes and punishing unwanted ones. The purpose of the
      investigators study is to show the efficacy of specific localized neurofeedback training in
      comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus
      symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned.
      Before and up to 6 month after the training EEG-recordings are performed.
    


Intervention name(s): Tomographic Neurofeedback; Non Tomographic Neurofeedback
Intervention type(s): Device; Device
Intervention description(s): EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex and deliver feedback for the patient; EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adult; Aged; Alpha Rhythm; Auditory Cortex; Chronic; Electroencephalography; Female; Humans; Male; Neurofeedback; Prospective Studies; Questionnaires; Tinnitus; Treatment Outcome
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Condition: Cold Hypersensitivity
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on
      Korean Patients With Cold Hypersensitivity in the Hands
    


Intervention name(s): Ojeok-San; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other intervention name(s): OJS; corn starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cold Hypersensitivity; Korean medicine; Ojeok-san; Cold intolerance
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis
      Suppurativa (HS) participants in normal medical practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the
        treating investigator as per approved label in Korea will be enrolled.
      
Keywords: Adalimumab; Safety; Hidradenitis Suppurativa; Korean participants
The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus
Condition: Insulin Resistance and Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus
      (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only
      bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long
      term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who
      undergo GBP experience normalization of their blood glucose and are able to discontinue their
      anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen
      in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies
      suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part
      result from excluding the duodenum from the flow of nutrients. With the use of enteral
      feeding tubes, we hope to better understand the factors in the human gut that may predispose
      obese individuals to the development of insulin resistance and T2DM.
    


Intervention name(s): Placement of nasogastric feeding tube; Nasojejunal feeding tube
Intervention type(s): Procedure; Procedure
Intervention description(s): Glucose tolerance test via nasogastric feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3; Glucose tolerance test via nasojejunal feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Condition: Peritoneal Carcinomatosis
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma; Peritoneal Neoplasms; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed
      with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical
      surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues
      (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia
      intraperitoneal intraoperative chemotherapy with paclitaxel
    


Intervention name(s): Paclitaxel; Radical surgery-peritonectomy
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ovarian cancer
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of Dr.
      Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)

      1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.
    

Detailed description: 
      Detailed Description : The study was conducted as an open-label, randomized, single-dose,
      2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers
      and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each
      period, subjects were housed from the evening before dosing until after the 36-hour blood
      draw. Single oral 3 mg doses were separated by a washout period of 7 days.
    

Intervention name(s): Finasteride
Intervention type(s): Drug
Intervention description(s): Finasteride tablets 1 mg
Other intervention name(s): Propecia
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence,Finasteride,Crossover
Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The
      required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the
      hospital will enroll 10 to 40 consecutive patients, depending on case availability on the
      date conducting the survey, with dyslipidemia and classified as high risk as defined by the
      protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.

      For the second phase, each subject will be followed for survival status at 36 months after
      enrollment. Such follow-up will be done by searching the Thai National Vital Event
      Registration Database using subjects' Population Identification Number. All activities
      regarding case selection and data collection will be done by well trained clinical research
      associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating
      Center (SCC) for this project is based and are independent of the investigator. Random
      auditing visits will also be performed by auditors independent of the SCC. These are to
      ensure not only high quality data but also protecting right and well being of subjects.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at
        least 3 months
      
Keywords: Lipid-lowering
Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The study is aimed to assess the efficacy of two dietary supplements composed of a Wheat
      Polar Lipid Complex (WPLC) in reducing skin aging signs, in particular in improving
      firmness/elasticity, skin moisturization and skin surface properties.
    

Detailed description: 
      A double blind, parallel groups, placebo-controlled study is carried out on 72 healthy female
      subjects aged between 30 and 60 years old showing slight-moderate clinical signs of skin
      aging over the face. The study foresees 56 days of products intake. Evaluations of the
      parameters under study are performed at baseline, after 14, 28 and 56 days of products
      consumption. Moreover post-treatment evaluations are performed 56 days after the end of
      product intake.
    

Intervention name(s): Wheat Polar Lipid Complex Oil; Wheat Polar Lipid Complex Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The study foresees the intake of 2 capsules per day during 84 days; The study foresees the intake of 2 capsules per day during 84 days; The study foresees the intake of 2 capsules per day during 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Better Pediatric Asthma Outcomes Through Chronic Care
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a
      chronic care model to the care of poor, minority, inner-city children with asthma, at risk of
      the worst outcomes for the leading chronic disease of children.

      The specific aims are to:

        1. Develop a computer support system to deliver peer-driven, patient-linked Guideline
           prompts at the point of care using affordable information technology;

        2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom
           control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and

        3. Evaluate the added effect on outcomes of family-focused, supportive education delivered
           by a community health worker.

