bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      There is increasing evidence that the effectiveness of allergy immunotherapy to control
      symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid
      administered during a single regimen of subcutaneous (SC) injections or of sublingual
      administration.

      Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are
      being developed to compare with the current dose of 5100 SU. The purpose of this study is to
      evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA
      MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to
      grass pollen, to enable selection of the best dose to go into a larger scale study to assess
      the efficacy and safety of the higher cumulative doses.
    

Detailed description: 
      Structure: Single center, parallel group, single-blind, randomized study There will be three
      treatment groups, two groups receiving a different, cumulative dose of Grass MATA MPL and the
      third group receiving placebo only.

      Duration: The duration of the study from screening to final visit after treatment is expected
      to be approximately 7 weeks. There will be a telephone follow up at 1, 3, 6 and 12 months
      after treatment.
    

Intervention name(s): Grass MATA MPL 10200; Grass MATA MPL 18200; Placebo
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
Condition: Metabolic Syndrome; Obesity; Insulin Sensitivity
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the
      acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on
      metabolic parameters and gene expression in subcutaneous adipose tissue.
    


Intervention name(s): Glucose dependent insulinotropic polypeptide (GIP)
Intervention type(s): Other
Intervention description(s): GIP-Infusions for 4 h in a postprandial concentration
Intervention MeSH terms: Gastric Inhibitory Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Euglycemic-hyperinsulinemic clamp; fat biopsies; microarray analysis; quantitative real time PCR; overnutrition; low grade-inflammation
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
Condition: Problem Behavior; Aggression; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression; Problem Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether war-traumatize male adolescents with
      behavioral and emotional problems who participate in mind-body skills groups will have
      improvement in behavioral and emotional problems, aggression, and posttraumatic stress
      disorder (PTSD) symptoms, compared to a wait list control group.
    

Detailed description: 
      Mind-body skills incorporate meditation, guided imagery, breathing techniques, autogenic
      training, biofeedback, genograms, and self-expression through words, drawings, and movement
      in a small group setting. These groups have been used in war-traumatize populations in
      Kosovo, Gaza and the United States. This study will be investigating the effect of the
      mind-body skills groups on boys with behavioral and emotional problem at a high school in
      Gaza to determine if there is improvement in behavioral and emotional problems, aggression,
      and posttraumatic stress disorder. The results will be compared to a control high school with
      boys who will not be attending mind-body skills groups and who have experienced similar
      levels of trauma and also have behavioral and emotional problems.

      The mind-body skills groups will be held for 2 hours once a week for 10 weeks and then once a
      month for 10 months. Measures will be taken at baseline, after the 10 week mind-body skills
      group program and again at 10 month follow-up.
    

Intervention name(s): Mind-Body Skills Groups
Intervention type(s): Behavioral
Intervention description(s): Mind-Body Skills groups consist of small groups of about 8-10 participants who learn and practice meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Problem Behavior; Aggression; Posttraumatic Stress Disorder; Adolescents
Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Dystocia; Hemorrhage
Study type: Interventional

Summary: 
      Patients having Cesarean section after they have been in labor for many hours bleed much
      more, in average twice as much, as compared with patients having an elective Cesarean
      section. The investigators believe a simple change in practice might contribute to reduce
      this bleeding. This study will involve the use of oxytocin (also known as syntocinon),
      ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is
      routinely used to help contract the uterus and keep it contracted after the delivery of the
      baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through
      the intravenous line, while carboprost is given as an injection in the muscle. Although they
      are not routinely given in every case, these are very frequently given as rescue medications
      to patients who fail to respond appropriately to oxytocin. This study is designed to
      determine if ergonovine or carboprost given in association with oxytocin, in a preventive
      way, after delivery of the baby and placenta, can reduce the amount of blood loss during
      Cesarean sections following a trial of labour.
    

Detailed description: 
      The objective of the investigators study is to compare the efficacy of intravenous ergonovine
      and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to
      decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin
      receptors has been recently demonstrated in cultured human myometrial cells after continuous
      and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk
      of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and
      augmentation of labor. Therefore, addition of a different uterotonic agent, involving a
      different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in
      women undergoing CS following failure to progress in labor, who are at a greater risk for
      PPH.
    

Intervention name(s): Oxytocin; Ergot; Carboprost
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours; Ergot 0.25mg IV; Carboprost 0.25mg IM
Other intervention name(s): syntocinon; ergonovine maleate; Hemabate®
Intervention MeSH terms: Oxytocin; Carboprost; Carboprost tromethamine; Ergonovine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; postpartum hemorrhage; Cesarean delivery; failure to progress in labor
Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions
Condition: Development and Design of Mobile App; Preventive Physiotherapy; Exercise Adherence; Cervical and Thoracic Spine
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      Postural alignment in the cervical and thoracic regions is affected by various risks such as
      smartphone use in particular young adults. The small screen of smartphones causes ergonomic
      risk for posture and musculoskeletal system. Previous studies found that neck, shoulder, and
      upper back pain associated with the overuse of smartphones. Neck pain often arises from
      unideal postures. Participants should be informed about these risks and encouraged to
      exercise to be protective. Digital health apps' use is rising by the day and health apps
      offer opportunities for both healthcare professionals and users.

      Therefore, this study aimed to develop an app including preventive exercise interventions to
      keep postural alignment in cervical and thoracic spine regions employing an iterative,
      user-centred design and to test the usability of the app and evaluate its effectiveness with
      a pilot randomized controlled trial
    


Intervention name(s): App-based group; Control group
Intervention type(s): Other; Other
Intervention description(s): Participants received home exercise programs by a postural alignment exercise mobile app we developed.
The postural alignment app included 3 main emerged themes were recorded as self-assessment, neck/shoulder, and upper back-specific exercise content, and motivational notifications.
Participants can evaluate themselves in the application thanks to the self-assessment, receive motivational notifications during the day, and exercise reminders on the days determined by them. They can apply the exercise program with the formed exercise content videos.
The exercise program consists of combined exercises that postural alignment plus exercises of neck spinal stabilization, stretching, and strengthening of neck/shoulders/upper back regions.
Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.; Participants received home exercise programs as a paper handout.
The exercise program was the same for app-based and control groups.
Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: mHealth; Postural alignment; Preventive physiotherapy; Exercise adherence; Neck pain; Upper back pain
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the impact of escitalopram on quality of life and
      social functionality in patients with major depressive disorder with anxiety symptom.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-center,
      prospective (a study in which the participants are identified and then followed forward in
      time for the outcome of the study), single-arm (all participants receiving one intervention)
      study. Approximately 260 participants will be enrolled in this study. This study consists of
      two phases: screening phase and treatment phase. In the treatment phase, participants will
      receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of
      escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks,
      based on the investigator's clinical judgment. Safety evaluations will include assessment of
      adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical
      examination which will be monitored throughout the study. The total study duration will be
      approximately 2 years.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram will be administered as oral tablets 10 mg per day and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Depressive Disorder; Depression; Anxiety; Escitalopram; Quality of life; Social functionality
Effects of Antioxidant Dentifrice on Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic
      acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival
      redness.
    


Intervention name(s): Experimental toothpaste; Control toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Experimental toothpaste was containing 0.3% L-ascorbic acid 2-phosphate magnesium salt and 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.; Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
Other intervention name(s): L-ascorbic acid 2-phosphate magnesium salt toothpaste; Fluoride toothpaste
Intervention MeSH terms: Ascorbic Acid; Ascorbate-2-phosphate; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; antioxidant; dentifrice; Ascorbic Acid Derivative; L ascorbic acid 2 phosphate magnesium salt
10% Carbohydrate Drink for Preventing Post-operative Nausea and Vomiting (PONV) After Spinal Morphine
Condition: Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally
      are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal
      approach, combining several means to minimize PONV, has found wide acceptance as a standard
      of care. In our hospital, most of the patients are supposed to fast after midnight The oral
      rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not
      this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is
      not investigated yet. The aim of this study is to investigate the effect of preoperative oral
      rehydration therapy on the incidence of PONV.
    

Detailed description: 
      We enroll patients who are undergoing TKR under spinal anesthesia with 0.5% heavy bupivacaine
      10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25%
      bupivacaine 20 ml.

      The enrolled patients will fast after midnight and in the morning they are allowed to drink
      10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10%
      carbohydrate drink is drunk between evening and midnight and extra water if needed in the
      study group. In the control group, the patients are allowed to drink until midnight. Total of
      water consumption between 18.00-24.00 will be recorded in both groups. In the morning, the
      study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. The
      premedications should not include sedation or GI mobility drugs. Before starting anesthesia,
      the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh
      their feeling from 0-10.

      The surgery and pain therapy will be tha same in both groups and the PONV (incidence,
      severity and rescue therapy) at recovery room and 24 hours postoperative period will be
      recorded.
    

Intervention name(s): 10% carbohydrate drink
Intervention type(s): Dietary Supplement
Intervention description(s): In the study group, 10% carbohydrate drink 400 ml will be given between 18-24 hr the night before surgery and another 400 ml will be drunk at 6-7 hr in the morning of surgery.
Other intervention name(s): Green mate (orange favor)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative nausea and vomiting (PONV); Spinal morphine; Total knee replacement (TKR); blood sugar; carbohydrate drink
Adult ALL Treatment at Diagnosis
Condition: Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      The present study has been designed to give participating centers the possibility of better
      understanding the diagnostic and prognostic factors of ALL patients.
    


Intervention name(s): Vincristine; Vincristin, Daunorubicine, Asparaginase, Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Steroids pre-treatment; Induction therapy
Intervention MeSH terms: Methotrexate; Vincristine; Asparaginase; Daunorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL; Adult
Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      Funding Source - FDA OOPD

      Pioglitazone is currently used in clinical practice to treat diabetes and this study will
      examine the potential use of a low dose of the same drug for the treatment of polycystic
      kidney disease. The purpose of this study is to determine whether the diabetes drug
      pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic
      kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the
      treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low
      dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest
      that effective pioglitazone dosing for polycystic kidney disease may be lower than that used
      to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst
      disease in humans.
    

Detailed description: 
      Patients will be randomize to placebo or 15 mg pioglitazone for 12 months, and then be
      crossed over to the other arm. Patients will undergo MRI of the liver and kidney and
      MRspectroscopy of the lumbar spine (if they choose as this is ancillary study) three times
      during the study. Assessments will be every 3 months and include blood work, blood pressure,
      and body water assessments.
    

Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone; Placebo
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, single dose (four inhalations), four-way cross over study in healthy
      subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics
      (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will
      be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two
      strip configuration. The NDPI will be configured with different combinations of each compound
      and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device.
      Study drug will be administered through the inhaled route to healthy subjects in single doses
      (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF
      (400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100
      µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg)
      over four treatment periods. Each treatment period will be separated by a washout of 7 to 21
      days. After the four treatment periods, a follow up visit will take place 7 to 21 days
      following the final dose of study medication and the maximum duration a subject will be
      involved in the study is eighteen weeks.

      Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of
      FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart
      rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected
      throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and
      clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the
      study.
    


Intervention name(s): UMEC /VI; UMEC; VI; FF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA). UMEC/VI (blended together) will be available as dry powder in the dose of 125 µg /25 µg per inhalation.; Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA). UMEC will be available as dry powder in the dose of 125 µg per inhalation.; Vilanterol is a long-acting beta2 agonist (LABA). VI will be available as dry powder in the dose of 25 µg per inhalation.; Fluticasone Furoate is a novel inhaled corticosteroid (ICS). FF will be available as dry powder in the dose of 100 µg per inhalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: GW642444 (Vilanterol); pharmacokinetics; pharmacodynamics; GSK573719 (Umeclidinium); healthy subjects; GW685698 (Fluticasone Furoate)