bioihbjkbjnl/mcl2 huggingface dataset:
Premenstrual Syndrome and Interpersonal Counseling
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      This study aims to test the effectiveness of interpersonal counseling in PMS symptom
      management in university students experiencing PMS symptoms.
    

Detailed description: 
      People diagnosed with Premestrual Syndrome were identified through an online questionnaire.
      80 people who were identified and accepted to study were divided into two groups as
      experiment and control. Initially, pre-menstrual screening tool, interpersonal relationship
      dimensions scale and perceived stress scale were applied to all groups. Then, 8 sessions of
      interpersonal counseling, each lasting 40 minutes, were applied to the experimental group for
      2 months. Scales were repeated for both groups after the application was completed. Repeated
      measurements were made 3 months later.
    

Intervention name(s): interpersonal counseling
Intervention type(s): Behavioral
Intervention description(s): In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: premenstrual syndrome; interpersonal counseling
Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in
      women with obesity, a possible influence of wheat gluten on food choices, body weight,
      resting metabolism and circulating inflammation markers and adipokines. The volunteers will
      be randomized into two groups, half of them will initiate the experiment by taking 2 placebo
      muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins
      containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th
      experimental weeks will be evaluated body weight, body composition, lipid profile, glucose,
      insulin, leptin, adiponectin, and inflammatory markers.
    

Detailed description: 
      It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be
      kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency
      Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of
      food consumption and daily intake of gluten. The volunteers will be randomized into two
      groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4
      weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of
      gluten/each for 4 weeks (Gluten phase). After that, volunteers will be transferred for the
      other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be
      instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th
      experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be
      submitted to indirect calorimetry, electrical bioimpedance, blood collection and
      anthropometry (weight and height). The volunteers will also respond a questionnaire about
      life habits, family history, previous history, physical activity and food frequency. Blood
      samples will be used to assess blood count, lipid profile, glucose, insulin, leptin,
      adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four
      weeks after the end of the experiment, and return to the alimentary routine, body weight,
      blood sample, calorimetry and bioimpedance will be reassessed.
    

Intervention name(s): gluten phase; placebo phase
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention; 2 cakes without gluten will be consume during the 4 weeks of intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-masked, crossover, randomized, controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: gluten; adipokine; obesity; diet
Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
Condition: Macular Hole Retinal Detachment; Myopic Traction Maculopathy
MeSH terms: Retinal Detachment; Retinal Perforations; Myopia; Macular Degeneration; Dissociative Disorders
Study type: Observational

Summary: 
      The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic
      traction maculopathy who received viterctomy including internal limiting membrane peeling and
      scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal
      reattachment and macular hole closure, the shape of staphyloma determined by optical
      coherence tomography and 3-dimensional magnetic resonance imaging were assessed.
    


Intervention name(s): Vitrectomy with scleral shortening
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who underwent vitrectomy with scleral shortening for macular hole retinal
        detachment or myopic traction maculopathy
      
Keywords: Myopic traction maculopathy
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
Condition: Healthy
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and
      antioxidant status at rest and after exercise, on mitochondrial respiration and calcium
      release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.
    

Detailed description: 
      Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized
      treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile,
      exercice test, end of treatment
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: persons
Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
Condition: Malaria; Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test three candidate malaria vaccines in new combinations to
      assess their efficacy at preventing malaria infection and triggering immune responses against
      malaria.
    

Detailed description: 
      Two of the vaccines ('FP9 ME-TRAP' and 'MVA ME-TRAP') have been designed at the University of
      Oxford. The other vaccine (PEV3A) has been designed jointly between the Swiss Tropical
      Institute and a Swiss company called Pevion Biotech Ltd. These are new vaccines that have
      been given to only a limited number of people before.

      We aim to test these vaccines by:

        -  assessing their ability to prevent malaria infection

        -  determining how good they are at triggering a detectable immune response against malaria

        -  studying their safety further

      Volunteers will be given up to six vaccinations over three months and will then be exposed to
      malaria infection. We do this by allowing mosquitoes infected with malaria to bite them under
      closely regulated conditions and observing if and when they develop blood stage malaria. If
      the vaccines provide some protection from malaria infection then either they will not develop
      malaria after the bites or the time taken to develop malaria will be longer. If not all
      volunteers are protected then we will be able to try and improve our vaccines by comparing
      the immune responses of volunteers who are protected to those not protected.

      The information we get from this study may help to prevent malaria infection and disease in
      those who live in endemic areas and in travellers. The results of this study will be
      published in scientific journals and may be presented at professional meetings.
    

Intervention name(s): PEV3A; FP9 ME-TRAP; MVA ME-TRAP
Intervention type(s): Biological; Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria Vaccine
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a
      single oral dose of fezolinetant under fasted and fed conditions in healthy female
      participants. The study will also evaluate the safety and tolerability of a single oral dose
      of fezolinetant under fasted and fed conditions in healthy female participants.
    

Detailed description: 
      Each participant will participate in 2 treatment periods separated by a washout of at least 5
      days between investigational product (IP) administration in each period. Participants will be
      admitted to the clinical unit on day -1 of period 1 and will be in clinical unit for periods
      1 and 2. On day 1 of each period, participants will receive fezolinetant followed by a
      72-hour blood sampling period. The study will be completed with an end-of-study visit (ESV)
      which will take place 5 to 9 days after the 72-hour blood sampling period in period 2 or at
      the time of early discontinuation from the study.
    

Intervention name(s): Fezolinetant
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ESN364
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics of Fezolinetant; Effect of Food; ESN364
Buteyko Method for Asthmatic Children With Mouth Breathing
Condition: Asthma; Mouth Breathing
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Interventional

Summary: 
      To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of
      asthmatic children with mouth breathing.
    


Intervention name(s): Buteyko Method
Intervention type(s): Other
Intervention description(s): Intervention will be held twice a week during 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; Breathing exercises
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Condition: Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High
MeSH terms: Colorectal Neoplasms; Microsatellite Instability
Study type: Observational

Summary: 
      Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5%
      in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H
      status received palliative chemotherapy have not clear yet. In this study, the investigators
      observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative
      first-line chemotherapy.
    

Detailed description: 
      Colorectal cancer (CRC) is the one of most common cancer in the world. Loss of function of
      DNA mismatch repair (MMR) is an important mechanism of CRC development. Mutation or
      modification of MMR genes result in MMR protein deficient (dMMR) and microsatellite
      instability (MSI). It has been reported that the dMMR or MSI high (MSI-H) phenotype is
      present in approximately 15-18% of CRC patients. Most dMMR/MSI-H tumors are sporadic CRC, and
      only approximately 3% of dMMR/MSI-H tumors are Lynch syndrome (LS) or hereditary nonpolyposis
      colorectal carcinoma (HNPCC).

      The dMMR/MSI-H status was reported to be a predictive marker for adjuvant chemotherapy.
      Multiple retrospective studies showed that dMMR/MSI-H is correlated with a favorable
      prognosis in stage II/III CRC. Previous studies suggested that dMMR/MSI status may be a
      predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-FU) in
      patients with stage II disease, but not in those with stage III disease. For metastatic
      colorectal cancer (mCRC), the relationship of the MMR/MSI phenotype and prognosis is unclear.
      Some researchers found that CRC patients with the dMMR/MSI-H phenotype have a worse
      prognosis. But other researchers thought the dMMR/MSI-H phenotype is no associate to efficacy
      and survival of palliative chemotherapy, even is benefit for efficacy and survival.Therefore,
      the aim of this study was to clarify whether the status of dMMR/MSI-H affected
      progression-free survival (PFS) in mCRC patients who received first-line palliative
      chemotherapy.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The metastatic colorectal patients with different MMR or microsatellite status received
        palliative chemotherapy
      
Keywords: Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High; Chemotherapy
Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory
      may help doctors identify biomarkers related to cancer.

      PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine
      samples from patients with prostate cancer and healthy volunteers.
    

Detailed description: 
      OBJECTIVES:

        -  To identify a potential novel marker of prostate cancer in the blood and urine,
           11-dh-TXB2, to be used as a screening tool for prostate cancer as well as in detection
           of early relapse in patients previously treated for early-stage prostate cancer.

      OUTLINE: Blood and urine samples are collected and analyzed for plasma and urinary 11-dh-TXB2
      levels by HPLC and tandem-mass spectrometry.
    

Intervention name(s): high performance liquid chromatography; laboratory biomarker analysis; mass spectrometry
Intervention type(s): Other; Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cancer clinic
      
Keywords: recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer
Total Knee Arthroplasty and Clinical Findings
Condition: Orthopedic Disorder; Arthropathy of Knee; Pain, Joint; Proprioception; Radiography
MeSH terms: Musculoskeletal Diseases; Arthralgia
Study type: Interventional

Summary: 
      Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee
      Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee
      osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and
      IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity
      angle,malaligment, functional status and knee joint position sense.
    

Detailed description: 
      Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA
      group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were
      included in the control group. Systemic venous blood samples of the patients were taken to
      evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess
      pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis
      Index) score was used to evaluate the functional status. Valgity and malaligment measurements
      were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee
      joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken
      once from patients in the control group, and twice in pre-op and post-op sixth weeks from
      study group.
    

Intervention name(s): Total Knee Arthroplasty
Intervention type(s): Procedure
Intervention description(s): Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TPS After Upper Blepharoplasty
Condition: Efficacy of a Technique (Brassiere Sutures)
Study type: Observational

Summary: 
      Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with
      favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the
      efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.
    

Detailed description: 
      This is a prospective, randomized, comparative, case series study of 100 eyelids (50
      consecutive women patients) treated with cosmetic upper blepharoplasty by a single surgeon.
      Patients were randomized to receive traditional upper blepharoplasty with a single running
      suture skin closure versus orbicularis oculi muscle fixation to periosteum (brassiere
      sutures) prior to skin closure. Patient age, follow-up length, complications and treatment
      were analyzed. The mean of TPS, BFS and TPS/BFS ratio was measured before and after surgery
      at 3 anatomic landmarks.

      56 eyelids (28 patients) were treated with traditional single suture blepharoplasty and 44
      eyelids (22 patients) had brassiere sutures. After surgery, the mean change in TPS was 2.10
      mm with brassiere sutures compared to 2.04 mm without (p <.001). The mean change in BFS was
      3.33 mm with brassiere sutures compared to 3.19 mm without (p <.001), The mean change in
      TPS:BFS ratio at all 3 anatomic landmarks was statistically significant in both groups but
      the change was statistically greater with the use of brassiere sutures (p <.001).

      Brassiere sutures during upper blepharoplasty were associated with a postoperative increase
      in TPS decrease in BFS, and increase in TPS/BFS.
    

Intervention name(s): Traditional upper blepharoplasty; Brassiere suture with blepharoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): The skin incisions were marked using a skin marking pen. Preseptal orbicularis skin and muscle were removed using a size-15 scalpel blade and scissors. Hemostasis was achieved with conservative electrocuatery. The skin was closed with a running 6-0 nylon suture.; Prior to skin closure as above, three 6-0 polyglactin sutures are passed along the lateral fourth of the orbital rim. The sutures attach the inferior orbicularis oculi edge to the arcus marginalis of lateral ROOF. Sutures are placed until there is a visible "plumping" of the sub-brow tissues.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prospective, randomized, observational case series study included 110 eyelids (50 patients)
        that underwent cosmetic upper blepharoplasty and brassiere suture.
      
Keywords: Upper blepharoplasty; brassiere sutures; tarsal platform show; eyeshadow space; brow fat span
Safety Study of Human Milk Oligosaccharides in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      First-in-human phase 1 study conducted in healthy adult male and female volunteers to
      determine the safety and tolerability of increasing doses of PBCLN-003, which are
      concentrated human milk oligosaccharides (HMO).
    


Intervention name(s): PBCLN-003
Intervention type(s): Drug
Intervention description(s): Human Milk Oligosaccharide Concentrate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test the Combination of Two Different Kinds of Medications for the Treatment of Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Test the safety, tolerability and improvement of blood sugar control with combination therapy
      in individuals with Type 2 Diabetes.
    


Intervention name(s): LY2428757; TT223; Placebo for LY2428757; Placebo for TT223
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 14 mg subcutaneous injection 1 time a week for 5 weeks; subcutaneous injection once a day for 4 weeks; subcutaneous injection 1 time a week for 5 weeks; subcutaneous injection once a day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluating the Efficacy of Opti-Speech for Speech Treatment
Condition: Articulation Disorder; Dysarthria; Prelingual Deafness
MeSH terms: Deafness; Dysarthria; Articulation Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if feedback from a three-dimensional real-time
      visualization of the tongue, a program called Opti-Speech, can be used to improve speech.
    

Detailed description: 
      Participants will be asked to complete the Goldman Fristoe Test of Articulation along with
      several other assessment tests. Then speech treatment, guided by Opti-Speech, will be
      provided to the participant for up to 10 treatment sessions. The participant will be asked to
      come back after the final treatment for a 2-month follow-up assessment.
    

Intervention name(s): Opti-Speech
Intervention type(s): Device
Intervention description(s): Uses visual feedback of the tongue's motion to guide speech sound production
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment