bioihbjkbjnl/mcl2 huggingface dataset:
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with
      metastatic pancreatic cancer after first-line chemotherapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the therapeutic activity of trabectedin, in terms of progression-free survival
           (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed
           after gemcitabine-containing first-line chemotherapy.

      Secondary

        -  To assess the safety profile of this drug.

        -  To assess the response rate and response duration.

        -  To assess the overall survival of these patients.

        -  To assess the PFS rate at 9 and 18 weeks.

        -  To perform blood, plasma, and tumor tissue sampling for biological studies, in order to
           identify biomarkers predictive for resistance or sensitivity to trabectedin, and to
           characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor
           activity in translational research studies.

      OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3
      weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

      Blood samples and tumor tissue are analyzed for identifying biological markers predictive for
      resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor
      activity in translational research studies.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): trabectedin; trabectedin
Intervention type(s): Drug; Drug
Intervention description(s): 1.3 mg/mq as a 3 hour continuous infusion every three weeks; 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
Other intervention name(s): YONDELIS; ET 743
Intervention MeSH terms: Trabectedin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas
A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3 part, randomized, double blind, placebo controlled study evaluating the safety,
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple
      ascending subcutaneous (SC) doses of CB4211 in healthy non obese subjects and subjects with
      NAFLD.
    

Detailed description: 
      Part A: Part A is a randomized, double blind, placebo controlled, single ascending dose
      sequential group study evaluating the safety, tolerability, PK, and PD of a single SC dose of
      CB4211 in healthy non obese subjects.

      Part B: Part B is a randomized, double blind, placebo controlled, multiple ascending dose
      sequential group study evaluating the safety, tolerability, PK, and PD of once daily SC doses
      of CB4211 over 7 days in healthy non obese subjects.

      Part C: Part C is a randomized, double blind, placebo controlled, multiple dose, parallel
      group study evaluating the safety, tolerability, PK, and PD of once daily SC doses of CB4211
      over 28 days in subjects with NAFLD.
    

Intervention name(s): CB4211 Dose 1; CB4211 Dose 2; CB4211 Dose 3; CB4211 Dose 4; CB4211 Dose 5; CB4211 Dose 6; CB4211 Dose TBD; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 3-part, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, PK, and PD of single- and multiple-ascending SC doses of CB4211 in healthy subjects and subjects with NAFLD. Study treatment (CB4211 or placebo) will be administered SC into the abdomen (and if needed, upper and lower thigh) as bolus injections.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fatty Liver Disease; Liver Disease; Fatty Liver; Nonalcoholic Liver
Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicentre, prospective, randomized, open-label study will compare the safety and
      efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation
      of cyclosporine, with those of mycophenolate mofetil and long term continuation of
      cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction
      treatment and followed by 8 month treatment with corticosteroids. The anticipated time on
      study treatment is 12 months. Participants who will complete the initial 12-month study and
      who will provide written informed consent will be eligible to participate in a 60-month
      follow-up phase.
    


Intervention name(s): Cyclosporine; Daclizumab; Mycophenoate Mofetil; Prednisolone; Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped.; Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14.; Mycophenoate mofetil 1 gram (g) (2*500mg tablets or 4*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.; Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.; Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng/mL from week 12 to week 39, and 5-10 ng/mL from week 39 to week 52.
Other intervention name(s): Neoral; Zenapax; CellCept; Solupred; Rapamycin
Intervention MeSH terms: Cyclosporine; Sirolimus; Prednisolone; Cyclosporins; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tele-Rehabilitation Study for People With a History of Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke results in long-term disability for many people, and particularly for survivors of
      stroke who have cognitive impairments. However, a decreasing proportion of stroke patients
      are able to access or receive publicly funded rehabilitation. The investigators have shown in
      previous studies that in-person delivery of the Cognitive Orientation to daily Occupational
      Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals
      has resulted in improvements in functional independence and executive function. In a small
      pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the
      investigators found the delivery method was feasible and that participants were satisfied
      with the treatment and demonstrated clinically significant improvements on personally
      meaningful activities. The investigators will investigate the feasibility, preliminary
      efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability
      post-stroke. The study design is a single-blind (assessor), randomized wait-list control
      trial with a one-month retention follow-up. All therapy and testing sessions will be
      delivered online. We hypothesize that participants will demonstrate improvement in everyday
      activities and community participation.
    


Intervention name(s): Cognitive Orientation to Occupational Preformance (COOP)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Treatment of Primary Menstrual Pain With Kanion Capsule
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this clinical trial are:

        -  To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;

        -  To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.
    


Intervention name(s): Kanion Capsule
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary dysmenorrhea; Herbal remedy
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to directly compare the bone forming effects of 20 microg/day of
      teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric
      variables and biochemical bone formation markers after 6 months of therapy in postmenopausal
      women with osteoporosis.
    


Intervention name(s): Teriparatide; Strontium ranelate; Transiliac bone biopsy
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Teriparatide; Strontium ranelate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Infant Nutrition and Brain Development
Condition: Healthy; Infant Development
Study type: Interventional

Summary: 
      Research study on the role of early life nutrition on brain and cognitive development during
      infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were
      compared and a breastfed group was considered as epidemiological reference.
    

Detailed description: 
      This nutritional intervention study involved assessments in both the mother and her infant.
      The mother was asked to complete self-report questionnaires and to undergo a brief cognitive
      assessment. If the mother was not breastfeeding, a study product was provided and was
      consumed by the infant daily up to 12 months of life. The study also involved magnetic
      resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation
      of cognitive outcomes, including general cognitive development, and social-emotional
      development.

      Once all trial subjects completed the 6-month timepoint (intervention part), an inferential
      statistical analysis of all data up to 6 months was performed.

      Product codes (blinding) were broken to compare groups and an appropriate operational
      framework was put in place to maintain the individual assignment unknown to the Sponsor and
      Sites until the end of the trial.
    

Intervention name(s): Infant Formula: enriched level of myelin-relevant nutrients; Infant formula: standard level of myelin-relevant nutrients
Intervention type(s): Other; Other
Intervention description(s): Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).
The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.; Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).
The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
Other intervention name(s): Infant Formula; Infant Formula
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants.
3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Nutrition, Brain Development, Cognition, Heathy Infants
Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and
      reduced motion in the joints. That can reduce quality of life.

      OA can occur in any joint, but usually affects the hands, knees, hips or spine.

      The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to
      treat OA in the knee.
    


Intervention name(s): PENNSAID Gel; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks; 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Other intervention name(s): diclofenac sodium 2.0% w/w
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Arthritis; NSAIDs; Topical NSAID; Diclofenac; PENNSAID
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Condition: Acute Deep Vein Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Observational

Summary: 
      To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein
      thrombosis with or without pulmonary embolism in cancer patients.
    

Detailed description: 
      Method: consecutive patient sampling. Patients were (are) included in the study in
      consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria
      were not present.
    

Intervention name(s): Fragmin (dalteparin sodium )
Intervention type(s): Drug
Intervention description(s): Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
Other intervention name(s): Fragmin
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients are identified in primary care setting.
Fortified Skimmed Mother's Milk in the Management of Chylothorax
Condition: Chylous Pleural Effusion Following Cardiothoracic Surgery
MeSH terms: Pleural Effusion; Chylothorax
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the use of fortified skimmed mother's milk is a
      safe alternative to specialized formula in the treatment of chylothorax following
      cardiothoracic surgery.
    

Detailed description: 
      A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery.
      The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is
      to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has
      time to heal. This formula is generally not well tolerated and mother's of our patients have
      expressed a desire to continue using breast milk. A few case reports have been published, but
      there have not been any studies to date looking at this. Data will be collected to include
      information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge
      information.
    

Intervention name(s): Skimmed mother's milk; Specialized Formula
Intervention type(s): Other; Other
Intervention description(s): Fortified skimmed mother's milk will be given to the skimmed mother's milk group. The fortifier is a standard fortifier we use in our population; Infants will receive our standard of care - specialized formula
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endoscopic Full Thickness Biopsy, Gastric Wall.
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      The proposed study will assess the efficacy and safety of the innovative endoscopic technique
      for the acquisition of full thickness gastric muscle wall biopsies. Having access to full
      thickness biopsies will allow an increased understanding of the pathophysiology of
      gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,
      pseudoobstruction and other motility disorders. This information is essential to development
      of more targeted and effective therapy than currently available. Despite the high prevalence
      of functional gastrointestinal disorders and its significant impact on social and health care
      costs, the underlying cause is not well understood and there is no effective specific
      treatment to successfully alleviate patient symptoms.
    

Detailed description: 
      Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap
      (SEMF) technique to acquire full thickness gastric tissues successfully and safely in
      preclinical studies.

      The proposed study will assess the efficacy and safety of the innovative endoscopic technique
      for the acquisition of full thickness gastric muscle wall biopsies. Having access to full
      thickness biopsies will allow an increased understanding of the pathophysiology of
      gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,
      pseudoobstruction and other motility disorders. This information is essential to development
      of more targeted and effective therapy than currently available. Despite the high prevalence
      of functional gastrointestinal disorders and its significant impact on social and health care
      costs, the underlying cause is not well understood and there is no effective specific
      treatment to successfully alleviate patient symptoms.
    

Intervention name(s): Full thickness gastric biopsy; Full thickness gastric biopsy
Intervention type(s): Other; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Condition: Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if small oral doses of milk protein are safe and
      effective in decreasing sensitivity to cow's milk in allergic children.
    

Detailed description: 
      This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years
      with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns
      Hopkins and Duke University) and will undergo initial screening and double-blind,
      placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk.
      Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those
      who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who
      develop desensitization will continue with daily milk intake and undergo a third DBPCFC.
      Those in the treatment group who are not desensitized will return to strict avoidance. Those
      in placebo group will be offered to begin treatment or continue with strict milk avoidance.
      Symptom and diet information will be collected initially and at regular intervals. Bloodwork,
      skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be
      done initially and at periodic intervals.
    

Intervention name(s): cow's milk powder; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Food Allergy; Oral Immunotherapy; Immunoglobulin E