bioihbjkbjnl/mcl2 huggingface dataset:
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal
      teratology and dysmorphology, and infant development up to age 3.
    

Detailed description: 
      This will be an observational cohort trial of the pregnancy of women who conceive in RMN
      trials, and of their resulting infants through the first 3 years of life.

      Study specific procedures will include a patient completed log of prescribed and over the
      counter medications taken during a normal pregnancy, a review of their pregnancy, delivery,
      and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and
      yearly review of infant medical records, growth charts, and a yearly parent administered
      developmental questionnaire (Ages and Stages) for the first three years of the infant's life.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will include women with infertility who receive ovulation stimulation drugs
        within the context of a Reproductive Medicine Network sponsored trial as well as their
        infants.
      
Biospecimen description: 
      Mothers of newborn infants will be asked to consent to the collection of buccal cells from
      their infants for DNA testing. Fathers will also be asked to provide buccal cells via buccal
      swab smears, if blood has not been obtained from them in the course of an RMN trial. The DNA
      specimens will be available for use in other vetted studies to enable study of independent
      genetic and environmental factors and gene-environment interactions for a broad range of
      birth defects and infertility.
    
Keywords: Infertility; Ovulation stimulation; Pregnancy
Early Stability of the Delta-TT Cup With Polyethylene Insert Versus a Ceramic Insert. A RSA Study.
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The goal of this study is to study the stability of the Delta-TT cup with polyethylene insert
      and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means
      of RSA to assess whether the differences in stiffness of the cup will have an influence on
      incorporation and mechanical stability.

      It is hypothesized that there will be more micromotion on the short-term (<2 years) in the
      patients with the ceramic insert because of the higher stiffness, however, all components
      will be considered stable on the short and long-term.
    

Detailed description: 
      Rationale: Roentgen Stereophotogrammetric Analysis (RSA) is a very accurate measurement
      technique used to obtain micromotion of the implants relative to inserted tantalum markers in
      the surrounding bone. Using RSA, long-term predictions of prosthetic loosening can be made
      based on a two years follow-up. Therefore, it is recommended to analyse all (new) prosthetic
      components by means of RSA.

      Objective: The goal of this study is to study in a randomised trial the stability of the
      Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined
      with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of
      the cup will have an influence on incorporation and mechanical stability. It is hypothesized
      that there will be more micromotion on the short-term (<2 years) in the patients with the
      ceramic insert because of the higher stiffness, however, all components will be considered
      stable on the short and long-term. Secondary goal is to compare the stability of the C2
      femoral stem, to the H-MAX femoral stem as well as to compare it to relevant migration
      results of similar stems from the literature. These RSA results will contribute to knowledge
      about the early stability and long-term prosthetic loosening of these cementless stems.
    

Intervention name(s): H-MAX stem & Delta-TT cup + polyethylene; H-MAX stem & Delta-TT cup + ceramic; C2 stem & Delta-TT cup + ceramic
Intervention type(s): Device; Device; Device
Intervention description(s): H-MAX femoral stem & Delta-TT cup with a polyethylene insert; H-MAX femoral stem & Delta Delta-TT cup with a Ceramic insert; C2 femoral stem Delta Delta-TT cup with a Ceramic insert
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Sun Protection Factor Assay (SPF Assay 18676)
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation-SR15-78_Y73-167).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims
Condition: Domestic Violence
Study type: Interventional

Summary: 
      The current study is a randomized controlled trial comparing the effects of 6 weeks of
      physical exercise training versus group therapy on self-esteem as well as on the various
      subdomains of physical self-esteem among women who have experienced domestic violence within
      the last two months at the time of data collection
    

Detailed description: 
      The present study design includes three arms (two intervention arms): Physical Exercise
      (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random
      allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone
      interview by one of the authors. A permutated block design with a block size of three was
      used. For each participant in Groups A and B, the assigned intervention was started the week
      following the initial interview, and lasted 6 weeks.
    

Intervention name(s): Counseling/support group therapy; Physical Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims; 6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing
Condition: Behavior, Risk
Study type: Interventional

Summary: 
      The purpose of this study is develop and pilot test a personalized HIV intervention with
      youth experiencing homelessness by creating and field testing prevention messages that
      address real-time predictors (e.g., sexual urge, use to use drugs, and substance use) of HIV
      risk behaviors,to evaluate the feasibility and acceptability of the intervention and to
      evaluate the intervention outcome effects on HIV risk behaviors (e.g., condomless sex, number
      of sexual partners, pre-exposure prophylaxis(PrEP) awareness, substance use during
      sex,Intravenous(IV)drug use)
    


Intervention name(s): HIV; General health
Intervention type(s): Behavioral; Behavioral
Intervention description(s): At the completion of each EMA, participants in the intervention group (n=50) will receive messages that address:1) unsafe sexual behaviors, 2) alcohol/drug use, 3) PrEP interest, and 4) HIV testing. In addition, participants will have access to a button in the app that will link them to resources when/if they are the victim of sexual assault. Finally, intervention arm youth will be asked to set a behavioral goal related to HIV prevention during this session. Those goals will include increasing condom use, PrEP use, non-occupational post-exposure prophylaxis (nPEP) use, reducing number of sexual partners, not having sex with using drugs or drinking alcohol, avoiding IV drug use, getting testing for HIV, and testing and treating sexually transmitted infections (STIs) as needed; Participants in the attention control condition (n=50) will answer the same EMA items as the Intervention group. However, the intervention messages will contain content related to nutrition, physical activity, sleep hygiene, and tobacco use. Finally, control arm youth will be asked to set a behavioral goal related to general health during this session.Those goals will include getting 7+ hours of sleep, eating >= 5 servings of fruits or vegetables, not using tobacco products, exercising at least 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; homeless
Safety Study of ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A
      vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
    


Intervention name(s): ChAdOx1 85A; MVA85A
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Immunogenicity
Validation of Safety and Efficacy for Night Shift Therapy
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to assess the accuracy of Night Shift in the detection of supine
      sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
    

Detailed description: 
      The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in
      15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a
      baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the
      Night Shift for two nights without feedback to confirm their willingness to continue with the
      study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be
      conducted as soon as possible to the completion of the 28-nights of treatment. During
      enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime
      sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments
      were completed post-treatment on the morning after the 28th night of treatment. Subjects
      completed daily logs to confirm device utilization and identify potential non-device related
      factors that could influence study completion.
    

Intervention name(s): Deliver therapy when the supine position is detected
Intervention type(s): Device
Intervention description(s): Application of vibrotactile feedback to the neck when the supine position is detected
Other intervention name(s): Night Shift
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; position therapy; snoring; positional
AR101 Real-World Open-Label Extension Study
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is enrolling participants by invitation only. This is an open-label, safety
      extension study for subjects who participated in the ARC007 study.
    

Detailed description: 
      This is a Phase 3, multi-center, North American, open-label, long-term, safety extension
      study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and
      completed the study.
    

Intervention name(s): AR101
Intervention type(s): Biological
Intervention description(s): AR101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; Food Allergy
Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining these treatments before surgery may kill more tumor cells in patients with
      non-small cell lung cancer.

      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation
      therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or
      stage IIIA non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate, duration of response, and survival in patients with bulky
           stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel, carboplatin,
           and radiotherapy followed by surgical resection.

        -  Assess the toxicity of this regimen in this patient population.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5
      weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the
      absence of unacceptable toxicity. At approximately 4 weeks after completion of
      chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If
      disease is unresectable, patients receive an additional 2 weeks of radiotherapy.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.
    

Intervention name(s): carboplatin; paclitaxel; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Other intervention name(s): paraplatin; taxol
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Intervention model description: Concurrent Paclitaxel, Carboplatin, and External-Beam Radiation Followed by Surgical Resection in Locally Advanced Non-Small-Cell Lung Cancer
Primary purpose: Treatment
Keywords: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
Condition: Cardiovascular Disease; Dietary Modification; Cardiovascular Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      A randomized controlled clinical trial comparing the effect of substitution of unsaturated
      fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal
      weight and obese subjects with elevated LDL cholesterol.
    

Detailed description: 
      Background: Increased intake of saturated fat may influence LDL cholesterol and other
      cardiovascular risk factors different in normal weight and obese subjects. Methods: The study
      is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with
      normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (>3.0
      mmol/l). Dietary intervention: Randomization will be to one of two balanced weight
      maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet
      substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods,
      and a control diet with whole fat dairy and meat with saturated fats that are not fat
      reduced.

      Primary research question: Compare the effect of substitution of unsaturated fat from nuts
      and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and
      obese subjects with elevated LDL cholesterol.

      Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts
      and oils for saturated fat on cardiometabolic risk factors including insulin resistance,
      inflammation and serum PCSK9 in normal weight and obese individuals.
    

Intervention name(s): unsaturated fat for saturated fat; saturated fat
Intervention type(s): Other; Other
Intervention description(s): Substituting unsaturated fat for saturated fat; a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Condition: Hypertension; Vascular Diseases; Cardiovascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that renal denervation decreases blood
      pressure and is safe when studied in the absence of antihypertensive medications.
    


Intervention name(s): Symplicity Spyral™ multi-electrode renal denervation system; Sham Procedure
Intervention type(s): Device; Procedure
Intervention description(s): After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.; After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Other intervention name(s): Renal angiography; Renal Denervation; Renal angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Uncontrolled hypertension; Renal denervation
Telatinib Safety and Pharmacokinetics Study in China Patients With Advanced Solid Tumors
Condition: Solid Tumor, Adult
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability
      and pharmacokinetic profile of telatinib in China patients with advanced solid tumor
    

Detailed description: 
      This is an open-label, nonrandomized, phase I, escalating dose study to evaluate the safety,
      tolerability and pharmacokinetic profile of telatinib. .

      This study is comprised of two stages. The 1st stage follows the traditional 3+3
      dose-escalation design. Telatinib mesylate tablets will be administrated orally to patient
      twice daily at a starting dose of 600 mg bid. Patients will be successively enrolled into
      three cohorts from low-dose to high-dose (600 mg bid, 900 mg bid, and 1200 mg bid). For each
      cohort, patient will be first enrolled for single-dose PK and safety observation. After
      one-day interval, patient will then be resumed for a 21-day continuous treatment to assess
      safety, tolerability and PK profile with multiple dosing.

      The dose-limiting toxicity (DLT) observation period will be 23 days, starting from the first
      day of single dosing till the end of the 21-day continuous treatment.

      If first 3 subjects at a dose level complete a cohort without experiencing any DLT, subjects
      for the next higher cohort will be recruited. If 1 of the first 3 subjects experiences DLT,
      then up to three additional subjects (total up to six subjects) will enrolled at that dose
      level. If more than 2 patients at a dose level experienced DLT, dose escalation will be
      halted. And the dose level will be declared the toxic dose. The MTD is defined as the
      previous (lower dose) dose level.

      If MTD is not observed even at 1200 mg bid, dose-escalation will not be continued.
    

Intervention name(s): Telatinib Mesylate
Intervention type(s): Drug
Intervention description(s): Telatinib mesylate tablets will be administrated twice a day orally
Other intervention name(s): BAY 57-9352, TEL0805, EOC315
Intervention model: Single Group Assignment
Intervention model description: This study is comprised of two stages. The 1st stage will follow the traditional 3+3 dose-escalation design in patients with advanced solid tumor The 2nd phase will be conduced in Gastric cancer patients, primarily for PK data collection
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer, VEGFR inhibitor
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX
      and INFUSE in achieving bone fusion.

      The secondary objective of this clinical trial is to assess clinical outcome measurements.
    


Intervention name(s): Actifuse ABX; INFUSE, plus master granules (MGG)
Intervention type(s): Procedure; Procedure
Intervention description(s): bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion; bone substitute in posterolateral instrumented lumbar fusion with interbody fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: actifuse; INFUSE; InductOs; DDD; degenerative disk disease; PLIF; PITF; PLF; poterolateral lumber fusion; Bone substitute; bone graft; synthetic bone substitute
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT
      plus etidronate and no treatment over 5 years in the prevention and treatment of
      glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.
    

Detailed description: 
      Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17
      Consultant Chest Physicians. Consenting patients were randomised in a central office to
      either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of
      the patients was requested by the co-ordinating office annually for 5 years after entry to
      the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric
      fractures of the thoraco-lumbar spine and changes in bone mineral density.
    

Intervention name(s): Hormone Replacement Therapy and Etidronate
Intervention type(s): Drug
Intervention MeSH terms: Etidronic Acid; Hormones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HRT; Etidronate; Fractures; Osteoporosis; Asthma; Glucocorticoids