bioihbjkbjnl/mcl2 huggingface dataset:
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
Condition: Arteriovenous Fistulae
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      A cohort including more than 100 maintenance hemodialysis patients will be followed up
      according to a certain Following-up System of Native Arteriovenous Fistulae (AVF)
      prospectively. The assessment results of the Following-up System of AVF help the physicians
      make decisions of AVF surgery and puncture methods. The results of this study would identify
      the effect of the system on survival of AVF. Other 100 hemodialysis patients from other
      centers will be treated by routine protocol and compared to the experiment goup.
    

Detailed description: 
      The Following-up System of AVF includes 3 stages. In the 1st stage, before AVF surgery
      operation, the contents of Following-up System of AVF include history, physical exam,
      ultrasonography detection. The assesment results will guide the methods of the AVF surgery
      operation. In the 2nd stage, before AVF puncture firstly and 3 months after AVF operation,
      the contents of Following-up System of AVF include physical exam and ultrasonography
      detection. The results will help the nurses and doctors make a decision of the method of AVF
      puncture. In the 3rd stage, during the following 2 years after AVF puncture successfully, the
      contents include physical exam and ultrasonography detection regularly. The adequacy of
      hemodialysis by using AVF will be assessed by urea clearance index (Kt/V).

      The data of patients in other hemodialysis centers will be recorded and compared to the
      patients in experiment group.
    

Intervention name(s): Assessment guiding surgery and puncture for AVF
Intervention type(s): Procedure
Intervention description(s): Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; chronic renal failure; arteriovenous fistulae
A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily
      compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
    


Intervention name(s): V120083; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules; Capsules; Capsules to match V120083 and/or naproxen
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain; Osteoarthritis Knee
A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3
Condition: Bleeding Hemorrhoids
MeSH terms: Hemorrhoids; Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product
      (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).

      Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control
      product usage: according to label, 3-4 times daily application to rectal region.

      At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge,
      swelling, itching, discomfort and painkiller usage.

      Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing
      treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are
      examined by study physician who assesses hemorrhoid severity.
    


Intervention name(s): PP110 Gel; PP110 Medicated wipes; Preparation-H Cream
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk
      factors on type 2 diabetic patients.

      Study Hypothesis:

        1. Nexium causes an increased gastrin secretion that increases the insulin secretion and
           thereby a reduction of HbA1c

        2. Probiotics changes the gut flora and bloodpressure

        3. Probiotics causes a change in inflammation and thrombosis.
    


Intervention name(s): nexium; nexium; Yoghurt; placebo+placebo
Intervention type(s): Drug; Drug; Dietary Supplement; Drug
Intervention description(s): 40 mg once daily is tested together with Yoghurt; nexium and placebo are tested; Yoghurt; placebo and placebo are tested.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine the usefulness of a stress reduction treatment in
      helping minority patients with major depression get better. Subjects will receive six weeks
      of either mindfulness-based stress reduction and problem solving therapy or psychoeducation.
    

Detailed description: 
      The purpose of this study is to determine the usefulness of a stress reduction treatment
      compared to psychoeducation in helping minority patients with major depression get better.

      The study will last 10 weeks. During the main portion of the study, subjects will receive
      either individual weekly sessions of stress-reduction therapy or psychoeducation for six
      weeks. The stress reduction therapy will consist of mindfulness-based stress reduction and
      problem solving therapy, which focuses on linking psychological problems with psychosocial
      issues and helping you use your skills and resources to improve your functioning. The
      psychoeducation will consist of six sessions of education on depression and the treatment and
      management of symptoms. Each session will last 50 minutes, and four of the visits will also
      include filling out questionnaires which will take approximately 15-30 minutes to complete.
      One month after the last session, subjects will come in for a follow-up visit with a study
      clinician to see how they are doing and to fill out questionnaires.
    

