bioihbjkbjnl/mcl2 huggingface dataset:
Breadth of Donor Options for People With Inherited Diseases Requiring Allogeneic Hematopoietic Stem Cell Transplant in the Era of Alternative Donor Transplants Using Post-Transplantation Cyclophosphamide
Condition: Primary T-cell Immunodeficiency Disorders; Common Variable Immunodeficiency
MeSH terms: Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Observational

Summary: 
      Background:

      People who have certain immune system diseases often need a procedure called allo HSCT. This
      is short for allogeneic hematopoietic stem cell transplant. This might cure people with these
      diseases. Many people who need allo HSCT need donors who are relatives with similar genes.
      But the disease may also affect those in the donor pool. This may mean there are fewer
      options for people with inherited diseases. Researchers want to collect data on how
      transplant candidates and their donors are found.

      Objective:

      To find out how genetic diseases and the ways they are inherited affect the breadth of
      options for allo HSCT donors.

      Eligibility:

      Records from studies that have already been done. These will be for people ages 4 and older
      who were evaluated for allo HSCT or to be donors.

      Design:

      Participants already signed a consent form for their records to be shared.

      Researchers will study the participant data.

      Data will be stored in an electronic system. Researchers will use passwords to protect the
      data.
    

Detailed description: 
      This protocol is a retrospective review of donor search results for patients with inherited
      immunodeficiency diseases requiring allogeneic hematopoietic stem cell transplant (allo
      HSCT).

      The study will involve collecting information related to the donor search for transplant
      candidates and their prospective donors, using records in CRIS, Crimson, the HLA lab, and
      records in the transplant coordinator office (such as shipping logs of HLA typing kits). The
      study will not involve the use of specimens or participant contact.

      The participants whose records will be reviewed will be those who were evaluated for allo
      HSCT or donation on an NIH primary immunodeficiency transplant protocol at a time when haplo
      donors were eligible (March 30, 2012 to present for GATA2, January 1, 2015 for CGD, October
      6, 2015 to present for 16-C-0003, and May 21, 2014 to present for DOCK8).

      The Principal Investigators on the included protocols have granted permission to conduct this
      study and have verified that none of the original protocols or informed consent documents
      preclude such a review of clinical data.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Retrospective chart review of patients who with inherited immunodeficiency diseases
        requiring allogeneic hematopoietic stem cell transplant (allo HSCT)at the NIH Clinical
        Center.
      
Keywords: Prospective Donors; Immunodeficiency
The Effect of Exercise With Wearable Walking Assist Robot in Various Environments
Condition: Aging
Study type: Interventional

Summary: 
      This single-blinded, randomized, controlled trial includes 60 healthy adults. The
      participants were randomized to four different groups. The first group performed over-ground
      walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied
      resistance mode, the third group performed stair ascent with GEMS-H applied assist mode, and
      the fourth group were designated as the group that performed inclined gait with GEMS-H
      applied assist mode on a treadmill. Each group is divided in 15 participants.
    

Detailed description: 
      At the first visit, the subjects are fully informed of the study if appropriate after
      determining whether they meet the selection criteria. If the subjects meet the selection
      criteria, the participants were randomized to four different groups. The first group
      performed over-ground walking without GEMS-H, the second group performed over-ground walking
      with GEMS-H with resistance mode, the third group performed stair ascent with GEMS-H with
      assist mode, and the fourth group were designated as the group that performed inclined gait
      with GEMS-H with assist mode on a treadmill. Each group is divided in 15 participants. Each
      group completed 30 minutes exercise at least three times per week (total 10 sessions). All
      measurements were conducted before and after the intervention.
    

Intervention name(s): Over-ground walking without GEMS-H; Over-ground walking with GEMS-H with resist mode; Stair ascent with GEMS-H with assist mode; Incline walking with GEMS-H with assist mode
Intervention type(s): Other; Device; Device; Device
Intervention description(s): Over-ground walking without GEMS-H (30 min per session, at least 3 times per weeks, total 10 sessions); Over-ground walking with GEMS-H with resist mode (30 min per session, at least 3 times per weeks, total 10 sessions); Stair ascent with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions); Incline walking with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: wearable hip assist robot
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
Condition: Pulpotomy; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A
      total of 200 primary molars with deep caries were treated with two different pulpotomy
      medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion
      criteria for tooth selection were no clinical and radiographic evidence of pulp pathology.
      During 36 months of follow-up at 3-month intervals, clinical and radiographic success and
      failures were recorded.
    


Intervention name(s): Biodentine; ProRoot (Aggregate)
Intervention type(s): Drug; Drug
Intervention description(s): Biodentine pulpotomy agent; ProRoot MTA pulpotomy agent
Other intervention name(s): 77509635; 75896452
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulpotomy; pediatric dentistry; primary molars
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
Condition: Osteoarthritis, Knee; Arthritis; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total
      Knee Arrhtoplasty (TKA)
    

Detailed description: 
      A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain
      Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing
      pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This
      will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA
      procedures; 58 patients will be randomly selected to be treated postoperatively with an
      active TENS unit and the other 58 patients will be randomly selected to be treated with the
      placebo TENS unit (control group). Patients will be enrolled at two sites within the
      Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and
      control groups will receive a femoral nerve catheter, standard during a primary TKA. It is
      hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic
      usage, reduce pain, and allow for a quicker return to function following TKA.
    

Intervention name(s): EMPI Select TENS; Placebo EMPI Select TENS
Intervention type(s): Device; Device
Intervention description(s): The unit is capable of 0-60 milliamps of output current.; The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty (TKA); Transcutaneous Electrical Nerve Stimulation (TENS); Pain; Function; Knee Osteoarthritis
Intraperitoneal Local Anaesthetic in Bowel Surgery
Condition: Colorectal Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the addition of a local anaesthetic infusion into the abdomen to
      patient controlled analgesia in the management of postoperative pain and recovery after bowel
      surgery. Half of the patients will have an infusion of a local anaesthetic called ropivacaine
      and half will have an infusion of placebo in addition to their normal pain relief.
    

Detailed description: 
      The purpose of this randomised controlled blinded trial is to determine the effectiveness in
      every day practice of intraperitoneal local anaesthetic (IPLA) infusion on postoperative
      recovery following bowel resection in an optimised Enhanced Recovery After Surgery (ERAS)
      setting.

      The investigators hypothesise that, in an optimised ERAS setting, intraperitoneal
      instillation and infusion of the local anaesthetic ropivacaine to the site of maximal
      visceral dissection for 48 hrs will result in an improved functional postoperative recovery
      following both open and laparoscopic bowel surgery.

      This research will provide evidence to allow recommendation on the routine inclusion of IPLA
      into the multimodal analgesia component of ERAS programs for bowel surgery.
    

Intervention name(s): Ropivacaine; 0.9% Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intraperitoneal instillation and infusion; Intraperitoneal instillation and infusion
Other intervention name(s): Naropin; Normal Saline
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intraperitoneal; ropivacaine; bowel resection; local anaesthetic; recovery
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Condition: Coronary Arteriosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis
Study type: Observational

Summary: 
      Diabetic type 2 patients (DB2) has a higher prevalence of coronary artery disease (CAD) than
      non-diabetic persons. Presence of CAD results in murmurs arising from the filling of the
      arteries and can be detected by the CADScor System and can together with biological patient
      profile indicate the risk of presence of CAD in the patient. In the pilot study 100
      asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with
      computed tomography (CT) cardiography and single-photon emission computed tomography (SPECT)
      for assessing if combination of patient profile (gender, age etc) combined with above
      measures may give rise to new improved risk scoring method for he DB2-patient.
    

Detailed description: 
      The study is intended as a pilot observational study for evaluation of a new risk scoring
      method, CADScor System, is relevant for assessment of CAD in the DB2-patient.

      The primary end point will be to document that the hypothesis of combining the CADScor System
      measure with other patient profile data will increase the accuracy of the method for
      determination of risk of presence of CAD.

      The secondary endpoint will be to show that a receiver operating characteristic curve (ROC)
      of > 80% for correct determination of presence of CAD will be achieved.

      The further objective of the study will be to confirm the relevance of performing a large
      scale study with equivalent objectives.

      As controls in the study will be applied CT angiography, CT-calcium and resting and drug
      induced CT-scintigraphy.

      It is assumed that 15-20 of enrolled patients in the study will suffer from CAD.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic type 2 patient
      
Biospecimen description: 
      Blood samples for biobank to be used in potential new studies.
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study will demonstrate feasibility and collect pilot data via a pilot randomized trial
      of 20 participants on the effectiveness of a web-based delivery system of behavioral plus
      nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of
      age that has been found to be efficacious in face to face delivery.
    

Detailed description: 
      Optimizing nutritional status and growth improves health outcomes and survival in children
      with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate
      in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for
      age and gender for children with CF1. Evidence based practice guidelines recommend that
      nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and
      maintain a BMI > 50th percentile, however across 117 CF centers in the United States 57% of
      girls and 56% of boys failed to meet this recommendation1. The investigators have developed a
      highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its
      efficacy when delivered face-to-face to produce weight gain and its superiority over
      nutrition education alone. Although endorsed by the CF Foundation as an evidence-based
      treatment, it is not available to most CF Centers or families due to lack of trained
      personnel, cost, and distance issues. With funding from the CF Foundation the investigators
      developed a web-based delivery system of their efficacious behavioral plus nutrition
      intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes
      Award the investigators have conducted beta testing of the web-intervention and made
      appropriate modifications. The current study represents the next steps in refining and
      testing our web-based intervention. This study will demonstrate feasibility and collect pilot
      data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment
      naïve participants.
    

Intervention name(s): Web Intervention
Intervention type(s): Behavioral
Intervention description(s): Behavioral
Other intervention name(s): Be In Charge
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Behavioral Intervention; Children
5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study
Condition: Fetal Weight
MeSH terms: Body Weight; Fetal Weight
Study type: Observational

Summary: 
      5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation
      and fetal weight will be estimated using the hadlock formula using biometry measured by both
      ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.
    


Intervention name(s): 2D and 5D LB ultrasound comparison for fetal weight estimation
Intervention type(s): Other
Intervention description(s): 2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal pregnant women
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was
      designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in
      preventing the recurrence of cerebral infarction in patients who had suffered a cerebral
      infarction 1 to 6 months prior to entering the trial.
    


Intervention name(s): cilostazol; placebo of cilostazol
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet 100 mg, twice daily, over 1 year; oral tablet, 0 mg twice daily, over 1 year
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin
      for children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or
      injury of the immature brain. It is a leading cause of childhood onset disability.

      Many experimental animal studies have revealed that erythropoietin is useful to repair
      neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;
      neuroprotection effect, angiogenesis, and anti-inflammation.

      On the basis of many experimental studies, erythropoietin is suggested as a potential therapy
      for cerebral palsy.
    

Intervention name(s): Erythropoietin
Intervention type(s): Drug
Intervention description(s): 250 IU/kg, Twice a week for 4 weeks
Other intervention name(s): Espogen produced by LG Life Science
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Erythropoietin; Rehabilitation
Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the
      management of difficult tracheal intubation, and it is considered as a gold standard. The
      disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical
      practice recently.This study compares FOB and DE for awake orotracheal intubation in obese
      patients with anticipated difficult airway.
    

Detailed description: 
      Forty obese patients with anticipated difficult airways were randomised to undergo awake
      orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The
      conditions of orotracheal intubation, the time needed to view the vocal cords and to complete
      the orotracheal intubation, the hemodynamic changes and the adverse events including
      bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness
      and memory after surgery were recorded. The ease of view the vocal cords and passing the
      tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS)
      by operator.
    

Intervention name(s): Fiberoptic bronchoscope; Disposcope endoscope
Intervention type(s): Device; Device
Intervention description(s): In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB; In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Fiberoptic bronchoscope; Disposcope endoscope; Awake orotracheal intubation
Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis
Condition: Osteoporosis; Vertebral Fracture
MeSH terms: Osteoporosis; Spinal Fractures
Study type: Interventional

Summary: 
      In the present feasibility and pilot study we aim to investigate the effect and safety of
      patient education with or without additional physical training or mindfulness/medical yoga in
      patients with manifest spinal osteoporosis (at least one vertebral fracture).

      The study includes a 10-week intervention period with once weekly theory education with or
      without additional physical training or mindfulness/medical yoga (randomized groups).
      Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up
      post-intervention observation are included in the study design.
    

Detailed description: 
      The SOL-study (School of Osteoporosis in Linköping) is a feasibility and pilot study on
      patient education in manifest spinal osteoporosis. The study design is interventional with
      patients randomized to one of three different interventions, i.e.

        1. Theory only (T group)

        2. Theory and physical exercise (TPh-group)

        3. Theory and mindfulness/medical yoga (TMMY-group)

      The intervention period is 10 weeks, including 1 hour theory session/week (same for all
      groups) and for TPh- and TMMY-groups a one hour group training session is scheduled before
      the theory session.

      Inclusion criteria are: 1) manifest spinal osteoporosis (diagnosed osteoporosis and > 1
      vertebral fracture [VF]); 2) > 3 months had passed since the most recent VF; and 3) age over
      60 years.

      Clinical testing and questionnaire evaluation are performed at three timepoints; 1) Baseline
      (T1), i.e. before intervention; 2) Post-observation (T2) i.e. after a passive observation
      time of 4 months); and 3) Post-intervention (T3) i.e. after the interventions. A one year
      follow up post-intervention is performed by questionnaire evaluation.
    

Intervention name(s): Patient education (Theory); Physical training; Mindfulness and medical yoga in group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Theory/Lectures (1h/week)
Interventions given once weekly for 10 weeks.; Physical training group (1 hour/week)
Interventions given once weekly for 10 weeks.; Mindfulness/medical yoga in group (1hour/week)
Interventions given once weekly for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patient education; yoga; mindfulness; physical training