bioihbjkbjnl/mcl2 huggingface dataset:
Water-only Fasting in the Treatment of Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This purpose of this study is to examine the safety and feasibility of water-only fasting to
      treat hypertensive patients.
    

Detailed description: 
      This is a prospective, open label, single arm, intervention study to examine the safety and
      feasibility of water-only fasting to treat hypertensive patients. Additional aims include
      describing mean changes in resting blood pressure as well as markers of cardiovascular health
      and inflammation between baseline and end of fast, end of refeed, 6-weeks post departure, and
      12-months after 6-weeks follow-up.
    

Intervention name(s): Water-only Fasting
Intervention type(s): Other
Intervention description(s): Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fasting; water-only fasting; whole-plant-food diet
Utilization of HIV Clinical Services in Rural India
Condition: HIV Infections; Sexually Transmitted Infections
MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This community-based clinical trial based in two districts of rural Maharashtra, India
      compares utilization of an intervention model of "fully-decentralized," or rural primary
      clinic-based, HIV testing and care services, with a control model of the Indian government's
      partially-decentralized HIV services, offering rural referral clinic testing and urban-based
      HIV care.
    

Detailed description: 
      India has one of the highest estimated number of HIV cases globally. Sixty percent of its HIV
      cases occur in rural residents, yet there is no system of HIV testing or care services for
      them. Preliminary studies have identified very low HIV testing utilization among men and
      recently pregnant women in rural Maharashtra, even though these are, by government policy,
      high-priority target groups for rural HIV testing, diagnosis, and prevention.

      This study will compare two models of rural HIV testing and care services in two districts of
      Maharashtra, India. The "Control" model is the Indian government's current strategy of
      "partially decentralized" rural-based HIV testing services at a secondary-level Community
      Health Center clinic, which serves a village group population of 30,000. HIV care including
      antiretroviral therapy is provided a the rural district headquarters in the district urban
      center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV
      testing which will be offered at the Community Health Center, two Primary Health Centers, and
      eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.

      The primary outcomes of this trial are to assess and compare utilization rates for these two
      types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and
      older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral
      risk characteristics of services utilizers in each model, and characteristics of utilizers
      versus non-utilizers between and within each model. Clinical care outcomes include WHO
      Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes
      for HIV-infected pregnant women.
    

Intervention name(s): HIV Testing and Care Services
Intervention type(s): Behavioral
Intervention description(s): Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV/AIDS; Voluntary Counseling and Testing; Rural India; HIV Care; Health Services Research
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from
      nasopharyngeal mucosa, compared to placebo.
    

Detailed description: 
      This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study.
      All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or
      placebo intravenously and then followed by Day 36.
    

Intervention name(s): CT-P27; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Influenza A treatment drug.; Placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: efficacy; safety
Vaccination Trial of a Recombinant MVA-BN-WEV Vaccine in Healthy Adult Subjects
Condition: Equine Encephalitis
MeSH terms: Encephalomyelitis, Equine; Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety and tolerability as well as immune responses to the MVA-BN-WEV vaccine in
      the 3 treatment groups receiving different doses.
    


Intervention name(s): MVA-BN-WEV Dose 1; MVA-BN-WEV Dose 2; MVA-BN-WEV Dose 3
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 x 10^7 Inf.U MVA-BN-WEV vaccine; 1 x 10^8 Inf.U MVA-BN-WEV vaccine; 2 x 10^8 Inf.U MVA-BN-WEV vaccine.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess the Safety, Tolerability, and Effects of MK-0974 (Telcagepant) on Exercise Tolerance in Patients With Stable Angina (MK-0974-014)
Condition: Angina Pectoris; Coronary Heart Disease; Calcitonin Gene-related Peptide Receptor
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina, Stable
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety of telcagepant in coronary artery disease (CAD)
      participants with stable angina during exercise treadmill testing and evaluate whether
      calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise
      tolerance in these participants. Primary hypothesis is that telcagepant does not
      significantly decrease exercise duration compared to placebo, as measured by a treadmill
      exercise test; that is, the true treatment difference in exercise duration (MK-0974 -
      Placebo) >= -60 seconds.
    

Detailed description: 
      Amendment 3 of the protocol reduced the dose of telcagepant to be administered from a single
      dose of 900 mg to a single dose of 600 mg. Pooled data from both the 600-mg and the 900-mg
      group wiil be utilized in the analyses. Also due to supply issues regarding the 300 mg
      telcagepant capsules, 280 mg telcagepant tablets with demonstrated bioequivalence to the 300
      mg telcagepant capsules, could be administered to participants enrolled after the
      implementation of Amendment 3.
    

Intervention name(s): telcagepant; Placebo to telcagepant
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0974
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: angina pectoris; coronary artery disease; calcitonin gene-related peptide; exercise tolerance,
NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effects of oral and inhaled
      administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled
      NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth
      wash fluid in healthy non-smokers, current smokers and patients with COPD.
    

Detailed description: 
      Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by
      the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible
      NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the
      production of NO under oxidative stress conditions generates reactive nitrogen species that
      may amplify the inflammatory response in COPD.
    

Intervention name(s): Aminoguanidine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 500mg; 2ml
Other intervention name(s): Nebulased Aminoguanidine; Nebulase saline solution
Intervention MeSH terms: Pimagedine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Aminoguanidine; Nitric oxide
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Condition: Breast Cancer; Breast Neoplasm; Artificial Intelligence; Ultrasonography; Benign Breast Disease
MeSH terms: Breast Neoplasms; Breast Diseases; Fibrocystic Breast Disease
Study type: Observational

Summary: 
      The accuracy of breast examinations and ultrasonography performed clinically to detect breast
      mass varies greatly depending on the physician&#39;s skill level, and the accuracy of breast
      examinations by non-experts is particularly low. In this study, we aimed to validate whether
      the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose
      of improving the sensitivity of detecting breast masses through breast examination.
    

Detailed description: 
      [Background] This research team would like to conduct this study based on the idea that the
      sensitivity of breast palpation can be improved by moving away from traditional breast
      palpation, which is simply performed by hand, and using auxiliary examination equipment based
      on ultrasonic sensor technology. In particular, our research team focused on the waveform of
      the ultrasound itself rather than the visual images obtained through the ultrasound device.
      In the existing breast ultrasound, the medical staff reads images created through ultrasound
      from multiple sensors to confirm the possibility of breast cancer, and this is read based on
      the medical staff&#39;s very subjective opinions. However, ultrasonic waveforms acquired
      through ultrasound can store information about the waveform as data and thus be implemented
      as objective values.

      [Study design] Prospective, multi-institutional

      [Study protocol]

      ① Preoperative ultrasound sensor-based diagnostic equipment was applied to 200 patients with
      breast mass among patients admitted to the breast surgery department, and prospectively
      obtained ultrasound echo signal data generated by the mass.

      ② For this purpose, the researcher uses equipment containing a single ultrasound sensor to
      manually scan the mass lesion area and no evidence disease area.

      ③ Diagnostic performance (judgment for presence or absence of a tumor) of diagnostic tool
      based on ultrasound sensor technology through an artificial intelligence algorithm designed
      based on ultrasound wavelength and frequency optimized for mass detection.

      [Objectives]

        1. Primary endpoint Sensitivity/specificity/predictive value/accuracy/positive &amp;
           negative predictive of diagnostic performance

        2. Secondary endpoint Artificial intelligence algorithm efficacy
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent Idiopathic Scoliosis (AIS) can change the respiratory dynamics and performance of
      the inspiratory and expiratory muscles, affecting ventilatory capacity. This was a
      randomized, controlled, open study to test the impact of a physiotherapeutic program of
      aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic
      scoliosis. Patients with AIS were randomly assigned to the aerobic exercise-training program
      group or the no treatment group. There was a significant increase in Pimax and Pemax in the
      group which received physiotherapy.
    

Detailed description: 
      Study Design: This was a randomized, controlled, open study to test the impact of a
      physiotherapeutic program of aerobic exercises on respiratory muscle strength, in patients
      with adolescent idiopathic scoliosis (AIS). Objective. To analyze, by means of maximum
      respiratory pressure measurements, the conditioning of the respiratory muscles after four
      months of aerobic exercise training. Summary of Background Data. AIS can change the
      respiratory dynamics and performance of the inspiratory and expiratory muscles, affecting
      ventilatory capacity.

      Methods: Patients with AIS, aged between 10 and 20 years, were randomly assigned to the
      aerobic exercise-training program group or the no treatment group. They were evaluated for
      respiratory muscle strength before and after the treatment period, by means of a manometer,
      and radiographs of the chest and spine. The physical therapy exercise protocol consisted of
      three weekly sessions, including stretching, aerobic exercises (first mild and then
      accelerated) and relaxation techniques, for a period of four months.
    

Intervention name(s): Aerobic exercise program
Intervention type(s): Other
Intervention description(s): Three weekly sessions, with an interval of one day between each, lasting 60 minutes each, and divided into three separate stages: - A 10-minute warm-up (stretching and low intensity aerobic exercises such as slow, gradual walking); - 40 minutes of aerobic exercise on an electric treadmill, with the work intensity maintained at a 60% to 80% of the maximum heart rate; - 10 minutes of winding down and relaxation (stretching exercises, low energy expenditure aerobics and relaxation techniques).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scoliosis; Muscle Strength; Respiratory function tests; Exercise therapy
Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making
      tumor cells more sensitive to the drug.

      PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating
      patients who have prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer
      treated with calcitriol and carboplatin. II. Determine the palliative response in patients
      with cancer-related pain treated with this regimen. III. Determine the response in patients
      with bidimensionally measurable disease treated with this regimen. IV. Determine the duration
      of prostate-specific antigen, palliative, and measurable disease responses in patients
      treated with this regimen. V. Determine the survival of patients treated with this regimen.
      VI. Assess the quality of life of patients treated with this regimen. VII. Determine the
      qualitative and quantitative toxic effects of this regimen in these patients.

      OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day
      2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease
      progression. Quality of life is assessed at baseline and then every 4 weeks until disease
      progression. Patients are followed every 4 weeks until disease progression and then every 3
      months thereafter.

      PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
    

Intervention name(s): calcitriol; carboplatin
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Calcitriol; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer
The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment
Condition: Patient Compliance
Study type: Interventional

Summary: 
      this study is a randomized clinical trial to evaluate the effect of sending weekly reminders
      to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and
      participants of the study will be divided between the two groups randomly. the intervention
      group will receive weekly reminders about the importance of oral hygiene and appliance care
      with adherence to scheduled appointments. the difference between these parameters will be
      evaluated between the control and intervention groups to describe the importance of weekly
      reminders to enhance the compliance and cooperation of the patient. the oral hygiene of the
      patient will include plaque level(plaque index), gingival statue level( bleeding index), and
      white spot lesion . appliance care will be recorded when in case of bracket failure and
      appointments missed will also be recorded .
    


Intervention name(s): weekly mobile reminder
Intervention type(s): Other
Intervention description(s): a weekly reminder will be sent to participants in the intervention group via mobile internet applications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: patient compliance; orthodontic patients; reminder
The Effect of Rosuvastatin on Adenosine Metabolism
Condition: Adenosine Metabolism
Study type: Interventional

Summary: 
      The aim of this study is to show whether rosuvastatin influences adenosine metabolism.
      Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation
      by increased adenosine receptor stimulation.
    


Intervention name(s): placebo; rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 1 dd for 7-10 days; 1 dd 20 mg for 7-10 days
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: rosuvastatin; dipyridamole; caffeine
Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
Condition: Androgens (Deficiency); Male
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of a testosterone replacement therapy
      called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and
      other symptoms of PADAM and safety will be studied.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Testogel (Testosterone, BAYV001915); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months; 5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial androgen deficiency of aging males (PADAM)
Optimal Time for Staple/Dressing Removal
Condition: Surgical Wound Healing; Surgical Wound Infection; Patient Satisfaction
MeSH terms: Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Observational

Summary: 
      The medical literature does not provide sufficient information or recommendation regarding
      the optimal time to remove the staples and the bandage after a cesarean section. The goal of
      this study is to compare 5 groups of patients:

        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1

        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4

        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1

        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7

        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

      Since there is no definite protocol for staple and dressing removal, we will adapt the above
      protocol each for a 3-4 month period of time. Patients will be contacted to either return for
      a follow up visit or to answer a telephone survey.
    


Intervention name(s): questionnaire
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing a cesarean section at our facility
      
Keywords: Caesarian section; Surgical Wound
CTCs in Cervix Cancer
Condition: Cervical Cancer; HPV
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      This study is a validation study to confirm the ability of Telomescan OBP-401 to identify
      CTCs in patients with HPV 16 / 18 associated cervical cancer. CTCs identified will be tested
      for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.
    


Intervention name(s): Blood Assayed for CTCs
Intervention type(s): Diagnostic Test
Intervention description(s): All study participants will have 15 mL of blood drawn for the purpose of the study.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Two groups will be recruited: the case group will consist of 16 participants with advanced
        or recurrent cervical cancer; the control arm will consist of 16 participants without a
        history of cervical cancer or high grade pre-cancer of the cervix.
      
Biospecimen description: 
      DNA will be used to test CTCs identified for the presence of the HPV 16 / 18 E6 protein,
      confirming a cervical cancer origin.