bioihbjkbjnl/mcl2 huggingface dataset:
Joint Injections for Osteoarthritic Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on
      injection of a sugar solution in and around the knee, can decrease pain and disability from
      knee osteoarthritis (OA).
    

Detailed description: 
      OA is a common, debilitating condition for which there is no cure and no known cause.
      Prolotherapy (PrT) is an injection-based therapy for chronic musculoskeletal pain in which an
      irritant solution is injected at painful ligaments and tendons to produce stronger connective
      tissue and decrease pain. Although limited studies suggest PrT is effective may be effective
      for low back pain, its use has not been rigorously studied in human clinical trials for
      osteoarthritis.

      Participants in this study will be randomly assigned to receive one of three treatments:
      standard PrT, injections with a saline placebo, or a pamphlet with recommendations for home
      knee physical therapy. Injections will be given at Weeks 1, 5, and 9; injection group
      subjects will have the option to receive an additional 2 sets of injections. All participants
      will be assessed for a total of 1 year. A set of disease-specific and general quality-of-life
      questionnaires will be used to assess participants' outcomes . A randomized subset of
      participants (N=38)will receive magnetic resonance imaging (MRI)of the knee at baseline and
      52 weeks. At study completion, participants who did not receive PrT will have the option to
      receive up to five sessions of PrT at no cost. Data will be collected for this group (minus
      MRI) and will be analyzed separately. Enrollment is limited to residents of Southern
      Wisconsin.
    

Intervention name(s): Dextrose Prolotherapy; Saline Prolotherapy; At-home physical therapy exercise group
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Injection procedure: 50% dextrose is diluted with .9% 'normal' saline and 1% lidocaine to achieve 15% dextrose for ligament injections and 25% dextrose for intra-articular injection.; 7 mL 9% 'normal' saline and 3mL 1% lidocaine; Subjects in the at-home physical therapy exercise group will receive a patient information pamphlet about knee osteoarthritis and conservative care instructions for standard at-home physical therapy exercises
Other intervention name(s): Dextrose; Saline; Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Injection Therapy
Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults
      and adolescent subjects with mild to moderate atopic dermatitis.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of the
      0.2% BID and 0.5% concentrations of RVT-501 in patients with atopic dermatitis.
    

Intervention name(s): RVT-501 0.2% ointment; RVT-501 0.5% ointment; Vehicle ointment
Intervention type(s): Drug; Drug; Other
Intervention description(s): Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cell Phone Reminders Intervention
Condition: HAART Non-Adherence; HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study will use a longitudinal, experimental design. Participants will be randomized to
      either the intervention or the control group.

      The intervention will involve cell phone support, including reminders, assessment of barriers
      to adherence, problem solving and referrals conducted by an Adherence Facilitator.

      Control group participants will participate in all on-study evaluations, except the
      intervention exit interviews.
    

Detailed description: 
      Forty participants, non-adherent to HAART at study start, will be randomly assigned to either
      a 1) "Cell Phone Adherence Facilitator" group (intervention group) or a 2) control group. In
      the intervention group, a Cell Phone Adherence Facilitator will initiate a short (typically
      five minutes or less) contact Monday through Friday (excluding major holidays) with each
      participant to enhance their adherence to HAART. Occasionally, calls may be longer if crises
      arise that can be addressed by the Adherence Facilitator. Calls from the Adherence
      Facilitator will occur once or twice a day (depending on dosing schedule) and go on for 24
      weeks in the intervention group. Calls will occur at a time soon after the prescribed dose is
      supposed to be taken, but also one convenient to the participant and the Adherence
      Facilitator.

      All participants regardless of condition will be followed for 48 weeks. This intervention
      will be examined as a tool to address participant-specific, healthcare systems and
      participant-provider relationship barriers to ARV adherence.
    

Intervention name(s): Cell Phone Intervention
Intervention type(s): Behavioral
Intervention description(s): Cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator.
Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Cell phone; HAART
Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This study does not target any disease or condition in itself, but is evaluating the safety,
      tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy
      volunteers.

      A longer-term objective is to apply the findings from this study to design and later conduct
      a clinical development programme of GT-002 as a medication to treat schizophrenia.
    


Intervention name(s): GT-002; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending dose; Comparator single ascending dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single ascending dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics
Long-Term Follow-Up Study of Psoriasis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long-term safety and profile of psoriasis
      patients who have completed participation in a previous study and who received treatment with
      MEDI-507.
    

Detailed description: 
      This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis
      patients who have completed participation in a previous study and who received treatment with
      MEDI-507. Patients must have had an ALC > 30% lower than baseline (defined as baseline prior
      to any MEDI-507 exposure); or an absolute CD4 count of < 250 cells/uL. This study will also
      evaluate the development and durability of anti-MEDI-507 antibodies.
    

