bioihbjkbjnl/mcl2 huggingface dataset:
Oral Morphine Versus Ketamine in Pain Management
Condition: Pain, Procedural
MeSH terms: Pain, Procedural
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will mainly focus on procedural pain management using oral morphine versus rectal
      ketamine during paediatric burn and wound dressing at Mbarara Regional Referral Hospital.
    

Detailed description: 
      Subjects will be randomly assigned to one of the two treatment groups A and B. Guardians of
      patients who are scheduled for burn wound care will sign written consent pre- operatively
      about procedural pain management. Group A will receive rectal ketamine while those in Group B
      will receive only traditional standard of care protocols.
    

Intervention name(s): GROUP A; GROUP B
Intervention type(s): Drug; Drug
Intervention description(s): Rectal Ketamine will be administered at 6 mg/kg and with a rectal nozzle it's infused through the rectum. The rectal ketamine will be administered after scoring pain just before the start of the procedure and then about 15 minutes later the procedure will start when the patient has achieved a nystagmus.; The tradition standard protocols involve the use of 0.3mg/kg of oral morphine about an hour before the start of the procedure before the start of the procedure to allow for the onset of action of oral morphine for every single procedure in this arm.
Other intervention name(s): KETAMINE GROUP; MORPHINE GROUP
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Rectal ketamine versus oral morphine in pain management in paediatric wound and burns
Masking: Single (Participant)
Primary purpose: Treatment
Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
Condition: Neurodermatitis
MeSH terms: Neurodermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether the treatment of acute neurodermitis with
      silver-contained textiles is equivalent or more effective to the conservative exogenous
      treatment with a corticosteroid. Secondary aim is to define skin comfortability of the
      textiles.
    


Intervention name(s): silver-contained textiles; corticosteroid
Intervention type(s): Device; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
Condition: Heart Repolarization
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effect of naltrexone and bupropion
      extended-release combination on cardiac repolarization in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called naltrexone HCl/bupropion HCl (NB). NB is
      approved by the U.S. Food and Drug Administration (FDA) in addition to a reduced-calorie diet
      and increased physical activity for chronic weight management in adults who are obese or who
      are overweight and have at least one additional weight-related condition such as high blood
      pressure, diabetes or high cholesterol. This study is conducted to determine the potential
      effect of NB relative to placebo on cardiac repolarization.

      The study will enroll approximately 84 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to 1 of 6 treatment sequences, which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Naltrexone/Bupropion + Placebo + Moxifloxacin

        -  Placebo + Moxifloxacin + Naltrexone/Bupropion

        -  Moxifloxacin + Naltrexone/Bupropion + Placebo

        -  Naltrexone/Bupropion + Moxifloxacin + Placebo

        -  Placebo + Naltrexone/Bupropion + Moxifloxacin

        -  Moxifloxacin + Placebo + Naltrexone/Bupropion

      This study is consisted of 3 periods separated by a washout period (Days 11 through 25).
      Participants will be admitted to the clinic on Day -2 (Check-in) of each study period and
      will remain confined to the clinic until the morning of Day 12 of each study period. On Day
      -1 and Day 11 of each period, participants will undergo 24 hour Holter recordings using an
      ambulatory electrocardiograph recorder.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 96 days.
    

Intervention name(s): Naltrexone HCl/bupropion HCl; Placebo; Moxifloxacin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Naltrexone HCl/bupropion HCl extended-release tablet.; Naltrexone/bupropion placebo-matching tablets.; Moxifloxacin tablet.
Intervention MeSH terms: Moxifloxacin; Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether LY2140023, when added to standard-of-care
      antipsychotic treatment, will improve negative symptoms.
    

Detailed description: 
      The primary objective of this study was to test the hypothesis that treatment with LY2140023
      compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic,
      would demonstrate significantly greater reduction of negative symptoms, as assessed by the
      16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients
      included in this study were concurrently receiving 1 of 4 second generation antipsychotics
      (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.
    

Intervention name(s): LY2140023; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 milligrams (mg), oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg.; Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.; United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)
Other intervention name(s): pomaglumetad methionil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is the report to assess supplementation with soybean peptides on blood pressure among
      people with mild hypertension. Overall, soybean peptide consumption for 8 weeks could
      successfully reduce mean diastolic and systolic BP through the suppression of
      Angiotensin-converting enzyme (ACE) linked to downstream suppression of angiotensin II
      formation, which further decreases the sympathetic outflow that leads to hypertension.
    

Detailed description: 
      This is the report to assess supplementation with soybean peptides on blood pressure among
      people with mild hypertension. Thirty subjects with systolic blood pressure (SBP) between 120
      and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized
      to ingest 2 bags of soybean peptides or placebo per day for 8 weeks of a stage.
      Anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical
      markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride
      (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT) were examined every
      four weeks.
    

Intervention name(s): Soybean peptides; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects receive two bags soybean peptides per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.; Subjects receive two bags of starch placebo of similar appearance per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: soybean peptides; clinical trial; blood preesure; SBP; DBP
PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer
Condition: Ovarian Cancer; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate
      for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy.
      This study will administer 7 days of treatment with a targeted therapy called Lynparza.
      Lynparza and/or other PARP inhibitors have been FDA approved for the treatment of ovarian and
      breast cancer. Tissue biopsy will be done before a 7 day course of Lynparza in order to
      correlate molecular changes to response to treatment. Participation in this trial will
      require an additional tumor biopsy which will occur either before or after treatment of
      Lynparza.
    


Intervention name(s): Lynparza
Intervention type(s): Drug
Intervention description(s): Lynparza taken orally at a dose of 300mg twice daily for 7 days
Other intervention name(s): Olaparib
Intervention MeSH terms: Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Crossover Trial of AD036 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to
      examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with
      obstructive sleep apnea.
    

Detailed description: 
      The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep
      apnea. The study is a three-period single-dose randomized crossover design in which patients
      will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3
      treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final
      crossover HSAT for an end of study (EOS) Visit.
    

Intervention name(s): AD036; Atomoxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration before bed; Oral administration before bed; Oral administration before bed
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Half Life of DLBS1033 in Healthy Volunteers
Condition: Healthy Condition
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.
      This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major
      proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight
      Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a
      drug that consists of serin protease enzyme, suspected that the mechanism of action of
      lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded
      that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic
      effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic
      of this drug. As a pilot study, the aim of this study is to evaluate biological half life of
      DLBS1033.
    


Intervention name(s): DLBS1033
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was open label-single arm trial, which was done at Pharmacology and Therapeutic Department and Clinical Pathologic Department of Faculty Medicine of University of Indonesia Cipto Mangunkusumo Hospital. The study drug was enteric coated DLBS1033 tablet, which contained 490 mg bioactive protein fraction; and produced by PT Dexa Medica, Tangerang, Indonesia.
Masking: None (Open Label)
Primary purpose: Basic Science
Risk Factors for Anal Sphincter Damage During Vaginal Delivery
Condition: Anal Sphincter Injury; Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Observational

Summary: 
      Vaginal delivery may cause various levels of damage to the anal sphincter. According to the
      literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal
      delivery suffer from fecal incontinence. This has an adverse effect on the quality of life.
      Different risk factors such as: first births, instrumental delivery, high birth weight,
      prolonged second stage, epidural anesthesia etc. were assessed and found to be associated
      with anal sphincter disruption. The purpose of this study is to assess risk factors for anal
      sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D
      transperineal US).
    


Intervention name(s): 3D transperineal Ultrasound
Intervention type(s): Other
Intervention description(s): 3D transperineal Ultrasound after vaginal delivery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population are women between ages 17 and 40 after their first delivery at the
        Hadassa Mount Scopus hospital in Jerusalem, Israel.
      
Keywords: Anal Sphincter injury; Fecal Incontinence
Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers
Condition: HIV Infection
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The development of a safe and effective HIV-1 vaccine strategy would probably be the best
      solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost
      immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus
      relevant to pursue the development of different candidate vaccines in prime-boost vaccine
      strategies to identify the most promising prime-boost combinations and to integrate
      scientific inquiry into trial protocols from the beginning to maximize learning
      opportunities.
    

Detailed description: 
      Phase I/II, multicenter, national, open-label, randomized trial HIV including 4 prophylactic
      prime-boost HIV vaccines strategies:

      Volunteers are randomly allocated in a 1:1:1:1 ratio at trial entry to 4 parallel arms with
      the following prime-boost strategies:

      Arm 1. MVA HIV-B primes at Week 0 and Week 8 + LIPO-5 boosts at Week 20 and Week 28 Arm 2.
      LIPO-5 primes at Week 0 and Week 8 + MVA HIV-B boosts at Week 20 and Week 28 Arm 3.
      GTU-MultiHIV B primes at Week 0, Week 4 and Week 12 + LIPO-5 boosts at Week 20 and Week 28
      Arm 4. GTU-MultiHIV B primes at Week 0, Week 4 and Week 12 + MVA HIV-B boosts at Week 20 and
      Week 28
    

Intervention name(s): LIPO-5; MVA HIV-B (MVATG17401); GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Intervention type(s): Biological; Biological; Biological
Intervention description(s): LIPO-5: 1mL IntraMuscular, 2 shots;; MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;; GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Other intervention name(s): ANRS LIPO-5 vaccine candidate; ANRS MVA HIV-B (MVATG17401) vaccine candidate; FIT Biotech GTU-MultiHIV B vaccine candidate
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
fMRI of Hypothalamic Responses to Taste, Temperature and Glucose
Condition: Healthy
Study type: Interventional

Summary: 
      The study will consist of five occasions with one week in between. BOLD signal intensity of
      the hypothalamus will be measured using fMRI. Measurements will be done before and after
      drinking 300 ml plain water or water to which glucose and/or ethyl butyrate will be added.
    

Detailed description: 
      The hypothalamus is known to be important for control of feeding behaviour as well as the
      regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive
      method, which detects transient haemodynamic changes in the brain, using blood oxygen level
      dependent (BOLD) signal differences.

      In order to investigate the role of hypothalamic neural activity in response to taste,
      glucose and temperature, fMRI will be performed before, during and after ingestion of 300 ml
      plain water or water with added ethyl butyrate (pineapple flavour), added glucose or added
      ethyl butyrate plus glucose. All beverages will be consumed at 22 °C and the combination will
      also be drunk at 0 °C.

      The study uses a randomised cross-over design in 16 healthy male subjects with a normal body
      weight. There will be an interval of at least one week between the five occasions.

      BOLD signal intensity of the hypothalamus will be continuously measured for 21 minutes (5
      minutes baseline, 4 minutes during drinking and 12 minutes after drinking).
    

Intervention name(s): Water; Glucose; Ethyl butyrate; Glucose + ethyl butyrate; Glucose + ethyl butyrate 0 C
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Water, 300 ml, at room temperature; Water containing 50 g glucose, 300 ml, at room temperature; Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature; Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature; Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cancer Fatigue Education Program
Condition: Patient With Histologically Confirmed Malignancy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of the present project is to develop, implement and evaluate a pilot regional
      patient education program on the management of one of the main side effects of chemotherapy
      in cancer patients, that is fatigue.

      A carer (doctor or nurse) trained in educational techniques will be responsible for the
      patient. The carer will first identify modes of behavior and competences that the patient
      must acquire in order to optimize his/her management of fatigue ("educational diagnosis"). An
      education program, based on a contract of goals will be proposed after this diagnosis phase.
      The expected results are, in the short-term, a significant reduction in the mean level of
      fatigue in patients receiving chemotherapy who benefited from individual educational
      management. In the longer term, the aim is to evaluate the impact of this program on patient
      quality of life and use of healthcare structures in comparison with conventional management.
    


Intervention name(s): fatigue education program
Intervention type(s): Behavioral
Intervention description(s): the carer will help the patient develop competences on the following points: how to evaluate the severity of the fatigue; learn to recognize symptoms or prodromes showing associated difficulties (anxiety, fear, depression); how to improve control of fatigue by setting up suitable strategies (management of periods of activity and rest, physical and/or intellectual exercises, dietary program, complementary therapy); learn to ask for and accept the help of close relations or carers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cancer; fatigue program education
Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke
Condition: Acute Ischemic Stroke; Nursing
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      In the clinical setting, it is difficult to obtain effective rehabilitation during the acute
      phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a
      limitation in number and variety of rehabilitation professionals in Low- and middle-income
      countries. It is necessary to shift tasks to other healthcare providers who are trained to
      provide rehabilitation like nurses. The purpose of this study is to examine the feasibility
      and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute
      stroke inpatients.
    

Detailed description: 
      Ischemic stroke is the main cause of disability in the world. More than 70% of stroke
      patients show various degrees of neural function impairment. Early rehabilitation in acute
      phase is beneficial for improving patient's activity of daily livings and motor function.
      However, it is difficult to obtain effective rehabilitation during the acute phase of stroke
      because of the insufficiency of professional rehabilitation therapists in stroke wards in
      China. The investigators assume that implementing program based on modified Barthel Index can
      realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The
      present study is to conduct quasi-experimental research to confirm the feasibility and
      effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
    

Intervention name(s): The modified Barthel Index-based rehabilitation nursing program; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.; Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care