bioihbjkbjnl/mcl2 huggingface dataset:
Oxidative Stress in Hypobaric Hypoxia
Condition: Hypobaric Hypoxia; Metabolomics; Oxidative Stress; Acute Mountain Sickness
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional

Summary: 
      The trial investigates changes in metabolism during high altitude expedition up to 6865m. A
      mass-spectrometry based platform is used to detect different oxidative stress related
      metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory
      parameters.
    

Detailed description: 
      Background

      Altitude related illness, which include acute mountain sickness (AMS), high altitude
      pulmonary edema (HAPE) and high altitude cerebral edema (HACE), is common in subjects exposed
      to high altitude during professional or leisure time activities. There are independent risk
      factors such as: individual susceptibility and rate of ascent. HAPE is a potentially
      life-threatening complication of high altitude stay, mostly occuring within the first 2-5
      days of exposure. Although there is a controversial discussion, excessive hypoxic pulmonary
      vasoconstriction is thought to be the main trigger for developing HAPE. Beside the
      controversial discussion if hypobaric hypoxia leads to oxidative stress it is not known
      whether oxidative stress contributes to AMS or HAPE.

      Objective

      The investigators hypothesize that reactive oxygen species are generated during high altitude
      stay and contribute to the development of acute mountain sickness. Furthermore they would
      like to describe other changes in metabolic pathways possibly contributing to vessel tone
      dysregulation.

      Methods

      36 healthy volunteers will examined during an high altitude medical research expedition to
      Mount Muztagh ata (7549m) in Western China. Acute mountain sickness scores and clinical
      parameters will be assessed. Metabolomics analysis of more than 390 parameters, using a mass
      spectrometry-based targeted metabolomic platform, is used to detect systemic oxidative stress
      and functional impairment of enzymes that require oxidation-sensitive co-factors. Furthermore
      routine laboratory test will be done, for example CRP, creatinine and interleukines
    

Intervention name(s): Hypoxic exposure
Intervention type(s): Other
Intervention description(s): Hypoxic exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: high altitude; hypobaric hypoxia; metabolomics; oxidative stress; acute mountain sickness
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Condition: Peripheral Vascular Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Intermittent Claudication
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which
      subjects with intermittent claudication (IC) will be randomized to receive a single treatment
      of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline)
      administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower
      extremities during one procedure to evaluate the safety, tolerability, and potential activity
      of VLTS-934 as compared with a saline placebo.
    

Detailed description: 
      This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which
      subjects with IC will be randomized to receive a single treatment of VLTS-934 (84 mL, or a
      total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular
      (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to
      evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a
      saline placebo.
    

Intervention name(s): VLTS-934
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Peripheral arterial disease
Liraglutide as add-on to Insulin in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to:

      Part 1:

      To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly
      controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

      Part 2:

      To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects
      counterregulatory hormones and cognitive performance during hypoglycemia.
    


Intervention name(s): Liraglutide; Placebo; Liraglutide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.; Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.; Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.; Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Cognitive performance; Hypoglycemia; Insulin; Glucagon-Like Peptide 1; Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Incretins; Hormones
Expression of Steroid Receptors in Endometrium
Condition: Endometrium
Study type: Observational

Summary: 
      Expression of steroid receptors in endometrium during ovarian stimulation.
    

Detailed description: 
      The purpose of this study is to examine in stimulated cycles a) whether there is a difference
      in expression of steroid receptors in stroma and glands of endometrium between different days
      during the follicular phase b)whether there are secretory changes detected by endometrium
      histology before ovulation c)whether there is an association between expression of steroid
      receptors in endometrium and exposure to oestradiol and progesterone during the follicular
      phase.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        infertile women
      
Biospecimen description: 
      endometrial tissue
    
Keywords: Steroid receptors; Endometrium; IVF; Follicular phase
Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or
      high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and
      postural control in sedentary healthy adults.
    

Detailed description: 
      The primary aim of the study is to compare the effects of a moderate intensity aerobic
      exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high
      intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart
      rate) on measures that probe cortical synaptic plasticity using transcranial magnetic
      stimulation (TMS) in sedentary healthy adults.
    

Intervention name(s): Moderate intensity exercise.; High intensity exercise.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.; High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers
Condition: Serious Gram-negative Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses
      of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.
    


Intervention name(s): Intravenous infusions of WCK 5222; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefepime-zidebactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain
Condition: Inflammation; Pruritus; Hyperalgesia
MeSH terms: Hyperalgesia; Neurogenic Inflammation; Pruritus; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to quantitatively characterize the effects of L-menthol as a topical
      counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the
      TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.
    

Detailed description: 
      This study is designed as an experimental model in healthy humans.
    

Intervention name(s): Topical L-menthol 40%; Vehicle, topical ethanol 96%
Intervention type(s): Other; Other
Intervention description(s): Naturally occurring local anaesthetic, counterirritant and TPRM8-agonist. CAS Number: 2216-51-5; Organic solvent CAS Number: 64-17-5
Other intervention name(s): Menthol
Intervention MeSH terms: Ethanol; Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Condition: Bilateral LASIK Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and efficacy of a new eye drop formulation with REFRESH
      PLUS® in participants following LASIK surgery.
    


Intervention name(s): carboxymethylcellulose sodium based new eye drop formulation; carboxymethylcellulose sodium based eye drops
Intervention type(s): Drug; Drug
Intervention description(s): 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.; 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Other intervention name(s): REFRESH PLUS®
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
Condition: Supplement
Study type: Interventional

Summary: 
      The purpose of this study is to compare the frequency of appearance of the total clinical
      manifestations (expected adverse event: nausea, vomiting, heartburn, abdominal pain,
      gas/swelling, diarrhea, headache, shortness of breath, metallic taste and constipation) after
      consuming microencapsulated iron and comparator for 14 days.
    

Detailed description: 
      Subjects will consume a daily dose once per day for 14 days with a washout period of two
      menstrual cycles between the two products. After this washout period, subjects will return to
      the clinical and will undergo identical procedures with counter order of the intervention.

      Each day of the study will be recorded in a diary by each subject. Participants will be
      requested not to change their regular life habits and diet during the entire study.
    

Intervention name(s): Experimental product consumption; Comparator product consumption (Iron sulphate)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch; Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      Positive results in preclinical and clinical studies in adults and infants with Prader-Willi
      syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The
      objective of this study is to document effects of oxytocin intranasal administrations on
      behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.
    

Detailed description: 
      Two groups of patients will be constituted according to their age; "Group 1" children aged
      from 3 to 6 years (n = 20) and "Group 2" children aged from 7 to 12 years (n = 20). Within
      each group, subjects will be randomized to receive either oxytocin or placebo for 12
      consecutive weeks. A second period of 12 consecutive oxytocin treatment weeks will then be
      performed for all patients, followed by a 4-week observation period to document effects after
      discontinuation of treatment.
    

Intervention name(s): Oxytocin; Placebo; Oxytocin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study drug is oxytocin in intra-nasal administration, Syntocinon®, reconditioned as a placebo-like spray. The dosage administered will be 8 International Unit, ie 1 spray (4 International Unit per spray) in each nostril per day for the first 12 weeks, in 3 and 6 years old patients. The dosage administered will be 16 International Unit or 2 sprays in each nostril per day for the first 12 weeks, in 3 to 6 years old patients.; Placebo should be used as a spray, similar to that of the oxytocin. The dosage administered will be 1 spray in each nostril per day for the first 12 weeks in 3 to 6 years old patients. The dosage administered will be 2 sprays in each nostril per day for the first 12 weeks, in 7 to 12 years old patients.; Each patient will receive oxytocin in open label (Syntocinon® not reconditioned) from week 13 to week 24 according to the same dosages.
Other intervention name(s): Intranasal administration of oxytocin (Week 1 to 12); Intranasal administration of placebo (Week 1 to 12); Intranasal administration of oxytocin (Week 13 to 24)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children will receive after randomization either placebo or oxytocin administration (daily intranasal) for a total duration of 12 consecutive weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prader-Willi syndrome; Oxytocin; Behavioural troubles
A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This study aims to compare the clinical performance and subjective acceptance of the
      comfilcon A and the omafilcon B soft contact lenses.
    

Detailed description: 
      This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross
      comparison. Thirty subjects will use each lens type for two weeks in random sequence.
      Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn
      on a daily wear basis.

      The final optical design of comfilcon A contact lens was optimized to improve the quality and
      two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to
      evaluate the modified optical design.
    

Intervention name(s): comfilcon A; omafilcon B
Intervention type(s): Device; Device
Intervention description(s): toric contact lens; toric contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Study of SARS in Children
Condition: Epidemiology
Study type: Observational

Summary: 
      Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a
      novel SARS-associated coronavirus. According to the epidemiological data, it is highly
      infectious by intimate contact, respiratory secretion, or direct contact with infectious body
      fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS
      cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under
      20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to
      now shows that SARS is mainly a disease of adults. The data of clinical presentation and
      epidemiological prevalence in teenage group and children are lacking. Therefore, this project
      is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology
      of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric
      wards or visited ER and received blood sampling due to the need of clinical
      diagnosis/management would be enrolled. After the necessary laboratory examinations were
      done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.
    


Time perspective: Other
Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants
Condition: Healthy Participant
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4
      (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.
    


Intervention name(s): GST-HG171/Ritonavir; Itraconazole; GST-HG171/Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3; Administered orally once daily for 9 days from Days 8 through 16; Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14
Intervention MeSH terms: Ritonavir; Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Genital Wart and Sexuality in Adolescence
Condition: Adolescent Development; Genital Wart; Sexual Dysfunction; Sexual Disorder, Physiological
MeSH terms: Warts; Condylomata Acuminata; Sexual Dysfunction, Physiological
Study type: Observational

Summary: 
      The adolescence is a landmark in perceiving the sexuality and awareness about the sexual
      experiences. Genitals warts were shown to be a potential risk to impair the sexual functions
      in women. Adolescence is a vulnerable period in which the individuals may be prone to the
      negative effects of the disorders affecting sexual functions such as genital warts. The
      current study aimed to investigate the impact of genital warts on sexual functions in female
      adolescents.
    

Detailed description: 
      This current study aimed to elucidate the impact of genital warts on female sexual function
      in adolescence. The current study also targeted to reveal whether there is any correlation
      between the genital warts and the female sexual dysfunction, as well as the sexuality related
      distress. The current study is conducted at Youth Center Outpatient Clinic of Ankara City
      Hospital which is a high-volume tertiary health care center in Turkey. The study was
      prospectively designed and data were collected between the 1 August 2020 and 1 February 2021.
      Totally 90 female adolescents between the age of 17-21 who had regular sexual intercourse
      with heterosexual partners were included. The Study group composed of 45 adolescents who had
      genital warts and the Control group included 45 healthy adolescents. Female sexual function
      Index (FSFI), Arizona Sexual Experiences Scale (ASEX) and Female Sexual Dysfunction Scale
      (FSDS) scores were compared between the two groups to evaluate the sexual functions.
      Difference between two independent means (two groups) power analysis demonstrated that this
      study achieved a power of 0.99, 0.98 , 0.99 with a 5% level of significance for comparison of
      45 adolescents with genital warts and 45 healthy adolescents in terms of FSFI, ASEX, and FSDS
      scores, respectively.
    

Intervention name(s): Clinical assessment
Intervention type(s): Other
Intervention description(s): FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The current study included 45 adolescents with the diagnosis of genital warts as the Study
        group and 45 healthy adolescents as the Control group.
      
Keywords: Genital wart; Female sexual dysfunction; Late adolescence; Sexuality related distress