Intervention name(s): Follow up from previous treatment with MEDI-507
Intervention type(s): Other
Intervention description(s): There will be no investigational drugs administered under this protocol.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient has previously completed participation
      
Keywords: Previously enrolled on a MEDI-507 for psoriasis
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate and to compare the efficacy and safety of a triple
      modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard
      tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It
      shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary
      endpoint.
    

Detailed description: 
      A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III
      study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen
      with a triple standard tacrolimus FK506 / MMF / steroid regimen.
    

Intervention name(s): tacrolimus
Intervention type(s): Drug
Intervention description(s): Immunosuppression
Other intervention name(s): FK506E, MR4
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Tacrolimus; Kidney transplantation; Transplantation, kidney; Renal Transplantation; Transplantation, renal
Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction
Condition: Sacroiliac Joint Somatic Dysfunction; Pain; Disability Physical; Treatment
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and
      cartilage) that cause impairments and movement restrictions. It is one of the primary sources
      of low back pain among female population and often misdiagnosed. Almost 15-30% patients are
      suffering from sacroiliac joint dysfunction who presented with the complaint of low back
      pain. The aim of the study is to determine the effect of mulligan's mobilization with and
      without clamshell exercise on pain, disability and quality of life in patients with
      sacroiliac joint dysfunction.
    

Detailed description: 
      A Randomized controlled trial will be conducted at Fatima Memorial Hospital Physiotherapy
      Clinic & Boston Physiotherapy and wellness Clinic through consecutive sampling technique on
      32 patients which will be allocated through simple random sampling through sealed opaque
      enveloped into group A & group B. Group A will be treated with only mulligan's mobilization
      with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the
      clamshell exercise. Group B will be treated with mulligan's mobilization with movement and
      clamshell exercises. Outcome measures will be conducted through pain, disability and quality
      of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21.
      After assessing normality of data by Shapiro Wilk test, it will be decided either parametric
      or non-parametric test will be used within a group or between two groups.
    

Intervention name(s): Mulligan mobilization; clamshell exercise
Intervention type(s): Other; Other
Intervention description(s): Mulligan Mobilization designed to reduce pain and improve the patient's range of motion. Mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise.; As a general exercise, the clamshell can help strengthen your medial glutes, bringing more power and stability to your hips. This group treated with mulligan's mobilization with movement and clamshell exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Validation of the Stardust Cardio-Respiratory Recorder
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to
      Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and
      accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our
      study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure
      apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with
      clinical suspicion of OSA were selected. Three-order randomized evaluations had been
      performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used
      at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG
      lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and
      analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI
      from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded
      technicians.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulatory patients with complains of OSA
Post Marketing Surveillance for Contac Bien Z in Japan
Condition: Allergic Rhinitis; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      This is a post-marketing surveillance study on a marketed cetrizine hydrochloride
      formulation.
    


Intervention name(s): Cetrizine hydrochloride
Intervention type(s): Other
Intervention description(s): As provided on the patient information leaflet
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy
        stores in Japan.
Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit
Condition: Intra-Uterine Death
MeSH terms: Stillbirth; Fetal Death
Study type: Observational

Summary: 
      All stillbirths in Stockholm during 2017 were analysed according to the primary outcomes
      which were preventable/non-preventable deaths and the level of delay. The secondary outcomes
      were: causes of death, standard of care pre and post stillbirth and if a summary of the
      possible causes of death was made as well as the planning of supervision of the next
      pregnancy.
    

Detailed description: 
      This is a retrospective cohort study. A multidisciplinary team consisting of three
      obstetricians, one midwife and one neonatologist was assembled. The team represented the
      largest hospitals in the region-Karolinska University Hospital and Stockholm Soderl Hospital.
      Each team member in the audit group had access to all the medical patient charts from the
      hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each
      team member independently assessed each case regarding causes of death,
      preventable/non-preventable deaths, the level of delay if there was any and the standard of
      healthcare provided to the patients with stillbirth, the postmortem examination of infant and
      mother and if there were any recommendations given for the next pregnancy. Multiple meetings
      were organized for discussing the results of the individual assessment of each case. To
      enable an ethical discussion every member of the audit group signed a confidentiality form
      and all cases were assessed by comparison with local guidelines in praxis.
    

Intervention name(s): Analysis of IUFD
Intervention type(s): Other
Intervention description(s): Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All stillbirths in Stockholm 2017
      
Keywords: IUFD
Mobile Application For Educating Diabetics About Foot Care
Condition: Diabetic Foot, Mobile Application, Patient Education
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      Purpose: Our aim was to develop a training program on the mobile application and to assess
      the effect of this training on the participants' knowledge about foot care, their
      self-efficacy and their behavior levels.
    

