bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Early and Late Time-Restricted Feeding on Body Composition
Condition: Time Restricted Feeding
Study type: Interventional

Summary: 
      A randomized controlled trial to determine the effectiveness of either morning or evening
      time-restricted feeding on body composition in sedentary, breakfast eating overweight and
      obese adults. Three parallel groups were assigned to either morning fasting (MF), evening
      fasting (EF), or a control group and asked to do the intervention for 6 weeks. Changes in
      body composition (change in weight, percent body fat percent, and percent lean body mass) are
      the primary outcome, and hunger and satiety ratings and physical activity are secondary
      outcome measures.
    


Intervention name(s): Time restricted feeding
Intervention type(s): Behavioral
Intervention description(s): Restricting the eating window to about 8 hours a day, during waking hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women
Condition: Covid19; Depression, Anxiety; Pregnancy Related
MeSH terms: COVID-19; Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated
      in patients with covid-positive pregnancies in the 3rd month after birth.
    

Detailed description: 
      Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale are evaluated
      in 250 covid-positive pregnant women in the 3rd month after birth. The results will be
      compared with the results of covid-negative pregnant women who gave birth in the same period.
    

Intervention name(s): Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores
Intervention type(s): Other
Intervention description(s): The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Maternal attachment, edinburgh depression score and postpartum anxiety scale scores of 250
        covid-19 positive pregnant women between the ages of 18-45 and 250 covid-negative pregnant
        women are compared.
GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
Condition: Extranodal NK-T-Cell Lymphoma, Nasal Type
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide,
      pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line
      treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma,
      nasal type.
    

Detailed description: 
      Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of
      non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for
      stage IE/IIE diseases has good response rate but with high relapse rates, ranging from
      20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for
      patients with stage IE/IIE diseases. But the optimal treatment schedule has not been
      established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy
      radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and
      safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be
      measured.
    

Intervention name(s): GELAD; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4; Radiotherapy: 50-56Gy
Other intervention name(s): Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
Intervention MeSH terms: Dexamethasone; Gemcitabine; Etoposide; Pegaspargase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies
Condition: Metastatic Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant
      prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging
      therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily,
      enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three
      weeks.
    

Detailed description: 
      Prostate cancer is a hormonally-driven disease and androgens are key in the growth of both
      normal prostate and prostate cancer cells. Once mCRPC is evident, most patients receive a
      second-generation hormonal therapy to further suppress the synthesis or androgens
      (abiraterone) and to block androgen receptor (AR) activation, nuclear translocation and DNA
      binding (enzalutamide).

      Conventional imaging of prostate cancer has limitations in staging, restaging after
      biochemical relapse, and response assessment. Functional imaging with positron emission
      tomography (PET) can target various aspects of tumor biology and is clearly superior in the
      detection of extra-prostatic disease. 18F-fluciclovine is a synthetic amino acid transported
      across mammalian cell membranes by amino acid transporters that are upregulated in prostate
      cancer cells.

      18F-fluciclovine is approved for PET imaging to identify sites of prostate cancer recurrence
      in men with rising prostate specific antigen (PSA) following prior definitive treatment. This
      study describes the changes in 18F-fluciclovine PET scan and compare these results with PSA
      and conventional computerized tomography (CT) and bone scans, in mCRPC patients treated with
      abiraterone acetate-prednisone, enzalutamide or docetaxel.
    

Intervention name(s): 18F-fluciclovine PET Scan
Intervention type(s): Drug
Intervention description(s): The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
Other intervention name(s): Axumin
Intervention model: Single Group Assignment
Intervention model description: Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.
Masking: None (Open Label)
Primary purpose: Other
Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

Summary: 
      This multicenter, prospective study of children with hydrocephalus will examine whether or
      not ventricle size is associated with poor cognitive outcomes. It is expected that results
      will indicate larger ventricular size at 6 months after surgery for the initial treatment of
      hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the
      Hydrocephalus Clinical Research Network (HCRN), a network established to conduct
      multi-institutional clinical trials on pediatric hydrocephalus.
    

Detailed description: 
      The current literature is inconclusive regarding the direct association between large
      ventricle size and poorer cognitive outcomes. This uncertainty stems from relatively few
      studies, problems with study design (possible confounding factors), varying study populations
      of hydrocephalus, and conflicting evidence. If the association is proven then aggressive
      strategies must be developed to maximally decrease ventricular size in these children to
      preserve long-term cognitive functioning. However, if the association is disproven then
      previous reservations for procedures such as Endoscopic Third Ventriculostomy (ETV) or
      higher-resistance shunting to prevent overdrainage complications will be further minimized.
      Either finding has a major potential to further improve the quality of life in our pediatric
      hydrocephalus patients. This study is unique as it will include pediatric patients presenting
      with hydrocephalus from a wide range of etiologies. This study is also unique in that we
      propose to conduct a brief pre-operative neuropsychological examination to act as internal
      controls along with the outcomes obtained at a more extensive neuropsychological examination
      at six months after initial hydrocephalus treatment surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
      
Keywords: Pediatric Hydrocephalus; Ventricular Size; Neuropsychological Outcomes; Quality of Life
Eccentric Motor Control After SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      This project will characterize lower extremity eccentric muscle function among individuals
      who have undergone locomotor training after spinal cord injury and will evaluate the effect
      of downhill training at slow to moderate speeds - targeted to rehabilitation eccentric
      function of the hip and knee.
    

Detailed description: 
      Lower extremity eccentric motor control is is critically important for locomotor function but
      is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary
      evidence indicates that eccentric deficits persist among individuals with SCI. This proposal
      aims to characterize eccentric motor control of the muscles about the hip and knee during
      locomotion and evaluate the efficacy of downhill gait training at slow speeds as an
      intervention to improve eccentric function of the hip joint and knee joint during walking.
    

Intervention name(s): Untrained and Trained SCI Hip or Knee
Intervention type(s): Behavioral
Intervention description(s): Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of hip control or knee control, members of this group will be trained at slow to moderate gait speeds,
Other intervention name(s): DH Hip or Knee
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals from the community that are healthy and without musculoskeletal or orthopedic
        impairments will serve as healthy case-controls. The individuals with chronic spinal cord
        injury will come from outpatient clinic referrals and former participants in locomotor
        training rehabilitation programs.
Gut Oxygenation and Laparoscopy
Condition: Laparoscopy; Laparotomy; Oxygenation,; Ischemia-Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation.
      during surgery and for 6 days after operation, intestinal oxygen tension and
      ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is
      associated with reduced splanchnic blood flow and ischemia-reperfusion injury.
    


Intervention name(s): Laparoscopy; left colectomy by laparotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Left-Colectomy; PatientS will be operated by laparotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LAPAROSCOPY,; LAPAROTOMY,; OXYGENATION,; ISCHEMIA-REPERFUSION INJURY
First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon
      (GlucaGen®). This is the first time NNC9204-1513 is given to humans.

      Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is
      decided by chance (like flipping a coin). Neither the participant nor the study doctor will
      know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double
      -blinding). In case of emergency, this information will be readily available.

      NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently
      not available on the market (doctors cannot prescribe this medicine). The participant will
      receive two or three single injections below the skin. One injection will contain
      NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that
      looks like the actual study drug but without any active ingredients. If a third injection is
      given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given
      using different devices and volumes. In order to mask these external differences, a "double
      dummy" approach will be used, that means when you get either of the study medicine
      (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called
      'placebo' (it will not have any effect on the body). Dependent on the injection volume to be
      administered, injections are given by either syringe with needle or an injection pen (NovoPen
      Echo®). The study will last for up to 39 days.
    


Intervention name(s): NNC9204-1513; Glucagon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose.
Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.; Participants will receive single dose of 1 mg glucagon s.c. injection.; Participants will receive single dose of placebo (for double dummy injections).
Other intervention name(s): GlucaGen®
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
Condition: Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
MeSH terms: Atrial Fibrillation; Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI)
      performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line
      therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial
      fibrillation (AF).
    


Intervention name(s): cryoballoon ablation system; Antiarrhythmic Drugs
Intervention type(s): Device; Drug
Intervention description(s): AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paroxysmal Atrial Fibrillation; Cryoablation; Pulmonary Vein Isolation
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive
      disorder
    


Intervention name(s): Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
Condition: Hernia Repair With Compartment Syndrome
MeSH terms: Compartment Syndromes; Hernia
Study type: Interventional

Summary: 
      This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE®
      Reconstructive Tissue Matrixin the repair of hernias.
    

Detailed description: 
      At least 100,000 ventral hernia repairs are performed in the U.S. each year. Recently,
      biologically-based implants derived from acellular human dermis, porcine small intestinal
      submucosa, and porcine dermis have been reported in a variety of complex abdominal wall
      repair procedures. A variety of surgical techniques and implant placement methods have been
      described, with no one standard technique achieving precedence. Biologic implant
      reinforcement of a myofascial closure by means of component separation, or at a minimum,
      where three-layer fascial approximation is not possible, sublay placement (i.e., closure of
      the posterior rectus sheath under the implant) are described strategies. These techniques
      allow placement of the implant against an intact fascial layer and may improve implant
      incorporation into host tissue.

      The Musculoskeletal Transplant Foundation (MTF) has manufactured and processed Flex HD
      Acellular Hydrated Dermis. This acellular dermis is derived from human skin. In complicated
      ventral hernia repairs, this type of graft tissue is necessary. Flex HD has been shown to
      reduce operative time, lower operative costs and provides minimal elasticity.

      The Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization
      dedicated to providing quality allograft tissue through a commitment to excellence in
      education, research, recovery and care for recipients, donors and their families. MTF is a
      national consortium comprised of academic medical institutions, organ procurement
      organizations and tissue recovery organizations. From their inception, they have been both
      donor-focused and surgeon-driven. Since their inception in 1987, MTF has recovered more than
      60,000 donors and distributed more than 3 million grafts for transplantation.

      The Foundation was established by surgeons and teaching institutions to meet the need for a
      high quality and consistent allograft supply.
    

Intervention name(s): Flex HD; Strattice
Intervention type(s): Device; Device
Intervention description(s): Flex HD mesh for hernia repair; Strattice mesh for hernia repair
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hernia; human tissue; mesh
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Condition: Stroke; Atrial Fibrillation
MeSH terms: Stroke; Atrial Fibrillation
Study type: Interventional

Summary: 
      The goal of this research study is to develop a smartphone application capable of monitoring
      paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient
      ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The
      study team plans to develop a highly effective and easy to use cardiovascular surveillance
      system to monitor patients for pAF on a nearly continuous basis. People involved in the
      development of this system include patients, their caregivers, health care providers, and
      computer programmers.
    


Intervention name(s): Testing Devices; Cardea Solo by Cardiac Insight; Kardia Mobile by AliveCor
Intervention type(s): Device; Device; Device
Intervention description(s): Pulsewatch system testing application on smartphone with smartwatch.; Gold-standard cardiac monitor for comparison of testing devices.; Mobile ECG device for comparison of testing devices during the extended use period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Cardiac Arrhythmias