bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
Condition: Radius Fractures; Edema; Pain
MeSH terms: Edema; Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Interferential current is a form of electrotherapy that is obtained by placing two different
      plates that produce medium frequency waveform current, resulting in a low frequency
      interferential waveform in deeper tissues. It was shown interferential current electrotherapy
      is beneficial for reduction of traumatic edema in tissues and pain control.

      Patients with conservatively managed distal radius fractures were recruited after casts are
      shed, and were treated with one session(30 minutes) of different protocols of interferential
      current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand
      grip strength and visual analogue scale for pain.
    


Intervention name(s): Electrotherapy, interferential current; Control
Intervention type(s): Device; Other
Intervention description(s): Interferential current, entry frequencies and beat frequencies were set differently in 2 groups, amplitude was individualized and increased until patients felt a comfortable tickling sensation.; No current except for first 5 seconds, device open but does not appy electrotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radius fracture, Interferential current, edema, pain
Prognostic Value of Biochemical Markers in Cerebrospinal Fluid for Functional Outcome of Spinal Cord Injured Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The project is aimed to develop predictive indices of spinal cord injury severity through the
      analysis of cerebrospinal fluid of patient collected during acute injury.
    


Intervention name(s): Lumbar puncture
Intervention type(s): Other
Intervention description(s): The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal Cord Injuries; Cerebrospinal Fluid
Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal
Condition: Schistosomiasis; Anemia; Underweight; Stunting; Intestinal Parasites
MeSH terms: Schistosomiasis; Intestinal Diseases, Parasitic; Anemia; Growth Disorders; Thinness
Study type: Observational

Summary: 
      SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the
      immune response of children to childhood vaccine antigens, as well as the impact of this
      infection on their nutritional status and their haemoglobinaemia.
    

Detailed description: 
      SchistoVAN aims to study the interactions between chronic parasite infections such as
      schistosomiasis and the immunological and nutritional status of children. In this scope, the
      investigators conducted a case-control study where one group of children is infected with
      schistosoma haematobium and the other is not infected with this parasite.

      The investigators then stimulated whole blood of these children with various vaccine antigens
      to address their immune function and study the influence of schistosomiasis infectious state
      on their overall immune condition.

      Aims of the study:

      To evaluate the interaction between schistosomiasis and the nutritional status of children
      and their haemoglobinemia.

      To evaluate the influence of schistosomiasis on children's specific immune response towards
      EPI vaccine antigens, the inflammatory status of children and nutritional serologic markers.

      To compare schistosomiasis diagnostic tools (evaluation of circulating cathodic antigen (CCA)
      strip for diagnosis of urinary schistosomiasis in comparison with microscopy and urinary
      dipsticks)

      To study prevalence of intestinal parasites such as Blastocystis hominis
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Residents of 3 villages from the Senegal Valley River, belonging to the Podor District in
        Saint-Louis Region in Northern Senegal: Agniam Towguel, Fanaye Diery and Niandane.
        Subcohort of a previous study "AnoPalAnoVac" (ClinicalTrials.gov ID: NCT01545115)
      
Biospecimen description: 
      Whole blood Sera Urine Stool
    
Keywords: Schistosoma haematobium; schistosoma mansoni; Anemia; Underweight; stunting; Blastocystis
Effects Of The Mindfulness Meditation Practices On Cognition
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional
      subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an
      improvement of these deficits, and reduces symptoms of anxiety and depression. However, the
      studies that demonstrated these improvements did not use a control group, nor controlled the
      use of medication. In the present study the investigators will examine the effects of the
      mindfulness practices (same protocol of 8 weekly sessions used in the study that showed
      positive effects in this disorder) in the performance of adult patients and healthy people
      (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by
      validated questionnaires before and after treatment/standby.
    


Intervention name(s): Active comparator (meditation) with healthy subjects; Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The control group with healthy subjects that was participate in meditation ("active" control group); In the eight weeks following the first session of cognitive tests, the participants made a practice of weekly meditation group lasting 2 hours. Practices with each group (patients and "active" controls) occurred on different days. With regard to meditation practices were performed in a sitting posture with emphasis on daily life. Each weekly session involved meditation practices with trained professional, practical proposals for home exercise and a discussion group. Meditation compact discs (CDs)were given to participants for practices at home, which proposed activities for 5 minutes to 1 week and 2 weeks for 10 minutes 3-5, and finally 15 minutes for 6-8 weeks. After 8 weeks of treatment the second session of tests was held that involved the same tasks in session 1.
Other intervention name(s): Mindfulness
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meditation; Cognition; Attention Deficit Disorder with Hyperactivity
A Study to Determine the Feasibility and Acceptability of Conducting a Phase III Randomised Controlled Trial Comparing Stereotactic Ablative Radiotherapy With Surgery in paTients With Peripheral Stage I nOn-small Cell Lung Cancer cOnsidered Higher Risk of Complications From Surgical Resection
Condition: Oncology
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      Stage I non-small cell lung cancer (NSCLC) is curable and surgery is considered the standard
      of care for fit, good performance status patients. However, a high proportion of patients
      with stage 1 NSCLC are elderly and/or have medical co-morbidities and are therefore at higher
      risk of surgical complications. The optimal treatment for these patients is unknown. SABR may
      be an equally appropriate treatment but this need to be formally assessed. Funded by the NIHR
      Research for Patient Benefit, SABRtooth is a UK multi-centre, two-group individually
      randomised controlled feasibility study of patients with peripheral stage I non-small cell
      lung cancer considered at higher risk from surgery. In total, 54 patients are planned to be
      recruited from 4 treatment sites and 2 referral sites. This study aims to determine the
      feasibility and acceptability of performing a largescale definitive randomised phase III
      trial comparing surgery with stereotactic ablative radiotherapy (SABR). The qualitative
      substudy is an exploration of the reasons for nonparticipation in the SABRTooth trial. As the
      two treatments are very different, patients may have a strong preference for either surgery
      or SABR, or may feel uncomfortable to have a decision between such distinct options taken out
      of their hands. Understanding why patients choose not to participate or do not take up their
      treatment allocation will be crucial in demonstrating that recruiting to a larger scale phase
      III trial is feasible. We will explore what patients, who have declined particpation in the
      study or who intiailly consented but subsequently fail to take up their randomimsed treatment
      arm, understand, perceive and feel about, how the SABRTooth trial was presented to them and
      their expectations of study burden.
    


Intervention name(s): Treatment by Surgical resection; Stereotactic Ablative Radiotherapy (SABR)
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults
Condition: Serum Cholesterol; Gut Microbiome
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether the daily consumption of 5 g of milk polar
      lipids influences serum lipids and gut microbiota composition in healthy adults.
    

Detailed description: 
      Healthy adults will be recruited to participate in a randomized, single-blind, controlled,
      13-week crossover trial. Participants will follow a 2-week run-in control period consuming
      their habitual diets. Participants will then be randomized to consume 20 g of milk fat daily
      in the form of either a reconstituted milk polar lipid (MPL)-rich dairy beverage (MPL;
      providing 5.3 g MPL daily) or a control dairy beverage (CTL; providing 0.3 g MPL daily), each
      for 4- weeks, separated by a 3-week washout period. Participants will be instructed to
      consume intervention treatment/control beverages at breakfast (50 g) and dinner (50 g) and
      reconstitute the powders in water immediately prior to consumption. With the exception of the
      intervention beverages, participants will be asked to maintain their normal diet and exercise
      habits throughout the study. Venous blood will be collected after a 12-hour overnight fast
      into EDTA-coated (glucose analysis) and serum (lipid analyses) collection tubes. Passive
      drool and stool samples will be collected at the end of the run-in period (baseline) and
      intervention periods (treatment and control). Participants will be asked to complete a 5-day
      dietary record, food preference/liking/sedentary behavior surveys, and 7-day physical
      activity diary at the beginning and end of intervention periods.
    

Intervention name(s): Milk Polar Lipids; Milk Fat
Intervention type(s): Other; Other
Intervention description(s): Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.; Effects of the addition of 20 g milk fat.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Milk; Polar Lipids; Phospholipids; Cholesterol; Microbiota; Microbiome
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor
      of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC), as a PET imaging biomarker
      of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well
      characterized histological marker of prostate cancer tumor aggressiveness but a quantitative
      non-invasive method for PSMA detection and monitoring is not currently available. Development
      of such an imaging biomarker would be useful to differentiate indolent from aggressive
      prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies.
      The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake
      in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators
      propose to study patients initially diagnosed with biopsy-positive prostate cancer to
      determine if DCFBC uptake and location by PET imaging will be positively correlated with
      prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of
      suspected metastatic disease will be compared to conventional imaging modalities (CT, bone
      scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be
      compared with expression levels of PSMA and other prostate cancer relevant markers (PSA,
      Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with
      clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived
      prediction of pathologic stage).
    


Intervention name(s): 18F-DCFBC
Intervention type(s): Drug
Intervention description(s): A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Primary Prostate Cancer
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a
      pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a
      subset of patients.
    


Intervention name(s): Lubiprostone; Lubiprostone; Lubiprostone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12 mcg capsule once daily (QD); 12 mcg capsule twice daily (BID); 24 mcg capsule twice daily (BID)
Other intervention name(s): Amitiza®; Amitiza®; Amitiza®
Intervention MeSH terms: Lubiprostone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Condition: Brain Tumor; Central Nervous System Tumor
MeSH terms: Neoplasms; Brain Neoplasms; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      that they stop growing or die. bone marrow transplantation and peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      bone marrow transplantation and/or peripheral stem cell transplantation in treating patients
      who have recurrent medulloblastoma or CNS germ cell tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response and progression-free survival in patients with recurrent
           medulloblastoma or CNS germ cell tumors treated with intensive melphalan and
           cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell
           rescue.

        -  Determine the acute and delayed toxic effects of this regimen in these patients.

      OUTLINE: Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested.
      Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and
      melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are
      reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow
      transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning
      4 hours after ABMT and continuing until blood counts recover.

      Patients are followed every 6 months through year 4 and then annually thereafter.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.
    

Intervention name(s): Sargramostim; cyclophosphamide; melphalan; autologous bone marrow transplantation; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure; Procedure; Procedure
Intervention description(s): Given IV; Given IV; Given IV
Other intervention name(s): M-CSF; GM-CSF; Granulocyte macrophage-colony stimulating factor; Prokine; Leukine; NSC #6137; Cytoxan; NSC #026271; IND #7089; ylalanine mustard; L-PAM; L-sarcolysin; Alkeran; NSC #8806
Intervention MeSH terms: Cyclophosphamide; Melphalan; Molgramostim; Sargramostim
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood brain tumor; childhood central nervous system germ cell tumor; recurrent childhood medulloblastoma
System for Quantifying the Functional Strength of the Grip and Pinch Movements
Condition: Hand Injuries and Disorders
MeSH terms: Hand Injuries
Study type: Interventional

Summary: 
      This study developed a system to quantify the functional strength of young adults without
      motor impairment during grip and pinch movement. Making it possible to know the accuracy of
      the value of these strength, the range of motion performed and whether the grip force was
      maintained throughout the range of motion. In addition to checking the functionality,
      reliability and reproducibility of the system.
    

Detailed description: 
      Quantifying grip and grip movement is essential as it allows for a basis in upper limb
      functionality. However, when there is access, it causes changes in the hands and changes the
      motor in relation to the force and range of motion, or generates changes in activities of
      daily living. Thus, a system with 5 devices, where each one the devices were prints in
      three-dimensional, and instrumented with force sensor for static-dynamic force analysis e
      potentiometer for analysis range of motion, during the execution of movements cylindrical
      grip, spherical grip, hook grip, pulp-pulp pinch, and pulp- side pinch in different
      activities of daily living. Elaborated a data storage interface through MATLAB® software that
      allows recording the data of each device. For the system functionality tests, 30 volunteers
      were selected for both sexes, young adults between 20 and 39 years old, students of the
      Physiotherapy and Graduate courses of the University of Mogi das Cruzes. The tests are
      divided into two sessions and are repeated after 7 days of the first test
    

Intervention name(s): handgrip strength; Door handle device; Tap device; Door pull handle; Linear Switch device; Door Key device
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): First, the hand measurements of each volunteer were evaluated, followed by the measurement of handgrip strength using the Jamar® dynamometer. And later the tests were performed using the system that contains the 5 devices to quantify the hand strength.; To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.; To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.; To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion; To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.; To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.
Other intervention name(s): Jamar dynamometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF
      5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis
      and implantation outcomes.
    

Detailed description: 
      The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we
      suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth
      factor that have multi-ways to might improve embryo development in vitro so we decide to
      design a trial to compare the embryogenesis by sibling Oocytes of the same patient between
      two arm of the same culture media and the same culture condition. One arm with Cytokines and
      the other is traditional one and closely monitor the outcome within the 2 arms and record the
      results.
    

Intervention name(s): Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: In Vitro culture of human embryos
Study to Evaluate Solesta for Treatment of Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in
      the treatment of fecal incontinence for a total of 24 months after completed treatment.
    


Intervention name(s): Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
Intervention type(s): Device
Other intervention name(s): Solesta
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment