bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
Condition: Tourette Syndrome; Cannabis
MeSH terms: Tourette Syndrome; Syndrome; Marijuana Abuse
Study type: Observational

Summary: 
      Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la
      Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics
      and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability
      in GTS. Herein, By using an open-label, prospective design, our aim is to determine the
      preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult
      patients with GTS.
    

Detailed description: 
      Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder
      characterized by the presence of multiple motor and one or more phonic tics continuing for at
      least one year. In Israel, although consumption of cannabis is outlawed, there is an option
      to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by
      inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant,
      has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013.
      Previous studies suggested that MC has a good effect on tics, quality of like and with good
      tolerability among patients with resistant GTS.

      In the current study, we prospectively followed-up patients eligible for MC according to MOH
      restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each
      subject signed a written informed consent before inclusion in the trial. Also, since driving
      under the influence of cannabis is forbidden by the Israeli law, patients were instructed and
      gave their oral commitment to avoid driving. The study was approved by the research ethics
      (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked
      dried buds. The treating neurologist (S.A.) and patient together decided on the method of
      consumption during the visit before initiating treatment. Patients were assessed 4 and
      12-weeks following treatment initiation to gather data regarding treatment efficacy,
      tolerability and SEs.
    

Intervention name(s): Medical Cannabis
Intervention type(s): Drug
Intervention description(s): Patients with GTS were assessed before, 4 and 12 weeks after Medical cannabis initiation for consumption habits, efficacy and side effect profile
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with resistant Tourette syndrome
      
Keywords: Cannabidiol; Cannabis; Medical Cannabis; delta(9)-Tetrahydrocannabinol; Tourette Syndrome
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,
      in addition to metformin, results in better glycemic control, as measured by HbA1c, over a
      treatment period of 52 weeks, compared to the addition of glimepiride to metformin in
      subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin
      Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in
      co-administration with dapagliflozin, added to current background therapy with metformin
      compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week
      52.
    


Intervention name(s): Saxagliptin; Dapagliflozin; Glimepiride; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to
      palivizumab when administered to preterm infants entering their first RSV season and children
      with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and
      second RSV season.
    

Detailed description: 
      This study is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to
      evaluate the safety, pharmacokinetics (PK), anti-drug antibody (ADA) response, and
      descriptive efficacy for MEDI8897 in high-risk infants eligible to receive palivizumab when
      entering their first or second RSV season (Season 1 or Season 2, respectively). Approximately
      900 palivizumab-eligible infants entering their first RSV season will be enrolled into one of
      2 cohorts: (1) preterm cohort, including approximately 600 preterm infants (≤ 35 weeks
      gestational age [GA]) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 300
      infants with CLD of prematurity or hemodynamically significant CHD. A minimum of 100 infants
      with hemodynamically significant CHD will be enrolled. Within each cohort, randomization will
      be stratified by hemisphere (northern, southern) and subject age at the time of Season 1
      randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months).
    

Intervention name(s): MEDI8897; Palivizumab
Intervention type(s): Drug; Drug
Intervention description(s): Anti-RSV monoclonal antibody with an extended half-life; Approved anti-RSV monoclonal antibody
Intervention MeSH terms: Palivizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus Infections; Preterm Infants; Lower Respiratory Infection
TechSAge Tele Tai Chi for People Aging With Mobility Disabilities
Condition: Aging; Disability Physical
Study type: Interventional

Summary: 
      This study uses videoconferencing to deliver an evidence-based exercise program, Seated Tai
      Chi for Arthritis, to adults aging with long-term mobility disabilities. In the 8-week Tele
      Tai Chi intervention, participants will use a tablet or computer to join a small-group,
      online class (1hr, twice weekly) from home; during each session, participants will exercise
      as a group along with the pre-recorded video lessons and have the opportunity for social
      interaction (via video chat) before and after class. The study will examine the effects of
      the Tele Tai Chi program on physical activity and social connectedness for adults aging with
      long-term mobility disabilities, a population likely to experience barriers to exercise
      participation.
    

Detailed description: 
      This study is part of the Rehabilitation Engineering Research Center on Technologies to
      Support Aging-in-Place for People with Long-Term Disabilities (RERC TechSAge). This study
      uses videoconferencing to translate an evidence-based exercise program for older adults,
      Seated Tai Chi for Arthritis, from an in-person setting to a remote class and to a different
      population, adults aging with mobility disabilities. In the 8-week Tele Tai Chi intervention,
      participants will use a tablet or computer to join a small-group, online class (1hr, twice
      weekly) from home; during each session, participants will exercise as a group along with the
      pre-recorded video lessons and have the opportunity for social interaction (via video chat)
      before and after class. The study will examine the effects of the Tele Tai Chi program on
      physical activity and social connectedness (primary outcomes), as well as exercise
      self-efficacy, falls efficacy, depression, quality of life, and pain (secondary outcomes) for
      adults aging with long-term mobility disabilities, a population likely to experience barriers
      to in-person exercise participation.
    

Intervention name(s): Tele Tai Chi Intervention for Persons Aging with Long-Term Mobility Disabilities
Intervention type(s): Behavioral
Intervention description(s): • 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class.
Other intervention name(s): Seated Tai Chi for Arthritis
Intervention model: Single Group Assignment
Intervention model description: All participants will be screened and assigned to the same condition in a phased/rolling enrollment.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mind-body exercise; tai chi; technology
Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
Condition: Methamphetamine Abuse; Methamphetamine Dependence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The research proposed in this application will determine the initial efficacy, safety and
      tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a
      pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human
      laboratory study will be conducted. The proposed study is innovative and important because it
      will provide the impetus for the conduct of double blind, placebo-controlled trials to
      further demonstrate the efficacy of combined oxazepam and naltrexone for managing
      methamphetamine dependence.
    


Intervention name(s): Methamphetamine (Desoxyn®)
Intervention type(s): Drug
Intervention description(s): The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of N1539 Following Abdominoplasty Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of N1539 in
      subjects with acute moderate to severe pain following abdominoplasty surgery.
    


Intervention name(s): N1539; Intravenous Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Intravenous meloxicam
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominoplasty; Pain; Analgesia; N1539; Phase 3
Zinc Absorption From Biofortified Rice
Condition: Healthy
Study type: Interventional

Summary: 
      One of the newest strategies to combat micronutrient deficiencies is the biofortification of
      staple foods, where higher levels of minerals are obtained through breeding of staple crops.
      The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when
      compared with a control rice fortified with zinc just before consumption.
    


Intervention name(s): Zinc biofortified rice; Rice extrinsically fortified with zinc
Intervention type(s): Other; Other
Intervention description(s): 1.12 mg zinc per meal; 1.12 mg zinc per meal
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Referrals for CLTI: Qualitative Study
Condition: Chronic Limb Threatening Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Observational

Summary: 
      The goal of this qualitative study is to explore the experiences of patients who have been
      diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to
      answer are:

        -  What are the perceptions and experiences of patients between first symptom of CLTI and
           vascular surgery assessment

        -  What is important to patients during this process.

      Participants will be interviewed and their words analysed using reflexive thematic analysis.
    

Detailed description: 
      There are delays at every stage of the patient journey from developing chronic
      limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients.
      There is currently limited national and international guidance on how and when to refer
      patients with suspected CLTI to specialist vascular surgery services. The use of qualitative
      interviews will allow us explore perceptions and experiences of patients with CLTI being
      referred to vascular surgery services, and identify possible ways to improve the process via
      interviews. This study will provide novel information on patient experience, and together
      with other work provide a framework for improvement of the referral process for CLTI.
    

Intervention name(s): Qualitative interview
Intervention type(s): Behavioral
Intervention description(s): No intervention
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with chronic limb-threatening ischaemia in the last year
A New Approach for Catheter Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This is a retrospective cohort study of radiofrequency ablation for the treatment atrial
      fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the
      investigators propose a hypothesis regarding the underlying electrophysiological mechanism of
      AF, as well as a novel approach for catheter ablation of AF.
    

Detailed description: 
      The investigators propose a new electrophysiological mechanism for AF: the superposition
      hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort
      study to determine if superposition potentials (SP) can identify the critical regions where
      AF is sustained and if ablating SPs can improves the long-term efﬁcacy.

      The study consecutively collected patients with underwent the first catheter ablation for
      symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF
      (lasting <7 days), persistent AF (lasting >7 days and <1 year without electrical
      cardioversion) and long-term persistent AF (lasting >1 year), aged between 18 and 80 years
      old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at
      each clinic visit. The eligible patients were divided into two groups: the pulmonary vein
      isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive
      clinical history and procedural data of patients were collected from electronic medical
      records.
    

Intervention name(s): PVI alone; PVI + SPs ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): pulmonary vein isolation; pulmonary vein isolation + SPs ablation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        These cases are from a university hospital
The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia
Condition: Hypotension; Spinal Anaesthesia
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The aim of this study was to examine the effect of keeping the patient in a sitting position
      for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the
      formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the
      block characteristics.
    


Intervention name(s): sitting position; supine position
Intervention type(s): Procedure; Procedure
Intervention description(s): keeping the patient in a sitting position after spinal anaesthesia; keeping the patient in supine position after spinal anaesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: spinal anaesthesia; ephedrine
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and
      beneficial in the treatment of Primary Sclerosing Cholangitis.
    

Detailed description: 
      In this protocol, we propose the assessment of potential beneficial effects of the
      antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and
      Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten
      patients: one group will receive low dose vancomycin, one group will receive high dose
      vancomycin, one group will receive low dose metronidazole and one group will receive high
      dose metronidazole. Each group will be treated for three months.
    

Intervention name(s): Vancomycin; Vancomycin; Metronidazole; Metronidazole; Vancomycin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different drug doses
Intervention MeSH terms: Metronidazole; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination
      (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with
      an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography )
      after two cycles of chemotherapy.
    

Detailed description: 
      Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin,
      vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD
      (study treatment), depending on randomization. Radiotherapy is planned after chemotherapy or
      immunochemotherapy.

      PET scans will be performed before inclusion, after 2 cycles of chemotherapy and after 4
      cycles of chemotherapy (if PET after two cycles was positive), at the end of treatment and
      during follow-up period.
    

Intervention name(s): Doxorubicin; Bleomycin; Vinblastine; Dacarbazine; Brentuximab Vedotin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 25mg/m2; 10mg/m2; 6mg/m2; 375mg/m2; 1.2 mg/kg
Intervention MeSH terms: Doxorubicin; Bleomycin; Dacarbazine; Brentuximab Vedotin; Vinblastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HL
Importance of the Current Density in TENS
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional

Summary: 
      The purpose of this study is demonstrate the importance of density current of TENS in the
      effect about H-reflex in healthy volunteers.
    

Detailed description: 
      TENS have been used to treatment against pain and reflex modulation. However, the most part
      of evidence do not show the current density. This parameter has been demonstrated like a
      important factor in the effect of the current about the outcome measures.

      This study show the difference between the same subjective sensation "strong but comfortable"
      in current density and the relation with the effect about H-reflex.
    

Intervention name(s): TENS; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands); Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: H-Reflex; Current Density; TENS
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain
Condition: Back Pain; Neck Pain
MeSH terms: Back Pain; Neck Pain
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the influence of coping strategies and
      catastrophizing thoughts on disability and the prognosis of back and neck pain in patients
      treated within the Spanish National Health Service. Patients will be given a visual analog
      scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck
      Disability Index (NDI) to rate the degree of disability, and the Coping Strategies
      Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be
      given at baseline and three months later.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated within the Spanish National Health Service for subacute or chronic neck or
        back pain
      
Keywords: back pain; neck pain; prognosis; catastrophizing; coping strategies; disability; Prognosis for back and neck pain
A Dose-finding Study of ASP4070
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to evaluate the efficacy, safety, and dose-response of
      ASP4070 vaccinated in patients with cedar pollinosis.
    

Detailed description: 
      Subjects were vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms were
      evaluated after cedar pollen exposure in a chamber at 4, 8 and 12 weeks after the last
      vaccination to identify the timing of the onset of therapeutic effect.
    

Intervention name(s): ASP4070; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal vaccination at 2-week intervals; Intradermal vaccination at 2-week intervals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cedar pollinosis; ASP4070; DNA plasmid vaccine