      The key product of the computer support system is a guideline prompt that serves as the
      mechanism for integrating patient specific data with standards of care. 548 children, ages
      5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in
      CT, and receiving care at one of four Federally Qualified Community Health Centers will be
      recruited. All sites will have access to the computer support system and the to-be-developed,
      Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of
      prompts delivered at the point of care on patient outcomes will be compared to the effect of
      no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education
      will be assessed in combination with prompted care compared to no-prompt care and compared to
      no education. All patients will receive standard screening and outreach to keep appointments.
      Data will be obtained from medical records, medical and pharmacy claims data as well as
      patient and parent interviews at baseline and quarterly for 18 months.
    


Intervention name(s): electronic (computer based) provider feedback tool
Intervention type(s): Behavioral
Intervention description(s): All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
Other intervention name(s): UCAN Control Asthma Program; Medication Assessment Prompt (MAP)
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: pediatric; asthma; translational research; health information technology
A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the safety and effectiveness of three doses of
      asoprisnil, compared to placebo, in the treatment of women with endometriosis.
    

Detailed description: 
      Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive,
      estrogen-dependent disease that occurs in menstruating women of reproductive age. Although
      all major endometriosis therapies are effective for the treatment of pain, no single
      treatment is superior to others in terms of efficacy. The major drawbacks of the current
      medical therapies are severe side effects such as hot flushes and osteoporosis. The objective
      of this study is to determine the safety and efficacy of asoprisnil 5, 10, and 25 mg tablets,
      compared to placebo, administered daily for 12 weeks to women with endometriosis, by
      assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea,
      dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens
      the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed
      endometriosis will be enrolled.
    

Intervention name(s): Asoprisnil; Asoprisnil; Asoprisnil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5mg Tablet, oral Daily for 12 weeks; 10 mg Tablet, oral Daily for 12 weeks; 25 mg Tablet, oral Daily for 12 weeks; Tablet, oral Daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic pain; Dysmenorrhea; Dyspareunia; Infertility; Asoprisnil
Re-feeding Gastric Residuals in Preterm Infants
Condition: Premature; Infant, Light-for-dates
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether re-feeding of gastric residuals reduces the
      time needed to establish full enteral feedings in premature infants. Infants with gestational
      ages 23-28 weeks at birth will be randomized within one week to receive either gastric
      residuals or fresh formula or breastmilk whenever significant residuals during feeding
      advancement require clinical assessment for continuing feedings. Primary outcome measure is
      time to establish full enteral feedings (120cc/kg/day).
    

Detailed description: 
      Infants with gestational ages 23-28 weeks at birth will be randomized within one week to
      receive either gastric residuals or fresh formula or breastmilk whenever significant
      residuals during feeding advancement require clinical assessment for continuing feedings.
      Feeding advancement determined by clinical physicians.
    

Intervention name(s): Re-feeding residuals; Fresh Feeding Breastmilk or Formula only
Intervention type(s): Procedure; Procedure
Intervention description(s): In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.; In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: premature infant; feeding; residuals; fresh feeds; full feeds; digestive system
Procalcitonin in Pleural Pleuritis
Condition: Pleuritis; Pleural Empyema
MeSH terms: Empyema; Empyema, Pleural; Pleurisy
Study type: Observational

Summary: 
      The purpose of this study is to determine pleural level of procalcitonin in differents
      situations of pleuritis.
    

Detailed description: 
      Determine pleural level of procalcitonin in pleuritis. Two periods First period evaluation in
      vitro study/ Determine adequat technique included type of samples tubes for adequat analysis.

      Second periods : Patient with pleuritis . Empyema or not
    

Intervention name(s): pleural level of procalcitonin
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with pleuritis
      
Keywords: pleuritis; empyema; procalcitonin
Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test different types of exercise training for people with
      multiple sclerosis (MS). The exercise program is based on physical activity guidelines that
      have been developed specifically for people with MS. The investigators believe these
      guidelines will be effective for improving physical fitness and function in persons with
      mild-to-moderate MS.
    

Detailed description: 
      Most adults with multiple sclerosis (MS) are physically inactive. One approach to address
      physical inactivity in this population has involved the provision of physical activity
      guidelines. Such physical activity guidelines are an important tool for exercise
      prescription, promotion, and monitoring, and recommend that people with MS "participate in at
      least 30 minutes of moderate intensity aerobic activity 2 times per week and strength
      training exercises for major muscle groups 2 times per week." The guidelines were developed
      from a systematic literature review and have yet to be tested for efficacy in improving
      fitness or other outcomes. This study will test that efficacy of aerobic and resistance
      training alone and in combination (based on the MS physical activity guidelines) for
      improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in
      persons with MS who have mild-to-moderate disability. Such an examination will be important
      to confirm the efficacy of the exercise prescription for people with MS and health-care
      providers. The investigators will further perform an exploratory analysis of blood biomarkers
      and eye imaging parameters to examine some of the mechanisms of exercise training effects in
      persons with MS.
    

Intervention name(s): Resistance exercise; Stretching exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups; The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: multiple sclerosis; exercise; home-based; training; fitness