Detailed description: 
      The universe of this randomized controlled study consisted of 130 patients who had presented
      to a training and research hospital in Istanbul. The data were collected during the period
      March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic
      Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the
      Mobile Application Training.
    

Intervention name(s): Diabetic foot education
Intervention type(s): Other
Intervention description(s): Give Diabetic foot education via mobile phone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Diabetic foot, mobile application, patient education
CRI in POTS in Adolescents
Condition: Postural Orthostatic Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia
Study type: Observational

Summary: 
      The investigators aim to study whether the Compensatory Reserve Index (CRI) (an FDA approved
      device that assesses intravascular volume) can be used to evaluate severity of Postural
      Orthostatic Tachycardia Syndrome (POTS) and whether the CRI value has a correlation with
      severity of psychosocial symptoms and functional impairment associated with POTS.
    

Detailed description: 
      Autonomic dysfunction (or dysautonomia) describes several medical conditions linked to the
      autonomic nervous system. One of these is Postural Orthostatic Tachycardia Syndrome (POTS).
      In pediatric populations, symptoms of autonomic dysfunction include an increase in heart rate
      when standing up (tachycardia), dizziness, nausea, vomiting, fatigue, headaches, abdominal
      discomfort, and sleep disturbances. POTS is specifically characterized by orthostatic
      intolerance and a forty beats per minute (bpm) increase in heart rate upon standing. The
      etiology of POTS is poorly understood, and there is limited literature on the management of
      POTS in pediatric populations. In the U.S., POTS is estimated to affect 1-3 million people.

      The ability of the CRI algorithm to accurately distinguish individuals with varying
      tolerances to reduced central blood volume can be attributed to a unique function of the
      algorithm, which analyzes and compares the entirety of each waveform in a window of time to
      trend subtle features that correspond with varying degrees of central volume loss. CRI can
      also detect vascular changes associated with postural orthostatic tachycardia syndrome. CRI
      will be evaluated in subjects at supine and standing positions along with traditional
      orthostatic measures.

      Following CRI measurements, subjects and their parents will be asked to complete a series of
      surveys to assess their psychosocial symptoms and functional impairment. The CRI measurement
      and survey completion will occur over the course of one clinic visit.
    

Intervention name(s): CRI device (non-invasive vitals sign measurement)
Intervention type(s): Device
Intervention description(s): Survey administration, Orthostatic vital measurements
Other intervention name(s): Survey administration, Orthostatic vital measurements
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include adolescents with POTS 12-21 years old and adolescents
        without POTS 12-21 years old. One parent will be required to attend the study visit.
      
Keywords: POTS; Postural Orthostatic Tachycardia Syndrome; Dysautonomia; CRI; Compensatory Reserve Index
Manipulating the Microbiome in IBD by Antibiotics and FMT
Condition: Exacerbation of Ulcerative Colitis; Ulcerative Colitis, Active Severe; Crohn's Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut
      microbiome. The results of previous studies on the effectiveness of antibiotics and fecal
      macrobiota transplantation (FMT) are contradicting.

      Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe
      colitis in an addition to standard corticosteroid therapy (UC and isolated "UC-like" Crohn's
      colitis). The secondary aim is to assess the outcome of FMT in those not responding to five
      days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant
      disease to at least two immunosuppressive medications, may be treated with either
      interventions.
    


Intervention name(s): AB (antibiotics); CS (corticosteroids) Only
Intervention type(s): Drug; Drug
Intervention description(s): PO Vancomycin 250mgX4/d for 3 weeks
PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks
PO Doxycycline 2mg/kg X2/d (up to 100mgX2/d) - for 3 weeks; OR- For children younger than 8 years: PO Ciprofloxacin 10mg/Kg X2/2 (up to 250mgX2/d) for 3 weeks
Patients with known allergy to one of the drugs may be treated with oral Gentamycin (2.5mg/KgX3/d) for 3 weeks instead of the allergenic drug.; methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses)
PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks
Other intervention name(s): Ciprofloxacin-Ciprodex®; Doxycycline-Doxylin®; Gentamycin-Gentamicin®; Amoxicillin-Amoxyclav®; Vancomycin-Vanco-Teva®; Metronidazole-Flagyl®
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Metronidazole; Vancomycin; Doxycycline; Ciprofloxacin; Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: IBD: Inflammatory Bowel Diseases; CD: Crohn's Disease; UC: Ulcerative Colitis; ASC: Acute Severe Colitis; FMT: Fecal Microbiota Transplantation; PUCAI: Pediatric Ulcerative Colitis Activity Index; Ciprofloxacin, Doxycycline, Gentamycin, amoxicillin, vancomycin, metronidazole,ciprofloxacin