bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Cetirizine on Bronchoconstriction
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of cetirizine, an oral antihistamine, on
      wheezing in patients with allergic rhinitis. Patients presenting to the pediatric emergency
      department who have a history of allergic rhinitis and who are wheezing will be asked to
      participate. Half of patients will receive a dose of cetirizine and the other half will
      receive placebo and their response will be monitored over the course of their emergency
      department visit with vital signs, physical examinations, and measurement of
      bronchoconstriction with spirometry.
    

Detailed description: 
      This is a prospective randomized, placebo-controlled trial to look at the effect of
      cetirizine on bronchoconstriction in patients with allergic rhinitis who present to the
      Pediatric Emergency Department with wheezing. Oral second generation antihistamines such as
      cetirizine are already the standard of care for allergic rhinitis. Wheezing pediatric
      patients with allergic rhinitis who are not already on this therapy will be randomized to
      receive either age-appropriate-dosed cetirizine or placebo in addition to standard asthma
      therapy at the discretion of the treating clinician, and will be monitored every 30 minutes
      with asthma scores and FEV1 measurements. At the conclusion of 3 hours, each patient who
      received placebo will receive a dose of cetirizine, and each patient who received cetirizine
      will receive a placebo medication dose, such that initiating therapy for allergic rhinitis is
      delayed by no more than 3 hours.
    

Intervention name(s): Cetirizine Hydrochloride 1 MG/ML; Placebo - Concentrate
Intervention type(s): Drug; Drug
Intervention description(s): Cetirizine oral suspension; Similar-appearing liquid to cetirizine oral suspension
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nicotinamide (NAM) and Pyridoxine (Vitamin B6) on Muscle Regeneration ("Satellite-01 Study").
Condition: Muscle Injury
Study type: Interventional

Summary: 
      Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and
      commitment of satellite cells after a muscle injury
    

Detailed description: 
      NAM/B6 oral administration after a muscle injury ("Satellite-01 study"): Effect on satellite
      cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying
      and committed satellite cells, respectively) on sections of muscle biopsies from the
      stimulated leg (leg 2) by muscle biopsies, comparing the study intervention (NAM/B6) to the
      control intervention (placebo)
    

Intervention name(s): NAM/B6
Intervention type(s): Dietary Supplement
Intervention description(s): Single daily dose administration will take place from Day 0 (V1) to Day 8 (V4) around 8 am after an overnight fast from the subsequent evening at 9 pm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair
Condition: ACL Rupture; Replacement
MeSH terms: Rupture
Study type: Observational

Summary: 
      About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the
      repairing and replacement of injuries of the anterior cruciate ligament. After less than 10
      years it appeared that a relatively important number of patients showed complications on the
      basis of synovitis. The situation of another group of patients on the other hand evolved
      favourably without complications. The study to focuses on this group of patients and attempts
      to determine how the replacement without problems ab initio, evolved in the time.

      It concerns a group of 57 patients who received an implantation in the UZ Ghent between
      November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who
      received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by
      means of standardized questionnaires and a clinical examination. The radiological result will
      be determined by the degree of integrity of the ligament that was implanted at the time. In
      this way the study could give an idea about the degree in which the technical success of the
      intervention correlates with the clinical success 20 years later.
    


Intervention name(s): Questionnaires; RX
Intervention type(s): Other; Other
Intervention description(s): KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),; X-rays and clinical investigation of the knee 20 years after surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
      
Keywords: ACL
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
Condition: Diarrhea
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      It is generally recommended that oral rehydration should be used as first-line therapy to
      treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink
      regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended
      treatment.

      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a
      new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN
      in children with acute gastroenteritis (AGE).
    

Detailed description: 
      It is generally recommended that oral rehydration should be used as first-line therapy to
      treat or prevent dehydration in children with acute gastroenteritis (AGE). Despite the proven
      efficacy of oral rehydration therapy it remains underused. The main reason for this is that
      an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the
      duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS
      decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to
      drink regular ORS interfere with compliance with the recommended treatment. Parents, but also
      health care professionals, demand safe, effective, inexpensive, but also well tolerated and
      accepted ORS for management of AGE.

      Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now
      frequently employed for the management of AGE. The proposed study will be the first
      double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to
      be derived by children and caregivers from its use. If positive, this new ORS may become a
      routine recommendation for children with AGE.

      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a
      new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.
    

Intervention name(s): oral rehydration solution Hipp ORS Apple 200; ESPGHAN ORS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase); Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhea
Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A
Condition: Fanconi Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a
      hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector
      carrying the FANCA gene for patients with Fanconi Anemia of Subtype A .

      CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or
      cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a
      lentiviral vector carrying the gene FANCA (orphan drug) . After transduction the cells will
      be inoculated in patients in order to restore their hematopoiesis with genetically corrected
      stem cells.
    

Detailed description: 
      The main objective of this open-label Phase I / II clinical trial is to evaluate the safety
      and therapeutic efficacy of a hematopoietic gene therapy procedure with an orphan drug
      consisting of a lentiviral vector carrying the FANCA gene for patients with Fanconi's Anemia
      Subtype A.

      The drug to be administered to the patients consists of the cellular product resulting from
      the transduction of autologous CD34 + cells with the therapeutic lentiviral vector
      PGK-FANCA.Wpre *.

      The dose of cells to infuse in the patients will be that obtained from the transduction
      process of between 3x10^5 and 4x10^6 CD34 + cells / kg of patient body weight.

      The cells will be infused intravenously in a single dose, after complete the transduction
      process.

      Follow-up period: 3 years after infusion of transduced cells. However, patients will be
      monitored outside the clinical trial over a 10-year period.

      Follow-up of the grafted transduced cells will be performed on peripheral blood and bone
      marrow samples.
    

Intervention name(s): IV administration of Genetically Engineered Hematopoietic Stem/Progenitors Cells (HSPCs); Genetically Engineered Hematopoietic Stem/Progenitor Cells; Laboratory Biomarker Analysis; Filgrastim; Plerixafor; Bone Marrow Aspiration
Intervention type(s): Procedure; Biological; Other; Biological; Drug; Procedure
Intervention description(s): Undergo infusion of genetically modified hematopoietic progenitor cell therapy; Correlative studies; Given subcutaneously (SC); Given SC
Other intervention name(s): Genetically Engineered HSPCs; Filgrastim XM02, Filgrastim-sndz, G-CSF (Colony Stimulating Factor), Neupogen, r-metHug-CSF, Recombinant Methionyl Human Granulocyte CSF, rG-CSF, Tbo-filgrastim, Zarxio; AMD 3100, JM-3100, Mozobil, SDZ SID 791
Intervention MeSH terms: Plerixafor; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to use imaging technologies to demonstrate the effects of
      teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women
      with osteoporosis.
    

Detailed description: 
      As teriparatide is approved for up to 24 months of treatment in the US, patients will be
      given the option to continue in a 6-month extension phase upon completion of 18 months of
      teriparatide treatment. This extension will allow for collection of additional bone quality
      data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in
      Canada may be given the opportunity to participate in the 6-month extension phase, contingent
      upon Health Canada approval of the use of teriparatide treatment for 24 months.
    

Intervention name(s): teriparatide
Intervention type(s): Drug
Intervention description(s): 20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Other intervention name(s): LY333334; FORTEO; FORSTEO
Intervention MeSH terms: Teriparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis
Halliwick Hydrotherapy and Snoezelen
Condition: Autism Spectrum Disorder; Autism; Sensory Disorder
MeSH terms: Sensation Disorders; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effectiveness of the Halliwick concept in the
      adapted Snoezelen multi-sensory environment, in the gross mobility of children belonging to
      the autism spectrum.
    

Detailed description: 
      The study involved 54 children, aged 4 to 8, all of whom belonged to the autism spectrum
      (ASD) and all had cognitive limitations. The duration of the intervention was 3 months by
      specialized pediatric physiotherapists and hydrotherapists certified by the program
      "PEDIATRIC SPECIALIZATION" and NDT- BOBATH. All children were assessed through the WOTA 1 and
      PEDI assessment tests.
    

Intervention name(s): Hydrotherapy- Snoezelen; Snoezelen
Intervention type(s): Other; Other
Intervention description(s): Multi sensory approach in water; Multu Sensory approach on land
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design of the present study included two groups of children with autism. A first group of 26 children formed the core group with the Halliwick philosophy - hydrotherapy in water in a multi-sensory Snoezelen environment. A second group of 27 children was the Snoezelen on-site control-intervention group with two sessions per week, which was the measure of comparison and support of "reasonable" hypotheses, in order to evaluate the hypothesis that Halliwick hydrotherapy in a multi-sensory environment in combination with intervention on land leads to better therapeutic results.
The application of the tests was done by the 2 examiners, who were pediatric physiotherapists - hydrotherapists with many years of experience (more than 10 years) in approaching motor problems of children with stroke. The tests were videotaped and then graded by the two examiners separately, which was considered important in order to ensure the objective grading of the assessment tests.
Masking: Single (Participant)
Primary purpose: Treatment
High-Dose Steroid for Knee Arthroplasty
Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Knee Osteoarthritis; Perioperative/Postoperative Complications; Surgery
MeSH terms: Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior
      to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on
      postoperative pain and postoperative inflammation.
    

Detailed description: 
      This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain
      after Knee Arthroplasty in a Fast-Track setting.

      The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid
      given as an intravenous bolus after the spinal anaesthesia has been given, but before the
      surgery starts.

      The hypothesis is that by attenuating the inflammatory response to the surgery itself by the
      steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon
      ambulation 24 hours after unilateral Knee Arthroplasty.

      Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis on
      Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are
      screened and offered inclusion in the study.

      The two groups will be randomized and doubleblinded. One group will be treated, as the
      current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the
      medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

      The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg
      bodyweight).

      The patients will be monitored the first 7 days after surgery, during the admission to the
      hospital, and by a Pain-diary in the patients own home.

      Blood tests will be taken preoperatively and postoperatively to determine the effect of the
      highdose steroid on the inflammatory response. Also a series of blood tests determining the
      glucose-metabolism after the steroid-admission.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): An intravenous bolus dose of dexamethasone given prior to surgery.
Other intervention name(s): Dexa-ratiopharm
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized doubleblinded controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Arthroplasty; Knee Replacement; Perioperative Medicine
Evaluation of Barriers to Postpartum Care in HIV Infected Women
Condition: HIV Infection; Pregnancy
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to evaluate why the majority of HIV infected women in the Harris
      County Health District system who are pregnant do not come to clinic for their HIV disease
      after they have a baby through questionaires administered prepartum and questionaires and
      structured interviews postpartum. The study will ask subjects questions about HIV, drug use,
      depression and social problems.
    

Detailed description: 
      This study is evaluating information pre and postpartum to assess what are barriers to
      patients coming into care for HIV after they have a baby. We will try to evaluate recurrent
      themes in questionaires and interviews to try and identify the barriers to care.
    

Intervention name(s): questionaires and structured interviews
Intervention type(s): Other
Intervention description(s): We will do questionaires on pregnant women before they have their baby and after they have their baby. We will do structured interviews after they have their baby
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV infected pregnant women
Feasibility Study of CVC Diagnosis Via Ultrasound in Children
Condition: Ultrasound for Diagnosis of CVC Position in Children
MeSH terms: Disease
Study type: Interventional

Summary: 
      After the placement of a central venous catheter in children, a routine chest X-ray will be
      performed in order to examine the correct position of the catheter. In this feasibility study
      the investigators intend to evaluate whether the ultrasound is as sufficient as the chest
      X-ray to verify the correct position of the central venous catheter in children with the
      purpose to prevent radiation on children in the future.
    

Detailed description: 
      For punctures of a central vein in very small children, ultrasound is an useful tool which
      allows for exact examination of the relevant anatomy in order to visualize the target vessel,
      so as to facilitate the puncture in real-time. However, to ascertain the correct position of
      the central venous catheter (CVC), a chest X-ray is still the gold standard. The main
      disadvantage of the X-ray is the children's exposure to radiation. That's why the
      investigators intend to perform this study whether the ultrasound is as sufficient as the
      chest X-ray to verify the correct position of a central venous catheter in children.
    

Intervention name(s): Ultrasound for diagnosis of CVC position in children
Intervention type(s): Procedure
Intervention description(s): Using the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: children, ultrasound, central catheter
Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
Condition: Post-Stroke Upper Limb Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional

Summary: 
      Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and
      improve upper limb function for post-stroke patients. However, there were no studies to
      compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
    

Detailed description: 
      Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and
      improve upper limb function for post-stroke patients. However, the treatments of BoNT-A
      injection are associated with high cost and invasive treatment. Recent studies have showed
      that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment
      method for the spasticity. However, there were no studies to compare the effect of rESWT and
      BoNT-A injection for treatment on spasticity.
    

Intervention name(s): Shock Wave; Botulinum toxin A
Intervention type(s): Device; Drug
Intervention description(s): 42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.; 42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group A : shock wave, group B: Botulinum Toxin Injection
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extracorporeal Shock Wave; Spasticity in stokes; Botulinum toxin