bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included
      clinician-based (recession depth, recession width, probing depth, clinical attachment level,
      keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage
      (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine
      hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters
      that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).
    


Intervention name(s): E-CTG
Intervention type(s): Procedure
Intervention description(s): Envelope connective tissue graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to evaluate the effectiveness of REGN475 compared to
      placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history
      of inadequate joint pain relief or intolerance to current analgesic therapy.
    


Intervention name(s): REGN475; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Study of Blood Treated With Cytolin
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from
      blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.
    

Detailed description: 
      The initial phase of this in vitro study regarding the potential mechanisms of action of
      Cytolin was completed in January 2011. Given the data set to date, a decision has been made
      to extend the study. The extension will allow the Company to further confirm and extend the
      initial findings regarding the potential mechanism of action of Cytolin.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult human subjects willing and able to have blood drawn at Massachusetts General Hospital
        in Boston, MA at baseline, three months and six months. All healthy volunteers have been
        enrolled and enrollment is now open only to subjects with earlyh HIV infection.
      
Keywords: HIV; monoclonal antibody; immune therapy; pathogenesis; cytotoxic T lymphocyte; anti-CD4; anti-self; viral replication; Acute Infection
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
Condition: Functional Mitral Regurgitation; Heart Failure
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for
      repair of functional mitral regurgitation.
    

Detailed description: 
      The objective of this prospective, single-center, open label, feasibility test is to assess
      the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in
      treating functional mitral regurgitation (FMR) associated with heart failure.
    

Intervention name(s): Mitral Loop Cerclage Annuloplasty
Intervention type(s): Device
Other intervention name(s): MLC series (MLC-B-45-75-R and other 11 models)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Percutaneous mitral valve repair; Coronary sinus annuloplasty; Mitral loop cerclage
The Chest Physiotherapy and Breathing Exercises Management of Patients Following Open Heart Surgery: a National Survey of Practice in Turkey.
Condition: Chest Physiotherapy
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      Chest physiotherapy and breathing exercises are an important non-pharmacological treatment
      modality in order to prevent and minimize postoperative respiratory complications in patients
      undergoing open heart surgery. Different respiratory techniques are used after cardiac
      surgery, but there is no opinion about which technique or exercise is effective. The purpose
      of this study, practical application of chest physiotherapy to patients who have had open
      heart surgery in Turkey and to identify methods of breathing exercises.
    

Detailed description: 
      In this study, cardiovascular surgery in Turkey to employees or physiotherapist who worked in
      intensive care units was planned as e-mail or by reaching to answer the survey questions via
      telephone.

      The universe of study in Turkey cardiovascular surgery physiotherapists are all actively
      working or have worked in intensive care.
    

Intervention name(s): Physiotherapists working in intensive care
Intervention type(s): Other
Intervention description(s): Physiotherapists working in intensive care will be reached by mail or telephone. Physiotherapists will be asked to complete the prepared questionnaire.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        physiotherapists working in cardiovascular intensive care
      
Keywords: open cardiac surgery; breathing exercises; chest physiotherapy
Safety and Effectiveness of Resistance Exercise Training in Patients With Pompe Disease.
Condition: Pompe Disease; Muscle Weakness
MeSH terms: Muscle Weakness; Glycogen Storage Disease Type II
Study type: Interventional

Summary: 
      The purpose of this research study is to determine if exercise will help improve muscle
      strength, endurance, and quality of life in individuals with Pompe disease. This is a
      research study to further define the outcome of patients with Pompe disease treated with a
      combined diet and exercise therapy.
    

Detailed description: 
      Eligibility: Subjects that are age 16 years or older, have been diagnosed with Pompe disease
      by genetic testing, and are showing symptoms such as muscle weakness

      Time Commitment:

      The study will last for 8 months. This study consists of a baseline visit of and return
      visits at week 9, week 16, week 24, and week 32. At the week 9 visit the subject will be
      given an individualized exercise plan which will be carried out over the next 24 weeks. The
      subject will be asked to return for three more visits at week16, week 24 and week 32. The 24
      week training period will involve 3 workouts a week approximately 15-30 minutes each. It will
      also involve a breathing exercise that the subject can do at home twice daily for 10-15
      minutes per session. The study visits will include the exercise plan, physical exam, blood
      draw and questionnaires.

      Anticipated Benefits:

      The possible benefits include a delay in progression of muscle weakness. The knowledge gained
      from this study will help researchers understand the effect of exercise on the disease. This
      may eventually lead to new forms of prevention of symptom onset in the future.
    

Intervention name(s): Resistance Exercise Training
Intervention type(s): Other
Intervention description(s): Resistance Exercise Training: knee extension and elbow flexion each 3 times per week 3 sets each session; 10 reps/set for 6 months
Respiratory muscle strength training: 25 repetitions -twice daily, 6 days/week for 6 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; Pompe disease; Pompe
Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital
Condition: Quality of Life; Cervical Cancer; Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Observational

Summary: 
      To study the quality of life of patients earlier diagnosed for cervical cancer and cervical
      intraepithelial neoplasia (CIN).
    

Detailed description: 
      In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related
      survival gain are experienced by side-effect that may reduce quality of life (QoL). We
      therefore, study the quality of life of patients earlier diagnosed for cervical cancer
      patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cervical intraepithelial neoplasia (CIN) or cervical cancer patients
Body Weight and Vascular Function
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      An increased body mass impairs vascular function (VF), an important characteristic of
      subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases.
      However, a wide variety of in vivo VF markers exists each measuring different aspects of VF.
      Each of these markers addresses a different aspect of the vasculature. Studies comparing
      under standardized conditions the differences and relationships of the many different VF
      measurements in lean and abdominally overweight / obese subjects are missing. Also, there is
      a great need to know which of these markers are sensitive to dietary challenges.

      Therefore, it is imperative to conduct an extensive study on dietary effects and
      interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and
      overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for
      cardiovascular disease. The investigators propose to examine, in a two-way
      parallel-randomized human intervention study, the effects of weight-loss in abdominally
      overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation
      and vascular activity during the fasting and both the postprandial and hyperinsulinemic
      state. Furthermore, differences - and relations between - VF measurements and plasma
      biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese
      male subjects.
    


Intervention name(s): Weight-loss treatment; No-weight loss treatment
Intervention type(s): Other; Other
Intervention description(s): A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks.; Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Body Weight; Obesity; Weight Loss; Vascular Function Markers
A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 study is to evaluate the pharmacokinetics (PK) and safety of a
      single dose of CSTI-500 10 mg in subjects with Prader-Willi syndrome (PWS) between 13 and 50
      years of age with a genetically confirmed diagnosis of PWS.
    

Detailed description: 
      This is an open-label, single center, Phase 1 study to evaluate the PK and safety of a 10 mg
      single oral dose of CSTI-500, a triple monoamine reuptake inhibitor (TRI), in patients with
      genetically confirmed PWS. The study will consist of a Screening Period of up to 1-3 days
      prior to the Baseline Visit (Visit 2). In addition to the Screening Visit (Visit 1), eligible
      subjects will attend five in-clinic site visits for PK blood draws and safety assessments
      over a 6-day period. At Visit 2 all subjects will receive one single oral dose of CSTI-500 10
      mg. Approximately 14 patients aged 13 to 50 years who meet all eligibility criteria will
      receive one single dose of CSTI-500.
    

Intervention name(s): CSTI-500
Intervention type(s): Drug
Intervention description(s): Single 10 mg capsule
Other intervention name(s): AMR-001181
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PWS; Phase 1; Single Dose; Non randomized; PK; Safety
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in
      NASH patients after 36 weeks of treatment
    

Detailed description: 
      The study will be performed in patients with NASH. The primary endpoint will be the
      assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).
    

Intervention name(s): PXL065; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): PXL065 oral tablet; Placebo oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children
Condition: Asthma; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Research Title: The effect of vitamin D replacement on airway reactivity, allergy and
      inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic
      children.

      Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an
      immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract
      and airway hyperreactivity.

      Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and
      inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic
      children.

      Design: Double blind placebo control prospective study comparing the effect of Vitamin D
      replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled
      breath condensate in asthmatic pediatric population with vitamin D deficiency.

      Participant selection: The study group will consist of pediatric patients (age 6-18 years)
      followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.

      Patients with mild-moderate asthma with low or insufficient vitamin D levels that are
      currently not receiving anti-inflammatory treatment will be recruited.

      Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving
      placebo).

      Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance
      preparation once weekly for 6 weeks between visit two and three.

      Three visits will be conducted. Each subject will undergo evaluation including a respiratory
      questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2
      and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC)
      (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1,
      3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled
      allergens will be performed (visit 2, 3).

      Primary end point: Airway reactivity as assessed by methacholine challenge test.

      Secondary outcome parameters: All other parameters are the secondary end points.
    


Intervention name(s): Vitamin D3 as "BABY D3"; placebo
Intervention type(s): Drug; Other
Intervention description(s): drops, 70 drops (= 14000 units), once weekly for 6 weeks; drops, 70 placebo drops, once weekly for 6 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Asthma; Vitamin D; airway reactivity; metacholine challenge test
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell-Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for
      patients with resectable non-small cell lung cancer. The exploration of new drugs and
      regimens are warranted. Therefore the aim of this study is to evaluate the clinical response
      rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable
      non-small cell lung cancer stage IB, IIA-B, IIIA.
    


Intervention name(s): Gemcitabine; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
Condition: Acute Myeloid Leukaemia; Chronic Myeloid Leukaemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid
      leukaemia.

      Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells
      by transferring a gene into the T cells, which allows them to recognize fragments of a
      protein called WT1. This protein is present on the surface of leukaemia cells at very high
      levels. The gene transferred to the T cells enables them to make a new T cell receptor (TCR),
      which will allow them to attack leukaemia cells with high levels of WT1 on their surface.

      Using this form of gene therapy the investigators can convert some of the patient's immune
      system's own T cells into T cells that the investigators hope will be much more effective at
      recognizing and killing leukaemia cells.
    

Detailed description: 
      This trial concerns a novel approach to generating leukaemia antigen-specific T cells for
      adoptive cellular therapy in HLA-A*0201 patients with acute myeloid leukaemia (AML) and
      chronic myeloid leukaemia (CML)

      In this study, patient T cells will be gene-modified using a GMP grade retroviral vector
      containing the genes for a WT1-specific, HLA-A2-restricted T cell receptor. This ex vivo gene
      therapy will generate T cells expressing the WT1-specific TCR and thus able to recognise
      WT1-expressing target cells.

      The autologous Cys1 WT1 TCR-transduced T cells will be re-infused back into adult leukaemia
      patients following lymphodepleting conditioning.
    

Intervention name(s): WT1 TCR-transduced T cells
Intervention type(s): Genetic
Intervention description(s): Two patient cohorts:
Cohort 1 (up to 6 patients) = ≤ 2 x 107/kg WT1 TCR-transduced T cells
Cohort 2 (12 patients)= ≤ 108/kg WT1 TCR-transduced T cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gene therapy; WT1 TCR; AML; CML
Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch#
      1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject
    


Intervention name(s): LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R); LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Intervention MeSH terms: Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      The purpose of this study is to determine the feasibility of routine referral to genetic
      counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or
      fallopian tube cancer.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine
        mullerian cancer.
      
Biospecimen description: 
      multi-gene panel testing
Survey on Precision Medicine and Digital Health
Condition: Health Behavior; Health Knowledge, Attitudes, Practice; Health Attitude
Study type: Observational

Summary: 
      The investigators have created an anonymous online survey that queries current topics in
      precision medicine.
    

Detailed description: 
      The investigators have created an anonymous online survey to assess the educational
      requirements and current gaps in knowledge related to advances in precision medicine. These
      include questions that focus on digital health, wearable technologies, genetic sequencing,
      and CRISPR to assess survey participants' interest and knowledge level.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Online survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Anyone who access and is interested in participating in the online survey.
Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is investigating the effect of testosterone treatment on
      paraoxonase level in male patients with hypogonadotrophic hypogonadism
    


Intervention name(s): Sustanon
Intervention type(s): Drug
Intervention description(s): 250 mg/21 days
Other intervention name(s): no name
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: hypogonadism; paraoxonase; Hipogonadism