bioihbjkbjnl/mcl2 huggingface dataset:
Intrapartum Hydration
Condition: Labor Stage, First; Labor Stage, Second
Study type: Interventional

Summary: 
      The purpose of this study is to determine that maternal hydration during labor with fluids
      containing glucose at a rate of 125 ml per hour does not affect the duration of labor
      compared to Ringer Lactate at a rate of 250 ml per hour.
    

Detailed description: 
      During labor it is a common practice that the parturient is fastening and having fluid
      replacement through intravenous hydration (IVH), the rational being to avoid aspiration of
      gastric content in a situation of need for urgent intervention and general anesthesia with
      tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution
      that does not contain sugar, but the volume is not adjusted to the weight of mother, the
      level of effort or relaxation she is experiencing and it may well be below the required
      amount. From studies in the field of sport medicine it is clear that the amount of fluid
      reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and
      the level of personal achievement in sports. Only few studies dealt with the amount and
      contents of IVH during labor that will be sufficient and meet all physiologic requirements of
      the parturient and her fetus.
    

Intervention name(s): 0.9% Saline with glucose 5%; Ringer lactate; Ringer lactate - Controls
Intervention type(s): Other; Other; Other
Intervention description(s): intravenous hydration at a rate of 125 ml per hour during labor; intravenous hydration at a rate of 250 ml per hour during labor; intravenous hydration at a rate of 125 ml per hour during labor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effects on emotions and neural activity of a one time dose of
      intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
    

Detailed description: 
      Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and
      emotional responses. The usual treatments for Frontotemporal dementia focus on reducing
      agitation and aggressive behaviours. However, these drugs do not help all patients who
      experience blunting of emotion and loss of empathy. This study will evaluate the effects on
      emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in
      patients with FTD and healthy controls.
    

Intervention name(s): Intranasal oxytocin; Saline Nasal Mist
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.; Participants will be randomized to receive placebo on either study visit 2 or 3.
Other intervention name(s): Syntocinon; Placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Frontotemporal Dementia; emotion; oxytocin; fMRI
Perioperative Ketamine for Pain With Gastric Bypass
Condition: Laparoscopic Gastric Bypass Surgery; Ketamine
Study type: Interventional
Phase: Phase 2

Summary: 
      Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain
      after surgery, however there are disadvantages. Because of the way opioids work, gastric
      bypass patients may have an increased risk of having sedation or problems with breathing. In
      patients with sleep apnea, opioids may increase the risk of severe apnea.

      Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may
      have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice
      for laparoscopic gastric bypass patients.

      This study is being done to find out if intraoperative ketamine infusion combined with
      continuation for twenty-four hours post-surgery provides superior pain control and decreases
      post-operative opioid use versus standard non-ketamine therapy.
    


Intervention name(s): Ketamine; Standard therapy
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
Ketamine infusion not titrated.; Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses.
Other standard surgical post-op care
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary objective is to determine if meals of different fat and fiber content affect
      postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our
      hypothesis is that a high-fiber meal will have a greater reduction in testosterone
      composition compared with a high-fat meal.
    

Detailed description: 
      The study participants are 15 women with PCOS between the ages of 19-40. All participants
      must be in good health, non-smokers, and not pregnant or lactating. For three days prior to
      both study visits, participants follow a standard 2,000 calorie meal plan of approximately
      30% fat, 55% carbohydrate and 15% protein. On the morning of the two study visits,
      participants arrive at the General Clinical Research Center at 0700 h. A venicatheter is
      inserted into an antecubital vein for collection of blood samples and the catheter is kept
      open with saline. A baseline blood sample is taken for measurement of estradiol,
      progesterone, glucose, insulin, testosterone, and sex hormone binding globulin (SHBG).
      Participants are then served the test meal and asked to consume it within 15 minutes. The
      high-fat, low-fiber and low-fat, high-fiber meals are isocaloric and are 62% and 6% fat, 24%
      and 81% carbohydrate, and have 1g and 26.8g of fiber, respectively. After each meal, a blood
      sample is taken at 30 minutes and every hour for six hours for measurement of testosterone,
      SHBG, glucose and insulin. During this time participants remain comfortably seated or
      reclined. After the last blood draw, the catheter was removed and participants are given a
      complementary meal.
    

Intervention name(s): Meal Composition
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meal; composition; postprandial; PCOS; androgen
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Currently marketed CGM sensors have an approved functional lifetime of up to 1 week.
      Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to
      accurately monitor glucose levels for 30 days. The purpose of this study is to assess the
      safety and functionality of the device in human patients for consecutive 15 days.

      GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration,
      meaning less patient interventions, and is therefore will be much more user friendly.
      Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the
      critically important hypoglycemic range, meaning that better management of patient's
      condition may be attained.
    

Detailed description: 
      GluSense-LTone 2e3 is a continuous glucose monitoring (CGM) system. It is a semi-invasive,
      optical fiber-based device with a lifetime of up to one month. The purpose of this study is
      to assess the safety, accuracy, calibration requirements and effective lifetime of the
      device.
    

Intervention name(s): Boost Nutritional Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Boost- Nutritional Supplement
Other intervention name(s): boost HP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      First randomization:

      After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all
      courses of chemotherapy (induction, consolidation courses before ASCT)

      Second randomization:

      After achieving 1st CR: all patients received non intensive consolidation course Familial HLA
      typing required for all patients

      Patients with HLA-identical sibling:

      Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st
      CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR;
      received 2 more courses of intensive consolidation chemotherapy All others patients received
      an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative
      conditioning regimen For patients aged over 51 and less than 61= arm m: intensive
      chemotherapy consolidation course.
    


Intervention name(s): Zavedos; Cerubidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Daunorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia in first complete remission
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to people with and without liver problems. People can join the study if
      they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.

      Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of
      the brain. The purpose of this study is to find out whether having liver problems influences
      how iclepertin is taken up in the body. All participants take iclepertin once as a tablet.

      Participants are in the study for 2 to 3 weeks. During the first part of the study, they stay
      at the study site for 4 nights. Afterwards, there are 5 visits to the study site and 1 call.
      The site staff measures the amount of iclepertin in the blood. The doctors also regularly
      check participants' health and take note of any unwanted effects.
    


Intervention name(s): BI 425809 (iclepertin)
Intervention type(s): Drug
Intervention description(s): BI 425809 (iclepertin)
Intervention MeSH terms: BI 425809
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Guided Imagery and Progressive Muscle Relaxation as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer
Condition: Breast Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Guided Imagery and Progressive Muscle
      Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety
      and depression in patients with either prostate or breast cancer.

      This study includes a total of 200 patients with prostate and breast cancer randomly assigned
      to either a control or intervention group.

      The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a
      cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle
      progressively tensing and relaxing).

      Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and
      quality of life. Additionally, saliva samples were collected prior and after the sessions as
      to assess saliva cortisol and saliva α-amylase.

      The same measurements were received by the patients of the control group as to allow
      comparisons.
    


Intervention name(s): Guided Imagery and Progressive Muscle Relaxation
Intervention type(s): Other
Intervention description(s): 4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: guided imagery; progressive muscle relaxation; complimentary and alternative medicine; quality of life; stress; pain; anxiety
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the potential effect that the administration of food or antacid medication may
      have in the oral absorption of dacomitinib relative to the administration of dacomitinib in
      absence of food or antacid medication
    


Intervention name(s): dacomitinib fasted; dacomitinib fed; dacomitinib+antacid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Overnight fasted subjects will receive a single 45 mg dose of dacomitinib; Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal; Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dacomitinib; PF-00299804; fed; fasted; antacid; relative Bioavailability
The Effect of Under-nutrition on the Human Microbiota
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a difference exists in the gut, oral,
      vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy
      and obese pregnant women. In addition, the investigators are setting out to determine if a
      micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of
      under-nourished pregnant women.
    


Intervention name(s): Moringa and Lactobacillus rhamnosus GR-1
Intervention type(s): Dietary Supplement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Gut microbiome; Vaginal microbiome; Oral microbiome; Human milk microbiome; Nutritional Status
Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I
Condition: Complex Regional Pain Syndrome, Type I
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the
      treatment of pain associated with complex regional pain syndrome type I (CRPS-I).

      The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and
      an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended
      follow-up period will be terminated for all participants after the last participant enrolled
      completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the
      12-week trial period and extended follow-up period.
    


Intervention name(s): Placebo; Neridronic acid 62.5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo administered as intravenous infusion.; Neridronic acid administered as intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neridronic Acid; Neridronate; CRPS; RSD
Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.
Condition: Pelvic Floor Muscle Weakness; Urinary Incontinence in Old Age; Sexual Dysfunction; Quality of Life
MeSH terms: Muscle Weakness; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Alteration of hormonal structure and decreasing of muscle tissue with aging causes pelvic
      floor dysfunction. Over age of 65 so many factors such as decrease in volume of muscle
      tissue, decrease in the amount of estrogen / testosterone, and low level of physical activity
      cause problems such as incontinence, prolapse, constipation and sexual dysfunction The aim of
      this study is to investigate the effectiveness of pelvic floor exercise program on sexual
      dysfunction, incontinence, quality of life and physical activity level in elderly.
    

Detailed description: 
      Pelvic floor problems including prolapse, voiding and defecation dysfunction have been seen
      in approximately 37% of women aged 60-79 years and incontinence is the leading pelvic floor
      dysfunction. The International Incontinence Society (ICS)defines that all types of
      involuntarily urinary leakage as urinary incontinence. The incidence of urinary incontinence
      is 26.6% in women aged 65-74 and 41.8% in patients aged 75 and over. Sexual dysfunction is
      also frequently encountered problem in pelvic floor disorders in people older than 65 years.
      The aim of this study is to investigate the effectiveness of pelvic floor exercise program on
      sexual dysfunction, incontinence, quality of life and physical activity level in elderly.
      Pelvic floor exercises programme contains different contractions of pelvic floor muscle. Each
      exercises have slow and fast twitch muscle exercise contraction.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Pelvic floor exercise programme include repetition of pelvic floor muscle contraction during twice a week for 8 weeks performed by an expert pelvic health physiotherapist.
Pelvic floor education programme include pelvic floor anatomy, information about pelvic floor dysfunction and behavioral changes.
Other intervention name(s): Education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups Study Group and Control Group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic floor exercise; Urinary incontinence; Sexual dysfunction
Effect of Prebiotics on Function and Pain in Patients With Osteoarthritis and Obesity
Condition: Osteo Arthritis Knee; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Obesity
Study type: Interventional

Summary: 
      The purpose of the present study is to determine if prebiotic supplementation can, through
      changes in the intestinal gut microbiota, lead to improvements in knee function and physical
      performance and reduce knee pain in adults with obesity and idiopathic metabolic knee
      osteoarthritis. We hypothesize that prebiotics will reduce systemic and local (knee joint)
      inflammation, thus improving knee function, lower pain medication use, and enhance
      performance of daily life activities.
    

Detailed description: 
      Primary outcome:

      1. To determine the change in knee joint function and physical performance in adults with
      obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or
      placebo.

      Secondary outcomes:

        1. To determine the change in knee pain in adults with obesity and knee osteoarthritis
           treated for 6 months with oligofructose-enriched inulin or placebo.

        2. To examine the change in body composition (fat mass and lean mass) in participants
           treated with oligofructose-enriched inulin or placebo.

        3. To evaluate the change in quality of life in participants treated with
           oligofructose-enriched inulin or placebo.

        4. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin
           supplementation in metabolic OA through examination of gut microbiota composition and
           short-chain fatty acid concentrations.

        5. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin
           supplementation in metabolic OA through examination of serum inflammatory and
           metabolomics markers.
    

Intervention name(s): Prebiotic oligofructose-enriched inulin; Placebo maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Synergy1; Equicaloric dose of maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Gut microbiota; Prebiotic