bioihbjkbjnl/mcl2 huggingface dataset:
Smartphone App for Analysis of General Movements in Young Infants
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      Analysis of spontaneous movements in young infants from video recordings is recommended as an
      early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such
      video recording have previously been performed in follow-up programs at hospitals using semi
      standardized video set-ups. The research group behind this study develops a smart-phone
      application that makes it possible for parents to video film their infant spontaneous
      movements at home, upload and send the video for analysis at the hospital provided by
      experts. The objectives of the study are to assess the feasibility of the In-Motion app for
      video recording of infant spontaneous movements, upload and send the video to St. Olavs
      Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120
      high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will
      participate. Parents will record their infant spontaneous movements and answer
      questionnaires. Video quality will be evaluated by experts within the field and their use for
      computer-based assessment will be evaluated.
    


Intervention name(s): in-Motion app
Intervention type(s): Device
Intervention description(s): mobile phone application for recording fidgety movements at home
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        High-risk infants included in the regular clinical follow-up program comprising a standard
        examination at 3 months corrected age.
      
Keywords: Infants, newborn; General Movements; Video Recording; Mobile Applications; Prognosis; Parents
Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
Condition: Leiomyomas; Fertility
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas
      embolization, in women between 18 and 40 years old.
    

Detailed description: 
      Uterine artery embolization (UAE) is an effective treatment for leiomyomas, that has been
      proposed to replace hysterectomy in women who don't want any more pregnancy. Few authors have
      investigated the results of UAE in women desiring subsequent pregnancy. It might represents
      an alternative to multiples myomectomies by laparotomy , which results on postoperative
      fertility remain disappointing. The main goal of this study is to evaluate spontaneous
      fertility after uterine embolization, in women between 18 and 40 years old. The functional
      outcome, the efficiency, complications and side-effects of UAE will be also reported
      especially on the reproduction function. This will be an open prospective, multicentric,
      non-randomized, interventional study. Within the context of an experimental phase II essay,
      an optimal Simon plan with 2 stages is required. The current study is the first step. It will
      include 30 patients treated in the Gynecology departments of Pr MADELENAT and Pr Mathieu
      CAPUTO (BICHAT Hospital, Paris) and Pr Ville (Poissy Hospital, Poissy). Preliminary results
      will be reported at 1 year postoperative which correspond to the participation period of 15
      months and the total follow-up period will be 2 years. Inclusion criteria will be the women
      whom multiples myomectomies by laparotomy would be necessary, with symptomatic myoma and an
      immediate wish of pregnancy. The number of first pregnancies among women who try to be
      pregnant (conception rate) and among all women (fertility rate) will be calculated. The
      effects of the embolisation on the genital physiology, the leiomyomas and the ovarian
      function will be evaluated by questionaries, clinical examination, biology exams (hormones),
      ultrasound and IRM at 3, 6 and 12 months, and coelioscopy and hysteroscopy at 3 months. The
      pregnancy progress will be evaluated in a longer study.
    

Intervention name(s): embolization
Intervention type(s): Procedure
Intervention description(s): fertility after embolization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine embolization; leiomyomas; fertility; myomectomies
Duration of Red Blood Cell Storage Prior to Transfusion
Condition: Iron, Blood Level Abnormal
Study type: Interventional

Summary: 
      This study will determine the minimal duration of red blood cell (RBC) storage that leads to
      increases in circulating non-transferrin-bound iron in healthy human volunteers
      post-transfusion. The results from this study will help guide national guidelines for
      appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food
      and Drug Administration (FDA) criteria. The overall objective of this research is to improve
      the safety of refrigerated storage of red blood cells before transfusion.
    

Detailed description: 
      Recent studies suggest that older stored blood is associated with worse outcomes in certain
      hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up
      to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a
      storage lesion and the survival of transfused red cells decreases with increasing storage
      time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain
      parts of the body. The investigators have preliminary data in mice and humans suggesting that
      delivery of a significant iron load from aged red cells leads to the production of a
      potentially toxic form of circulating iron called non-transferrin-bound iron.

      In this prospective study of healthy volunteers, each subject will be randomized to receive
      transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome
      will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron
      concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours
      after transfusion.
    

Intervention name(s): Blood Transfusion; Packed red blood cells
Intervention type(s): Procedure; Other
Intervention description(s): A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.; Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.
A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.
The number of weeks in storage are as follows:
1 week
2 weeks
3 weeks
4 weeks
5 weeks
6 weeks
Other intervention name(s): Red blood cell (RBC) transfusion; PRBC
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Blood Transfusion; Iron; Red Blood Cells
Evaluation of the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The blood lipid profile plays a role in health and disease states and is affected by many
      genetic and lifestyle factors. On the more extreme side, hyperlipidemia (a condition
      characterized by hypertriglyceridemia, hypercholesteremia, or both) is a risk factor for
      coronary heart disease (CHD) 1. CHD is the most common form of cardiovascular disease (CVD);
      it is characterized by arterial obstructions or blockages, and is a leading cause of heart
      attacks and strokes 2. Specifically, blood lipids including triglycerides (TG), total
      cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), and the ratio of TC: high
      density lipoprotein (HDL) cholesterol, are key modifiable risk factors for CHD.
      Hyperlipidemia is thought to be caused or promoted by sedentary lifestyle, obesity, or
      uncontrolled type 2 diabetes 2. Therefore, lifestyle factors, like the modification of
      dietary lipids to maintain a healthy blood lipid profile are warranted.

      There are many beneficial effects of omega-3 fatty acids in terms of cardiovascular disease
      and the nervous system in general, as well as emerging research on DHA supplementation in
      acute brain and spinal cord injury. Demand for dietary omega-3's, either through increased
      fish consumption or through DHA supplementation, is expected to increase, particularly as the
      baby boomer population adds to the ranks of senior citizens concerned about and/or
      susceptible to health issues such as dementia and Alzheimer's Disease. Availability of EPA
      and DHA in circulation is an important parameter in understanding biologic properties of
      fatty acids.

      The purpose of this study is to evaluate the pharmacokinetic characteristics of ascending
      doses of NutriterraTM, as measured by plasma levels of total EPA, DHA, DPA and ALA under fed
      conditions. In addition, after a two-week (minimum) washout period, subjects will take
      product for 16 weeks to evaluate effects on cardiovascular markers as a measure of efficacy.
    


Intervention name(s): NutriterraTM; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutriterra 1000mg; Corn Oil 1000mg
Other intervention name(s): Canola Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Organizational Skill Training (OST) in Schools
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The primary aim of this project is to address the need for an effective school-based
      intervention for elementary school-aged students with Organization, Time Management, and
      Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that
      it can be implemented in school settings. Investigators are learning to adapt an individual,
      clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive
      Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To
      this end, investigators will be collecting data on implementation (such as feasibility and
      acceptability), program development (what changes to the individual OST-C program were made
      based on findings during this study) and limited outcome data (repeated measures collection
      and pre- and post-treatment collection on a small sample, no control group).
    


Intervention name(s): Organizational Skills Training (OST) Intervention
Intervention type(s): Behavioral
Other intervention name(s): Organization, Time Management, and Planning (OTMP)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Organization, Time Management, and Planning (OTMP)
RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee
Condition: Articular Cartilage Lesion of the Femoral Condyle
MeSH terms: Fractures, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect®
      in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of
      microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible
      patients attended two screening visits and were booked for arthroscopy approximately 2 weeks
      later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a
      procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar
      tissue. Patients randomized to MF had the procedure performed at the time of their
      arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the
      arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee
      procedure, during which the ACI procedure using ChondroCelect® was performed. Patients
      subsequently followed the same rehabilitation program and had follow-up assessments up to 12
      months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000
      protocol. Subject to satisfying the eligibility criteria, patients who had participated in
      the initial 12 month trial could enter the extension trial. The 12-month visit for the
      initial study was the baseline visit for the extension study. During the extension study,
      patients have follow-up assessments up to 60 months post-surgery.
    

Detailed description: 
      see above
    

Intervention name(s): ChondroCelect implantation; Microfracture
Intervention type(s): Drug; Procedure
Intervention description(s): 10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.
The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm².; A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.
Other intervention name(s): CCI; subchondral drilling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cartilage; Articular; Femoral; Knee
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
Condition: Pain, Chronic; Pain, Intractable; Pain, Back
MeSH terms: Chronic Pain; Pain, Intractable; Back Pain
Study type: Interventional

Summary: 
      The Nalu Neurostimulation System is capable of delivering multiple therapy options to address
      patient needs. The study will confirm the efficacy, safety, comfort and compliance with the
      Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back.
      Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other
      study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation
      System.
    

Detailed description: 
      The study is a prospective, multi-center, open-label, single-arm clinical study with each
      subject serving as their own control. The study will confirm device efficacy, safety, comfort
      and compliance with the system.

      Subjects who meet the protocol specified eligibility criteria and provide documented informed
      consent will be considered for study participation. There are three phases in the study:
      Screening/Baseline Phase, Trial Phase, Permanent Implant Phase. On confirmation of
      eligibility during the screening/baseline phase, subjects will enter the Trial Phase where
      they will undergo a trial with the Nalu Neurostimulation System. Trials will be done per
      standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in
      their back pain, during the trial phase, will continue to the permanent implant phase.

      Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and
      medical practices and will be programmed for stimulation with one or more therapies to
      optimize pain reduction. All subjects receiving a permanent implant will be followed for
      3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up
      and programming, as required. Adverse Event data will also be collected to support a safety
      endpoint.

      Multiple outcome domains will be captured throughout the study to confirm system performance
      and subject response to the device. These include Visual Analogue Scale (VAS) for pain,
      Numeric Rating Scales for pain, EQ-5D (QoL), the Oswestry Disability Index (ODI), PROMIS
      Sleep Disturbance SF, Beck's Depression Index (BDI), pain and paresthesia maps, pain and
      wearability diaries.

      At study completion, subjects will return to standard clinical practice.
    

Intervention name(s): Nalu Neurostimulation System
Intervention type(s): Device
Intervention description(s): The Nalu Neurostimulation System is a Spinal Cord Stimulation system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Stimulation; Chronic Leg and Back Pain; Failed Back Surgery Syndrome (FBSS)
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will explore the effectiveness of a computer based neurobehavioral
      intervention in improving cognition and emotion regulation in a college freshmen population.
      It will increase understanding of emotion-regulation and cognition at a neural-circuit level
      and aid development of new interventions for emotion regulatory problems.
    


Intervention name(s): Computerized Neurobehavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Targeted, computerized interventions completed from the participants' own home on a computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
SFX-01 After Subarachnoid Haemorrhage
Condition: Subarachnoid Hemorrhage, Spontaneous
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in
      Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.
    

Detailed description: 
      The study is a randomised, double-blind, parallel-group design comparing SFX-01 (300 mg)
      taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily for up to
      28 days versus placebo in 90 patients who have had SAH and present within 48 hours of ictus.

      Subjects will receive SFX-01/Placebo in order to review potential outcomes investigating the
      long-term complications of SAH such as Delayed Cerebral Ischaemia, as reflected by
      Trans-Cranial Doppler (TCD) readings. The objective is to demonstrate safety and search for
      signals of efficacy in patients that have had SAH.

      A sub-study will be conducted in up to 12 patients where an External Ventricular Drain (EVD)
      fitted; serial CSF samples will be taken pre- & post-dose on two occasions to determine
      pharmacokinetics of Sulforaphane in CSF in comparison with plasma pharmacokinetics. Sub-study
      patients will undergo all other procedures (with the exception of lumbar puncture).

      Treatment duration is up to 28 days; follow up duration is 28 days, three and six months. The
      planned trial period is 24 months.
    

Intervention name(s): SFX-01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An intervention releasing sulforaphane.; Placebo otherwise identical to Active product
Other intervention name(s): Sulforadex; Cyclodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study is to determine the efficacy of split-course irradiation with concurrent
      chemotherapy in locally advanced none-small cell lung cancer patients.
    

Detailed description: 
      This Phase II study is to determine the efficacy of split-course chemoradiotherapy(CCRT) in
      locally advanced non-small cell lung cancer.

      Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1
      day's duration, combined with split-course thoracic radiotherapy of 51 Gy/17 fractions and
      15-18 Gy/5-6 fractions administered in the first and second courses, respectively, with about
      one-month break. The primary endpoint is progression-free survival, which is calculated from
      the start of RT to the first identification of disease progression or death. Progression-free
      survival will be calculated using the Kaplan-Meier method. Toxicities will be graded
      according to CTCAE V.4.0.
    

Intervention name(s): split-course radiotherapy; Concurrent chemotherapy
Intervention type(s): Radiation; Drug
Intervention description(s): Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV. The disease is re-evaluated three weeks after the end of the initial course using CT. The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost. In the second course, the tumor is repositioned and scanned. The residual tumor is then treated with the second course of radiotherapy. A dose of 15-18 Gy/5-6f is delivered to the residue tumor.; Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small cell lung cancer; Split-course Chemoradiotherapy
Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Observational

Summary: 
      The purpose of the study is to assess in a prospective series of patients with high tumor
      burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET
      performed over (after 4 treatments), and at the end of the first-line treatment on
      progression-free survival at 2 years.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        High Tumor Burden Follicular Lymphoma patients
      
Biospecimen description: 
      Burden tissue sample
    
Keywords: Follicular Lymphoma; PET; GELA
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
Condition: Anticoagulation; Mechanical Heart Valve Replacement
Study type: Observational

Summary: 
      The optimal valve substitute for patients between 60-70 years is controversial. We compared
      anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve
      replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the
      risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not
      requiring permanent anticoagulation.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients received heart valve replacement and were retrospectively allocated in three
        groups