bioihbjkbjnl/mcl2 huggingface dataset:
Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the clinical efficacy and toxicity of anti-PD-1
      monoclonal antibody alone with anti-PD-1 monoclonal antibody plus autologous dendritic
      cells-cytokine induced killer cell (DC-CIK) immunotherapy in advanced tumor
      patients.Furthermore,to characterize response to therapy we intent to evaluate the role of
      cell-free DNA (cfDNA) and immune repertoire based on the next generation sequencing.
    


Intervention name(s): Anti-PD-1 plus DC-CIK; Anti-PD-1 alone
Intervention type(s): Biological; Biological
Intervention description(s): Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.; Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced solid tumor; DC-CIK; anti-PD-1 antibody; immunotherapy
Advanced Pelvic Floor Training Program for Prostate Cancer Surgery
Condition: Prostate Cancer Patients Undergoing Radical Prostatectomy
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Radical prostatectomy is a common and effective treatment for prostate cancer but is
      associated with urinary incontinence that can persist for several months after surgery and
      significantly reduce quality of life. Studies have shown that routine performance of pelvic
      floor exercises after radical prostatectomy can aid in the recovery of urinary control;
      however, conventional pelvic floor exercises do not produce consistent results. Research
      indicates that incorporating other deep abdominal muscles can further activate the pelvic
      floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'
      and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises
      with activation of supportive muscles. Our proposed study will be the first to test the
      effect of an advanced pelvic floor exercise training program that includes Pfilates and
      Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim
      of this study is to assess the feasibility of conducting a full-scale RCT of an advanced
      pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,
      and Hypopressives techniques on urinary incontinence. Feasibility will be determined by
      measuring recruitment success, retention, outcome capture, and intervention adherence,
      tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate
      cancer in the advance pelvic floor training program will report greater improvement in
      urinary incontinence and health-related quality of life.
    


Intervention name(s): Advanced Pelvic Floor Muscle Exercise (APFX)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prostate cancer; Radical prostatectomy; Pelvic floor muscle exercises; Pfilates; Hypopressives; Urinary Incontinence
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The optimal strategy in advanced non small cell lung cancer with stable disease is not well
      known. There is no published study assessing an early change of chemotherapeutic drugs in
      these patients.Accordingly, we conduct this trial with the objective to improve the rate of
      objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine
      association for patients with stable diseases (SD).
    

Detailed description: 
      Patients with stage IV NSCLC and measurable disease are included in a randomized phase II
      trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine
      doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent
      cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2
      d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and
      paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose
      decrease if needed). Response criteria are assessed with RECIST classification by the
      investigator panel.
    

Intervention name(s): cisplatin; Gemcitabine; Taxol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non small cell lung carcinoma; Cisplatin; Gemcitabine; Paclitaxel
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
Condition: Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is investigate the relationship between BIS™ and propofol
      with/without remifentanil across a wide range of hypnotic states.
    

Detailed description: 
      This is a single-center, prospective, non-randomized, cross-over study to collect data to
      evaluate the relationship between BIS™ and anesthetic regimens. The subjects will receive two
      regimens of anesthesia with different drug combinations, with at least a 1-week washout
      period between regimens. Subjects will be sequentially assigned to start with either Propofol
      (P) or Propofol with 4 ng/ml of Remifentanil (R) regimens while BIS™ bilateral sensor placed
      on the subject's forehead. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
      scale, refer to Appendix A, will be used to measure the level of alertness in sedated
      subjects with Tetanic Electrical Stimulation (TES) being used once subjects reach a MOAA/S
      score <2.
    

Intervention name(s): BIS
Intervention type(s): Device
Intervention description(s): Subjects will be sequentially assigned to the propofol or propofol and remifentanil group. The purpose is to capture the BIS value in association with these anesthetics.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The subjects will receive two regimens of anesthesia with different drug combinations, with at least a 1-week washout period between regimens. Subjects will be sequentially assigned to start with either propofol or propofol with remifentanil regiments.
Masking: None (Open Label)
Primary purpose: Other
Distraction and Vibration for Minimizing Pain During Childhood Vaccination
Condition: Pain Due to Childhood Vaccination
Study type: Interventional

Summary: 
      Vaccine pain control is one of the actions suggested to support the delivery of vaccines that
      are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main
      reasons why children and their parents fail to do them properly. Thus, it is very important
      to investigate which interventions can bring greater benefit in the control of pain.This is a
      randomized clinical trial aiming to assess the impact of video distraction and vibration
      device on pain during the vaccination of children between one and three years.
    


Intervention name(s): Buzzy specific vibration device; Distraction
Intervention type(s): Device; Behavioral
Intervention description(s): It is a device that produces vibration; The distraction will be obtained through tablet with videos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women
Condition: Hormone Replacement
Study type: Interventional
Phase: Phase 4

Summary: 
      Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds
      of all austrian women suffering from depression or anxiety disorders are over 45 years old.
      The serotonergic system, partially regulated by the steroid hormones estrogen and
      progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To
      examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four
      postmenopausal women will be measured using positron emission tomography (PET). The
      volunteers will participate in two PET scans. The first PET scan will be performed right
      before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment
      with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging
      study hypothesizes that the expression of the main inhibiting serotonergic receptor (the
      serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might
      lead to new strategies in the treatment of psychiatric illnesses during and after the
      menopausal transition.
    


Intervention name(s): estradiol valerate; micronized progesterone; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Progynova® 21; 2mg/d; Utrogestan®; 200mg/d; maltodextrin
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Endovascular Limb Salvage in Trinidad and Tobago
Condition: Limb Salvage Rates With Endovascular Therapy
Study type: Observational

Summary: 
      The purpose of this study was to investigate limb salvage rates in patients with critical
      limb ischemia after endovascular revascularization.
    

Detailed description: 
      A retrospective analytical study assessing limb salvage attempts and outcomes in 157
      consecutive patients with CLI and tissue loss. It was for the period of May 2018 and May 2021
      at Eric Williams Medical Sciences Complex.

      The objectives of this study include Primary: To determine the success rate of target lesion
      revascularisation using endovascular limb salvage techniques in Critical limb ischemia
      patients with minor and major tissue loss.

      Secondary objectives included:

        1. to compare and contrast limb salvage rate to international standards

        2. to assess the maintenance of amputation-free survival and bipedal ambulation

        3. to evaluate the angiosome concept and its effect on wound healing

        4. to evaluate primary patency rate

        5. to assess the overall morbidity and mortality of endovascular treatment for critical
           limb ischemia

        6. to observe the outcomes of various wound healing techniques and its efficacy
    

Intervention name(s): Endovascular revascularisation
Intervention type(s): Procedure
Intervention description(s): Peripheral vascular angioplasty or stenting
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are recruited from EWMSC, Trinidad who presented with CLI.
      
Keywords: Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
High Sensitive CRP in Prediabetics and Diabetes
Condition: Assess Level of High Sensitive CRP in Diabetics and Prediabetics
MeSH terms: Prediabetic State; Hypersensitivity
Study type: Observational

Summary: 
      The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic
      and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR
      and HbA1c
    

Detailed description: 
      This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly
      diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic
      individuals as a control group. The study individuals will be recruited from the Diabetes and
      Internal Medicine Clinics of Fayoum University Hospital
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study individuals were recruited from the Diabetes and Internal Medicine Clinics of
        Fayoum University Hospital
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
Condition: COPD; Pre-Lung-Transplantation; Hypercapnia; Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency; Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to study the effects of a complex pulmonary rehabilitation
      program on mobility measured by 6 minute walking distance (6MWD) and physical activity,
      measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL
      (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.
    


Intervention name(s): continuous endurance training; interval training
Intervention type(s): Other; Other
Intervention description(s): at 60 percent of peak Watt; at 100 percent of peak Watt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Pre-Lung-Transplantation; Intervall versus continuous training; 6 MWD
Treatment of Disruptive Behaviors in Fragile X Syndrome
Condition: Fragile X Syndrome; Disruptive Behavior
MeSH terms: Fragile X Syndrome; Syndrome; Problem Behavior
Study type: Interventional

Summary: 
      Disruptive behaviors such as self-injury, aggression, and property destruction pose
      significant health-related issues to children diagnosed with fragile X syndrome (FXS),
      impacting the child's quality of life and causing significant distress to families.

      Access to appropriate treatment for families is severely limited by factors such as cost of
      care, shortages of qualified treatment providers, and geographic spread of children with FXS
      across the country. To address these potential issues, the effectiveness of administering a
      standardized function-based behavioral treatment for problem behaviors in FXS will be
      evaluated using telemedicine. The proposed study intervention therefore offers a tremendous
      step forward in clinical research both in the field of FXS and in the field of developmental
      disabilities more broadly, and thus will have a significant impact on public health.
    


Intervention name(s): Behavior analytic treatment
Intervention type(s): Behavioral
Intervention description(s): Function-based treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
    


Intervention name(s): Botulinum Toxins, Type A; Placebos
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Other intervention name(s): DaxibotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glabellar lines, frown lines
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
Condition: Healthy Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      single and multiple doses of XPF-001 in healthy volunteers.

      The effect of food on the pharmacokinetics of XPF-001 will also be studied.
    


Intervention name(s): XPF-001
Intervention type(s): Drug
Intervention description(s): Single oral dose, or 6 days of repeated oral doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy Volunteers
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.
    


Intervention name(s): ALN-TTRSC (revusiran); Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Ascending doses of ALN-TTRSC (revusiran) by subcutaneous (SC) injection; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RNAi therapeutic
FLXfit Post Market Outcome Study Protocol
Condition: Degenerative Disc Disease Lumbar
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This investigation will provide safety and effectiveness information on the use of the
      FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by
      evaluating:

        -  Safety as measured by the rate of serious operative and post-operative complications.

        -  Patients' quality of life, measured by health-related quality of life questionnaires up
           to 24 months following the procedure, as compared to patient's baseline.
    

Detailed description: 
      Interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous
      levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or
      retrolisthesis at the involved level(s). Patients should be skeletally mature and have
      completed six months of non-operative treatment
    

Intervention name(s): FLXfit Cage for fusion
Intervention type(s): Device
Intervention description(s): Evaluating patient outcomes and radiographic outcomes
Other intervention name(s): Transforaminal Interbody Fusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Up to 50 subjects participating in this post market study will be consecutively
             recruited from the Clinical Investigators standard patient populations.

          -  The Principal Investigator is responsible for assessing the eligibility of their
             potential subjects.
Study Evaluating SKI-606 (Bosutinib) In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia
      chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an
      escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with
      imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate
      the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified
      in Part 1 of the study.
    


Intervention name(s): SKI-606 (Bosutinib)
Intervention type(s): Drug
Intervention description(s): Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2.
SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CML. Chronic myelocytic leukemia. Philadelphia Chromosome. Japanese. SKI-606. Bosutinib. Imatinib resistant. Imatinib intolerant