bioihbjkbjnl/mcl2 huggingface dataset:
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
Condition: Ovulation Inhibition
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral
      contraceptive regimens.
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658K); EV/DNG (SH T00658L)
Intervention type(s): Drug; Drug
Intervention description(s): Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg; Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Contraceptive; Ovulation Inhibition
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
Condition: Advanced Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal
      LFG316 in patients with advanced age-related macular degeneration.
    


Intervention name(s): LFG316; LFG316; LFG316; LFG316
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMD,; ARMD,; Age-related Macular Degeneration,; Eye Disease,; Wet AMD,; Neovascular AMD,; Choroidal Neovascular Membrane,; Choroidal Neovascularization,; Drusen,; Geographic Atrophy,; Complement,; C5,; Antibody
Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV
      vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and
      effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct,
      readily produced in large quantities, and stable for long periods of time. This study will
      evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine,
      VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost,
      VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for
      proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in
      the world. The study's primary objective is to investigate the ability of a 6-plasmid DNA
      prime followed by a rAd5 boost to elicit HIV-specific cellular immune responses at mucosal
      surfaces.

      This study will last 12 months and participants will visit the clinic 15 times. Participants
      will receive three injections of the VRC-HIVDNA016-00-VP vaccine at Months 0, 1, and 2
      followed by an injection of VRC-HIVADV014-00-VP at Month 6. All injections will be given in
      the upper arm. At study visits participants will have a physical, medical history taken,
      blood collection, and risk reduction counseling. At some visits, rectal biopsies (via
      anoscopy or, optionally, by flexible sigmoidoscopy), saliva, semen, cervical and/or vaginal
      fluid samples will also be collected. Pregnancy testing for women will be done prior to each
      vaccination and study procedure.

      Participants will be contacted by study staff once a year for 5 years after the initial study
      visit for follow-up health and safety monitoring.
    

Intervention name(s): VRC-HIVDNA-016-00-VP; VRCHIVADV014-00-VP
Intervention type(s): Biological; Biological
Intervention description(s): Composed of six DNA plasmids in equal concentrations that encode Gag, Pol, and Nef from clade B (strains HXB2, NL4-3, NY5/BRU) and the HIV-1 Env glycoproteins from clade A (strain 92rw020), clade B (strains HXB2/BaL), and clade C (strain 97ZA012). Vaccine will be administered intramuscularly (IM) in the deltoid via needle-free Biojector.; A mixture of 4 recombinant serotype 5 adenoviral replication deficient vectors, each expressing HIV-1 proteins (clade B Gag-Pol fusion, clade A Env, clade B Env, clade C Env). Administered IM via needle and syringe.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?
Condition: Herpetic Gingivostomatitis
MeSH terms: Stomatitis, Herpetic; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this
      are dehydration, pain and hospitalisation. The objective of this randomized controlled trial
      is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms
      associated with acute herpes gingivostomatitis in children. This study will involve 80
      children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days.
      The primary outcome measure will be the duration (in days) of feeding and/or drinking
      difficulties.
    


Intervention name(s): Valacyclovir; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phenotype Depression Study
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      To facilitate the development of a personalized approach to the treatment of patients with
      major depression, this study is designed to elaborate the clinical and neurobiological
      phenotype of depressed patients with increased inflammation. The data obtained in this
      proposal will allow the investigators to test the hypothesis that depression and inflammation
      interact to elaborate a relatively discreet phenotype that warrants an individualized
      approach to diagnosis and treatment of patients with depression. Moreover, the identification
      of specific environmental risk factors for inflammation will foster the elaboration of
      preventative strategies for patients at risk.
    

Detailed description: 
      One hundred and thiry-five patients with major depression diagnosed based on DSM-IV TR
      criteria between the ages of 21 and 65 (males, females and minorities) will be recruited.
      Forty-five patients with high inflammation as defined by a CRP >3 mg/L will be enrolled along
      with 45 depressed patients with medium inflammation (CRP=1-3mg/L) and 45 depressed patients
      with low inflammation (CRP<1mg/L) will complete a 2 night inpatient stay in Emory University
      Hospital's research unit, the Atlanta Clinical and Translational Science Institute (ACTSI).
      Participants will undergo psychiatric and neurocognitive assessments, sleep studies and blood
      and cerebral spinal fluid (CSF) sampling.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        One hundred and thiry-five patients with major depression diagnosed based on DSM-IV TR
        criteria between the ages of 21 and 65 (males, females and minorities) will be recruited.
        Forty-five patients with high inflammation as defined by a CRP >3 mg/L will be enrolled
        along with 45 depressed patients with medium inflammation (CRP=1-3mg/L) and 45 depressed
        patients with low inflammation (CRP<1mg/L)
      
Biospecimen description: 
      Diurnal plasma samples are collected hourly from 9 am to 9 pm once; Cerebrospinal fluid once;
      mRNA from peripheral blood leuckocytes collected 5 times; DNA for analysis of genetic
      polymorphisms is collected once.
    
Keywords: Major Depressive Disorder; Depression
Fish Oil and Asthma in House Dust Mite Allergy
Condition: Allergic Asthma; Bronchial Inflammation; House Dust Mite Allergy
MeSH terms: Asthma; Dust Mite Allergy; Hypersensitivity; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Native populations consuming high amounts of fish suffer less from allergic diseases. The
      purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might
      have a disease modifying influence on asthmatics sensitized to house dust mite.
    

Detailed description: 
      Most asthmatics suffer from mild disease and non pharmacologic intervention would be
      beneficial for the majority of these subjects. We investigated the anti-inflammatory
      potential of polyunsaturated fatty acids (PUFA) in allergic asthma.

      In our parallel, double-blinded study, 23 patients allergic to house dust mite were randomly
      assigned to dietary supplementation with a PUFA enriched fat blend or placebo for five weeks.
      The verum contained eicosapentaenoic acid (EPA) 450 mg/day, docosahexaenoic acid 180 mg/day,
      stearidonic acid 60mg/day, and gamma-linolenic acid 60 mg/day; the placebo consisted of
      mainly unsaturated and monosaturated fatty acids. After three weeks, the patients were
      challenged with low doses of inhalative house dust mite allergen for two weeks.

      Following parameters were determined during low-dose allergen exposure in both groups:
      exhaled NO (eNO) as a marker of bronchial inflammation, clinical symptoms, FEV1, beta-agonist
      usage, and bronchial hyperreactivity, sputum eosinophils and sulfoleucotrienes. Compliance
      with the study protocol was controlled by the determination of PUFAs in plasma and
      erythrocytes.
    

Intervention name(s): polyunsatturated fatty acids (fish oil)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: polyunsatturated fatty acids; nutrition; low-dose allergen challenge; exhaled nitric oxide
A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in
      combination with SHR-1316 in patients with advanced malignancies and to provide a recommended
      dose (RP2D) for subsequent clinical studies.
    


Intervention name(s): SHR-1501; SHR-1316
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered intravenously
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aging Brain Changes, Executive Dysfunction and Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to look at the relationship between age related structural brain
      changes and changes in depressive symptoms,disability and several aspects of cognitive
      functioning following treatment with escitalopram.
    

Detailed description: 
      Age-related brain changes have been associated with development of late-life depression.
      Prominent among aging-related changes is decline in white matter disproportionately affecting
      frontal structures.Based on previous findings, we conceptualized treatment resistance,
      disability, and executive dysfunction as clinical phenomena contributed, at least in part, by
      compromised integrity of frontal neural systems. The study focuses on frontal white matter
      abnormalities in geriatric depression and their relationship to treatment response,
      disability,and executive dysfunction.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10mg tab daily
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression
Long-term Effects of Laser Refractive Surgery
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine if there are short- and long-term postoperative differences in
      visual and corneal outcomes between different laser refractive surgical procedures.
    

Detailed description: 
      We will measure postoperative differences in visual acuity, contrast sensitivity, corneal
      light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal
      topography and wavefront between PRK performed with epithelial removal by a laser or by a
      rotary brush and between LASIK performed by using a microkeratome or by using a femtosecond
      laser. Measurements will be made at baseline and at intervals over 5 postoperative years in
      21 LASIK patients, 20 PRK patients, and 20 unoperated controls.
    

Intervention name(s): Laser Refractive Surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Therapy With Telerehabilitation in Patients Living With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY)
      approach with the Telerehabilitation in patients living with HIV (PLWH).
    

Detailed description: 
      55 individuals living with HIV (PLWH) were included in the study. Among those individuals, 25
      individuals who volunteer to exercise with telerehabilitation will be grouped in the
      telerehabilitation group. The rest of the individuals who do not participate in the exercise
      group will be in the control group.

      Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attend
      sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an
      investigator over the videoconference through zoom. The investigator, who provides
      supervision during the sessions, also participates in the exercises simultaneously.

      Group 2: Control group: Individuals in the control group continue their routine drugs.

      Both the telerehabilitation exercise group and the control group continue their drug
      treatments during the 12 weeks of the period.
    

Intervention name(s): Telerehabilitation Group; Control group
Intervention type(s): Other; Other
Intervention description(s): The Telerehabilitation program includes a Biopsychosocial Exercise Therapy (BETY) approach.
BETY approach includes patient education on pain, functional body stabilization exercises (mind-body information management), dance therapy authentic movement (emotion-state information management), and sexual information management.
Telerehabilitation group participate in the sessions that last for one and a half hours, 3 days a week for 12 weeks, video conference over the Zoom program. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.; The control group participants include those who do not want to receive exercise treatment with telerehabilitation and take their routine medications during the 12 weeks period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Telerehabilitation; Biopsychosocial Approach
Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in
      India for a period of 1.5 years. Demographic profile of patients with heart failure with
      reduced ejection fraction on sacubitril/valsartan was recorded.
    

Detailed description: 
      Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of
      sacubitril/valsartan was assessed for a period of 6 months post index date.
    

Intervention name(s): sacubitril/valsartan
Intervention type(s): Drug
Intervention description(s): There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with
        a recording of LVEF <40% at index date with a prescription of sacubitril/valsartan
      
Keywords: heart failure with reduced ejection fraction; HFrEF; India; sacubitril; valsartan; electronic medical records; EMRs; retrospective; RWE
Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients
Condition: Critical Illness; Mechanical Ventilation; Intensive Care Unit
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of a transcutaneous electrical stimulation in critically ill
      patients compared to a sham electrical stimulation to decrease the incidence of diaphragm
      dysfunction before mechanical ventilation weaning.
    


Intervention name(s): Sham electrical stimulation; Transcutaneous diaphragm electrical stimulation
Intervention type(s): Device; Device
Intervention description(s): A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes; A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diaphragm dysfunction; Transcutaneous Electrical Stimulation; Intensive care unit; Mechanical ventilation
A Project to Study Probiotic Beauty Products on Skin Improvement
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The aim of the study was to use probiotic beauty products for 4 weeks and evaluate the impact
      of products on healthy skin.
    

Detailed description: 
      Twenty subjects were recruited and informed to apply the lotion gel twice per day (3~5 mg/cm2
      once) for 4 weeks. Two kinds of facial lotiongels, "A" gel and "B" gel, were provided to
      every subject. The "A" gel (TAC/Collagen lotiongel) was applied on subjects' right face and
      the "B" gel (placebo lotion) on their left face (formula showed as Table S2). Ordinary
      cosmetics usage was permitted but any change of usage was not allowed during the
      intervention. Outdoor activities (sun exposure) and the usage of sunscreen lotion were not
      limited in this study. Every subject was required to inspect his/her skin condition on week 0
      and 4. Before inspection, the face was washed with water and waited for 30 min in an
      air-conditioned room (25°C, humility 55 ± 5%). Among these 20 subjects, eight of them had
      severe acne with at least two acne lesions on each side of face when participating this
      trial. They were instructed for more visits to evaluate the symptom of acne on week 1 and 2.

      Skin hydration (Corneometer CM825, Courage + Khazaka Electroni, Germany), sebum (Callegari
      1930, Italy), and inflammation detection (Chroma Meter MM-500, Minolta, Japan) of upper cheek
      were measured in every subject. The improvement in inflammation was positively correlated
      with a decrease of a* value or an increase of L* value. VISIA® Complexion Analysis (VISIA®
      Complexion Analysis, U.S.A.) was also employed to measure the skin inflammation, porphyrins
      numbers and brown spot numbers of whole face. The result was presented as the mean value and
      the relative percentage (%) to the baseline.
    

Intervention name(s): TAC/Collagen gel; placebo lotion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Apply it twice per day for 4 weeks; Apply it twice per day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Investigate the Effect of Single and Repeated Oral Doses of ACT-539313 on What the Body Does to Flurbiprofen, Omeprazole, Midazolam in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effect of single and repeated oral doses of ACT-539313 on what the
      body does to flurbiprofen, omeprazole, midazolam in healthy participants.
    

Detailed description: 
      A screening evaluation will be performed within 3 to 28 days (or within 10 to 28 days for
      women of childbearing potential) before first study treatment administration. Prior to any
      screening assessment, participants must sign the informed consent form.

      Eligibility will be based on the results of the Screening and Day -1 assessments.

      The participants will be confined to the study site from the morning of Day -1 until the
      morning of Day 2, from the morning of Day 7 until the morning of Day 9 and from the morning
      of Day 14 until the morning of Day 16. Participants will return to the study site for the End
      of Study examination on Day 17.
    

Intervention name(s): ACT-539313; Flurbiprofen; Omeprazole; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg ACT-539313 (hard capsules) will be administered twice per day in period 2 (morning and evening of Day 8), period 3 (morning and evening of Day 9 to 14) and period 4 (morning and evening of Day 15).; One daily dose of flurbiprofen 50 mg will be administered in period 1 (morning of Day 1), period 2 (morning of Day 8), and period 4 (morning of Day 15).; A single dose of omeprazole 20 mg will be administered in period 1 (morning of Day 1), period 2 (morning of Day 8), and period 4 (morning of Day 15).; A single dose of midazolam 2 mg will be administered in period 1 (morning of Day 1), period 2 (morning of Day 8), and period 4 (morning of Day 15).
Intervention MeSH terms: Flurbiprofen; Midazolam; Omeprazole
Intervention model: Sequential Assignment
Intervention model description: Four-period, fixed-sequence drug-drug interaction study.
Masking: None (Open Label)
Primary purpose: Other