bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Distant Healing in Glioblastoma Treatment
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess whether distant healing effects survival time and loss of function for
      glioblastoma patients.
    

Detailed description: 
      Prayer, energy healing, and spiritual healing are widely used for all degrees of illness.

      Eisenberg (1998) reported that more that 26% of his survey sample used "energy healing"
      within the last year. Most of these practitioners believe that their inner intentions result
      in the benefits, either through the agency of love, energy, or a Higher Power (Benor 1992).
      However, the conventional community attributes benefits from these interventions to the
      patient's hope, expectation, or experience of support from a practitioner (Benson 1996). The
      proposed study is a double-blind randomized controlled clinical trial of "distant healing
      intentionality." Distant Healing (DH) is defined as a "mental intention on behalf of one
      person, to benefit another at a distance." This study will assess whether DH effects survival
      time and loss of function for glioblastoma patients under conditions where hope and
      expectation are controlled. The study will include approximately 150 patients who have
      rapidly progressing glioblastoma and are beginning radiotherapy. Patients will be
      photographed and assessed for quality of life, psychological status, and physical symptoms as
      well as health habits and attitude toward DH. After stratification by age and functional
      status (Karnofsky score), patients will be randomly assigned to either standard treatment
      with or without DH. Healers from diverse schools and backgrounds from communities across the
      United States will be assigned to patients by rotation, so that each patient in the DH group
      will be treated for two weeks by 10 different healers over the 20 week intervention.
      Experienced healers will have photographs of subjects and send "mental intention for health
      and well being" to subjects for one hour daily, three times per week. The healing
      intervention will be performed at a distance, and patients and healers will never meet, nor
      will patients know their group assignment. The study findings will provide the basis for
      developing a larger study, definitive trial.
    

Intervention name(s): Distant Healing
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Keywords: Glioblastoma; Brain tumor; Distant healing; Distance healing
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Condition: Gastritis Acute; Gastritis Chronic
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or
      Chronic Gastritis
    


Intervention name(s): Test(DW1401); Reference(Stillen tab.)
Intervention type(s): Drug; Drug
Intervention description(s): DW1401+Placebo of Stillen tab.; Stillen tab.+Placebo of DW1401
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)
Condition: Catheter Related Complication
Study type: Interventional

Summary: 
      investigators aim to compare the efficacy of intrathecal morphine, intravenous tramadol and
      transversus abdominis plane block in the treatment of catheter related bladder discomfort
      syndrome in patients scheduled for robotic assisted laparoscopic prostatectomy
    

Detailed description: 
      patients scheduled for robot assisted laparoscopic prostatectomy will be treated depending on
      the belonging group. In the morphine group patients will receive intrathecal morphine 0,15
      mg; in the transversus abdominis plane block patients will receive ropivacaine 80 mg; in the
      tramadol group patients will receive intravenous continuous infusion of tramadol 400 mg for
      the first 24 hours postoperatively. All data will be collected in the post anesthesia room
      and in the ward until the first post operative day.
    

Intervention name(s): intrathecal infusion; Intravenous Infusion; Ropivacaine injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): morphine 150 mcg will be used by intrathecal administration; tramadol administration; bilateral transversus abdominis plane block by using ropivacaine 80 mg
Other intervention name(s): morphine; tramadol; transversus abdominis plane lock
Intervention MeSH terms: Morphine; Tramadol; Ropivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment
Condition: Dentin Sensitivity; Periodontal Diseases
MeSH terms: Periodontal Diseases; Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of
      dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a
      period of 8 weeks.
    

Detailed description: 
      This study aim was to determine the efficacy of two Oral Hygiene Regimens in the reduction of
      dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a
      period of 8 weeks. The study was conducted in Piracicaba Dental School, Piracicaba, São
      Paulo, Brazil, using a double-blind/two treatment design. Sixty subjects (30 per group) that
      meet the inclusion and exclusion criteria were assigned to the groups: Test group
      (Non-surgical periodontal treatment + In-office application of Colgate Sensitive Pro-Relief -
      CSPR + tooth brushing with at home CSPR toothpaste) and Control group (Non-surgical
      periodontal treatment + In-office application of a fluoride-free prophy paste + tooth
      brushing with a Colgate Cavity Protection Toothpaste). Air blast sensitivity assessments were
      used to compare the efficacy of the two approaches using both the Schiff scale. The
      sensitivity parameters were measured at baseline, 1, 4 and 8 weeks.
    

Intervention name(s): In-office and at home Colgate sensitive pro-relief - CSPR; In-office Villevie® prophy paste + Colgate Toothpaste; Non-surgical periodontal treatment
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Prophylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.; Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.; Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments
Other intervention name(s): CSPR; Colgate Cavity Protection Toohtpaste
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dentin hypersensitivity; Periodontal disease; Arginine
Treadmill Stress Test With and Without Mask
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess if wearing a surgical mask affects the results of a
      standard treadmill test.
    

Detailed description: 
      The persons interested to participate will be informed of the implication and potential risks
      associated with the study. The participants that accept and meet the eligibility criteria
      will give written consent and be randomized into two groups. One group will first perform a
      treadmill test with a surgical mask and then repeat the test without a mask. The second group
      will do the first treadmill test without a mask and the second one with a surgical mask.
    

Intervention name(s): Treadmill test (Bruce protocol)
Intervention type(s): Diagnostic Test
Intervention description(s): Treadmill test performed with and without a mask.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Treadmill; Bruce; COVID-19; Mask; Healthy; Adults; METS; Metabolic equivalent; Borg; Exercise; Stress test
Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and tolerability between clopidogrel
      resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD
      equivalents.
    


Intervention name(s): aspirin + pregrel (Clopidogrel resinate); aspirin + placebo; aspirin + plavix (Clopidogrel bisulfate)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Aspirin: Aspirin Protect (Bayer) 100mg; Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg; aspirin : Aspirin Protect (Bayer) 100mg; plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHD; CHD equivalents
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and immune response to a single
      intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3)
      in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.
    


Intervention name(s): RSV MAT 60 µg; RSV MAT 120 µg; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.; One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.; One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators are conducting a research study to see if increasing the amount of nitrate
      (a substance found in large quantities in certain vegetables) in the diet can increase the
      ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D
      find exercise more uncomfortable than individuals who do not have T2D. This may be explained
      by the experimental studies showing that T2D can result in reductions in the supply of oxygen
      to the muscles. Studies have also shown that for a given level of activity, individuals with
      T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary
      nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of
      dietary nitrate on the responses to exercise may have a significant impact on the ability of
      individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2)
      experimental studies suggest that increased nitrate consumption has been shown to reduce the
      amount of oxygen required for a given level of exercise.

      The investigators will recruit 60 individuals with T2D. These people will take part in a
      randomised crossover design study where they will be asked to drink normal beetroot juice
      (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different
      walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).
      This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen
      required for a given level of exercise in individuals with T2D. To test brain function
      individuals will be asked to perform a standard computerised decision making task following
      consumption of the nitrate rich and nitrate depleted juices.
    


Intervention name(s): Beetroot
Intervention type(s): Dietary Supplement
Other intervention name(s): James Whites Drinks beetroot sports shot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess functionality, performance, and reliability of an
      accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in
      an at-home setting reported by the patient or caregiver, and to confirm the safety and
      clinical benefit of benralizumab administration in asthma patients with severe asthma.
    


Intervention name(s): Benralizumab
Intervention type(s): Biological
Intervention description(s): Benralizumab administered subcutaneously every 4 weeks
Intervention MeSH terms: Benralizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases,; Benralizumab
Safety and Efficacy of C21 in Subjects With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety
      and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need
      of mechanical invasive or non-invasive ventilation.

      In total, approximately 100 subjects will be enrolled and randomised to receive twice daily
      oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50).
      Subjects will be treated for 7 days.
    


Intervention name(s): C21; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): C21; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19
Reducing the Abuse Liability of Prescription Opioids
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly
      abused substances in the United States. Patients who take opioids for legitimate reasons may
      become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid
      dependence. It is very important that a way is found to provide pain relief while minimizing
      the addiction potential of these widely used pain medications.

      The study aim to find out if the use of another type of medication given in addition to an
      opioid will reduce the addiction potential of the opioid.

      The study is trying to find out if the ability of the opioid to relieve pain is changed when
      given with the other medication, and to see if the euphoric sensation or "liking" of the
      opioid pain medication is reduced when taken with the other medication.
    