Intervention name(s): Mindfulness Based Stress Reduction and Psychoeducation; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive six individual weekly 50-minute sessions of mindfulness based stress reduction (MBSR) as well as problem solving therapy (PST. PST is a type of therapy that focuses on psychosocial problems and using your skills and resources to function better. MBSR uses exercises in mindfulness to reduce stress.; Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depression
Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      "A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia
      repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile
      strength of the fascia transversalis."
    

Detailed description: 
      Hernia recurrences post-repair remain a confounding problem. The prospective study described
      herein tested Cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall
      resistance causes hernia, by incorporating the Tensiflex mesh prosthesis which is a modified
      version of mesh prosthesis of Stoppa technique in the surgical treatment of patients with
      hernia. The study was 2-phased: the first phase involved the pre-peritoneal implantation of a
      bi-layered mesh for anatomical replacement of the damaged fascia. The second phase involved
      the implantation of the bi-layered Tensiflex mesh prosthesis for definitive and seamless
      augmentation of tensile strength in the myopectineal orifice of Fruchaud.

      Eighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on
      day 3); however, by day 5, 86% reported pain intensity scores lower than 5. The median number
      of lost workdays was 7. Most importantly, the primary endpoint of 100% recurrence-free
      outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of
      workdays).
    

Intervention name(s): Wing shaped Tensiflex prosthesis
Intervention type(s): Device
Intervention description(s): Curative inguinal hernia repair techniqque
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All patients with confirmed inguinal hernias of all types
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tensile strength augmentation.
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Condition: Depressive Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression
      in people with Parkinson's disease.
    

Detailed description: 
      Depression is a serious medical condition that affects people's thoughts, feelings, and
      ability to function in everyday life. Depression can happen to anyone, but it is more of a
      risk in people with Parkinson's disease, a progressive brain disorder that is caused by a
      loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer
      from depression. These individuals experience different symptoms than those who have
      depression alone. For example, they are prone to higher rates of anxiety, sadness without
      guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts.
      Depression treatment can help people with Parkinson's disease who are depressed to manage
      both diseases and improve the quality of their lives. This study will evaluate the
      effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of
      depression in people with Parkinson's disease.

      Participants in this double-blind study will be randomly assigned to receive either
      atomoxetine or placebo for 8 weeks. All participants will report to the study site at
      baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments
      will be performed, including evaluations with the Inventory of Depressive Symptomatology
      (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants
      will be offered continued routine psychiatric care with the study physician upon completion
      of the study.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 to 80 mg orally once daily for 8 weeks; 40 to 80 mg orally once daily for 8 weeks
Other intervention name(s): Straterra
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Parkinson's Disease; Atomoxetine
Micronized dHACM Injectable for the Treatment of Achille Tendonitis
Condition: Tendonitis;Achilles
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as
      Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis
    

Detailed description: 
      Approximately 158 subjects will be enrolled in this study. Each patient will receive 1
      injection and be evaluated for efficacy and safety during a 12 month observation period.
      Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of
      enrollment and follow-up of all subjects.
    

Intervention name(s): Micronized DHACM; Saline Injection
Intervention type(s): Biological; Drug
Intervention description(s): 1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).; Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other intervention name(s): dHACM; 0.9% NaCL; Normal Saline; Sodium Chloride Injection, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Achilles Tendonitis
Evaluating Soft Contact Lens Prototypes for Myopia Control
Condition: Visual Acuity
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a multi-site, prospective, randomized, controlled, double-masked,
      four-arm-parallel-group, dispensing study. Each subject will be bilaterally fitted with one
      of four types of test articles and wear contact lenses of the assigned lens type during the
      entire course of the study. Test articles will be worn a minimum 8 hours per day and 5 days
      per week (subjects will be encouraged to wear study contact lenses 10 hours or more per day
      and 7 days per week) in a daily disposable modality for a minimum of 6 months and up to 1
      year for a total of 7 scheduled visits.
    


Intervention name(s): EMO-114; EMO-116; EMO-118; EMO-117
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.; Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.; Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.; Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
Other intervention name(s): Test Lens 1; Test Lens 2; Test Lens 3; Test Lens 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Esophageal Squamous Cell Carcinoma
Study type: Interventional

Summary: 
      Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of
      esophagus. Esophageal irritating symptom has been reported as an common adverse event, which
      could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not
      widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we
      propose that it may also be used to alleviate irritating symptoms caused by Lugo's
      chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was
      designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal
      discomfort .
    


Intervention name(s): N-acetylcysteine solution; sodium thiosulfate solution
Intervention type(s): Drug; Drug
Intervention description(s): use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy; use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
Intervention MeSH terms: Acetylcysteine; Sodium thiosulfate; Pharmaceutical Solutions; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: lugol chromoendoscopy; adverse event
Environmental Intervention for Weight Gain Prevention
Condition: Obesity
MeSH terms: Obesity; Weight Gain
Study type: Interventional

Summary: 
      The primary aim of this research is to evaluate the efficacy of a multicomponent
      worksite-based, environmental intervention in reducing weight increase and obesity over time
      in working adults.
    

Detailed description: 
      This study is a randomized trial designed to evaluate the effectiveness of a multi-component
      worksite intervention with strong environmental components to prevent weight gain. Six
      worksites will be randomized to either an intervention or a no-treatment control group. The
      intervention will be comprised of 1) changing the availability, portion sizes, and prices of
      foods and beverages sold to employees in their worksites in ways that encourage healthier
      food choices; 2) increasing the availability of physical activity opportunities at the
      worksite by implementing walking programs and increasing stairwell access and attractiveness;
      3) placing scales in the work environment to encourage body weight monitoring and to enable
      workers to set goals for their weight; and 4) to provide educational materials to all
      employees to make them aware of the environmental intervention and of behavioral practices
      likely to be effective in preventing weight gain. The intervention will be implemented for a
      2-year period in each intervention site. Effectiveness will be evaluated by assessing body
      weight, eating behavior and physical activity in a cohort of employees in both control and
      intervention sites at baseline and again 2 years later. Weight trends in these populations
      will also be compared to data from national and state-level annual surveys of weight in
      representative population samples. Data will be collected on the effects of specific
      intervention components via aggregate measures of food choice and physical activity.
    

Intervention name(s): weight gain prevention
Intervention type(s): Behavioral
Intervention description(s): Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items.
Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home.
Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations.
Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.
Other intervention name(s): worksite intervention; obesity prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; obesity prevention; worksite; environment; intervention
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary Objectives:

      Part A (dose ranging study):

      To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of
      signs and symptoms of rheumatoid arthritis at 12 weeks.

      Part B (pivotal study):

      To demonstrate that sarilumab added to MTX was effective in:

        -  reduction of signs and symptoms of rheumatoid arthritis at 24 weeks

        -  inhibition of progression of structural damage at 52 weeks

        -  improvement in physical function at 16 weeks

      Secondary Objectives:

      Part B:

      To demonstrate that sarilumab added to MTX was effective in induction of a major clinical
      response at 52 weeks

      To assess the safety of sarilumab added to MTX

      To document the pharmacokinetic profile of sarilumab added to MTX in participants with active
      rheumatoid arthritis who were inadequate responders to MTX therapy.
    

Detailed description: 
      The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B)
      broken down as follows:

        -  Screening: Up to 4 weeks

        -  Treatment: 12 weeks (Part A) and 52 weeks (Part B)*

        -  Follow-up: 6 weeks (for participants who would not continue in the long-term extension
           study).

      '*' Participants successfully completing their treatment period would be offered the
      opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).
    

Intervention name(s): Sarilumab; Placebo (for sarilumab); Methotrexate; Folic Acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Same weekly dose as received prior to enrollment; According to local standard
Other intervention name(s): SAR153191; REGN88
Intervention MeSH terms: Folic Acid; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment