bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Duloxetine in Psychological Resilience
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore benefits of duloxetine in enhancing psychological
      resilience and to understand the relevance of inhibiting of both serotonin (5HT) and
      norepinephrine (NE)to therapeutic responses.
    

Detailed description: 
      This is an investigator-initiated, single-site study consisting of 8 weeks of open-label,
      fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive
      Disorder (MDD).
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Pharmacotherapy; Duloxetine
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating the effect of acute exposure,
      acclimatization and re-exposure to high altitude on cerebral autoregulation
    

Detailed description: 
      Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3
      days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride)
      to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile.
      Participants will stay there for the next 8 nights and they will be spend the days (6-8 h
      daily) at the telescope station at 5050 m while undergoing testing as described above at the
      first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h
      ride, one way). After the first 8 day altitude sojourn participants will return to the
      Santiago area (520 m) for a 6 day recovery period.

      A second altitude sojourn with an identical schedule as the one described above and a final
      low altitude stay of 3 days will follow.
    

Intervention name(s): altitude exposure
Intervention type(s): Other
Intervention description(s): altitude exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: High altitude; Cerebral autoregulation; Transfer function analysis
A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab
Condition: Oropharyngeal Cancer; Hypopharyngeal Cancer; Laryngeal Cancer
MeSH terms: Head and Neck Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Hypopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled
      in this study. Patients are treated with standard chemoradiation in combination with
      concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation
      therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study
      is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control
      rate.

        -  Trial with medicinal product

        -  Trial with radiotherapy
    

Detailed description: 
      This clinical study translates our preclinical findings that concurrent and consolidation
      cetuximab improves efficacy of RT into the clinic. It is a phase II, randomized, open-label,
      single center study in patients with locoregionally advanced stage III-IV and/or total gross
      tumor volume (tGTV) > 70cc head and neck cancer. This study population is at high risk for
      locoregional recurrence after chemoradiation alone. Tumor stages to be included are T3-4 Nx,
      Tx N2b-N3 (N2b only if ≥ 3 ipsilateral nodes involved) M0 and/or tGTV >70 cc (any T, any N,
      M0) squamous cell cancers of the head and neck (HNSCC). All patients will receive in, the so
      called 'Induction Phase' standard chemoradiation (RT up to 70 Gy in combination with weekly
      CDDP 40 mg/m2) and add-on concurrent cetuximab (loading Dose 400 mg/m2, concurrent dose 250
      mg/m2 weekly). The patients are randomized to either add-on consolidation cetuximab (500
      mg/m2 biweekly x 6 over 12 weeks) (Arm A) or no further treatment (Arm B). Randomization will
      take place after Induction Phase. The total number of patients to be included into the study
      is 60 (30 patients per arm). Up to 6 patients may be replaced in case of early drop out to
      reach that aim.

      The sample size of 60 patients is considered to be sufficient to collect first information on
      clinical efficacy and the possible impact of various biomarkers on clinical endpoints. If the
      results of this study will demonstrate that the novel treatment regimen is safe and
      efficacious, a randomized multicenter phase III study will follow.
    

Intervention name(s): Cetuximab
Intervention type(s): Drug
Intervention description(s): Arm A: chemoradiation in combination with concurrent cetuximab Arm B: chemoradiation in combination with concurrent and consolidation cetuximab
Other intervention name(s): Erbitux®
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-dose AQ001S PK Study in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open label, single-center, single-dose, four-period crossover clinical
      study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution
      (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
    

Detailed description: 
      This is a randomized, open label, single-center, single-dose, four-period crossover clinical
      study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution
      (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
      Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2
      mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml.

      Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the
      study. The study drug will be administered by nebulization.

      The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S
      inhalation solution.

      The primary safety objective is to assess the safety of AQ001S inhalation solution.
    

Intervention name(s): Budesonide Inhalant Product
Intervention type(s): Drug
Intervention description(s): Single-dose of budesonide solution administered by nebulization.
Other intervention name(s): Budesonide solution administered by nebulization
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study drug will be administered by nebulization. The subjects will adhere to the following therapeutic scheme at each treatment period of 3 days, for 4 treatment periods:
One single dose of study medication on the first day of the treatment period, followed by
Minimum washout period of 3 days, i.e. minimum 72 hours between two drug administrations
The pharmacokinetics profile of budesonide in plasma, will be evaluated through pharmacokinetics parameters, calculated for each single dose, and based on 17 timepoints from 0 to 24h.
Masking: None (Open Label)
Primary purpose: Treatment
Topical Antimicrobial Effectiveness Testing
Condition: Antimicrobial Effectiveness
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to measure the antimicrobial effectiveness of
      ChloraPrep One-Step Frepp Applicator.
    


Intervention name(s): ChloraPrep One-Step; 70% isopropyl alcohol
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 ml applicator patient preoperative skin preparation; Curity Alcohol Prep Pads
Other intervention name(s): Positive Control
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Condition: Kidney Failure; Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional

Summary: 
      Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects
      morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are
      reduced, and likely contributes to the wasting. As TT in relatively safe physiologic
      replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we
      hypothesize that physiologic TT replacement will be effective in preventing and treating the
      loss of muscle mass and function in CKD patients, will improve quality of life and may reduce
      some cardiovascular disease (CVD) risk factors.
    


Intervention name(s): Testim (1% testosterone gel)
Intervention type(s): Drug
Intervention description(s): Subjects apply contents of gel packet to skin daily.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This is a multicenter study evaluating the effectiveness of nonoperative and operative
      treatments. The investigators wish to identify important clinical and radiographic
      determinants of outcomes in the management of adults with symptomatic lumbar scoliosis
      (ASLS).

      Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal
      and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects
      while we seek additional funding to follow all subjects through 8 years.
    

Detailed description: 
      Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged
      40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and
      either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society
      Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function
      and/or appearance.

      Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status,
      education) and comorbidities [mental health, body mass index (BMI) and bone mineral density
      (BMD)] on adverse events and treatment outcomes for both the nonoperative and operative arms.
      Incorporate these variables into a prediction model to help identify those patients most
      likely to benefit from either a surgical or nonoperative approach
    

Intervention name(s): Surgical intervention; Non-operative intervention
Intervention type(s): Procedure; Other
Intervention description(s): Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis; Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees; All Participants must be reasonable surgical candidate at enrollment
Physical Activity and Symptom Disturbance Regarding Cross-Trimester
Condition: Pregnancy Related
Study type: Observational [Patient Registry]

Summary: 
      This study will explore pregnant women's regular exercise intentions and behavior across
      trimesters (from first trimester, second trimester to third trimester).
    

Detailed description: 
      Based on the TPB, this study will explore pregnant women's regular exercise intentions and
      behavior across trimesters (from first trimester, second trimester to third trimester).
      Moreover, the study will explore the effect factors, predictors and transition factors
      regarding pregnant women's regular exercise intention and behavior across trimesters.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): standard prenatal care
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants were recruited from the prenatal outpatient departments of hospitals in
        Taipei, Taiwan.
Secretin Infusion for Pain Due to Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      -  To determine if intravenous secretin administration in escalating doses three times
           daily for three days will improve the pain from CP at the time of infusion, after each
           infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.

        -  To validate the safety of intravenous secretin administration at the dosage indicated in
           this study.
    

Detailed description: 
      12 patients will be enrolled in this study. Patients will be only those treated at
      Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made
      by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must
      be taking prescribed opioid analgesics for the specific treatment of CP at the time of study
      enrollment. Only patients between the ages of 18-70 and capable of providing informed consent
      will be considered eligible for the study.
    

Intervention name(s): Human Secretin
Intervention type(s): Drug
Intervention description(s): Dose Escalation
Other intervention name(s): ChiRhoStim
Intervention MeSH terms: Secretin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pancreatitis
A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of VX-548 in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-548
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantitative Study of Prevalence and Vulnerability Factors of Active Cyber Sexuality Among Teenagers in West Normandy
Condition: Teenager; Sex Behavior
Study type: Observational

Summary: 
      This study evaluates prevalence of active cybersexuality among teenagers (15-17 old) in West
      Normandy and find different factors of vulnerability that could induce this behaviour.
      Selection of teenagers in different schools (general, professional, agricultural,
      reintegration structure).
    

Detailed description: 
      the teen completes a questionnaire at the beginning of sexual education session. This
      questionnaire put in an anonymous box. After, there is a debate on the subject with the
      speaker, teenager ask questions about sexuality.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        population of teenagers of different school structures . make differences between the urban
        schools and the rural schools
      
Keywords: teenager; sexuality; internet
Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 %
      of all myocardial infarctions). There are several different causes behind MINCA where "true
      infarction" due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the
      main findings. The underlying diagnosis is often made by clinical findings sometimes with the
      help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give
      50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in
      median 12 days after the acute event. The present study aim at improve the diagnostic
      accuracy by an early CMR with latest technique.
    

Detailed description: 
      The present study aim at improve the diagnostic accuracy in MINCA with an CMR made 2-4 days
      after the acute event. The aim is to give 70 % of all patients with MINCA (35-70 years old) a
      definitive diagnosis made by CMR only. One-hundred and fifty patients will be included and
      compared with a similar historical sample where 50 % of the patients received a diagnosis
      made by a late CMR and clinical findings. The study has 80 % power to detect this 20 %
      absolute difference (p <0.05).
    

Intervention name(s): CMR
Intervention type(s): Procedure
Intervention description(s): Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
A Device Designed to Protect the Perineum During Labor
Condition: Perineal Tear
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective:

      To investigate the protective effects of a newly invented device for reducing tears in the
      perineum during vaginal childbirth.

      Design:

      A multicenter randomized control trial performed at three hospitals in Sweden, in
      Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200),
      cephalic presentation. They will be randomized to an intervention group, with a perineal
      protection device, and a control group deliver as normal.

      Main outcome measures:

      The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter
      rupture are measured.
    

Detailed description: 
      Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by
      physicians. Drawing be made of the tears by the midwife.
    

Intervention name(s): Perineal protection device
Intervention type(s): Device
Intervention description(s): Use of the device during delivery and inspection afterwards to see the tears.
Other intervention name(s): Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Delivery rupture; perineal protection device; reduce perineal tears
Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Acute Disease; Wounds and Injuries
Study type: Observational

Summary: 
      The presence or development of AKI impacts on outcomes in patients presenting with acute
      conditions to the ED. As a result, treating physicians are often concerned with the risk of
      AKI and take such risk in consideration when making subsequent therapeutic and diagnostic
      decisions which may result in delaying or withholding therapeutic measures in order to
      prevent further kidney damage (i.e. avoid imaging studies with contrast media).

      If clinicians could be informed early that a patient is at minimal risk for AKI, they could
      deploy timely and optimal diagnostic and treatment procedures for the underlying disease of
      the patient without major concerns for causing or exacerbating kidney damage
    

Detailed description: 
      In patients with acute diseases, it is mandatory for ED Physicians to immediately detect the
      presence of AKI or exclude; but unfortunately Serum creatinine (SCr) variations (based on
      KDIGO or AKIN criteria), take 24 to 48 hours to manifest the presence of acute renal ongoing
      damage. AKI is currently, infact, defined as an increase in SCr of 1.5-fold from baseline
      within 24 to 48 hours, and decrease in diuresis from admission in hospitalization, using
      KDIGO.

      As consequence, similarly to other biomarkers, such as troponins in acute coronary syndrome
      and D-dimer in pulmonary embolism, a laboratory test to rule in or rule out AKI is needed in
      critical patients in ED and our primary objective would be to evaluate the role of urine
      TIMP-IGFBP7 in this setting.

      Primary Objective of the BRAVA Study would be to evaluate the role of the urine biomarkers
      TIMP-IGFBP7 in predicting the occurrence of AKI in patients presenting to ED with different
      acute diseases and need for hospitalization.
    

Intervention name(s): Urine-TIMP-IGFBP7 biomarker for AKI
Intervention type(s): Diagnostic Test
Intervention description(s): Urine-TIMP-IGFBP7 biomarker for AKI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting to the ED who are determined to be at high risk for AKI.
      
Biospecimen description: 
      Urine
    
Keywords: AKI; Biomarkers; Urine TIMP-IGFBP7; Emergency Department