bioihbjkbjnl/mcl2 huggingface dataset:
Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate predictability of an abdominal compression-induced
      change of blood pressure for fluid responsiveness in children.
    

Detailed description: 
      The purpose of this study is to evaluate predictability of an abdominal compression-induced
      change of blood pressure for fluid responsiveness in children.

      When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and
      central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10
      seconds. Changes of blood pressure are continuously recorded during this period. About 3 min
      later, intravenous colloid fluid 10 mL/kg is infused for 20 min.

      To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography
      is performed before and after fluid administration. In addition, hemodynamic parameters
      including pulse pressure variation, systolic pressure variation, pleth variability index and
      central venous pressure are also recorded before and after fluid administration.

      Finally, patients will be divided into fluid responder group and non-responder group. If
      cardiac output measured using echocardiography increases over 15% after fluid administration,
      the patient is fluid responder. Using ROC curve, diagnostic power of abdominal
      compression-induced blood pressure change for fluid responsiveness will be evaluated.
    

Intervention name(s): abdominal compression
Intervention type(s): Procedure
Intervention description(s): When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy
      co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a
      serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive
      disorder.
    


Intervention name(s): Aripiprazole (Fixed dose); Aripiprazole (Titrated dose); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administered orally once daily, 3 mg daily, 6 weeks; administered orally once daily, 3 to 15 mg daily, 6 weeks; administered orally once daily, 6 weeks
Other intervention name(s): Aripiprazole; Aripiprazole; Placebo of aripiprazole
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
Condition: Healthy Japanese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability and serum
      Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.
    


Intervention name(s): UCB0107; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Pharmaceutical form: solution for infusion
Route of administration: intravenous use; Pharmaceutical form: solution for infusion
Route of administration: intravenous use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: UCB0107; Phase 1
Telephone Reminder to Increase Appointment Rates
Condition: Reminder Systems; Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Missed appointments to outpatient substance use treatment are common and costly and can have
      a negative effect on the health of patients.

      In this quasi-experimental study, the investigators used an on-off design to examine whether
      a reminder "plus" intervention (telephone call from therapist before first appointment) would
      increase attendance and improve cancellation and rebooking practices. Secondary outcomes
      included satisfaction with treatment and intention to complete the treatment program.
    


Intervention name(s): Reminder plus (telephone call from therapist)
Intervention type(s): Other
Intervention description(s): Reminder plus (telephone call from therapist)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Quasi-experimental with an OFF-ON design
Masking: Single (Participant)
Primary purpose: Health Services Research
Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhoea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the trial is to define the clinical benefit and possible mediators of the
      benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.

      The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers
      reflecting mast cell activation and small bowel tone.
    


Intervention name(s): Mesalazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks; 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; diarrhoea
Effects of Growth Hormone Releasing Hormone in HIV
Condition: HIV; HIV Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional

Summary: 
      HIV-infection and its treatment are often associated with an increase in belly fat, as well
      as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and
      increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may
      contribute independently to increased belly fat and to increased cardiovascular risk through
      effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth
      hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients
      with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat
      accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet
      known. The current study is designed to determine the effects of tesamorelin treatment on fat
      accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers
      of cardiovascular health including blood vessel thickness (carotid intima media thickness
      [cIMT]) and markers of inflammation in the body. The investigators hypothesize that
      tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers
      of inflammation, with either neutral or beneficial effects on glucose metabolism.
    


Intervention name(s): tesamorelin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose; Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection
Other intervention name(s): Egrifta, growth hormone releasing hormone, TH9507
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone; Tesamorelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; lipodystrophy; tesamorelin; Egrifta; growth hormone releasing hormone
Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      In this study the investigators will test the impact of a modified Ramadan Fasting regimen on
      health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of
      the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting
      consists of educational components around fasting, and advice for nutritional modifications
      in order to support health and well-being during Ramadan, while the control group will
      continue to fast as usual. The investigators will measure not only body weight/fat but also
      include measures of psychological well-being, and spiritual practice, and serum markers for
      blood lipids, and blood sugar. With this trial the investigators aim to determine, whether
      such modifications around Ramadan will be beneficial for health and well-being.
    

Detailed description: 
      see above
    

Intervention name(s): Modified Ramadan Fasting
Intervention type(s): Behavioral
Intervention description(s): The intervention aims to provide knowledge about fasting and its effects on the body/mind, and health advice around nutrition to support health and well-being of participants during Ramadan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ramadan; Fasting; Nutrition; Quality of Life
First-In-Human Study of Apramycin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study to assess the safety, tolerability and pharmacokinetics of
      escalating single doses of apramycin. This trial will be conducted as a single ascending dose
      trial in up to 5 sequential dose cohorts (group-comparison). Each cohort will consist of 8
      healthy subjects, 6 will receive apramycin and 2 placebo.
    


Intervention name(s): Apramycin injection; Placebo injection
Intervention type(s): Drug; Drug
Intervention description(s): 30-min infusion; 30-min infusion
Intervention MeSH terms: Apramycin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Anti-Bacterial Agents
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether simvastatin is effective in the improvement
      of IVF-ICSI outcome in Pcos patients.
    

Detailed description: 
      simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular
      smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial
      proliferation & decreasing steroidogenesis (production of progesterone &
      testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular
      risks and is characterized by ovarian theca-interstitial hyperplasia& hyperandrogenism .This
      study will test the hypothesis that simvastatin improves biochemical parameters& IVF-ICSI
      outcome in Pcos patients.
    

Intervention name(s): SIMVASTATIN
Intervention type(s): Drug
Intervention description(s): 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: pco; simvastatin; ivf; embryo transfer
Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
Condition: Analgesia; Acute Pain; Upper Extremity Injury
MeSH terms: Acute Pain; Arm Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will conduct a prospective, randomized, double-blinded study using an
      axillary brachial plexus block in patients undergoing elective surgery of the distal forearm
      and hand to characterize and describe the pharmacokinetics of bupivacaine associated with
      perineural dexamethasone.

      The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at
      different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing
      comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).

      Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a
      blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at
      least initially, in systemic absorption from the injection site.
    


Intervention name(s): Bupivacaine Hydrochloride; Bupivacaine Hydrochloride with Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.; Patients will receive a total volume of 30 ml of bupivacaine 0.5% with Dexamethasone 4 mg in an axillary block with a double puncture.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dexamethasone; Nerve Block; Adjuvant; Pharmacokinetic Analysis
The Effects of Different Montages of tDCS on Muscle Strength in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate the effects of different montages of tDCS on muscle strength in healthy adults
    

Detailed description: 
      Electrode montage or placement of tDCS over primary motor cortex can be categorized into
      unilateral (anodal or cathodal electrode over primary motor area) and bilateral tDCS (both
      anodal and cathodal electrode over the cortex). Previous studies reported benefits of
      different tDCS montages on muscle performance in healthy participants. However, there is no
      guideline for tDCS montages. This study aims to investigate immediate effects of different
      tDCS montages on muscle strength in healthy participants.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Dual/Cathodal/Anodal/Sham tDCS will be applied in 2 mA, 20 mins. All experiments will be performed in random order for each subject.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing
Condition: Embryo Transfer
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst
      implantation in women undergoing IVF treatment. This study will be the first dosing
      experience with this compound in women. It is important to characterize the pharmacokinetics
      of GSK557296 in women to determine the most appropriate doses and dosing regimens for future
      clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable
      more accurate characterization of any exposure-response relationship in future studies.

      Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10
      milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced
      embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging
      study to characterize the pharmacokinetics of GSK557296 in women to determine the most
      appropriate doses and dosing regimens for future clinical studies.

      This is a non-randomized, open label, adaptive design study in healthy female volunteers. A
      maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1
      will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow
      for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will
      receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based
      on the requirement of additional doses to be studies after PK data will be analyzed from each
      of the first 2 cohorts.
    


Intervention name(s): GSK557296 10 mg; GSK557296 150 mg; GSK557296 dose 3; GSK557296 dose 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID).; 150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day.; Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2.; Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts.
Intervention MeSH terms: Diketopiperazines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxytocin Antagonist; Embryo/Blastocyst Implantation
Probiotic Treatment for Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      A whole new research area studying the function of intestinal microorganisms, also known as
      gut microbiota, has emerged during the last decade. As a result, dietary supplementation with
      specific bacteria (or probiotics) holds great promise as a therapeutic strategy for a wide
      range of diseases, from obesity to anxiety and depression, all of which are major
      characteristics of Prader-Willi syndrome (PWS).

      The main objective of the current proposal is to determine the effects of Bifidobacterium
      animalis subsp. lactis (strain BPL1) supplementation in children and young adults with PWS.
      Specifically, participants will receive placebo or BPL1 for 6 months, and then this phase
      will be followed by a 6-month extension period in which all participants will receive BPL1.
      This study will allow us to 1) determine the effects on fat mass and glucose metabolism; and
      2) explore the effects on mental health symptoms by studying potential structural changes in
      the brain by magnetic resonance imaging (MRI) as well as using a number of psychiatric
      questionnaires.
    


Intervention name(s): Placebo; Probiotic; Follow-up probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention with a daily dose of placebo for 6 months; Intervention with a daily dose of probiotic for 6 months; Intervention with a daily dose of probiotic for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of
      u-AQP-2 induced by fasting
    


Intervention name(s): NSAID
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: AQP-2; NSAID; Urinary concentrating ability
Evaluate The Performance And Safety Of The Medical Device Jalucomplex®
Condition: Wrinkle
Study type: Interventional

Summary: 
      The Research Question of the present study is the following: in a population of men and women
      affected by facial and neck wrinkles, will linear hyaluronic acid (Jalucomplex®)
      significantly decrease the appearance of facial and neck wrinkles, results observed after 12
      weeks?
    

Detailed description: 
      This is an open, non-comparative study for evaluating the performance and safety of the
      medical device Jalucomplex in the treatment of facial and neck wrinkles.

      Similar dermal fillers have been used in several clinical investigations in humans with a
      good rate of clinical success and good safety profiles.

      Jalucomplex®'s acts by increasing tissue volume based on the natural ability of hydrophilic
      hyaluronic acid molecules to bind to an amount of water far greater than their own weight.
      This allows the material to fill intra-dermal spaces and supplement the intercellular matrix.
      Linear hyaluronic acid is a polymer that represents one of the essential components of human
      skin, subcutaneous and connective tissue; its ability to form complexes with water molecules
      increases the level of tissue hydration, turgidity and plasticity.
    

Intervention name(s): Jalucomplex
Intervention type(s): Device
Intervention description(s): Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Condition: Major Depressive Episode
MeSH terms: Depression
Study type: Interventional

Summary: 
      The study aimes at identifying whether positive expectations have an impact on the way
      depressive participants experience emotions in the form of sadness.
    


Intervention name(s): Placebo nasal spray; Film sequence
Intervention type(s): Other; Other
Intervention description(s): The placebo nasal spray consists of sesame oil and does not contain any active drug.; All groups watch the film sequence that is supposed to induce sadness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science