bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Assess the impact of midodrine administration on weaning of IV vasopressors

        2. Assess the cost effectiveness of using midodrine in critically ill patients
    

Detailed description: 
      A prospective randomized controlled clinical trial on total 60 critically ill patients
      admitted to critical care medicine department with indication to IV vasopressor due to septic
      shock on admission or during intensive care unit stay and they are randomly assigned to
      either of 2 groups as follows

        1. Group 1(n=30):will receive IV vasopressor infusion only

        2. Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion
    

Intervention name(s): Midodrine
Intervention type(s): Drug
Intervention description(s): The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge
Intervention MeSH terms: Midodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Midodrine; Septic shock; Norepinephrine; Weaning
Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD.
      However, although these interventions can be helpful, many patients remain symptomatic
      despite initial treatment. In this study, we will examine the relative efficacy of the
      addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a
      brief and intensive course of cognitive-behavioral therapy (CBT).
    

Detailed description: 
      This is a systematic controlled study examining the use of augmentation with pharmaotherapy
      for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study
      include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to
      ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the
      tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in
      patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6
      months follow-up to randomized treatment. Patients will initially have intensive (8 sessions
      over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied
      to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in
      conjunction with additional 5 sessions of prolonged exposure over 10 weeks.
    

Intervention name(s): Cognitive-behavioral therapy and paroxetine-CR
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PTSD; Anxiety; CBT; Exposure; Paroxetine; Paroxetine-CR
Appropriate Gestational Weight Gain in Overweight/Obese Women
Condition: Gestational Weight Gain
MeSH terms: Overweight; Body Weight; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy
      diet and physical activity for helping overweight/obese pregnant women to achieve appropriate
      gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the
      intervention is to help women achieve the lower bound of the GWG range recommended by the
      Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese
      women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2
      in-person counseling sessions and 11 telephone contacts with study dieticians trained in
      motivational interviewing techniques. The lifestyle intervention will be compared to usual
      medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks
      and 32 weeks gestation, within several days of delivery and at 6 months and 12 months
      postpartum.
    


Intervention name(s): Lifestyle Intervention; Usual Care
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gestational weight gain; Lifestyle; Intervention
The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the analgesic effect of GW493838 in patients with
      post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.
    


Intervention name(s): GW493838
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: neuropathic pain
Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Condition: Persistent Postsurgical Pain; Breast Cancer Female; Ductal Carcinoma in Situ
MeSH terms: Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Pain, Postoperative
Study type: Interventional

Summary: 
      The proposed study will be a pilot randomized controlled trial comparing treatment as usual
      (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention
      (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing
      persistent post-operative pain. The ACT intervention is a single individual therapy session
      scheduled two weeks following surgery. Potential participants will be recruited from the
      University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be
      recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the
      study is 72 participants. Study measures will consist of self-report questionnaires and
      medical record data. Data will be collected prior to surgery, one-week after surgery, and 3
      months after surgery.
    

Detailed description: 
      Psychological interventions addressing depression, anxiety, and psychological approaches to
      pain management in pre-surgical patients may serve to prevent the development of persistent
      post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment
      Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing
      the impairing impact of chronic pain and in treating depression and anxiety. ACT is a
      behavior therapy incorporating mindfulness, which aims to increase psychological flexibility
      via facilitating psychological acceptance and committed action in the direction of one's
      personally identified values. ACT has also shown promise in brief interventions, including a
      one day ACT workshop with patients with comorbid migraine and depression. The current study
      proposes to identify pre-operative breast cancer patients who are at increased risk for
      developing persistent post-surgical pain and to offer a brief ACT intervention with the aim
      of reducing the incidence of persistence post-surgical pain and psychological sequela.
    

Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): Single 2-hour individual Acceptance and Commitment Therapy coping skills session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Prevention
Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml
      inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under
      conditions of daily practice
    


Intervention name(s): Atrovent® Inhalation Solution
Intervention type(s): Drug
Intervention MeSH terms: Ipratropium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic obstructive airways disease recruited at pneumologists and internists
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      In the scoliosis screening program of the Student Health Service (SHS), Department of Health
      (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray
      examination basing on the screening protocol did not have Cobb angle greater than the
      referral threshold of 20°; ie they did not need specialist referral and thus were subjected
      to unnecessary x-ray exposure. Our primary objective is to determine whether a new
      radiation-free ultrasound system could identify subjects with Cobb angle greater than the
      referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The
      secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the
      accuracy of ultrasound assessment.
    


Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Scolioscan, the ultrasound system reported to be reliable and valid for spinal deformity assessment, will be used. The system composes of an ultrasound scanner with a linear probe of 100 mm in width and frequency range of 4-10MHz, a frame structure and a spatial sensor which is attached to the ultrasound probe for spatial data capture. Daily calibration will be performed using a phantom to assure accuracy of spine image formation and subsequent angle measurement.
Subjects will stand on the Scolioscan platform with a standardized posture kept stable with pegs throughout the scanning process.. After adjusting the ultrasound scanner setting, the probe will be steered from L5 to T1 spinous process for scanning.
SPA will be used to determine the ultrasound-based Referral Status through predicting whether the Cobb angle is beyond the referral threshold of ≥20° or not. There are two values for the Referral Status: either "for specialist referral" or "not for specialist referral".
Other intervention name(s): Scolioscan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Study With and Without Application of a Urinary pH Acidification Regimen
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

        -  To assess the influence of acidified urinary pH on the renal excretion of Neramexane

      Secondary:

        -  To assess the influence of acidified urinary pH on the renal excretion of N-OH
           Neramexane

        -  To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH
           Neramexane under physiological conditions and under the conditions of urine
           acidification

        -  To assess safety and tolerability of a repeated dose treatment of Neramexane under
           physiological conditions and under the conditions of urine acidification
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): 25 mg or 2x25mg tablets
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single site, Phase I, masked, randomized study to evaluate the safety and
      tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy
      adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth
      twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study
      visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be
      asked about any medical problems that have come up since the last study visit, have vital
      signs taken, review current medication use, and review any signs of potential adverse events.
      Blood and urine samples will also be collected at these visits, as well as throat and stool
      samples.

      Our goal is to assess the safety and tolerability of LGG when administered to healthy adult
      volunteers twice a day. Assessment of safety will be determined by vital sign measurements,
      physical examinations, clinical laboratory tests, and from the incidence and severity of
      adverse events that occur during study participation. Additionally, we will assess whether
      LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess
      the effect of LGG on the bacteria that normally live in the throat and GI tract by using
      culture-independent techniques. Volunteers enrolled in this study will also be invited to
      participate in a companion genetic study that will investigate the host immune response to
      the bacteria in LGG.
    


Intervention name(s): Lactobacillus rhamnosus GG ATCC 53103; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day dissolved in cow's milk or soy milk on an outpatient basis for six months.; Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis for six months.
Other intervention name(s): Culturelle; LGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Healthy adult volunteers; Lactobacillus rhamnosus GG; probiotic; dietary supplement; safety; Safety Assessment
Gastric Emptying and Insulin Response to Test Drink
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Surgery is a stress on the body and recovering well after surgery is very important to
      patients and their doctors. It is therefore important to prepare patient's bodies for the
      stress of surgery, and one way to do this is to provide proper nutrition. In the past,
      patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it
      is known that this practice is not beneficial to patient's recovery. In fact, it has been
      recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the
      production of insulin, which is a hormone that helps make the proteins needed for wound
      healing after surgery. This is currently practiced at the MUHC. It might also be beneficial,
      however, to drink a beverage that contains sugar and whey proteins (a protein isolated from
      milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added
      benefit of improving muscular strength. In this study, investigators will measure the level
      of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to
      determine how it compares to the level of insulin produced after drinking the sugary beverage
      used at the MUHC.
    

