bioihbjkbjnl/mcl2 huggingface dataset:
Thoracoscopic Sympathectomy for Blushing
Condition: Facial Blushing
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine outcome and side effects following thoracoscopic sympathectomy in patients
      treated for disabling isolated facial blushing and investigate if there are any significant
      differences between two different routine procedures: T2 or T2-T3 sympathectomy.
    

Detailed description: 
      To determine the outcome and side effects following thoracoscopic sympathectomy in patients
      treated for disabling isolated facial blushing. In addition, following randomization
      investigate if there are any significant differences between two different routine
      procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery
    

Intervention name(s): Level of sympathectomy
Intervention type(s): Procedure
Intervention description(s): T2 sympathectomy or T2-T3 sympathectomy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Facial blushing; Sympathectomy
Mother and Infant Study Cohort (MISC)-
Condition: Adiposity, Breast Feeding
MeSH terms: Obesity
Study type: Observational

Summary: 
      This study aims to explore breastfeeding and complementary feeding practices of mothers in
      the United Arab Emirates (UAE) and its relation to the early life determinants of obesity and
      non-communicable diseases (NCDs). This research study will follow a prospective cohort
      approach. Two hundred and fifty mother-infant pairs will be followed for 18 months.

      The hypothesis of this research study is that exclusive breastfeeding of the infant will
      provide potential protective effect against cardiometabolic risk factors. This study will
      also hypothesize that mothers who exclusively breastfeed their newborns would experience
      greater postpartum weight and body fat loss than mothers who are not breastfeeding.
    

Detailed description: 
      United Arab Emirates(UAE) is facing two critical situations: high incidence of obesity and
      chronic diseases and suboptimal infant feeding practices as reported by the Ministry of
      Health in the UAE. So early identification of preventive markers of cardiometabolic risk
      factors in breast milk is important for developing early intervention strategies to optimize
      health care for individuals and communities especially in countries suffering from high rates
      of obesity and chronic diseases such as the UAE.

      The purpose of this study is to prospectively follow up with the mothers and their infants
      (from 0-18months of infants age). It will explore breastfeeding and complementary feeding
      practices of mothers in UAE and its relation to the early life determinants of obesity and
      non-communicable diseases (NCDs). It will examine the components of human milk which might
      offer a protective benefit against obesity and its health consequences in infancy. It will
      also evaluate the feeding practices of the mothers and her nutritional status and relates it
      to their infants' growth and development.

      It is expected that this research study will fill an important knowledge gap in the
      understanding of the feeding practices of mothers and its relation to early-life determinants
      of obesity and other chronic diseases in the UAE.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The sample population is Emirati and Arab expatriate mothers, aged 19 to 40 years old;
        visiting Mother and Child Centers (MCH) and Primary Healthcare Centers (PHC) in Dubai and
        Sharjah.

        The selected mothers (who will be recruited during their 3rd trimester) were invited to
        participate in the study after being consented for their procedures and they will sign on
        the behalf of their babies
      
Biospecimen description: 
      Breastmilk samples, blood samples
    
Keywords: cohort; Noncommunicable diseases; pregnancy; infant; cognition; United Arab Emirates; gestational diabetes
Sarcopenia and Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The study investigates the effect of aminoacid infusion on proteinturnover in muscle from
      cirrhosis subjects, compared to healthy controls.

      The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation
      that follows cirrhosis.
    


Intervention name(s): Amino acid infusion; Bloodsamples, Biopsies.
Intervention type(s): Dietary Supplement; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Evaluating the Effects of Avanafil on Semen Parameters
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether avanafil will affect different aspects of
      sperm production.
    


Intervention name(s): avanafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg
Other intervention name(s): TA-1790; Stendra
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy male
Olmesartan Pediatric Pharmacokinetic (PK) Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with
      hypertension in ages 12 months - 16 years
    


Intervention name(s): Olmesartan medoxomil
Intervention type(s): Drug
Intervention description(s): Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Olmesartan PK in children
A Study of INO-A002 in Healthy Dengue Virus-naive Adults
Condition: Healthy Volunteers
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open label, single center, dose escalation study to evaluate the safety,
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers
      ages 18-60 years.
    

Detailed description: 
      This is a Phase 1, open label, single center, dose escalation study to evaluate the safety,
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers
      ages 18-60 years.

      The study will apply a 3+3 design such that 3 additional subjects will be enrolled into the
      cohort if one DLT (Section 7.3.1) is observed in one out of the first 3 subjects dosed during
      the 28-day period of safety and PK assessment. If no additional DLT is observed in 3
      additional subjects (i.e., 1 DLT in 6 total subjects), dosing will proceed to the subsequent
      cohort. However, if any additional DLT occurs (i.e., >1 DLT in 6 total subjects), then that
      dose will be deemed not tolerated and the prior dose will be considered the maximum tolerated
      dose (MTD).
    

Intervention name(s): INO-A002; CELLECTRA® 2000; Dengue Fever Antibodies (IgG)
Intervention type(s): Biological; Device; Device
Intervention description(s): Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).; Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.; To determine if the subject is Dengue seronegative at baseline
Intervention MeSH terms: Antibodies
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will adhere to a dose escalation scheme. There are five cohorts for Study ZIKA-dMAb 01. Participants (n=6 per cohort) will be administered INO-A002 at four dose levels: 0.5, 1, 2, and 4 mg DNA/dose.
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Seminal Plasma on Pregnancy Rate With IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      All couples planned for IVF will be asked to participate. After information and received
      informed consent they will be randomized into two groups.

      At the time for ovum pick up during an IVF procedure either half of the amount of seminal
      plasma or the same amount of physiological NaCl solution will be installed around the
      external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl
      solution will be prepared according to a prearranged randomization list by a technician.

      The success rate will be the number of diagnosed pregnancies and live births.
    

Detailed description: 
      All couples planned for IVF will be asked to participate. After information and received
      informed consent they will be randomized into two groups.

      At the time for ovum pick up during an IVF procedure either half of the amount of seminal
      plasma or the same amount of physiological NaCl solution will be installed around the
      external cervical opening in vagina.

      Normally we do not use the seminal plasma but now half of it will be installed and the other
      half analysed regarding a number of cytokines possibly involved in the immunological
      preparation of the female internal genitalia.

      The syringe with seminal plasma or physiological NaCl solution will be prepared according to
      a prearranged randomization list by a technician.
    

Intervention name(s): seminal plasma; Physiological NaCL solution
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia
Condition: Presbyopia; Near Vision; Miosis; Eye Diseases
MeSH terms: Eye Diseases; Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of
      Presbyopia
    

Detailed description: 
      A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the
      Treatment of Presbyopia
    

Intervention name(s): Aceclidine+Brimonidine combination ophthalmic solution; Aceclidine; Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aceclidine + Brimonidine combination ophthalmic solution; Aceclidine ophthalmic solution; Proprietary vehicle ophthalmic solution
Other intervention name(s): LNZ101; LNZ100
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Aceclidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multi-center, double masked, randomized, efficacy and safety study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmaceutical Solutions; Opthalmic Solutions; Eye Drops; CLARITY; Presbyopia; Miotic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in
      patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A
      (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180
      micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free
      follow up.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug
Intervention description(s): Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Condition: Transfusional Iron Overload; β-thalassemia Major; Pediatric Rare Anemia
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 2

Summary: 
      In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox
      in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients
      who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in
      this extension trial and receive chelation therapy with deferasirox for up to 4 years.
    


Intervention name(s): Deferasirox
Intervention type(s): Drug
Intervention description(s): Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.
Other intervention name(s): ICL670
Intervention MeSH terms: Deferasirox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: β-thalassemia major; iron overload; deferasirox; pediatric rare anemia
ABT-436 for Alcohol Dependence
Condition: Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly
      percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to
      placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more
      drinks per drinking day for men.
    

Detailed description: 
      Adrenocorticotropic hormone (ACTH) release from the pituitary gland via V1B stimulation is
      central to the hypothalamus-pituitary-adrenal (HPA) axis stress response (Carrasco & Van de
      Kar-2003, Herman & Cullinan-1997, Sapolsky et al-2000; Tsigos & Chrousos-2002). Chronic
      dysregulation of the HPA axis is common in major depressive disorder, anxiety disorders, and
      substance abuse disorders characterized by elevated AVP, increased responsiveness to AVP, as
      well as either increased or decreased overall HPA axis activity or responsiveness (Dinan &
      Scott-2005). HPA axis normalization via pituitary V1B antagonism is a mechanism for potential
      ABT-436 efficacy in these disorders (Schüle et al-2009). Limbic V1B antagonism in the brain
      may also contribute to efficacy (Roper et al-2011).

      Alcohol dependence, or alcoholism, is characterized by a chronic relapsing course, in which
      alcohol-associated cues and stress are known relapse triggers (Brownell et al-1986, Heilig &
      Egli-2006, Sinha & Li-2007). Recent research suggests that neural systems mediating
      behavioral stress responses may offer useful targets for pharmacotherapy of alcoholism. In
      animal models, excessive alcohol consumption that results from a history of alcohol
      dependence is accompanied by increased behavioral sensitivity to stress (Heilig & Koob-2007).
      Preclinical studies have shown that V1B antagonists can attenuate reinstatement of heroin and
      alcohol self-administration, and block dependence-induced exaggeration of alcohol intake, in
      rats. V1B antagonists have also been shown to block stress-induced reinstatement of drug and
      alcohol seeking in ethanol dependent rats (Zhou-2011). For these reasons the NIAAA Clinical
      Investigations Group (NCIG) proposes to test ABT-436 in a Phase 2, proof of concept trial for
      the treatment of alcohol dependence.
    

Intervention name(s): ABT-436; Matched Placebo - Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): Target dose - 400mg BID; Target Dose - 2 pills BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol; Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
Condition: Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      Evaluate the effect of lifestyle modification through the adoption of a DASH diet, with and
      without physical activity guidance, on blood pressure and insulin sensitivity in elderly
      patients with type 2 diabetes and hypertension.
    

Detailed description: 
      Data regarding the effects of physical activity and DASH-type diet on blood pressure control
      in patients with type 2 diabetes and hypertension are scarce in the literature, whether
      evaluating these isolated interventions or together. In addition, most studies do not measure
      BP using ABPM, which has a special importance in the assessment of pressure homeostasis in DM
      or are short-term studies. Were only two studies have been identified in the literature that
      evaluated the effect of the DASH diet on patients with type 2 DM; however, in both trials,
      being elderly was not an inclusion criterion. The first was an Iranian study that
      demonstrated in 31 non-hypertensive patients a significant reduction in BP after 8 weeks of
      following a DASH diet. In the second ECR, we demonstrated that in 20 hypertensive type 2 DM
      patients, all using antihypertensive drugs and with uncontrolled BP, a DASH-type diet for 4
      weeks associated with physical activity reduced the systolic BP assessed by ABPM by 12.5
      mmHg. However, the adopted design did not allow to separate the effect of diet from the
      effect of physical activity. On the other hand, the effect of a single session of walking
      followed by a 24-hour ABPM assessment showed a reduction in BP in hypertensive elderly and
      non-hypertensive patients, also without DM. So far it is not defined in patients with type 2
      DM and hypertension, especially the elderly, whether the DASH diet alone is as beneficial for
      BP as its association with physical activity, particularly, considering the difficulties of
      performing exercises in this group of patients. This is valuable information, as it would
      reinforce the role of diet therapy intervention even if in isolation in this age group.
      Furthermore, the role of the DASH diet with or without physical activity remains unknown on
      insulin sensitivity.
    

Intervention name(s): DASH; DASHPED
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive DASH diet orientation and recommended to maintain their usual physical activity; Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; Hypertension; Elderly; DASH; Steps
Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome
    

Detailed description: 
      AReMIS (Antiplatelet and Recurrent Myocardial Infarction Study) To compare the relative risk
      of new myocardial infarction (recurrent myocardial infarction or 'rMI') in patients with a
      history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using
      ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where
      aspirin is considered a covariate.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18 years or more, both genders,with an acute coronary syndrome, agreed to
        participate and able to respond to an interview in French and/or providing the details of
        an alternative replier (proxy) if necessary.
      
Keywords: Effectiveness study; Acute coronary Syndrome; Real-life; France
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
Condition: Healthy Volunteers; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer
      patients who receive radiation and chemotherapy.

      In this study, GC4419 will be mixed with a small amount of radioactive material in order to
      find out how much study drug is in the blood and to see how the drug is processed and
      eliminated from the body. The safety and how subjects tolerate the study drug will also be
      studied.
    

Detailed description: 
      This is an open-label, single-dose, 1-period study.

      On Day 1, a single 30 mg (~100 μCi) dose of [14C]GC4419 will be administered as an IV
      infusion over 15 minutes. Blood, urine, and fecal samples will be collected to measure total
      radioactivity (plasma, whole blood, urine, and fecal samples), for GC4419 and its metabolites
      GC4520 and GC4570 concentrations (plasma, urine, and fecal samples), and for metabolic
      profiling (plasma, urine, and fecal samples), as total amounts of radioactivity allow, for at
      least 168 hours postdose (Day 8).

      If discharge criteria are not met on Day 8, collection of blood will be collected
      approximately every 72 hours, and urine and feces collection will continue in 24-hour
      intervals thereafter (for determination of total radioactivity and metabolic profiling only)
      until the discharge criteria are met or up to a maximum stay of 28 days (Day 29).

      The clinic will attempt to contact all subjects (including subjects who terminate the study
      early) using their standard procedures approximately 14 days after the last sample collection
      to determine if any adverse event has occurred since the last sample collection.

      Six (6), healthy, adult, non tobacco using, male subjects will be enrolled.
    

Intervention name(s): GC4419
Intervention type(s): Drug
Intervention description(s): 30 mg (~100 μCi) dose of [14C]GC4419
Intervention MeSH terms: Avasopasem manganese
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Adult; Superoxide Dismutase; Absorption; Metabolism; Elimination; Mass Balance; Male Subjects