bioihbjkbjnl/mcl2 huggingface dataset:
Oral Peanut Immunotherapy for Peanut Allergic Patients
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize
      peanut allergic patients to peanuts in order prevent peanut allergic reactions.
    

Detailed description: 
      The goal of this proposal is to develop peanut OIT for patients with peanut allergic
      reactions. This approach is designed to utilize our extensive knowledge of the allergens
      involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower
      the risk of anaphylactic reactions and would down regulate peanut-specific T cells in
      peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT)
      have been unsuccessful primarily because of the side effects of therapy.
    

Intervention name(s): Peanut protein
Intervention type(s): Drug
Intervention description(s): Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.
Other intervention name(s): Peanut OIT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut allergy
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blind, placebo-controlled, multi-center study of the
      safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal
      women.
    


Intervention name(s): testosterone gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): once daily transdermal gel, 300 mcg; once daily transdermal placebo gel
Other intervention name(s): LibiGel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: testosterone; hypoactive sexual desire disorder; menopause
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and
      in clinical research requires several aspects to be taken into account, in particular the
      impact of disease activity on quality of life. To date, the effect of systemic lupus on
      quality of life has only been described using generic questionnaires. Among the specific
      questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows
      interesting psychometric properties. The determinants of quality of life specifically related
      to the disease are still unknown and could be studied using a longitudinal cohort thanks to
      the French version of the LupusQol.
    


Intervention name(s): Questionnaire about quality of life and satisfaction
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Post Isometric Relaxation and Mulligan Bent Leg Raise on Hamstring Tightness in High School Students
Condition: Hamstring Injury; Hamstring Tendon Injury
MeSH terms: Wounds and Injuries; Tendon Injuries
Study type: Interventional

Summary: 
      This project was a Randomized clinical trial conducted COMPARATIVE STUDY OF POST ISOMETRIC
      RELAXATION AND MULLIGAN BENT LEG RAISE ON HAMSTRING TIGHTNESS IN HIGH SCHOOL STUDENTS
    

Detailed description: 
      Non Probability Convenient sampling was done. Patients following eligibility criteria from
      high schools located in vicinity of Jhang district were considered. Sample size was
      calculated with Epitool calculator. 28 Participants were randomly allocated in two groups
      equally via convenient sampling method. Baseline assessment was done initially. Group A was
      given post isometric relaxation and Group B was given mulligan bent leg raise Duration of
      research was almost 6 months. All 28 involved subjects were given 12 treatment sessions over
      a six-week period, which consisted of 02 treatment sessions per week . Then tightness of
      hamstrings was assessed by AKET, SLR and FTF test. The baseline outcome measures consisted of
      pain assessment using Numeric rating scale (NPRS), knee joint goniometry in active knee
      extension test (AKET) and straight leg raise (SLR), modified finger to floor test (FTF) to
      assess the flexibility of hamstring muscles. . All participants were provided written
      informed consent prior to commencement of the procedures. Data was analyzed by using SPSS
      version 23.
    

Intervention name(s): post isometric relaxation and muligan bent leg raise; muligan bent leg raise
Intervention type(s): Other; Other
Intervention description(s): 6 week intervention; muligan bent leg raise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Observational

Summary: 
      The primary objective for this non-interventional study was to assess the quality of life of
      melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world
      setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L
      questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib
      and trametinib in clinical practice and to evaluate clinical outcomes in patients that
      started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to
      explore if treatment discontinuation affects clinical outcomes in real-world practice.
    

Detailed description: 
      The prospective registration of completely resected high-risk stage III melanoma patients
      treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on
      collaboration with 8 centers of excellence on melanoma patients treatment, according to their
      expertise and experience.

      Patients were recruited from participating centers in the routine setting. This was done only
      if the decision about starting treatment with dabrafenib and trametinib had already been
      made. All patients that complied with the inclusion criteria and that started treatment with
      dabrafenib+ trametinib during the recruitment period were considered to participate in the
      study, at investigator discretion.

      Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after
      treatment initiation in a quarterly base, according to clinical practice, including the first
      visit after treatment completion.
    

