bioihbjkbjnl/mcl2 huggingface dataset:
Ketamin Plus Propofol for Anesthesia Induction
Condition: Postoperative Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy
      surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg +
      ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio)
      for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia
      will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply
      for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU,
      Watcha score, FLACC score will record. Than all data will statistically analyse.
    

Detailed description: 
      ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy
      surgery in this randomised controlled study. The participants will divide into the 4 groups
      with computered random generation. The Different combination of propofol+ketamin mixture will
      apply at the induction of anesthesia. The groups will assign as group I,II, III and IV.
      Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75
      mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group
      III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and
      rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General
      anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV
      will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of
      stay in PACU, Watcha score, FLACC score will record. Than all data will statistically
      analyse.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Different mixture of ketamin-propofol will apply for anesthesia induction.
Other intervention name(s): ketofol
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, controlled
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      This is a randomized controlled trial aimed to design an intensive intervention to modify
      lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness.
      200 participants aged 35-74 years who have intermediate cardiovascular risk will be included.
      Subjects will be selected by consecutive sampling at urban primary care health centers from
      Salamanca (Spain) and they will be randomized to a control or an intervention group. Both
      groups will receive individual standardized counselling on healthy diet, daily physical
      activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals
      from the intervention group will receive additional group counselling and follow-up calls.
      The effect of the intervention will be assessed using lifestyles and quality of life
      questionnaires, metabolic control parameters, inflammation markers, anthropometric and
      vascular function measurements, and neuropsychological tests.
    


Intervention name(s): Individual counselling on lifestyles; Additional group counselling on lifestyles
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.; Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed.
Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Health education; Life style; Risk factors; Cardiovascular diseases; Cognitive performance; Quality of life
Sleep in Hospitalized Children at MSKCC
Condition: Pediatric Cancer Patients
Study type: Observational

Summary: 
      The investigators want to better understand how children sleep at night at MSKCC, so that the
      investigators can learn how to improve the sleeping environment.
    


Intervention name(s): questionnaires; actigraph
Intervention type(s): Behavioral; Device
Intervention description(s): Pre-hospital sleep questionnaire completed (Brief Infant Sleep Questionnaire (BISQ)7 in children 0-3 years old; Children's Sleep Habits Questionnaire (CSHQ)8 in children 4 years and older). Subsequent Day(s):
In-hospital sleep questionnaire completed between one and three times per subject (Sleep at MSK questionnaire (SAM), adapted from Sleep in a Children's Hospital (SinCH)9 by Dr. Lisa Meltzer). (Patients will be observed for up to 3 consecutive nights in total).; This device reliably measures sleep by monitoring the child's motion.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All eligible patients admitted to the pediatric floor at MSK.
      
Keywords: assess sleep; Sleep Deprivation; 16-866
Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA
Condition: Surgery; Surgical Incision; Patient Satisfaction
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      Total Hip Arthroplasty (THA) is a highly effective treatment for patients with symptomatic
      hip osteoarthritis. The surgical approach in THA is important as it influences postoperative
      clinical recovery, functional outcomes, and implant positioning [1]. The evolution of
      surgical techniques in THA has led to the development of minimally invasive surgery, which is
      performed through smaller skin incisions, reduced soft tissue disruption and greater muscle
      preservation [2-10]. This prospective, randomised control study compares clinical and
      radiological outcomes in THA performed using the standard posterior approach (PA) and its
      less invasive modification, the direct superior approach (DSA). The study will include 80
      patients with hip osteoarthritis undergoing THA. Following informed consent, patients will be
      randomised to one of the two treatment groups, and undergo THA using either the PA or DSA.
      The control group includes patients undergoing THA through the PA while the investigation
      group includes patients undergoing THA with the DSA. A further 25 patients randomly selected
      from each treatment group will undergo radiosteriometric analysis (RSA) to assess differences
      in early implant migration between PA and DSA groups.

      Clinical and radiological outcomes of interest will be recorded by blinded observers at
      regular intervals for 2 years after surgery. The findings of this study will enable an
      improved understanding of differences in postoperative clinical recovery, functional
      outcomes, and implant positioning in THA performed using the DSA compared to the PA approach.
    


Intervention name(s): Total hip arthroplasty
Intervention type(s): Device
Intervention description(s): Surgical intervention designed to replace arthritic joint with artificial implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total hip arthroplasty; Direct superior approach; Minimally invasive surgery; Implant position; Osteoarthritis; Posterior approach; Radiostereometric analysis
Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called
      RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given
      once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you
      may not be cured with R-CHOP-21. The most common ones are:

        -  Stage - how much DLBCL, PMBL, or FL3B you have

        -  LDH - a blood chemistry marker; and

        -  Whether you can do your normal daily activities. (performance status) We think that the
           best way to cure more patients with poor risk factors is to add new treatment to R-CHOP.
           You will get different chemotherapy after 4 cycles. This type of treatment is called
           risk-adapted therapy.
    


Intervention name(s): Etoposide, carboplatin, ifosfamide; Rituximab, Ifosfamide, Etoposide, Carboplatin; Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.; It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.; It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
Intervention MeSH terms: Cyclophosphamide; Ifosfamide; Isophosphamide mustard; Carmustine; Rituximab; Carboplatin; Etoposide; Etoposide phosphate; Mitoxantrone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin; Lymphoma; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; ifosfamide; etoposide; carboplatin; stem cell transplant; 08-026
Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant
Condition: RENAL INSUFFICIENCY, CHRONIC; LIVER FAILURE, ACUTE; HEART DISEASE
MeSH terms: Liver Failure; Liver Failure, Acute; Renal Insufficiency; Renal Insufficiency, Chronic; Heart Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and
      Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being
      considered and/or evaluated for any solid organ transplant (heart, liver or kidney)
    

Detailed description: 
      Primary Aim:

      To measure the antibody response to ProQuad® vaccination given earlier than the current
      recommended age in patients from the age of 6 months to 24 months who are being considered
      and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five
      years. These subjects would not reach the recommended ages to receive the vaccine before the
      transplant.

      Hypothesis:

      The Investigator proposes the hypothesis that the proposed study population will mount a
      clinically significant response to two (2) doses of the ProQuad® vaccine.

      Primary Endpoint:

      With respect to expected outcomes, the work proposed is expected to provide tools for
      optimizing the ProQuad® vaccination strategy in this population.

      Secondary Aim:

      To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who
      are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).

      Hypothesis :

      The Investigator proposes the hypothesis that the study population will have similar safety
      profiles compared to children who receive the vaccine at the recommended ages.

      Secondary Endpoint:

      The secondary outcome measure is represented by the children in the study having either no
      adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be
      monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or
      clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination
      report card that the parents/legal guardians of the participants in the study will complete
      for their child for 7 days after he/she receives each dose of the vaccine.
    

Intervention name(s): ProQuad
Intervention type(s): Biological
Intervention description(s): 2) Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
to participate in the three (3) antibody titer blood draws.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: vaccines; ProQuad; immunosuppressed; solid organ transplant; MMRV
Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be
      an effective treatment for HIV. Interleukin-2 may stimulate a person's white blood cells to
      kill lymphoma cells. Combining these treatments may be effective in treating AIDS-related
      primary central nervous system lymphoma.

      PURPOSE: Phase II trial to study the effectiveness of combining zidovudine, ganciclovir, and
      interleukin-2 in treating patients who have AIDS-related primary central nervous system
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and toxicity of zidovudine, interleukin-2, and ganciclovir in
           patients with AIDS related primary central nervous system lymphoma.

        -  Determine the response rate and overall survival of these patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

        -  Induction therapy: Patients receive zidovudine (AZT) IV and ganciclovir IV over 1 hour
           every 12 hours on days 1-14. Patients also receive interleukin-2 (IL-2) IV every 12
           hours on days 1-14 and a combination antiretroviral therapy consisting of nucleoside
           reverse transcriptase inhibitors (one of which must be AZT), nonnucleoside reverse
           transcriptase inhibitors, and protease inhibitors. AZT and ganciclovir treatment
           continues for an additional 7 days if partial response is achieved.

        -  Maintenance therapy: Patients receive IL-2 subcutaneously 3 times a week for 6 months.
           Patients also receive oral ganciclovir 3 times a day and combination antiretroviral
           therapy (AZT allowed, but not required). Treatment continues in the absence of disease
           progression or unacceptable toxicity.

      Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
    

Intervention name(s): aldesleukin; ganciclovir; zidovudine
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Zidovudine; Aldesleukin; Ganciclovir; Ganciclovir triphosphate
Primary purpose: Treatment
Keywords: AIDS-related primary CNS lymphoma
A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease
Condition: Alzheimer's Type Dementia
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy
      compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's
      Disease.
    


Intervention name(s): E2020; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.; Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer Disease; Dementia; Delirium; Amnestic; Cognitive Disorders; Donepezil; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Cholinesterase Inhibitors; Enzy
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are:

      Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are
      experienced but capsid inhibitor (CAI) naive.

      Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced
      but without resistance to TAF.
    


Intervention name(s): Lenacapavir; Placebo; B/F/TAF; TAF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered subcutaneously in the abdomen; Administered subcutaneously in the abdomen; 50/200/25 mg tablets administered orally once daily; Tablets administered orally
Other intervention name(s): GS-6207; Biktarvy®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds
Condition: Correction of Nasolabial Folds
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to verify that Dermalax (Deep) is not inferior to the reference device,
      Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects
      who voluntarily signed the informed consent and are judged to be eligible for this study will
      be intradermally injected both of study device and comparator device. Subjects will be
      randomized to receive injection of study device and comparator device on their each
      nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale
      (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject
      diary which will be given to subjects during the first 2 weeks after the injection. Any
      uncomfortable things and adverse events will be investigated from subject diary and follow up
      visits.
    


Intervention name(s): Dermalax(Deep); Restylane
Intervention type(s): Device; Device
Intervention description(s): Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period; Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biomarkers in Patients Undergoing Atrial Fibrillation Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The investigators aim to find biomarkers to determine the success of pulmonary vein isolation
      for the treatment of atrial fibrillation.
    

Detailed description: 
      The investigators perform an observational study in patients undergoing pulmonary vein
      ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not
      related to pulmonary vein isolation are also followed. The aim of the study is finding
      biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint
      is defined as reoccurrences of atrial fibrillation within the first three months after
      pulmonary vein isolation.
    

Intervention name(s): Catheter Ablation
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with atrial fibrillation schedulded for pulmonary vein isolation
      
Biospecimen description: 
      Blood plasma.