Detailed description: 
      This study involves the use of an investigational combination of drugs. "Oxycodone with
      Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S.
      Food & Drug Administration (FDA) has not approved these drug combinations for the purpose of
      this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e.
      oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic
      medications), but the administration of these drugs together has not been studied before or
      been approved by the FDA for this purpose.

      This is the first study involving humans to examine the safety of this combination of drugs
      and how they work together. The goal of the study is to find out what effects, good and/or
      bad, it has on people who take them. Because the combination has not been studied in humans
      before, information about the safety and effectiveness is incomplete and all of the side
      effects are not yet known.
    

Intervention name(s): Risperidone; Ziprasidone; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Risperidone 1mg to be used in combination with other drugs; Ziprasidone 80mg to be used in combination with other study drugs; Oxycodone alone in a capsule will be considered the control. Oxycodone 15 mg will also be used in combination with other study drugs
Other intervention name(s): Risperdal; Geodon; Oxycontin
Intervention MeSH terms: Oxycodone; Risperidone; Ziprasidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid
Long Term Results After Sleeve Gastrectomy
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it
      is gaining popularity as a single procedure. Long term data is scarce. In this retrospective
      study long term follow-up in relation to weight loss, comorbidities, re-do and revisional
      surgery is getting analyzed.
    

Detailed description: 
      Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it
      is gaining popularity as a single procedure. Long term data is scarce.

      Re-Do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass,
      roux-en y gastric bypass) and biliopancreatic diversion (BPD) is described in the current
      literature due to weight regain and reflux. The investigators want to analyze the frequency
      of this re-do/revisional surgery and want to compare weight loss and improvement in
      comorbidities.
    

Intervention name(s): laparoscopic sleeve gastrectomy
Intervention type(s): Other
Intervention description(s): laparoscopic sleeve gastrectomy
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent sleeve gastrectomy since 2007, being the first szrgical treatment
        for severe obesity are studied in the long term follow-up
      
Keywords: sleeve gastrectomy; long-term follow-up; gastroesophageal reflux disease after sleeve; revisional surgery
Safety Study of the Drug RG1068 in Patients With Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of RG1068 (Synthetic
      Human Secretin) when administered three times weekly to outpatients with obsessive compulsive
      disorder (OCD), to determine the impact of multiple subcutaneous injections of RG1068 on the
      symptoms of OCD, as measured by changes in clinical scales, and to evaluate the effect of
      RG1068 on ODC patients' anxiety, quality of life, and depression.
    

Detailed description: 
      This is an open-label, dose-escalation pilot study. Prospective participants will initially
      undergo a blinded placebo challenge to assess his or her ability to self-administer drug. A
      total of sixteen subjects, will be enrolled in one of two study arms (eight subjects per
      group), depending on whether or not they are receiving concurrent treatment with an SSRI. The
      first 8 patients enrolled will receive subcutaneous injections of RG1068 at 10 µg/kg and will
      be divided between those receiving SSRI's and those not receiving SSRI's. Those not receiving
      SSRI treatment will further be divided between newly diagnosed, SSRI-naïve patients and
      patients who received SSRI's in the past but who have discontinued treatment for at least
      twelve weeks prior to enrollment. If there are no drug-related serious adverse events, an
      additional eight patients will be enrolled and receive RG1068 at 20 µg/kg. This group will
      also be divided between those receiving SSRI's and those not receiving SSRI's. Those not
      receiving SSRI treatment will be further divided in the same manner as before; newly
      diagnosed, SSRI-naïve patients, and patients who received SSRI's in the past but who have
      discontinued treatment for at least twelve weeks prior to enrollment.
    

Intervention name(s): RG1068 (Synthetic Human Secretin)
Intervention type(s): Drug
Intervention MeSH terms: Secretin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Obsessive Compulsive Disorder; RG 1068 (Synthetic Human Secretin)
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
Condition: Heart; Decompensation, Right Ventricle; Echocardiography; Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The aims of the study is to investigate the right ventricular responses to mild hypercarbia
      after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial
      catheter and transesophageal echocardiography.
    

Detailed description: 
      The aims of the study is to investigate the right ventricular responses to mild hypercarbia
      after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial
      catheter and transesophageal echocardiography. Investigators hypothesize that induced mild
      hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary
      vascular resistance, and this reflect to the right ventricle, both volume and function. And
      this right ventricle effect could be noticed by echocardiography.
    

Intervention name(s): Hypercarbia
Intervention type(s): Procedure
Intervention description(s): PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment