bioihbjkbjnl/mcl2 huggingface dataset:
Endermotherapy for Children With Developmental Disabilities
Condition: Cerebral Palsy; Developmental Delay
MeSH terms: Cerebral Palsy; Developmental Disabilities
Study type: Interventional
Phase: Phase 2

Summary: 
      Children with developmental disabilities often sustain decreased range of motion in their
      extremities. The decrease in flexibility may be due to neuromuscular disorders such as
      spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint,
      leading to inappropriate habitual posture. Over time, muscle contracture may result for those
      muscle groups that are placed in a shortened position for an extended period of time. The
      most common site of muscle contractures among these children are gastrocnemius/soleus (lower
      limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further
      decline in functional abilities. Therefore, it is important to identify effective
      intervention strategies to enhance or maintain muscle flexibility in children with
      developmental dysfunctions.

      Commercially available endermotherapy device has been used to soften scar tissue following
      burn injuries. The mechanical stimulation applied may also have beneficial effects on
      relaxing the muscle tissue. The overall aim of the proposed study is to determine whether
      endermotherapy treatment has immediate effect in improving joint range of motion among
      children with developmental disabilities.

      The research hypothesis is that children in the endermotherapy group will have significantly
      more gain in ankle passive range of motion than those in the control group.
    


Intervention name(s): Endermotherapy; Passive manual stretching
Intervention type(s): Procedure; Procedure
Intervention description(s): The subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.; The subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: flexibility; muscle; stretching; cerebral palsy; developmental
Dynamic Combination Therapy on Chinese Herbal Granules to Improve the Symptoms in Convalescent Phase of Ischemic Stroke
Condition: Ischemic Stroke; Convalescence
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Convalescence
Study type: Interventional

Summary: 
      To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula
      (Fangji) based on differentiation of syndromes ("Zhenghou") according to the theory of
      traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic
      stroke, and to establish the pharmacodynamic model of "Zhenghou" according to the results of
      this trial.
    


Intervention name(s): Dynamic Chinese herbal granule formula; Placebo; Standard medical care
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): After evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules and weekly changed according to differentiation of syndromes (Zhenghou) of patients.; The 10 kinds of matched placebo granules were of the similar appearance, taste, smell with the corresponding Chinese herbal granules respectively. The interventional process of the placebo group is similar as the Chinese herbal granule formula group; Standard medical care is the basic treatment for all enrolled patients, including aspirin 75-100mg per day, standard rehabilitation training, treatment for their primary diseases, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Convalescence; Randomized Controlled Trial; Pilot Study; Traditional Chinese Medicine
A First-in-Human Study of QY101 Ointment in Adult Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, double-blind, vehicle-controlled，single and multiple ascending
      dose study to assess the safety, tolerability, and pharmacokinetics of QY101 ointment in
      Chinese healthy subjects
    


Intervention name(s): QY101 ointment or vehicle
Intervention type(s): Drug
Intervention description(s): QY101 ointment or vehicl topical applied to skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can
      be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the
      ability to find injured tissue, reduce and control inflammation, and assist in tissue repair.

      Prochymal™ MSCs will be infused into patients with moderate-to-severe Crohn's disease.
      Infusions will occur on two separate days, 7-10 days apart. Patients will be monitored for
      reduced Crohn's disease symptoms.
    

Detailed description: 
      Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can
      be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the
      ability to find injured tissue, reduce and control inflammation, and assist in tissue repair.

      Prochymal™ MSCs will be infused into patients with moderate-to-severe Crohn's disease.
      Infusions will occur on two separate days, 7-10 days apart. Patients will be monitored for
      reduced Crohn's disease symptoms. Patients will receive high or low dose. Study is open
      label.
    

Intervention name(s): Prochymal™ adult human mesenchymal stem cells; adult human mesenchymal stem cells
Intervention type(s): Drug; Drug
Intervention description(s): Cells in plasmalyte and containing dimethylsulfoxide; two infusions, one week apart, each comprising adult human mesenchymal stem cells
Other intervention name(s): PROCHYMAL; PROCHYMAL
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells
Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
      such as bevacizumab, can block tumor growth in different ways. Some block the ability of
      tumor cells to grow and spread. Others find tumor cells and help kill them or carry
      tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by
      blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy
      together with bevacizumab and to see how well it works in treating patients with metastatic
      colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI
           and bevacizumab therapy.

