bioihbjkbjnl/mcl2 huggingface dataset:
Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma
Condition: Esophageal Carcinoma
MeSH terms: Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal
      Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal
      Carcinoma
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal
      Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal
      Carcinoma.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days
      until the presence of progressive disease or unacceptable toxicity.
    

Intervention name(s): Liposomal Paclitaxel; Nedaplatin
Intervention type(s): Drug; Drug
Intervention description(s): Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.; Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
Intervention MeSH terms: Paclitaxel; Nedaplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Cancer; nedaplatin; Liposomal Paclitaxel
Dopaminergic Loss and Pain in Parkinson's Disease
Condition: Parkinson's Disease; Pain
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson
      disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess
      the relationship between the loss of dopaminergic neurons and the existence of pain in
      Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging
      (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain
      threshold, the investigators will establish correlations between dopaminergic degeneration
      and pain perception.
    

Detailed description: 
      Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap,
      cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.

      The clinical trial will be conducted in a single center (Neurology Department, Purpan
      Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty
      patients with Parkinson's disease, presenting pain disorders or not, will be selected. This
      clinical trial will last one year. All the exams, including image acquisition will be done
      the same day. These will take about 6 hours for each patient.

      Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate
      with pain intensity and also with thermal pain thresholds in patients suffering from
      Parkinson's disease.
    

Intervention name(s): ioflupane 123I (DATSCAN®)
Intervention type(s): Drug
Intervention description(s): One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Other intervention name(s): - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane; - FP-CIT
Intervention MeSH terms: 2beta-carbomethoxy-3beta-(4-iodophenyl)tropane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson's disease; pain; dopamine transporters imaging
Chronic and Acute Effects of Resistance Exercise on Older Subjects' Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The study aimed to evaluate the chronic and acute effects of high-intensity resistance
      training on blood pressure and its hemodynamic and neural determinators in healthy
      normotensive older subjects.
    

Detailed description: 
      To investigate the chronic and acute effects of resistance training on blood pressure and its
      hemodynamic and neural determinators in elderly, 24 healthy normotensive older subjects were
      randomly divided into 2 groups: trained and control. The trained group was submitted a
      progressive high-intensity resistance training. Before and after 16 weeks, as well as, before
      and after the one training session, blood pressure (clinic and ambulatory), cardiac output
      (CO2 rebreathing), and autonomic modulation (spectral analysis of heart rate and blood
      pressure variabilities) were measured
    

Intervention name(s): Resistance training
Intervention type(s): Behavioral
Intervention description(s): Progressive high intensity resistance training performed twice a week for 16 weeks, and achieving in 7 exercises for the main muscles, the protocol of 4 sets of 6RM and 2 of 4RM.
Other intervention name(s): strength training, weight training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: resistance training; blood pressure; hemodynamics; autonomic; Elderly Subjects
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of
      this trial is to compare two NN1250 (insulin degludec) formulations with each other and with
      insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin degludec; insulin glargine; insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily; Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily; Treat-to-target dose titration scheme, injection s.c., once daily; Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells. Combining
      monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic
      cancer.

      PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine
      and mitoxantrone in treating patients who have hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in
           patients with poor-risk hematologic malignancies.

        -  Determine the toxic effects of this regimen in these patients.

        -  Determine whether this regimen can induce cell apoptosis in these patients.

        -  Determine the effects of bevacizumab on coagulation profiles in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over
      30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease
      progression or unacceptable toxicity. Patients achieving partial or complete remission may
      receive a second course of therapy beginning approximately 30 days after the completion of
      the first course.

      Patients are followed until death.

      PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years.
    

Intervention name(s): bevacizumab; cytarabine; mitoxantrone hydrochloride
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Cytarabine; Bevacizumab; Mitoxantrone
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; relapsing chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; secondary acute myeloid leukemia; previously treated myelodysplastic syndromes; childhood myelodysplastic syndromes
A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Condition: Healthy Volunteer; Renal Impairments
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to compare the pharmacokinetic characteristics and safety of
      YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal
      impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made
      by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are
      AUCinf,Tmax, t1/2, CL/F and V/F.
    


Intervention name(s): YHD1119 75mg
Intervention type(s): Drug
Intervention description(s): A single oral dose
Other intervention name(s): YHD1119 150mg NF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
Condition: Healthy
Study type: Interventional

Summary: 
      Aim - determine the immediate and lasting effects of Exergaming frequency on work
      performance, health, motor, and cognitive function in clerical employees.
    

Detailed description: 
      Hypothesis - In sedentary clerical workers the introduction of even 1 session / week exercise
      can cause lasting and correlated improvements in work, motor, and cognitive function, and
      effect which plateaus at 2 compared with 3 sessions / week. However, 6 months follow up would
      show residual effects only at the 3/week frequency in those who had become sedentary again.
    

Intervention name(s): Exergame 2/week; Exergaming 3/week; Healthy control / Exergaming 1/week
Intervention type(s): Other; Other; Other
Intervention description(s): virtual training 2 times a week(8 week-long); virtual training 3 times a week(8 week-long); In the first 8 week-long only control group. For the next 8 weeks, the control group will do 1 workout per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: balance; movement; exergaming; work performance
The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery
Condition: Cesarean Section Complications; Postpartum Hemorrhage; Blood Loss, Surgical; Blood Loss, Postoperative; Postoperative Pain; Atony, Uterine
MeSH terms: Postpartum Hemorrhage; Uterine Inertia; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      This study compares the effect of starting intravenous oxytocin infusion early before uterine
      incision versus late after umbilical cord clamping on the blood loss during elective cesarean
      section
    

Detailed description: 
      Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality
      worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during
      cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery.
      Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several
      regimens of oxytocin have been tested during cesarean section with variable wanted
      (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the
      hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce
      a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the
      same dose administered after delivery of the fetus.
    

Intervention name(s): before uterine incision oxytocin; after clamping the umbilical cord oxytocin
Intervention type(s): Other; Other
Intervention description(s): blood loss during elective cesarean section; blood loss during elective cesarean section
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxytocin; cesarean section; uterine atony; Postpartum Hemorrhage
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment after
      single intravenous (IV) infusion of BV100
    

Detailed description: 
      To investigate the pharmacokinetics (PK) of rifabutin and excipient in subjects with renal
      impairment after single intravenous (IV) infusion of BV10=. In addition to investigate the
      safety and tolerability of BV100 in subjects with renal impairment and to investigate the PK
      of 25-acyl-rifabutin metabolite in subjects with renal impairment after single intravenous
      (IV) infusion of BV100
    

Intervention name(s): BV100
Intervention type(s): Drug
Intervention description(s): Rifabutin for infusion
Other intervention name(s): Rifabutin for Infusion
Intervention MeSH terms: Rifabutin
Intervention model: Sequential Assignment
Intervention model description: BV100 administered as a single intravenous infusion to subjects with varying degree of renal impairment and control volunteers with normal renal function.
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Fasting on the NLRP3 Inflammasome
Condition: Cardiovascular Disease; Inflammatory Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Background:

      - Restricting calories can help a person reduce risk factors for heart disease. Researchers
      have found that not eating or drinking anything but water for 24 hours prevents the
      activation of a component of the immune system, called the inflammasome. The inflammasome is
      associated with the development of diabetes and heart disease. Researchers want to learn more
      about the body s response to fasting.

      Objective:

      - To explore the benefits of calorie restriction on heart health.

      Eligibility:

      - Healthy adults ages 21 32 with a body mass index between 26 and 29.

      Design:

        -  Participants will be screened with a medical history, physical exam and blood test.

        -  Participants will not eat or drink after 10 p.m. before their first visit.

        -  Participants have breakfast at the clinic. The breakfast will be about 500 calories.
           Then they will not eat or drink (except water) for 24 hours.

        -  Participants will return to the clinic the next morning. They will have blood drawn.
           Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after the
           meal.

        -  Blood and urine tests at the end of the fast and following the meals will be done to
           confirm that participants have fasted for the full 24-hour period.
    

Detailed description: 
      A caloric restricted diet has numerous health effects including the reduction in numerous
      cardiovascular disease risk factors. The cellular programs activated by caloric restriction
      are similarly turned on in preclinical studies in response to a 24-hour fast. We have found
      that a beneficial effect of a 24-hour fasting blunts the activation of a component of the
      immune system, termed the inflammasome, which is associated with the development of diabetes
      and atherosclerosis. We would like to study the inflammasome in human blood cells to evaluate
      whether the beneficial immune effects of fasting/caloric restriction are operational in
      humans. Blood samples to test the immune response will be collected in subjects after a fixed
      caloric meal and in response to a 24-hour fast (water intake will not be restricted). The
      objective of this pilot study is to identify if these immune adaptive pathways can be
      activated in human subjects as a possible readout to test whether this pathway could be
      investigated as a therapeutic target to blunt/negate the inflammation associated with
      nutrient-excess associated diseases such as diabetes and/or atherosclerosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -Males and females between the ages of 21 and 37@@@-BMI between 23.5 and 29
      
Keywords: Inflammasome; Fasting; Sirt3
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the effect of food on the relative bioavailability of 2
      different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet
      formulations.
    


Intervention name(s): lumacaftor; ivacaftor
Intervention type(s): Drug; Drug
Other intervention name(s): VX-809; VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The overall study objective is to evaluate the effectiveness and safety of Trastuzumab
      emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and
      specifically in patients treated under compassionate use or early access program
    

Detailed description: 
      This is a retrospective, non-interventional, non-comparative, observational cohort study /
      registry in the Spain. The study design will reflect real-life clinical management of
      patients with HER2-positive MBC. Type and frequency of actual patient visits and all
      evaluations will be done as for routine clinical practice.

      The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or
      TDM1 in those early access systems is of utmost importance. These real-world patients with
      advanced breast cancer may have different characteristics than those enrolled in clinical
      trials and clinicians must often extrapolate into therapeutic decisions not fully supported
      by a robust evidence.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include a cohort of approximately 700 adult patients from the Spain with
        HER2-positive metastatic or locally recurrent unresectable breast cancer and who are
        treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early
        access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and
        Pertuzumab is made independently by the participant and their health care provider and is
        not mandated by the study design or protocol.
      
Keywords: Advanced HER2+ breast cancer; Pertuzumab; Trastuzumab emtansine; Compassionate use; Early access program; Effectiveness; Safety
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
Condition: Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of
      BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh
      muscle volume compared to placebo. The study will last for approximately 24 weeks.
    


Intervention name(s): Placebo; BYM338
Intervention type(s): Drug; Drug
Intervention description(s): BYM338
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chronic Obstructive Pulmonary Disease; COPD; cachexia; muscle wasting
Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether oral vitamin D supplementation improves the
      clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate
      the effects of vitamin D supplementation on several key aspects of the immune system of
      children with atopic dermatitis.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis; vitamin D
Anti-GPC3 CAR T for Treating Patients With Advanced HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether autologous T cells bearing chimeric antigen
      receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients
      with relapsed or refractory hepatocellular carcinoma (HCC).
    


Intervention name(s): anti-GPC3 CAR T
Intervention type(s): Biological
Other intervention name(s): CAR T cells redirected to Glypican-3 in cancer cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites
Condition: Immediate Implants
Study type: Interventional

Summary: 
      This article aims to provide a non- staged treatment protocol to placing dental implants in
      compromised fresh sockets in the aesthetic zone.
    

Detailed description: 
      This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield)
      to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue
      quality and quantity at the same time with implant fixture placement using a computer-guided
      surgical template.
    

Intervention name(s): Non-staged vestibular fresh socket therapy
Intervention type(s): Procedure
Intervention description(s): a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket
Other intervention name(s): osteoflex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: xenograft cortical flexible sheet; fresh extraction socket