bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and effectiveness of the experimental drug,
      a benzodiazepine drug, in long-term use and the effects on quality of life, social and
      occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.
    

Detailed description: 
      This trial is a long-term, open label, safety and efficacy study of an experimental
      medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study,
      investigators and patients must have first participated in Jazz Pharmaceuticals, Inc.
      Protocol 04-001-01. The study is designed for four stages that should last a total of 37
      weeks.
    

Intervention name(s): a benzodiazepine drug
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Generalized Anxiety Disorder
Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on
      normal skin

      To evaluate skin irritation
    

Detailed description: 
      This is a repeat insult patch test study. On treatment days, the investigational product
      PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open
      conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9
      applications in total) during the induction phase. Following a rest period of approximatley
      10-14 days, a single challenge application will be performed. Local tolerability will be
      assessed visually using an ordinal scoring system. If a cutaneous response observed in the
      challenge phase indicates possible sensitisation, or at the discretion of the investigator, a
      rechallenge will occur
    

Intervention name(s): PEP005 Topical Gel (0.01% concentration)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PEP005; Safety
Using Practice Facilitation in Primary Care Settings to Reduce Risk Factors for Cardiovascular Disease
Condition: Cardiovascular Disease; High Blood Pressure
MeSH terms: Cardiovascular Diseases; Hypertension
Study type: Interventional

Summary: 
      The primary purpose of this study is to evaluate the effectiveness of practice facilitation
      as a quality improvement strategy for implementing the Million Hearts' ABCS treatment
      guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive
      care in primary care practices in New York City. The ABCS refer to the following: Aspirin in
      high-risk individuals (A), Blood pressure control and management (B), Cholesterol management
      (C), and Smoking cessation (S). The long-term goal is to create a robust infrastructure to
      disseminate and implement evidence based practice guidelines (EBPG) findings in primary care
      practices and improve practices' capacity to receive and implement other EBPG findings in the
      future.
    


Intervention name(s): Million Hearts ABCS 6 Months; Million Hearts ABCS 9 Months; Million Hearts ABCS 12 Months; Million Hearts ABCS 15 Months; Standard Care Regimen 9 Months; Standard Care Regimen 12 Months; Standard Care Regimen 15 Months; Standard Care Regimen 18 Months; Standard Care Regimen 21 Months; Standard Care Regimen 24 Months; Standard Care Regimen 27 Months; Follow Up Post Intervention 21 Months; Follow Up Post Intervention 24 Months; Follow Up Post Intervention 27 Months; Follow Up Post Intervention 30 Months; Follow Up Post Intervention 33 Months
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).; The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).; The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).; The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
Other intervention name(s): Chronic Care Model
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cholesterol; smoking; aspirin; chronic care model
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic
      characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as
      a pelubiprofen 90 mg) tablet QD in healthy subjects.
    


Intervention name(s): pelubiprofen (30mg) tablet IR; pelubiprofen SR (as a pelubiprofen 90 mg) tablet
Intervention type(s): Drug; Drug
A Comparison of Telemedical and Conventional Antihypertensive Treatment
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare telemedical antihypertensive treatment based on home blood
      pressure monitoring and conventional antihypertensive treatment based on monitoring of blood
      pressure in the doctor's office.

      We want to test the hypotheses that telemedical treatment is more effective in lowering blood
      pressure, provide better quality of life and is more cost-effective.
    


Intervention name(s): Telemedical blood pressure monitoring
Intervention type(s): Device
Intervention description(s): Measurement of home blood pressure, three times per week for three months and once a week for three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telemedicine; Blood pressure; Quality of life; Cost-effectiveness
Safety and Tolerability of the Vaginal Gel PRO 2000/5
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes
      irritation when used daily.

      Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women
      who are not sexually active. However, it was not determined what side effects to skin in the
      vaginal area there might be in sexually active women.
    

Detailed description: 
      Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other
      disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and
      tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that
      multiple application of the gel was safe and well tolerated in healthy, sexually abstinent
      women but no clear association between the use of the gel and epithelial disruption was
      indicated. Because genital ulceration and inflammation may increase the risk of HIV
      infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for
      study participants with active sexual behavior.

      Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days.
      HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage
      in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort
      B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams
      to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix.
      Women and their male partners are questioned about gel usage.
    

Intervention name(s): PRO 2000
Intervention type(s): Drug
Primary purpose: Prevention
Keywords: HIV Seropositivity; Dose-Response Relationship, Drug; HIV Seronegativity; Mucous Membrane; Ulcer; Vagina; Anti-HIV Agents; Sexual Abstinence; Irritants; PRO 2000
Effects of Aloe Vera Toothpaste on Periodontal Parameters
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and
      gingivitis.

      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out
      period was allowed and then subjects used fluoride toothpaste for the next 30 days . This
      order was reversed in group 2.
    

Detailed description: 
      Toothpastes are used with tooth brushing to better control microbial plaque. Herbal
      toothpastes have recently gained attention. This study aimed to assess the effects of Aloe
      Vera toothpaste on dental plaque and gingivitis.

      This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque
      index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and
      then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI
      assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated
      Measure ANOVA tests were applied for statistical analysis.
    

Intervention name(s): Foramen Herbal Aloe toothpaste; fluoride toothpaste
Intervention type(s): Other; Other
Intervention description(s): use of aloe-vera toothpaste for 30 days in the test group.; use of signal toothpaste once a day for 30 days in the control group.
Other intervention name(s): signal
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: clinical trial; oral hygiene; Gingivitis; Aloevera; Toothpaste; anti-inflammatory agents
Effect of Low Frequency Ultrasound on Kidney Function
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic
      Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
    


Intervention name(s): Low Frequency Therapeutic Ultrasound
Intervention type(s): Device
Intervention description(s): 29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: low frequency ultrasound; glomerular filtration rate
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of
      a new Blood Glucose Monitoring System.
    


Intervention name(s): Blood Glucose Monitoring System.
Intervention type(s): Device
Intervention description(s): In vitro diagnostic medical device
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial
Condition: Pityriasis Versicolor
MeSH terms: Tinea Versicolor; Pityriasis; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      There are several topical treatment for Pityriasis Versicolor including ketoconazole and
      selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that
      has been reported to be effective in PV. The study aimed to reveal the mycological efficacy,
      safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and
      ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized
      controlled trial was performed in patients with PV during September-December 2018. Patients
      who involved in this study were allocated to SeS2 or ketoconazole 2% based on block
      randomization. Physical examinations, scale provocation test, Wood lamp and potassium
      hydroxide (KOH) examination were conducted to evaluate the treatment response and side
      effects on 7th - 14th day. Intention to treat analysis was performed in this study.
      cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).
    


Intervention name(s): shampoo with different composition
Intervention type(s): Drug
Intervention description(s): To reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mycological efficacy; ketoconazole; selenium disulfide 1,8%; Pityriasis versicolor
Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Double blind, placebo controlled trial to evaluate the effects of a nutraceutical containing
      high-molecular-weight hyaluronic acid (HA) and acetyl-11-keto-beta-boswellicacid (AKBA) in
      patients affected by knee osteoarthritis.
    

Detailed description: 
      The primary objective of the trial is to assess the feasibility of implementing
      Ultrasonography and Range of Motion (ROM) as objective measurements to correlate the
      improvement of the knee mobility with the pain reduction of the affected knee in the patients
      assuming nutraceutical containing hyaluronic acid (HA).

      The secondary objectives of the trial are:

        -  to assess the feasibility of implementing Actigraphy as objective measurements to
           correlate the improvement of the knee mobility with the pain reduction (optional).

        -  to evaluate the enrollment rate in one month.

      The explorative objectives of the trial are:

      • Preliminary data on efficacy of the tested product.
    

Intervention name(s): SYALOX® 300 Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis; Placebo comparator. No chemical effect expected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of Endothelium in Saphenous Vein Grafts
Condition: Endothelial Function of Saphenous Vein Grafts
Study type: Interventional

Summary: 
      This is a single center prospective study of 30 patients undergoing elective heart bypass
      surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo
      study is to evaluate the function of vein grafts from small tissue samples treated with a
      pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the
      veins in preparation of bypass grafting. It is unknown if different levels of pressure in the
      syringe affect the vein or damage the vein. Small sections of tissue samples which are
      normally discarded will be obtained immediately after retrieval from the leg and before
      grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no
      clinical endpoints in this study, however, clinical information will be obtained from the
      Society of Thoracic Surgeons database and will include demographics, risk factors, and
      perioperative outcomes.
    


Intervention name(s): Use of Maquet Vasoshield Pressure-limiting syringe on SVG; Use of non-regulated syringe on SVG
Intervention type(s): Other; Other
Intervention description(s): Use of Maquet Vasoshield Pressure-limiting syringe on SVG; Use of non-regulated syringe on SVG
Other intervention name(s): Maquet device; standard syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endoscopic vein harvest; saphenous vein graft; endothelial function
Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the potential of
      Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a
      positron emission tomography (PET) somatostatin receptor imaging agent in patients with
      neuroendocrine tumors.
    

Detailed description: 
      In the first part of the study, six healthy volunteers will undergo several sequential
      whole-body PET/CT scans starting from the moment of tracer injection up to six hours post
      injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in
      humans.

      In the second part of the study, six neuroendocrine tumor patients, with at least five
      positive lesions on routine clinical 68Ga-DOTA-peptide PET, will undergo a dynamic PET scan
      for the first 45 minutes, followed by three single static whole-body PET/CTs up to three
      hours post injection for an initial efficacy assessment (evaluation of the lesion detection
      rate) and pharmacokinetics study of Al18F-NOTA-octreotide in humans. Furthermore a first
      comparison with 68Ga-DOTA peptide PET will be performed.
    

Intervention name(s): Al18F-NOTA-octreotide; PET/CT; Venous blood samples
Intervention type(s): Drug; Device; Other
Intervention description(s): One intravenous injection of 4 MBq/kg; Part 1: Healthy volunteers will undergo consecutive whole-body PET scans, including one low-dose CT, for the first 90 minutes. At 150 ± 15 min and 300 ± 30 min post injection two additional static whole-body PET/CT scans will be acquired.
Part 2: Neuroendocrine tumor patients will undergo a dynamic PET scan for the first 45 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection.; Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements (only for patients) at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).
Other intervention name(s): 18F-AlF-NOTA-octreotide; 18F-IMP-466
Intervention MeSH terms: Octreotide; Al18F-NOTA-octreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET/CT; Somatostatin receptor imaging; Al18F-NOTA-octreotide
Sleep Management in Cancer Survivors
Condition: Insomnia
Study type: Interventional

Summary: 
      The pilot project will investigate three short-term intervention programs for sleep
      management in cancer survivors in a randomized controlled clinical study. Three programs to
      be examined in the study are:

        1. the mind-body bridging program (MBBP),

        2. mindfulness meditation program (MMP), and

        3. sleep education program (SEP).
    

Detailed description: 
      This pilot randomized study investigates whether the two awareness training programs (ATP),
      MBBP and MMP are effective in improving sleep disturbance and in reducing stress in
      post-treatment cancer patients. The two experimental conditions and the SEP control will each
      comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
    

Intervention name(s): Sleep Education Program; Mind-Body Bridging Program; Mindfulness Meditation Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Treatment as usual.; Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.; Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.
Other intervention name(s): SEP; MBBP; MMP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sleep Management; Awareness Training Programs; Mindfulness Meditation; Mind Body Bridging