bioihbjkbjnl/mcl2 huggingface dataset:
Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG
Condition: Pain Relief With HSG
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of our study is to determine the efficacy of oral diclofenac potassium combined with
      lidocaine cream on the pain scores during HSG.
    


Intervention name(s): diclofenac potassium + lidocaine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG; patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG
Other intervention name(s): combined therapy
Intervention MeSH terms: Diclofenac; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the
      number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical
      pregnancy and miscarriage rates, were analized.
    

Detailed description: 
      160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH
      agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and
      December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures
      were the number of oocytes retrieved, injected and fertilized, embryos transferred, and
      clinical pregnancy and miscarriage rates.
    

Intervention name(s): oocyte retrieval and ICSI procedure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GnRH antagonist; GnRH agonist; ICSI; miscarriage rate; pregnancy outcome
Efficacy of the Quell Wearable Device for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a 1-year trial designed to gather information about the use of the Quell for persons
      with chronic musculoskeletal low back pain.
    

Detailed description: 
      Research Objectives: This is a 1-year trial designed to gather information about the use of
      the Quell for persons with chronic musculoskeletal low back pain. The investigators
      hypothesize that those assigned to using the device will report reduced back pain compared
      with those in the control condition; with those using the device also showing improvement in
      sleep, mood, and level of activity. The investigators hypothesize that frequency of using the
      Quell (increased tolerability and adherence) will be correlated with greater reduction in
      pain. The investigators hypothesize that the device will be safe to use and will demonstrate
      a reduction in healthcare utilization (reduced clinic and Emergency Department visits).
      Finally, based on preliminary analyses limited by few subject numbers, the investigators will
      investigate whether certain individuals report greater benefit from using the Quell than
      others and, in particular, would predict that those with more intense and longer duration of
      pain will demonstrate most benefit.
    

Intervention name(s): Quell
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Assessment of Nociception on NCS-R
Condition: Disorder of Consciousness; Unresponsive Wakefulness Syndrome; Minimally Conscious State
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Study type: Observational

Summary: 
      The aim of this study was to investigate the relationship between behaviorally assessed
      consciousness levels and responsiveness to nociception in patients with disorders of
      consciousness (DOC)
    

Detailed description: 
      Patients with a clinical consensus of DOC were enrolled. The Coma Recovery Scale-Revised
      (CRS-R) was used to assess the DOC patients' consciousness levels and the Nociception Coma
      Scale-Revised (NCS-R) was used to evaluate their pain response over one week. Furthermore,
      the relationship between behaviorally assessed consciousness levels and pain response was
      analyzed.
    

Intervention name(s): The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
Intervention type(s): Diagnostic Test
Intervention description(s): All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All enrolled DOC patients were evaluated at least five times over one week by two trained
        professionals using the Chinese version of the CRS-R. The highest score was selected as the
        final bedside behavioral diagnosis of the patient's consciousness level. During the
        evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain
        response of all patients in random order at least once, and the best behavioral response
        (i.e., the highest score) of each subscale was recorded during resting, noxious, and
        physiotherapy conditions, respectively, according to the NCS-R guidelines. The patient's
        specific behavioral performance was also recorded.
      
Keywords: disorders of consciousness; unresponsive wakefulness syndrome; minimally conscious state; Nociception Coma Scale-Revised
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study designed to determine a dose and schedule of Tucaresol that can be
      administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with
      viral suppression without occurrence of significant adverse events and that results in
      significant changes in cell mediated immunity.
    


Intervention name(s): Tucaresol tablets 25 mg
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV-1 infection; Tucaresol; Viral suppression
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the change in suck and swallow competency from
      baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children
      with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies
      will be performed on treatment day 1 and on the day following treatment morning of day 6.
    

Detailed description: 
      The overall objective of this Phase 2 trial is to compare the change from baseline to morning
      of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children
      with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

      Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (OT) in infants and
      children who are in nutritional phase 1a will improve their suck and swallow, potentially
      even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and
      decreasing the risk of aspiration with oral feeding.

      Study Hypothesis 2: The Study team hypothesize that replacing OT in infants and children with
      PWS will result in improved eye contact, daytime alertness, and feelings of bonding between
      the parents and the infant.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 IU/day of oxytocin administered via nasal spray device each morning.; 4 IU/day of placebo administered via nasal spray device each morning
Other intervention name(s): Syntocinon; Saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk
Condition: Atherosclerosis of Artery
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      Cardiovascular disease is a common diagnosed and treated condition in private practices of
      primary health care. There is growing evidence that atherosclerotic plaques as predictors for
      stroke and heart attack are more prevalent than expected based on the clinical score in
      people with low risk for stroke and heart attack .

      Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be
      prescribed even if the clinical risk score is low or on the other hand if they can be
      observed even in high lipid levels.
    

Detailed description: 
      Both common and proximal internal carotid arteries and both common femoral arteries
      (including bifurcations) were screened by ultrasound in patients who came for a check-up to a
      primary care practice with no known cardiovascular disease and low risk for stroke and heart
      attack according to the AGLA/GSLA risk score which is mostly used in Switzerland.

      All patients agreed and gave written informed consent to be included in this study. Presence
      of plaques was defined as a focal carotid intima-media thickness >0.5 cm on ultrasound.
      Screening was performed by a medical doctor (DP) certified for the procedure using the
      following ultrasound system: Toshiba Nemio XG, probe 7.5 MhZ.
    

Intervention name(s): ultrasound guided detection of atherosclerotic plaques
Intervention type(s): Diagnostic Test
Intervention description(s): screening by ultrasound of atherosclerotic plaques
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The carotid and femoral arteries of 22 asymptomatic patients (9 females,13 males) aged
        between 41-72 having a low cardiovascular risk score based on blood pressure, nicotine
        abuse history, cardiac family history, blood analysis in fasting state for diabetes, lipid
        status including total cholesterol HDL-cholesterol, triglycerides and calculated
        LDL-cholesterol were screened by ultrasound.
      
Keywords: plaques detection by ultrasound
ProbioKid as Prevention Among Kids With Frequent URTI
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      This study was designed to evaluate the preventive efficacy of a 6-week prophylactic
      administration of Probiokid® on the incidence of respiratory infections and related
      complications in frequently sick children.
    

Detailed description: 
      The microbiota is very important for the development of the immune system in children. Lactic
      acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as
      probiotics (defined as live microorganisms that, when administered in adequate amounts,
      confer a health benefit on the host). Some probiotics were shown to sustain the development
      of immune competency in newborns, as well as to modulate the adaptive immune response and
      response to infections. For example, previous research suggests that probiotics decrease the
      incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available
      formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis,
      Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to
      decrease the rate of respiratory infection in children supplemented for 3 to 9 months.
      Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented
      for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10
      years-old) that frequently suffer of acute respiratory infections. In addition, the impact of
      a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic
      courses prescribed is assessed.
    

Intervention name(s): ProbioKid®; Pragmatic comparator
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Probiokid formulation includes three probiotic strains and fructooligosaccharides.; Standard of care as usual without a preventive intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Frequent respiratory infection; pediatrics; probiotics
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Condition: Bronchospasm; Activity/Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 4

Summary: 
      During this study, your child will need to attend up to 5 office visits and maintain regular
      telephone contact with the clinic. Certain office visits will include physical exams, medical
      history review, exercise challenge test (walking/running on a treadmill), electrocardiogram
      (ECG) tests, and lung function tests. All study related medications and medical examinations
      are provided at no cost. All study drugs are currently available by prescription to patients
      4 years and older.
    


Intervention name(s): Fluticasone propionate/salmeterol
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bronchospasm; asthma
Gabapentin for Abstinence Initiation in Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary Hypotheses:

      1. Gabapentin will significantly reduce alcohol consumption and promote abstinence as
      compared to placebo. The primary outcome measure will be the number of the heavy drinking
      days (defined as any day where the number of standard drinks was at least 5 for men and at
      least 4 for women) per week as measured by the timeline follow-back method.

      Secondary Hypotheses:

      1. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days
      abstinent.
    

Detailed description: 
      In an 8-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy
      of gabapentin in the treatment of alcohol dependence will be studied in 60 patients.
      Participants will be randomly assigned to treatment under double-blind conditions with either
      1) a fixed dosing schedule of gabapentin or 2) placebo. All participants will receive weekly
      supportive behavioral treatment that promotes abstinence from alcohol and other substances,
      encourages mutual-support meeting attendance, and facilitates compliance with study
      medication. The primary outcome measures will be: the reduction of heavy drinking days per
      week as measured by the timeline follow-back method.

      Participants will be alcohol-dependent men and nonpregnant women who report drinking a
      minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week
      over the past 28 days. The daily minimum drinking requirements are consistent with the
      commonly accepted definition of "binge drinking." A minimum requirement of having a heavy
      drinking episode 4 days a week would select for a population of individuals who are drinking
      excessively more days than not. A minimum threshold of weekly alcohol use is set to prevent a
      "floor effect" (i.e. participants with minimal alcohol use at baseline would be unable to
      demonstrate significant improvement.)
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.; Placebo, TID
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Withdrawal; Reducing Alcohol Consumption; Promoting abstinence in alcohol-dependent patients; Gabapentin
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to determine the safety and efficacy of an
      investigational drug in patients with Type 2 diabetes mellitus.
    


Intervention name(s): Comparator: Sitagliptin; Comparator: Placebo; Comparator: Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sitagliptin 10 mg tablet, once daily for 54 weeks; Placebo oral tablet once daily for 24 weeks; Pioglitazone 30 mg tablet once daily for 30 weeks
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
Condition: Mania
MeSH terms: Mania
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if taking a substance called omega-3 fatty acids is
      effective, safe, and well-tolerated for treating adolescents with major depressive disorder
      (also called simply "depression" or "clinical depression"). Another purpose of this study is
      to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient
      more or less likely to develop mania (i.e. periods of irritability or extreme silliness
      accompanied by decreased need for sleep, risky behaviors, feeling like the patient has
      special abilities, inability to sit still, and rapid speech) in the future. Yet another
      purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3
      fatty acids are not United States Food and Drug Administration (FDA)-approved to treat
      depression in adults or in children and adolescents.

      Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea
      foods, though they are also found in other food sources such as flax seed. Omega-3 fatty
      acids have been shown to play a role in affecting brain chemicals responsible for regulating
      mood and have been found to reduce symptoms of depression in medicated-patients with major
      depressive disorder.

      By completing this study, the investigators hope to better understand who benefits from
      treatment, why they do or do not respond to medications, and who is at greater risk for
      developing further mental illness. With this information, the investigators hope to be able
      to improve treatment and outcome in people with major depressive disorder.
    

Detailed description: 
      A. Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability
      of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive
      symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet
      DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance
      spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty
      acid levels to examine potential mediators of treatment response to omega-3 fatty acids in
      adolescents with a high risk for mania.
    

Intervention name(s): OMega 3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day; Placebo given twice a day which will be compared to Omega 3
Other intervention name(s): Fish oil; Olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mania; Adolescents at risk for Mania
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Condition: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of the trial is to prove the therapeutic value of the product and enable an
      effective and safe dosage schedule to be recommended
    

Detailed description: 
      The objective of this study is to determine the biologic activity of a Glycyphagus domesticus
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).

      The skin testing procedure, based on the Nordic Guidelines is the reference method for the
      biological calibration of in-House Reference Preparations (IHRP). The method is not intended
      for routine testing of allergen extracts. The use of this procedure is the basis for the
      definition of biological activity units: "the activity of an allergen extract is 10,000
      Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin
      reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by
      a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine
      dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique
      (prick testing) on at least 20 individuals who are clinically allergic and cutaneously
      reactive to the allergen concerned".
    

Intervention name(s): Standardization of allergenic extract (Gly. domesticus)
Intervention type(s): Other
Intervention description(s): Allergenic extract for cutaneous prick-test
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Allergen extract Standardization