bioihbjkbjnl/mcl2 huggingface dataset:
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
Condition: Skin Neoplasms
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      Skin cancer is the most common cancer in the US, with over a million new cases diagnosed
      yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing
      skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all
      age groups and also demonstrate increased exposure to natural and artificial UV radiation.
      Innovative interventions are needed to have an impact on skin cancer risk among young people.
      Unlike previous interventions, our skin cancer risk reduction intervention will be tailored
      (or personalized) to each individual participant and delivered via the Internet. The
      intervention will emphasize appearance concerns, which are known to be the primary motivation
      for UV exposure and lack of skin protection among young adults. This will be accomplished in
      part through the use of personalized facial images showing UV damage as well as computerized
      age progression demonstrations.

      Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet
      designed to increase skin protection and decrease sun exposure behavior among young adults at
      moderate to high risk of developing skin cancer. Participants will be randomized to the
      tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.

      Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family
      history of skin cancer), appearance consciousness, and past exposure and protective behaviors
      moderate intervention effects.

      Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk
      perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.

      The goals of future research would be to enhance the tailored intervention, for example, by
      adding additional contacts or Internet technologies or features, disseminate the
      intervention, assess the longevity of effects, and/or adapt the tailored intervention for use
      with other cancer risk behaviors or at risk groups.
    


Intervention name(s): UV4me; Skin Cancer Foundation website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator; Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.
Other intervention name(s): Tailored Intervention for Skin Cancer Risk Reduction
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention or control
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of
      polycystic ovary syndrome (PCOS) in overweight and obese women.
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LIK066 tablets for oral administration; Placebo tablets matching LIK066 tablets, for oral administration
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Polycystic ovary syndrome; PCOS; hyperandrogenism; insulin resistance; overweight; obesity
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Condition: Unilateral Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Unilateral
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of using bone conduction
      via the teeth to treat Single-Sided Deafness (SSD).
    

Detailed description: 
      The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided
      deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone
      component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled
      calibration software for subject calibration. The Sonitus BCD picks up sounds from a
      microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the
      natural pinna and ear canal. The signal picked up by the microphone is then transmitted
      wirelessly to a removeable bone conduction oral appliance located on the upper molars. The
      oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory
      signal to the teeth that reaches the skull via bone conduction and routed transcranially to
      the contralateral cochlea.
    

Intervention name(s): The Sonitus Bone Conduction Hearing System; SoundBite; SoundBite Hearing System
Intervention type(s): Device; Device; Device
Intervention description(s): Comparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unilateral Hearing Loss
Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the response to treatment with a novel esophageal stent loaded with 125I seeds
      for intraluminal brachytherapy versus a conventional covered stent in patients with advanced
      esophageal cancer.
    

Detailed description: 
      Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from
      cancer in China and sixth worldwide. Although the prognosis of surgical resection for
      esophageal cancer has been improved, more than 50% of such patients are inoperable and have
      to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the
      predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia
      and improve the quality of life of such patients, brachytherapy has previously been utilized.
      Recently, stent placement has been widely accepted to be an option for palliation of the
      symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture
      remains a challenge after stent placement. To combine the advantages of the immediate relief
      of the esophageal dysphagia with the stent placement and radiation therapy with
      brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the
      authors' institute. The technical feasibility and safety with this new stent has been
      demonstrated to be adequate in a healthy rabbit model. The current study is designed to
      demonstrate the preliminary results with this irradiation stent in patients with inoperable
      esophageal cancer compared to those using a conventional covered stent.
    

Intervention name(s): Esophageal stent placement; dysphagia scores; complications of therapy; survival time of therapy
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: esophageal Cancer; Dysphagia; Stent; interstitial brachytherapy
Effect of Food on Bioavailability of Modified Release Formulations of Imatinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food on the relative bioavailability of a single dose
      of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400
      mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week
      safety period at the end of the study. Each participant will receive all four treatments.
    


Intervention name(s): imatinib
Intervention type(s): Drug
Other intervention name(s): STI571
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; bioavailability; pharmacokinetic; STI571; modified release formulation of STI571; CML; Chronic Myeloid Leukemia; Philadelphia Chromosome; imatinib
A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
Condition: Breast Cancer; Lung Cancer; Ovarian Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide dose-finding information regarding the efficacy and
      kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to
      determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when
      supported by pegfilgrastim-mobilised PBPCs in whole blood.
    


Intervention name(s): carboplatin; paclitaxel; pegfilgrastim
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Chemotherapy; chemotherapy; Growth factor for mobilization
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumour; unknown primary tumour; carboplatin; paclitaxel
Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Condition: Sarcopenia
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline.
      There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular
      disease. Compared to those who are not sarcopenic, they also had worse prognosis in response
      to treatment for definite diseases, and spend more medical cost.

      Exercise appears to have an important role in management of sarcopenia. In the current study,
      the investigators provide an exercise program, including resistance/balance training for the
      elderly with sarcopenia or frailty in long-term care institution, and evaluate the effect.
    


Intervention name(s): Group exercise program; Self exercise program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in experimental group attend group exercise program, instructed by fitness trainer, at long-term care institutions.
Frequency: 3 times per week. Type: resistance/flexibility/balance training, including warm-up and cold-down. Duration: 1 hour per time, for 16 weeks.; Patients in control group receive oral education for self exercise program, mainly resistance muscle training. Patients are requested to do self-training for 16 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to
      Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in
      healthy adults (18 to 49 years of age).

      Study Objectives:

      Primary:

        -  To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein
           particle vaccine formulations.

      Secondary:

        -  To assess and compare the immunogenicity (neutralizing antibody and total anti-F
           antibody) of the 6 RSV-F protein particle vaccine formulations

        -  To confirm the "dose sparing" and "value added" effects of the aluminum phosphate
           adjuvant
    

Detailed description: 
      A total of 150 subjects will be allocated to 7 cohorts. Subjects will be randomly assigned to
      vaccine treatment or saline placebo in a 4:1 ratio, such that each cohort will include 20
      subjects who receive active vaccine (Groups A, B, C, D, F and G) and 5 subjects who receive
      placebo (Group E).

      Subjects will be followed for all AEs, including SAEs and non-serious AEs, from the time of
      each vaccination through 30 days following the second vaccination (Day 60±5). After Day 60,
      subjects will be contacted via telephone on a monthly basis (approximately Days 90, 120, 150,
      180, and 210) and asked about the occurrence of SAEs and SNMCs.
    

Intervention name(s): RSV-F Particle Vaccine; RSV-F Particle Vaccine; RSV-F Particle Vaccine; RSV-F Particle Vaccine; Placebo; RSV-F Particle Vaccine; RSV-F Particle Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose 1 + adjuvant / dose; Day 0 and Day 30; Dose 2 + adjuvant / dose; Day 0 and Day 30; Dose 3 + adjuvant / dose; Day 0 and Day 30; Dose 3 / dose; Day 0 and Day 30; Placebo; Day 0 and Day 30; Dose 4 / dose; Day 0 and Day 30; Dose 4 + adjuvant / dose; Day 0 and Day 30
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RSV
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and
      12 months of age have an acceptable immune response to the vaccine. The study will also
      determine whether the immune response to V419 is similar to that of participants who receive
      a licensed vaccine control.
    


Intervention name(s): V419; INFANRIX™ hexa; RotaTeq; Prevenar 13; ProQuad™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.; INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.; RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age; Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age; ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: combination vaccine; diphtheria; pertussis; tetanus; hepatitis B; Hep B; Haemophilus influenzae b; Hib; polio; poliovirus
NRX101 Glx Biomarker Validation Study
Condition: Bipolar Depression; Suicidal Ideation
MeSH terms: Depression; Bipolar Disorder; Suicidal Ideation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Subnormal level of Glutamate+Glutamine (Glx) in the Anterior Cingulate Cortex (ACC) of the
      brain has been associated with depression and PTSD. Similarly, interventions that increase
      the level of Glx in the brain, specifically electroconvulsive therapy (ECT) and intravenous
      ketamine infusion have been associated with a rapid decrease in depression and suicidal
      ideation. This effect has been demonstrated in a dose-dependent manner in randomized clinical
      assessments. D-cycloserine, a glycine site modulator of NMDA receptor function has been
      demonstrated to increase Glx in the ACC of normal volunteers. The purpose of this study is to
      determine whether NRX-101, an experimental drug containing a fixed dose combination of
      D-cycloserine and lurasidone (1) raises Glx by a greater amount than either placebo or
      lurasidone alone in patients with bipolar depression, and (2) whether that elevation in Glx
      is correlated with a decrease in depression.
    


Intervention name(s): NRX-101; Lurasidone HCl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth; Lurasidone HCl will be given twice a day by mouth; Placebo oral capsule
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biomarker
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The anatomic ACL reconstruction aims at functional restoration of the ACL to its native
      dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are
      correctly chosen for the tibial and femoral tunnels does the position of interference screw
      in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of
      interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL
      reconstruction. The purpose of this study was to compare graft orientation and inclination
      angle with posterolateral and anteromedial interference screw position in tibial tunnel in
      aperture fixation techniques.
    


Intervention name(s): Interference screw
Intervention type(s): Procedure
Intervention description(s): Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; screw fixation; graft inclination; reconstruction
Effect of a MVM Dietary Supplement on Indices of Human Health
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the health benefits of a recently developed
      multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This
      newly developed supplement - an advancement of a previous formula designed to enhance human
      health by providing RDA-levels of essential vitamins and minerals - contains eight
      phytochemicals selected to address fruit and vegetable undernutrition, and chosen on the
      basis that: 1) published research from cell culture, animal model and, when available, human
      clinical work, suggests that it may benefit human health, and 2) it is considered safe for
      human ingestion at proposed levels of consumption.
    

Detailed description: 
      This study will be an eight-week, randomized, placebo controlled, parallel arm clinical trial
      to compare markers of nutritional, inflammatory and oxidative status, cardiovascular and
      neurological health as well as microbial status in subjects consuming a novel
      multivitamin/multimineral/phytochemical (MVM/phytochemical) supplement compared to subjects
      consuming a placebo tablet. In addition, this study will evaluate whether the
      MVM/phytochemical supplement improves subjects sense of well-being as evaluated by a
      quality-of-life survey. The study will aim to enroll 112 consenting men and women
      characterized as having metabolic syndrome. Potential subjects will be recruited through
      flyers, newspapers and advertisements placed throughout the community. Consented subjects
      will undergo a 28-day washout, followed by a 56-day trial period. Biological samples (blood,
      urine, stool, saliva) will be collected at baseline (day 0) and at day 56. Diet and exercise
      history, as well as a quality of life survey, will be collected at these time points as well.
      Risk to participants is expected to be minimal and will be outlined through an informed
      consent.
    

Intervention name(s): MVM/phytochemical supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of an MVM/phytochemical supplement for 8 weeks; Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dietary supplement, cardiovascular health, oxidative stress
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of
      SAR302503.

      Secondary Objective:

      To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild,
      moderate and severe renal impairment and in matched subjects with normal renal function.
    

Detailed description: 
      study duration = 17 to 35 days
    

Intervention name(s): SAR302503
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:capsule
Route of administration: oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment