bioihbjkbjnl/mcl2 huggingface dataset:
Mental Health Apps for Mild Psychological Distress Amongst Adolescents
Condition: Psychological Distress
Study type: Interventional

Summary: 
      This study investigates mental health mobile apps, to understand their efficacy in reducing
      mild levels of psychological distress amongst adolescents. All participants will be provided
      with an app which is already available in the public domain, and will be asked to use the app
      for guided self-help. Half of participants will receive a weekly telephone call, whilst the
      other half will not.
    

Detailed description: 
      The subscription version of the app "Sanvello" has several self-help exercises based on
      Cognitive Behavioural Therapy (to identify and challenge their thinking styles) and
      Mindfulness practices (to connect them with the present moment). Participants will be asked
      to complete these exercises on a daily basis for five weeks.

      Telephone calls will be provided weekly to half of participants to provide information about
      the app, or a rationale for its use. This phone call will not serve to provide any extra
      intervention or therapy to the participants.
    

Intervention name(s): Mental Health Mobile Application
Intervention type(s): Other
Intervention description(s): Mobile phones will not be provided to participants, but app subscriptions will be provided.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD
Condition: Diabetic Nephropathy Type 2
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions
      in Patients with middle stage of Diabetic Kidney Disease.
    

Detailed description: 
      The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is
      performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai
      Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to
      Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital
      of Integrated Traditional Chinese Medicine and Western Medicine, China.
    

Intervention name(s): ShenqiDihuang Decoction; ShenqiDihuang Decoction placebo
Intervention type(s): Drug; Drug
Intervention description(s): ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks; traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks
Other intervention name(s): nseng, Astragalus, Rehmannia and other TCMs Decoction; Ginseng, Astragalus, Rehmannia Decoction placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Kidney Disease，Traditional Chinese medicine
New Methods to Measure the Immune Response to Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because
      of this it is a useful vaccine in which to develop new methods for studying immune responses.
      Measuring the immune response to vaccines helps us to understand how they work and whether
      they are likely to protect any individual against infection. For most vaccines we measure the
      immune system's production of antibody after a vaccine has been given. The investigators want
      to develop new methods that give a far more detailed picture of the antibody response to
      vaccines than has previously been possible. These methods will investigate the genetic
      instructions used by each antibody producing cell to make antibody. These methods have the
      potential to give new insights into the way vaccines work, which could be applied to studying
      vaccines and vaccine schedules in the future.
    


Intervention name(s): Hepatitis B vaccine
Intervention type(s): Drug
Intervention description(s): Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).
Other intervention name(s): HBvaxPRO, 10μg/ml, Sanofi Pastuer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in
      patients with hypertension
    


Intervention name(s): Fimasartan
Intervention type(s): Drug
Intervention description(s): Fimasartan 60 ~ 120 mg/po take one tablet once a day
Other intervention name(s): BR-A-657-K
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple secondary and tertiary centers
Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele
Condition: Cystocele
MeSH terms: Hypokinesia; Cystocele; Urinary Bladder Neck Obstruction; Urinary Bladder, Underactive; Hernia
Study type: Observational

Summary: 
      Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet
      obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO
      remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO
      in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.
    

Detailed description: 
      Between November 2010 and September 2018, all women with ≥ POP-Q stage II cystocele who
      visited the urogynecological department of a medical center for urodynamic evaluation were
      reviewed. Those women who have no complete data of maximum flow rate (Qmax), voided volume,
      post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were
      excluded from this study. The DU was defined when the PdetQmax was less than 20 cmH2O, the
      Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The
      BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12
      mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were
      allocated to the non-DU/BOO group.

      STATA software was used for statistical analysis. Wilcoxon signed-rank test or McNemar's test
      was used for statistical analysis as appropriate. P < 0.05 was considered statistically
      significant.
    

Intervention name(s): Urodynamic study
Intervention type(s): Diagnostic Test
Intervention description(s): The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position [14]. A 20-minute pad test for each woman was also performed [15, 16]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS [3]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.
Other intervention name(s): Pad test
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All medical records of women with ≥ POP-Q stage II cystocele who visited the
        urogynecological department of a medical center for urodynamic evaluation were reviewed.
      
Keywords: Bladder outlet obstruction; Detrusor underactivity; Cystocele
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 730357
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R)
    


Intervention name(s): BI 730357; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): 0 mg BI 730357 tablet orally on Day 1; 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of EUS Guided Treatment of Gastric Varices
Condition: Gastric Varices Bleeding
MeSH terms: Esophageal and Gastric Varices; Varicose Veins
Study type: Observational

Summary: 
      The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive
      treatment for Gastric Varices performed by Indiana University EUS physicians.
    

Detailed description: 
      Using an IRB approved database (IU IRB#1209009522; NCT02037659), data collected from the
      database will be evaluated to identify complications, risk of rebleeding, death within 1 year
      of treatment, varices eradication and need for re-intervention associated with cyanoacrylate
      tissue adhesive (Dermabond) treatment performed by Indiana University Endoscopic Ultrasound
      (EUS) physicians.
    

Intervention name(s): Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varices
Intervention type(s): Procedure
Intervention description(s): Subjects will have undergone treatment and been enrolled into the existing registry.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects were treated for Gastric Varices with bleeding using cyanoacrylate tissue adhesive
        and administered by endoscopic ultrasound.
A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the elimination of guselkumab glycoform variants
      following a single intravenous (IV) administration of guselkumab at a 10 milligram per
      kilogram (mg/kg) dose in healthy participants.
    

Detailed description: 
      This is an open-label single-dose study in healthy participants. All participants will
      receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per
      kilogram (mg/kg) over 60 minutes on Day 1. After the administration of study drug on Day 1,
      participants will stay in the clinical study unit until being discharged after the
      assessments on Day 2. Participants will be required to return to the study center for
      outpatient visits including safety assessments through Day 85 after study drug
      administration. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Guselkumab
Intervention type(s): Drug
Intervention description(s): Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; Guselkumab
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      Surgical stress induces stress hormone release and sympathetic hyperactivation.
      Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study
      investigate the effect of dexmedetomidine on stress responses and autonomic nervous system
      balance in patients undergoing major spine surgery.
    


Intervention name(s): dexmedetomidine group; control group
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery; 0.9% saline infusion
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak
Condition: Flu Like Symptom; Flu Like Illness
Study type: Interventional

Summary: 
      From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom
      (UK). During the same time, seasonal flu continued to circulate across the UK. With similar
      course of management at early stages, flu like symptoms were self-isolated to prevent the
      spread and further complications of infection. Present study aimed to evaluate the effect of
      self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in
      March 2020 during the Covid-19 outbreak in UK.
    


Intervention name(s): Individualised Ayurveda
Intervention type(s): Other
Intervention description(s): Saline warm water gargle, Steam, Paracetamol for body temperature and plenty fluid and rest, Food and herbs recommendation as per individual Ayurveda constitution, Using Ginger/ lemon/ turmeric/ honey recommended as per individual, Yoga breathing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
Condition: Allergy
MeSH terms: Hypersensitivity; Venom Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this study is to show that flow cytometry can be an accurate tool to help
      physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom
      allergy.

      75 patients having a story of reaction to hymenoptera venom will be selected for this trial.

      Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and
      Week 21 visit.
    


Intervention name(s): flow cytometry
Intervention type(s): Other
Intervention description(s): flow cytometry
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetic Study in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 clinical trial to evaluate insulin exposure using different formulations of
      Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
    

Detailed description: 
      Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin
      exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations
      administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced.
      Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and
      dosing, depending on randomization schedule.
    

Intervention name(s): Technosphere® Insulin Inhalation Powder; Technosphere® Insulin Inhalation Powder
Intervention type(s): Drug; Drug
Intervention description(s): 15 subjects in a three-way crossover (three different doses of TI Inhalation Powder [one 20 U, two 20 U and one 40 U cartridges); 16 subjects in a four-way crossover (four different doses of TI Inhalation Powder [one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)])
Other intervention name(s): Inhaled human insulin and Technosphere Powder; Inhaled human insulin and Technosphere Powder
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of
      Bifidobacterium in faecal samples will be investigated.
    

Detailed description: 
      This randomized, parallel, double-blinded intervention study of 6 weeks will include 88
      females, who will consume GOS for three consecutive weeks. Faecal samples will be collected
      at several time points to measure microbiota composition.
    

Intervention name(s): GOS 1; GOS 2
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 sachet each morning; 1 sachet each morning
Other intervention name(s): galacto oligosaccharide; galacto oligosaccharide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study applies a randomized, parallel, double-blind design of 6 weeks
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: galacto-oligosaccharides; prebiotics; microbiota
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Condition: Central Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a pilot study examining the effect of dietary supplements that contain soy products.
      The purpose of this study to find out if soy supplementation can help to reduce the storage
      of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the
      abdomen; it has the potential to increase the risk of certain health problems.
    

Detailed description: 
      Obesity is a leading risk factor for many chronic diseases in the USA. Abdominal fat,
      specifically visceral fat is metabolically active and can be detrimental to health. Abdominal
      obesity is especially high in postmenopausal women (prevalence rates 50- 70%) in whom
      estrogen deficiency may lead to accumulation of excess visceral fat. Although estrogen
      replacement therapy is effective in preventing visceral fat accumulation, its adverse effects
      warrant a search for a safer phytochemical that exerts estrogenic properties. Soy, containing
      isoflavones (estrogen-like compounds), is a promising dietary component in reducing abdominal
      obesity in menopausal women. The favorable effects of isoflavones were already demonstrated
      in animal studies.The effects of soy compounds as a dietary component in preventing and
      reducing abdominal obesity and its associated metabolic abnormalities will be examined among
      menopausal Women. We will use quantitative magnetic resonance spectroscopy/imaging (qMRS/I)
      to determine dose and effects of soy supplementation for preventing and treating abdominal
      adiposity. The results from this study will shed light on the application of soy as a novel
      dietary approach in preventing and managing abdominal obesity among peri- and early
      menopausal women.
    

Intervention name(s): soy supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity prevention; Soy supplementation
Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this project is to study the presence of expression differences - at RNA and
      protein level - of different members of the tachykinin family and kisspeptin and their
      receptors, between fertile women and infertile patients with different etiologies.
    


Intervention name(s): Ovarian puncture
Intervention type(s): Procedure
Intervention description(s): Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Infertility; Tachykinin; Kisspeptin