Detailed description: 
      It is hypothesized that the increase in plasma insulin following a mixed carbohydrate whey
      protein drink is significantly greater than that elicited by a carbohydrate drink.
    

Intervention name(s): Carbohydrate based drink; Whey protein based drink
Intervention type(s): Other; Other
Intervention description(s): After consumption of the test drink to record the insulin response and gastric emptying.; After consumption of the test drink to record the insulin response and gastric emptying.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Condition: Cannabis Toxicology
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This primary aim of this study is to assess the effects of passive (second-hand) inhalation
      of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood
      specimens. The results of this study will help inform the validity of oral fluid as a
      biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation
      of cannabis smoke could result in a positive toxicology result.
    


Intervention name(s): Cannabis
Intervention type(s): Drug
Intervention description(s): Participants will be exposed to cannabis smoke present in ambient air
Other intervention name(s): Marijuana
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between subjects Phase I study
Masking: Single (Participant)
Primary purpose: Diagnostic
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution
Condition: Ocular Hypertension; Primary Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics
      and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in
      adults. The study is a double-masked, multiple- ascending dose trial and will enroll four
      cohorts of up to 12 subjects. Dose cohorts will receive increasing doses of AKB-9778
      ophthalmic solution or vehicle-matched placebo daily for 7 days. Cohort 5 will enroll
      subjects with open angle glaucoma or ocular hypertension who will continue current
      prostaglandin therapy during the study. Cohort 5 subjects will receive the maximum tolerated
      dose from the previous cohorts.
    


Intervention name(s): AKB-9778 Ophthalmic Solution; Placebo Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): AKB-9778 Ophthalmic Solution; Matched vehicle-control
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia
Condition: Stomach Neoplasms; Metaplasia
MeSH terms: Stomach Neoplasms; Metaplasia
Study type: Interventional

Summary: 
      The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high
      risk group of gastric cancer. Many methods was developed to survey it, including multiple
      gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine
      screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used
      in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The
      investigators have confirmed such whitish discoloration is induced in gastric IM, with
      accuracy > 80% in a pilot study of the investigators. This prospective study will tell the
      accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.
    


Intervention name(s): Acetic acid chromoendoscopy
Intervention type(s): Procedure
Intervention description(s): Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
Intervention MeSH terms: Acetic Acid; Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Mass Screening; Endoscopy, Gastrointestinal; Stomach Neoplasms; Metaplasia; Diagnosis; Acetic acid; Chromoendoscopy
Qigong Therapy for Individuals With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient
      Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis
      (OA).

      Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater
      symptom improvement than sham treatment. 2) Individuals with a history of complementary and
      alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy
      than those without such experience.
    

Detailed description: 
      OA is the leading cause of disability in the United States. Standard treatment for OA is drug
      therapy; however, cost, side effects, and varying levels of effectiveness warrant the need
      for development of new treatments. Qigong therapy, which involves deep meditation, breathing
      exercises, and the harnessing of energy, may be an effective treatment for OA.

      According to traditional Chinese medicine, Qi (Chi) is the "life force" that flows through
      the body and keeps people healthy and vital. In the practice of traditional Chinese medicine,
      arthritis is thought to be due to a blockage of the flow of Qi or a buildup of abnormal or
      damaging Qi. It is believed that releasing this buildup or breaking the blockage of Qi
      through Qigong therapy may relieve OA symptoms.

      Participants will be randomly assigned to receive five sessions of either Qigong therapy or
      sham treatment over a period of 2 weeks. During Qigong therapy, a therapist will send his or
      her Qi to the arthritic knees through touch and meditation. Similar body work will be
      performed during the sham treatment, but no Qi will be harnessed. Self-report scales that
      measure pain, stiffness, anxiety, daily drug use, CAM use, and overall functioning will be
      used to assess participants. The assessments will occur at study start and at a 3-month
      follow-up visit.
    

Intervention name(s): External Qigong therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Knee pain; Arthritis; Qigong; Qi; Meditation; Breathing Exercises