        -  Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.

      Secondary

        -  Evaluate progression-free survival and overall survival.

        -  Determine the time to treatment failure.

        -  Evaluate the quality of life (EuroQOL EQ5D questionnaire).

        -  Explore the prognostic factors associated with the tolerability and efficacy of this
           treatment.

      OUTLINE: This is a multicenter study. Patients are stratified according to genotype
      (UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).

      Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90
      minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
      Treatment repeats every 2 weeks in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the
      completion of study therapy.

      After completion of study therapy, patients are followed every 2-3 months.
    

Intervention name(s): bevacizumab; fluorouracil; irinotecan hydrochloride; leucovorin calcium
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Condition: Cardiac Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The purpose of the study is to help determine if either crystalloid solution or colloid
      solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac
      patients.
    

Detailed description: 
      The study is designed to help detect if there is an advantage in giving one type of
      resuscitative fluid versus another in the setting of post-operative pediatric cardiac
      patients. The two types of fluid being compared are crystalloid solution (normal saline) and
      colloid solution (5% albumin). The primary outcome measurement will be how much volume of
      each type of fluid will be required in order to maintain hemodynamic stability as determined
      by mean arterial blood pressure within predetermined parameters. Other secondary outcomes
      will include determinations of lactate clearance, inotropic support requirements, urine
      output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs
      for each fluid based on number of required boluses and number of hours on mechanical
      ventilation.
    

Intervention name(s): 5% albumin; crystalloid
Intervention type(s): Other; Other
Intervention description(s): 5% albumin in 10cc/kg aliquots for postoperative volume resuscitation; saline in 10cc/kg aliquots for postoperative volume resuscitation
Other intervention name(s): colloid; albumin; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: crystalloid; colloid; pediatric; cardiac; resuscitation; Postoperative
Anesthesia for Obese Patients: Desflurane Versus Xenon
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is increasing in France, resulting in an increased demand for bariatric surgery.
      However obesity also alters physiopathological pathways and the pharmacokinetics of
      anesthestic agents. The investigators objective is to compare, among morbidly obese patients,
      the immediate and intermediary emergence kinetics after balanced anesthesia using
      remifentanil associated either with desflurane (reference arm) or with xenon (experimental
      arm).
    


Intervention name(s): Desflurane; Xenon
Intervention type(s): Drug; Drug
Intervention description(s): Patients undergo anesthesia using remifentanil associated with desflurane; Patients undergo anesthesia using remifentanil associated with xenon
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bariatric surgery; Anesthesia
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether folinic acid can improve developmental
      quotient of young Down syndrome patients, given that these present signs of folate deficiency
      which are known to cause reversible neurological, psychiatric and cognitive disorders.
    


Intervention name(s): folinic acid
Intervention type(s): Drug
Intervention MeSH terms: Leucovorin; Folic Acid; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Down syndrome; folinic acid therapy; cognitive functions
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
Condition: Safety Issues
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
    

Detailed description: 
      To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.

      To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence
      of positive reactions after the sensitivity test (skin test). To assess the presence of SAE
      after Diphtheria Antitoxin administration.
    

Intervention name(s): Diphtheria Antitoxin
Intervention type(s): Biological
Intervention description(s): Dosage form: Solution for injection
Dosage:
Perform sensitivity tests, and desensitization if necessary.
Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization).
The recommended DAT treatment dosage ranges (pediatric and adult) are:
Pharyngeal or laryngeal disease of 2 days duration 20,000 - 40,000 unit
Nasopharyngeal disease 40,000 - 60,000 unit
Extensive disease of 3 or more days duration, or any patient with diffuse swelling of neck 80,000 - 100,000 unit
Skin lesions only (rare case where treatment is indicated) 20,000 - 40,000 unit
Intervention MeSH terms: Antitoxins; Diphtheria Antitoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
Condition: Chronic Obstructive Pulmonary Disease; Anxiety; Depression
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will try to elucidate wheter the impact of a psychiatric intervention in patients
      hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at
      1 and 6 month after discharge.
    


Intervention name(s): Counselling
Intervention type(s): Behavioral
Intervention description(s): Visit by a psychiatrist at day-30 and day-180 after discarge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Shalamar Institute of Health Sciences
Condition: Effect of Didactic Intervention Regarding (DASH) on Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on
      Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore
    

Detailed description: 
      Objective: To explore the effect of didactic intervention regarding dietary approach to stop
      hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.

      Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of
      Cardiology (PIC) Lahore. From June 2018 to Oct 2018.

      Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at
      Punjab institute of cardiology Lahore, with systolic > 130 mm hg, diastolic > 80 mm hg were
      selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery
      method. For twelve weeks, only intervention group were given DASH education. Both groups were
      checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after
      education session. Pre-tested questionnaire was used for demographic, attitude and knowledge
      data collection.
    

Intervention name(s): DASH Education
Intervention type(s): Other
Intervention description(s): DASH health education about general knowledge of DASH diet Plan and lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)
Condition: Congenital Funnel Chest
MeSH terms: Funnel Chest
Study type: Observational

Summary: 
      The purpose of this study is to determine whether there is a metal wear debris after
      minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our
      hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to
      a locally and systemic immune reaction due to elevated metal contamination.
    


Intervention name(s): minimally invasive repair of pectus excavatum
Intervention type(s): Procedure
Intervention description(s): substernal insertion of a metal bar
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Biospecimen description: 
      whole blood, urine, tissue
Outcomes of Liver Transplantation in Low Weight Children After Reducing the Lateral Segment of a Living Donor, Adapting the Shape and Size of the Graft to the Needs of the Recipient
Condition: Liver Transplantation; Low-weight Children; Hyper-reduced Liver Grafts
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The shortage of organs has always been a problem in pediatric liver transplants due to the
      lack of donors with an adequate size. Different techniques of hepatic reduction have been
      described that allow to use larger organs in the pediatric population. However, in these
      techniques the maximum reduction achieved by segments 2 and 3 is excessive for low-weight
      children. Since 1997 the liver transplantation group at Hospital Italiano de Buenos Aires has
      developed and practiced a technique called hepatic hyper-reduction, which consists in
      reducing the lateral segment of a living donor, adapting the shape and size of the graft to
      the needs of the recipient. The investigators have performed approximately 50 pediatric liver
      transplants with live donors in low weight children in whom the hyper-reduction technique has
      been applied. The aim of the present study is to describe postoperative morbidity and
      mortality and analyze overall and graft survival.
    


Intervention name(s): Liver transplantation with hyper-reduced grafts
Intervention type(s): Procedure
Intervention description(s): Live donor liver transplantation using non-anatomical in-situ ultrasound-guided reduction of left lateral segments with preparation of a graft that is larger than a monosegment, but smaller than Segments 2 and 3.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pediatric patients undergoing living donor liver transplantation with hyper-reduced
        liver grafts at the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires
        between June 1997 and April 2018
      
Keywords: Liver; Transplantation; Hyper-reduction; Graft survival; Overall survival
Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis
Condition: Shoulder Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound
      guided and glenohumeral infiltration in glenohumeral arthritis
    

Detailed description: 
      To describe the efficacy in pain management and health related quality of life of
      suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with
      glenohumeral arthritis
    

Intervention name(s): Methylprednisolone Acetate; Lidocaine 2% Injectable Solution; Ropivacaine HCl Inj 7.5 MG/ML
Intervention type(s): Drug; Drug; Drug
Intervention description(s): depo-medrol 40 mg; 2ml of 2% lidocaine; 25 mg
Other intervention name(s): depo-medrol 40 mg; xilocaine; Ropivacaine
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Ropivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study of RO6806127 in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part study will assess the safety and tolerability of single ascending oral doses of
      RO6806127 in a group of healthy male participants and investigate the effect of high fat and
      high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a
      separate group of healthy male participants. The relationship between drug exposure and
      tolerability will be explored.
    


Intervention name(s): Placebo; RO6806127
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo, administered orally with approximately 240 mL of buffer; Administered orally with approximately 240 mL of buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Pharmacokinetic Analysis of Nicotinamide Riboside
Condition: Healthy Participants
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so
      far not analyzed.
    


Intervention name(s): Nicotinamide riboside
Intervention type(s): Dietary Supplement
Intervention description(s): NIAGEN, ChromaDex
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment