bioihbjkbjnl/mcl2 huggingface dataset:
Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The study compares procedural and post procedural outcomes for photoselective vaporization of
      the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of
      lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet
      obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight
      XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign
      prostatic hyperplasia (BPH).
    

Detailed description: 
      The study will compare procedural and post procedural outcomes for photoselective
      vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the
      treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder
      outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System
      (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of
      benign prostatic hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is
      not inferior to TURP.
    

Intervention name(s): Photoselective Vaporization of the Prostate; Transurethral Resection of the Prostate
Intervention type(s): Device; Device
Intervention description(s): GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.
GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator.; Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPH; Benign Prostatic Hyperplasia
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial compares the relative bioavailability of apraglutide in dual-chamber syringes
      (DCS) versus the reference formulation apraglutide in vials.
    

Detailed description: 
      This is a single-center, open-label, randomized, three-period, and six-sequence cross-over
      trial with two washout periods of at least 14 days to compare the relative bioavailability of
      apraglutide using DCS versus the reference formulation in vials, following SC administrations
      in healthy male and female subjects.

      Following consent, subjects will undergo a Screening procedure to see if they are suitable to
      be enrolled in the trial. Screening may be performed up to 28 days prior to the first
      injection procedure. All eligible subjects will receive the following treatments in three
      separate treatment periods:

        -  Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL

        -  Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a
           concentration of 6.25 mg/mL

        -  Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of
           the current formulation-reference There will be a 14-day washout period between the
           first and second treatment periods and between the second and third treatment periods.
    

Intervention name(s): Apraglutide
Intervention type(s): Drug
Intervention description(s): Peptide analogue of GLP-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Relative bioavailability; Dual-chamber syringe
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Condition: Heart Failure; Cardiac Resynchronisation Pacemakers
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      An evaluation of the role of resting and exercise cardiac output measurement, by the inert
      gas rebreathing method, in optimisation of patients with cardiac resynchronisation
      pacemakers.
    


Intervention name(s): Optimisation of VV delay
Intervention type(s): Device
Intervention description(s): Programmed VV delay altered on device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Pacemakers
ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial
Condition: Corneal Epithelial Defect
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. The
      study included two experimental groups (low-dose ZKY001 eye drops group and medium-dose
      ZKY001 eye drops group) and a placebo control group, with 60 subjects in each group.
    

Detailed description: 
      Each subject had the study drug instilled into the study eye according to the randomly
      obtained drug number.

      Duration OF THE STUDY：The screening period was D-5 to D-1, the experimental period was D0
      (the day of operation) to D5, and the observation period was D10±2.

      Statistical analyses were performed with the use of SAS software (version 9.4 or higher)
      without special instructions. All statistical tests were two-sided, with a significance level
      of 0.05. Enrollment analysis: the number of enrolled and completed cases in each center was
      summarized, and the list of dropped cases was made. Overall dropout rates in each group and
      dropout rates related to adverse events were compared between groups with the use of the
      chi-square test or Fisher's exact test.
    

Intervention name(s): lowe-dose ZKY001 eye drops; Medium-dose ZKY001 eye drops; ZKY001 simulated eye drops
Intervention type(s): Drug; Drug; Drug
Intervention description(s): eye drops; eye drops; eye drops
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS
Condition: Osteoporosis; Periodontitis
MeSH terms: Osteoporosis; Periodontitis
Study type: Interventional

Summary: 
      Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels,
      resulting in increased bone resorption including the jaws. Osteoporosis may have an influence
      on the periodontal condition of post-menopausal women and the risk for periodontal disease
      may increase due to osteoporosis. The hypothesis of the study was that non-surgical
      periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve
      the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG.
      Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship
      between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical
      periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in
      patients with periodontitis and osteoporosis.
    


Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): supra- and subgingival scaling, and root planning
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 25 patients with periodontitis (P) and osteoporosis (group 1), 25 systemically healthy patients with P (group 2) and 25 systemically and periodontally healthy individuals (group 3) were enrolled in this study.
Individuals were periodontally examined at baseline, 1 month and 3 months following the non-surgical periodontal therapy.
Participants in group 1 and 2 received non-surgical periodontal therapy including supra- and subgingival scaling, and root planning.Patients were advised and instructed to perform oral care twice a day, use interdental toothbrushes once a day regularly. No scaling and root planning was performed in the group 3.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-surgical periodontal treatment; bisphosphonates; interleukin-1β; interleukin-17; 8-hydroxydeoxyguanosine; alkaline phosphatase
HLA Sensitization Following Major Cortical Allograft Bone Procedures
Condition: Bone Cancer
MeSH terms: Bone Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to find out whether or not antibodies to the donor bone are
      present in the blood of patients who receive the donor bone.
    

Detailed description: 
      Patients who have bone cancer often have the cancerous bone removed by surgery and replaced
      with a piece of bone taken from a donor (a person who donates parts of their body to be used
      for transplants after their death). However, sometimes this replacement bone does not heal
      together with the patient's bone. The reason the bone does not heal is not known but it is
      thought that the patient's body may react to the donor bone by producing antibodies against
      cells on the donor bone. The purpose of this study is to find out whether or not antibodies
      to the donor bone are present in the blood of patients who receive the donor bone. You have
      been asked to participate in this study because you are scheduled to undergo this type of
      surgery.
    

Intervention name(s): retrieve blood samples
Intervention type(s): Procedure
Intervention description(s): blood samples obtain pre-op, 6 and 12 months post-op
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Orthopaedic clinic
Chinese Exercise Modalities in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will compare the effects of two Chinese and one Western exercise modalities on the
      signs and symptoms of Parkinson's disease.
    

Detailed description: 
      The long-term goal of this project is to study the effects of different exercise modalities
      on Parkinson's disease (PD). PD is a disorder whose primary disability stems from motor
      dysfunction including balance. Recent studies have shown that the risk of falling in the
      elderly can be reduced through the practice of the Chinese complementary and alternative
      medicine (CAM) such as T'ai Chi Chuan (TCC). This finding may be highly significant to PD.
      Although a recent report from Emory suggests PD patients can do well with aerobic (walk-run)
      exercise training (AET), it is still unclear whether the potential anti-Parkinsonian effect
      of such modalities is secondary to improved physical fitness (CRF), motor control or both.
      CAM interventions such as TCC may offer a unique opportunity to examine these fundamental
      questions.

      In PD we hypothesize that exercise training will reduce primary and secondary disability and
      that some of these changes represent adaptive reprogramming of central motor pathways. We
      will conduct a controlled double-blind, 16-week dose-response study of exercise based on
      caloric expenditure and thus on the cardiorespiratory fitness effects of exercise (CRF). The
      treatments will be Qi Gong (minimal caloric expenditure), TCC (low expenditure), and
      walk-cycle AET (moderate expenditure).

      We will examine exercise-induced change in motor control using quantitative measures of motor
      disability, including dynamic gait stability measures. We will also examine exercise effects
      on central and peripheral indices of Parkinsonian motor disability.

      A caloric "dose-response" effect of exercise would suggest CRF is a major determinant of the
      anti-Parkinsonian effects of exercise. If the Chinese modalities are as effective or superior
      to AET however, this would suggest that other mechanisms such as change in central motor
      programming may be playing a role (e.g. relaxation effects, reinforcement of central motor
      programs?). A better understanding of exercise-induced neural plasticity and motor control
      would offer a significant, and heretofore unexploited rehabilitative potential in PD.
    

Intervention name(s): Chinese exercise modalities
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: Parkinsons Disease; Chinese exercise
A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help
      people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people
      who smoke and will also look at blood levels of GSK598809 and nicotine.
    


Intervention name(s): GSK598809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose.; Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: healthy volunteers,; tolerability,; pharmacokinetics,; pharmacodynamics; safety,; smoking,
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to assess the efficacy of early oseltamivir treatment
      (started within 24 hours of the onset of influenza symptoms) in preventing the development of
      acute otitis media as a complication of influenza in children aged 1-3 years.
    


Intervention name(s): oseltamivir; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days; The dosage of placebo will be similar to the active drug
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; children; acute otitis media; oseltamivir
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
Condition: Coronary Artery Disease; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled,
      dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and
      planned percutaneous coronary intervention （PCI） will be randomized after informed consent,
      in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg
      loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading
      followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by
      7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28
      days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel
      antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease
      during and after PCI compared with clopidogrel.
    


Intervention name(s): Vicagrel 5mg; Vicagrel 6mg; Vicagrel 7.5mg; Clopidogrel 75mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent
      excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could
      play an important role in the development and exacerbating of insulin resistance. Therefore,
      the investigators propose to study the regulation of adipose tissue and skeletal muscle
      lipolysis, as well as further characterize the intracellular lipolytic pathways within these
      tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.
    


Intervention name(s): Hyperinsulinemic euglycemic clamp
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy normoglycemic men and type 2 diabetic men
      
Biospecimen description: 
      adipose tissue and skeletal muscle biopsies
Efficacy and Safety of Cilostazol for the Indication of CSPS
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Observational

Summary: 
      This is a multicenter, open-label, prospective study of cilostazol use for prevention of
      recurrence in patients with cerebral infarction.
    

Detailed description: 
      This is a multicenter, open-label, prospective study of cilostazol use to prevention of
      recurrence in patients with cerebral infarction.

      Qualified patients will be treated with cilostazol by physician's assessment. This study will
      be continued for 4 years. More than 600 patients for 4 years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients in restabilization status after cerebral infarction (excluding cardiogenic
        cerebral embolism)
      
Keywords: Cerebral Infarction Prevention; Cilostazol
Increasing the Effectiveness of the Diabetes Prevention Program
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in
      overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing
      the risk of developing weight-related health consequences. One-on-one DPP sessions, however,
      are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is
      less effective (4% average loss of body weight). The aim of this two-arm parallel randomized
      controlled trial is to increase the effectiveness of the GLB by integrating habit formation
      techniques, namely if-then plans and their mental practice, into the program. The study will
      provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting
      weight loss and in reducing weight-related risk factors for chronic health problems.
    

Detailed description: 
      Please see brief summary.
    

Intervention name(s): Enriched GLB; Standard GLB
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.; This arm is the standard Group Lifestyle Balance program
Other intervention name(s): Diabetes Prevention Program; weight loss program; implementation intentions; mental imagery; Diabetes Prevention Program; weight loss program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Group-delivered Diabetes Prevention Program; Obesity; Overweight; Lifestyle change; Healthy eating; Weight loss; Exercise; Cognitive-behavioral intervention; Implementation intentions; Mental imagery; Mental practice; If-then plans
Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels
Condition: Sexuality; Stigmatization; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Aim: Failure to exercise reproductive and sexual rights can increase the risk of unwanted
      pregnancies, HIV and sexually transmitted infections, sexual coercion and violence,
      especially in young women. All of these situations affect the physical and mental health of
      young girls, as well as the health of their families.For this reason, The Effect of Education
      Given to Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels: A
      Randomized Controlled Study was planned.

      Material and method: The research was conducted as a randomized controlled experimental
      study. The universe of the research consisted of female students studying at the Faculty of
      Health Sciences of Ağrı İbrahim Çeçen University between January and June 2022. The sample
      consisted of individuals who were studying at the Faculty of Health Sciences of Ağrı İbrahim
      Çeçen University between the same dates and who met the inclusion criteria of the research.
      "Descriptive Feature Form", "Sexual and Reproductive Health Stigma Scale for Young Women" and
      sexual health knowledge test were used to collect data. In the analysis of data; percentile
      distribution, chi-square, Fisher-Freeman- Halton Exact test, paired samples test, t-test in
      independent groups, Friedman Test, One Way ANOVA test, and post hoc analyzes (Bonferroni,
      Games Howell, Dunn) were used.
    


Intervention name(s): Face to face education
Intervention type(s): Behavioral
Intervention description(s): Face-to-face training was provided and supported by booklets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sexual health; knowledge; Stigma