Intervention name(s): dabrafenib + trametinib
Intervention type(s): Drug
Intervention description(s): There was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled.
Intervention MeSH terms: Trametinib; Dabrafenib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were recruited from participating centers in the routine setting. This was done
        only if the decision about starting treatment with darbafenib and trametinib has already
        been made. All patients that complied with the inclusion criteria and that start treatment
        with dabrafenib+ trametinib in the participating centers were considered to participate in
        the study, at investigator discretion.
      
Keywords: Malignant melanoma; Tafinlar; Mekinist; dabrafenib; trametinib; FACT-M questionnaire; generic EQ-5D-3L questionnaire; adjuvant
Chronic Study on Body Composition, Training, Performance, and Recovery
Condition: Damage Muscle; Body Weight Changes; Performance Enhancing Product Use
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The chronic phase of the study will evaluate the effects of pre-exercise and post-exercise
      ingestion of a multi-ingredient supplement on adaptations to a 6-week exercise program
      consisting of both resistance training and high intensity aerobic exercise, using a
      randomized, double-blind, placebo-controlled design. Participants will complete an
      enrollment/familiarization visit, a baseline testing session, followed by a 6-week supervised
      exercise intervention, and post-testing session identical to baseline testing. Participants
      will be randomized during the baseline session to groups receiving either 1) Active Treatment
      (pre-post supplementation), 2) placebo (noncaloric beverage), or 3) control, not
      participating in exercise or consuming a treatment. During the supervised 6-week resistance
      training program, participants will complete a moderate-intensity warm-up, a full-body
      resistance training workout (2 x per week) and an interval training session (1 x per week).
      Thirty-minutes prior to each training session, and within 15 minutes post-exercise,
      participants will consume their randomly assigned treatment beverage. Body composition, blood
      markers of muscle damage/recovery, strength, and performance tests will be measured before
      (baseline) and after training (Post) to evaluate the effects of supplementation. All data
      collection will be conducted by the Principal Investigator and Research Assistants. All
      subjects will report to the Applied Physiology Laboratory and Human Performance Center in
      Fetzer Hall for all testing and training sessions, which will span approximately 8 weeks.
    


Intervention name(s): Pre-workout plus and Protein recovery plus; Placebo; 6-week resistance training program
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): products consumed prior and after exercise; placebo product consumed prior and after exercise; participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Procellera and Negative Pressure Therapy for Acute Wounds
Condition: Wound
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Procellera speeds wound healing. The study will
      examine colonization (bacterial growth), pain and pain medication and reduced cost of care by
      using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound
      after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs
      that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is
      placed in your wound to help heal the wound faster.
    

Detailed description: 
      The study will consent 30 patients undergoing surgery through the abdominal wall and the skin
      incision will intentionally be left open. Subjects will be randomized using a random number
      generator. Each number will be placed in an envelope numbered 1-30. Arm 1 will be even
      numbers and Arm 2 will be odd numbers. A researcher not affiliated with the study will
      generate the numbers and place them in the envelopes. Arm 1 will place fifteen subjects on
      Negative Pressure Therapy Only and Arm 2 will place fifteen subjects on Negative Pressure and
      Procellera. Arm 1 (Negative Pressure Only) will have their dressing changed 3 times per week
      which is the standard of care for Negative Pressure Therapy. Arm 2 (Negative Pressure Therapy
      and Procellera) will have their dressing changed every 5 days. Arm 1 and 2 will have a tissue
      specimen taken on the 5th day only. The tissue will be taken from debrided material and sent
      for culture. The Negative Pressure Therapy Sponge, which is discarded after each dressing
      change, will be collected, lavaged with saline and the cells will be examined for macrophage
      function and the wound fluid will be tested for inflammation response. Photographs, wound
      measurements, pain scale and pain medication will also be completed at each dressing change.
      We will check the progress of the wound along with your surgeon during the subject's 30 day
      surgical follow up in the surgeon's office. The wound will be measured (if not healed),
      photograph's taken and their pain level assessed.
    

Intervention name(s): Procellera; negative pressure therapy
Intervention type(s): Device; Device
Intervention description(s): bioelectric wound dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: procellera
A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg
      tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz
      Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under
      fasting conditions.
    


Intervention name(s): Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.; Univasc® 15mg Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moexipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Flapless Approach in Periodontal Regeneration
Condition: Periodontitis, Adult; Intrabony Periodontal Defect
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The present investigation is designed in order to compare the radiographic and clinical
      effectiveness of flapless procedure performed alone or in combination with enamel matrix
      derivatives in the periodontal regenerative treatment of deep intrabony defects in patients
      with moderate or severe periodontitis. The study will have a follow-up of 12 months.
    


Intervention name(s): Flapless with Enamel Matrix Derivatives (EMD); Flapless without Enamel Matrix Derivatives (EMD)
Intervention type(s): Procedure; Procedure
Intervention description(s): Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.; Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Smart Phone for Stroke Upper Limb Motor Function Training
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke rehabilitation for stroke patients can enhance the upper and lower limb function,
      daily of daily activity improvement, and be beneficial to the family members' quality of
      life. Literature studies have supported the use of tele-rehabilitation to be as effective as
      stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to
      practice the mobile health model. Nevertheless, effects of tele-rehabilitation analysis for
      the proximal recovery of the stroke upper limbs still need to be explored. The main purpose
      of this research is to develop a smart phone with app system for stroke upper limb motor
      training, and further analyze its feasibility and treatment effects. The investigators
      randomly assigned chronic home stroke cases to the experimental group (n=20) and control
      group (n=20), each group received 8 weeks of treatment.
    

Detailed description: 
      Stroke rehabilitation (including occupational therapy and physical therapy) for stroke
      patients can enhance the upper and lower limb function, daily of daily activity improvement,
      and be beneficial to the family members' quality of life. Literature studies have supported
      the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke
      tele-rehabilitation model can use smartphones and apps to practice the mobile health model.
      This technology with remote rehabilitation have the important characteristics, including ease
      of use, high-intensity, repetitive exercises, and providing feedback information, to
      facilitate the recovery of training functions. Nevertheless, effects of tele-rehabilitation
      analysis for the proximal recovery of the stroke upper limbs still need to be explored. The
      main purpose of this research is to develop a smart phone with app system for stroke upper
      limb motor training, and further analyze its feasibility and treatment effects. The
      investigators randomly assigned chronic home stroke cases to the experimental group (n=20)
      and control group (n=20), each group received 8 weeks of treatment.
    

Intervention name(s): smart phone App rehabilitation; conventional rehabilitation
Intervention type(s): Other; Other
Intervention description(s): stroke subjects use smart phone to complete therapeutic tasks 5 min/session total 8 sessions/day with affected arm or bilateral arm movement for 6 weeks; stroke subjects receive conventional rehabilitation home program for 6 weeks(30min/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Gut Microbiome in Women With Polycystic Ovary Syndrome
Condition: PCOS; Obesity; Metabolic Syndrome
MeSH terms: Polycystic Ovary Syndrome; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Testing two different strategies for weight loss intervention and revealing possible changes
      in composition of gut microbiota, in order to provide more insight in the effect of dietary
      changes and weight loss treatments on gut microbiome in overweight and obese women with
      polycystic ovary syndrome (PCOS). The two strategies are:

        -  dietary advice plus myo-inositol and folic acid

        -  dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist
           Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in
           clinical features associated with PCOS and metabolic syndrome, longitudinal changes in
           gut microbiome with interventions.

      Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of
      treatment.
    


Intervention name(s): dietary advice plus myo-inositol and folic acid; dietary advice plus Liraglutide Pen Injector
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): dietary advice and lifestyle interventions and myo-inositol; dietary advice and lifestyle interventions and liraglutide pen injector
Intervention MeSH terms: Folic Acid; Inositol; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Almond Intervention in Type 2 Diabetes Mellitus
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This prospective cohort study of an almond-enriched diet (within the overall context of Asian
      Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM
      almond-enriched balanced diet improves glycemic measures and CVD risk factors.
    


Intervention name(s): almond
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention