bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Cross Sectional Study of Primary Intestine Lymphoma
Condition: Non-Hodgkin Lymphoma of Intestine
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      The purpose of this study is to determine whether whether surgical resection followed by
      chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and
      quality of life (QOL) in patients with primary intestinal lymphoma.
    

Detailed description: 
      Intestine is the one of commonly involved extranodal sites of non-Hodgkin's lymphoma (NHL).
      Thus, small and large Intestine account for approximately 30-40% of primary gastrointestinal
      tract lymphoma. More than 70% of intestinal lymphoma presents as localized disease, and
      surgery such as bowel resection is performed in many patients with intestinal lymphoma for
      diagnosis and treatment. However, it is still unclear whether surgical resection followed by
      chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and
      quality of life (QOL). Thus, we analyze the clinical features and treatment outcome of
      patients with NHL of intestine, and at the same time perform a multicenter cross-sectional
      study about the QOL in survivors of intestine NHL. We evaluates the treatment outcomes of
      patients with intestine NHL from hospitals affiliated with the Consortium for Improving
      Survival of Lymphoma (CISL) in Korea. We assess the QOL of survivors who completed their
      treatment using the EORTC QLQ-C30 questionnaire.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        University hosptial, general hospital, Cancer institute
      
Keywords: lymphoma, intestine, outcome, quality of life
Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
Condition: Extracorporeal Membrane Oxygenation Complication; Coagulation Factor Deficiency
Study type: Observational

Summary: 
      Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim
      of this study is to provide a detailed analysis of the activity of different coagulation
      factors and changes in functional coagulation measurements as in rotational thrombelastometry
      and multiple electrode aggregometry in the course of ECMO therapy.
    


Intervention name(s): Detailed coagulation monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care
        unit.
      
Keywords: ECMO; Coagulation monitoring; point-of-care
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Condition: Balance
Study type: Interventional

Summary: 
      This study involves the use of a newly designed shoe insole device (also referred to as a
      foot insole device) similar to various shoe insoles or inserts you can buy at a store or
      pharmacy.
    

Detailed description: 
      This study involves the use of a newly designed shoe insole device (also referred to as a
      foot insole device) similar to various shoe insoles or inserts you can buy at a store or
      pharmacy. Healthy participants will wear this insole device in their own athletic/tennis
      shoes over the course of one week. There are two key purposes of this study: 1. To determine
      how using this insole device for 1 week may effect a healthy individual's balance and
      postural sway while standing; and 2. To determine how using this insole device for 1 week may
      effect how an individual walks (gait), how hard they hit the ground as they walk, and foot
      pressure patterns with each step. Each individual's balance, postural sway, and walking gait
      (how you walk) will be analyzed before and after wearing the shoe insole device for the
      one-week time period.
    

Intervention name(s): experimental foot device
Intervention type(s): Device
Intervention description(s): Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people.
Other intervention name(s): proprioceptive foot device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: shoe insert; orthotics; sway
A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the comparability of TG103 injection subject to changes in
      the manufacturing process in Chinese healthy male subjects.
    

Detailed description: 
      This is a randomized, open-label, parallel-group, comparative study to evaluate the
      pharmacokinetic (PK) and pharmacodynamic (PD) profiles, safety, and immunogenicity of TG103
      injection produced by two different manufacturing processes in Chinese healthy male subjects.
      Approximately 24 eligible subjects will be randomized in a 1:1 ratio to receive a single dose
      of TG103 produced by the modified manufacturing process or TG103 produced by the original
      manufacturing process via subcutaneous (SC) injection.
    

Intervention name(s): TG103 produced by the modified manufacturing process; TG103 produced by the original manufacturing process
Intervention type(s): Drug; Drug
Intervention description(s): Drug: TG103 (a modified manufacturing process), 15mg, SC; Drug: TG103 (the original manufacturing process), 15mg, SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in
      children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes
      implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects
      determined to have a specific gene mutations implicated in glutamatergic signaling and
      neuronal connectivity.
    


Intervention name(s): AEVI-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily during the treatment period.; Oral doses of 100 mg, 200 mg or 400 mg of Placebo will be administered twice daily during the treatment period.
Other intervention name(s): MDGN-001; NFC-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines
Condition: Cardiomyopathy; Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized pilot phase I trial studies the side effects and best method of delivery of
      bone marrow derived mesenchymal stem cells (MSCs) in improving heart function in patients
      with heart failure caused by anthracyclines (a type of chemotherapy drug used in cancer
      treatment). MSCs are a type of stem cell that can be removed from bone marrow and grown into
      many different cell types that can be used to treat cancer and other diseases, such as heart
      failure. Bone marrow derived MSCs may promote heart muscle cells repair and lead to reverse
      remodeling and ultimately improve heart function and decrease morbidity and mortality from
      progression to advanced heart failure.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To demonstrate the safety of allogeneic human mesenchymal stem cells (hMSCs) administered
      by intravenous infusion in patients with left ventricular (LV) dysfunction and heart failure
      secondary to chemotherapy with anthracyclines.

      SECONDARY OBJECTIVE:

      I. To demonstrate the efficacy of allogeneic hMSCs administered by intravenous infusion in
      patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] < 40%)
      and heart failure secondary to treatment with anthracyclines.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive allogeneic hMSCs intravenously (IV) over 10-20 minutes once weekly
      for 4 weeks and standard of care drugs for heart failure.

      ARM II: Patients receive only standard of care drugs for heart failure.

      After completion of study treatment, patients are followed up monthly for 6 months and then
      at 12 months.
    

Intervention name(s): Laboratory Biomarker Analysis; Standard of Care; Mesenchymal Stem Cell Transplantation
Intervention type(s): Other; Other; Drug
Intervention description(s): Correlative studies; Undergo mesenchymal stem cell infusion; Undergo mesenchymal stem cell infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
Condition: GARDASIL Vaccination
Study type: Interventional

Summary: 
      Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a
      prospective, cluster randomized trial to determine which factors influence the acquisition of
      the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to
      26. This descriptive and interventional study will provide data to assess impact of a
      computerized tool upon HPV vaccine series completion. The interventional aspect of this study
      includes determination of patient assistance and provider support programs applicable to each
      woman's situation as well as the implementation of a computer software system for customized
      patient reminders.
    


Intervention name(s): Computer reminder system
Intervention type(s): Behavioral
Intervention description(s): Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human papillomavirus (HPV) vaccine; Gardasil vaccine
The Effects of Functional Strengthening in Spastic Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      Functional strengthening exercises have been proven to be effective in patients with spastic
      cerebral palsy. However, which exercise is the most effective is unknown. The aim of this
      study is to examine the effectiveness of three different progressive functional exercise
      programs in children with unilateral and bilateral spastic cerebral palsy.
    

Detailed description: 
      Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading
      to deficiencies in motor control, balance and functional abilities. All children with
      Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and
      plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the
      dorsiflexors are usually not active enough and usually these muscle problems lead to problems
      in the childrens' gait abilities. When rehabilitation programs are examined, the results of
      exercises addressing these problems do not have precise answers. Functional strengthening
      exercises have been proven to be effective in patients with spastic cerebral palsy. However,
      which exercise is the most effective is unknown. Which muscle goup has the most effect on
      gait, balance and functional activities is still unclear. Therefore, the investigator's aim
      in planning this study is to examine the effectiveness of three progressive functional
      exercise programs in children with unilateral and bilateral spastic cerebral palsy.
    

Intervention name(s): Physiotherapy and Rehabilitation
Intervention type(s): Other
Intervention description(s): The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antecedents of Obesity: Fetal Measures of Adiposity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound
      can predict infant adiposity by air displacement plethysmography at birth.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children born at the University of Utah Hospital, whose mothers received prenatal care also
        at the University of Utah Hospital.
A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to investigate if KY1005 results in improvement of
      eczema when given to participants with moderate to severe disease. Side effects of KY1005
      will also be explored.
    

Detailed description: 
      Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy,
      safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic
      dermatitis whose disease cannot be adequately controlled with topical medications or for whom
      topical treatment is medically inadvisable.
    

Intervention name(s): KY1005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A human anti-OX40 ligand monoclonal antibody; Matched placebo
Other intervention name(s): SAR445229
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exoskeleton-assisted Upper Limb Rehabilitation After Stroke
Condition: Stroke; Upper Extremity Dysfunction
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In recent studies, it has been observed that robotic devices make a positive contribution to
      motor recovery and the activities of daily living. However, studies about the effects of
      stroke rehabilitation with robotic devices are limited.

      This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor
      function and quality of life in stroke patients.
    

Detailed description: 
      Stroke survivors have difficulties in participating in activities of daily living due to
      functional disabilities. The majority of patients after stroke need rehabilitation to gain
      independence in daily life as the first target. Therefore, different treatment approaches are
      used in stroke rehabilitation.

      The use of technology in stroke rehabilitation has become very common in recent years.
      Robotic devices used in rehabilitation enhance the healing process by giving patients more
      intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have
      shown that robot-assisted devices provide positive motor recoveries, especially in the
      treatment of upper extremities. However, the optimal timing, duration, and dose of robotic
      rehabilitation that should be applied after stroke remain uncertain.

      In the light of this information, this study examines the effects of the robotic device
      produced for upper limb rehabilitation on daily life activities and motor function.
    

Intervention name(s): Exoskeleton robot for upper extremity; Conventional physiotherapy
Intervention type(s): Device; Other
Intervention description(s): Robot-assisted Treatment Program:
10 minutes elbow flexion/extension
10 minutes forearm supination/pronation
10 minutes wrist flexion/extension
10 minutes ulnar/radial deviation
Frequency: 2/week Duration: 12 sessions (6 weeks); Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Upper extremity; Robotic rehabilitation; Motor function; Quality of life
Stress Among Final Year BAMS Students in Relation With Covid Lockdown Through CSSQ-a Cross Sectional Survey
Condition: Covid Related Psychological Stress
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students
      as participants.we have also selected a group of 5 members for data colle tion.we have
      selected a validated Covid stress questionnaire and circulated through what's app and
      Gmail.we were received responses from each college with .we analyzed and interpreted data.
    

Detailed description: 
      We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students
      as participants.we have also selected a group of 5 members for data colle tion.we have
      selected a validated Covid stress questionnaire and circulated through what's app and
      Gmail.we were received responses from each college with .we analyzed and interpreted data.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): It is a survey based on questionnaire
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All final year students Of BAMS studying inside Kerala.
      
Keywords: Stress,covid,lock down days
Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
Condition: Failed Induction of Labor
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor
      induction.
    

Detailed description: 
      A prospective double blind randomized clinical trial. Conducted at Ain Shams University
      Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into
      two groups. Group (A):

      100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol
      manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet
      (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated
      every 6hours up to five doses.

      Group (B):

      100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated
      every 6 hours up to five doses.

      Primary Outcome

        -  Measure the time to cervical ripening. Secondary Outcome

        -  Measure the time to active labor.

        -  Number of misoprostol doses.

        -  Induction delivery time.

        -  Time to achieve vaginal delivery.

        -  Fetal outcome (Apgar score).
    

Intervention name(s): Estradiol; Placebo; Misoprostol
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Ethinyl Estradiol; Vagiprost
Intervention MeSH terms: Misoprostol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Estradiol; Misoprostol; Induction of labor; Cervical ripening; Bishop score
Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the pathophysiological effects of a single dose of methylprednisolone
      administered prior to total knee-arthroplasty surgery. The investigators examine the effect
      on complement activation.

      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
      receive placebo.

      The investigators hypothesize that the group receiving methylprednisolone will experience
      beneficial inhibition of the undesirable parts of the complement activation.
    

Detailed description: 
      The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
      postoperative pain, postoperative nausea and vomiting are well-documented.

      Anaesthesia and surgery are associated with a dramatic increase in the inflammatory response.
      The complement system participates in the disposal of products due to inflammatory damage.
      The complement activation generates proinflammatory mediators which amplifies the tissue
      damage and the inflammation.

      Glucocorticoid administration prior to surgery is thought to effectively reduce the
      inflammatory response and the activation of the complement system. The effect of
      glucocorticoids on specific complement markers after surgery is unknown and calls for further
      investigation.

      This study is embedded in a primary study registrated as: NCT02319343

      For further details please view the EudraCT registration:

      EudraCT nr.: 2014-003395-23
    

Intervention name(s): Methylprednisolone; Isotonic Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride; Placebo
Other intervention name(s): Solu-Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Glucocorticoid; Complement activation; Knee arthroplasty, total