bioihbjkbjnl/mcl2 huggingface dataset:
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Primary hypotheses:

      Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical
      manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal
      to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness
      will remain unchanged following the treatment procedure for both groups.

      Secondary (null) hypotheses:

        1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will
           remain unchanged in both groups;

        2. there will be no differences between groups with respect to 2a) neck joint cavitations
           and 2b) forces across the cervical spine measured during the manoeuvres.
    

Detailed description: 
      1. Develop a randomized controlled clinical trial design to optimize the testing of the
           effects of a sham vs real cervical manipulation.

        2. Use novel modifications of both a sham a real manipulation to create "procedures"
           designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of
           'patient post-treatment perception of treatment type' versus actual administered
           treatment (primary outcome #1).

        3. Quantitatively evaluate group differences in local soft-tissue tenderness by algometry
           (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion,
           myoelectric responses in selected neck muscles and forces imparted during the
           procedures.

        4. Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these
           procedures.
    

Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will be consenting adults, 21-55 years of age, male or female
        who have chronic mechanical neck pain (NP) rated as between 30 and 65 on an NRS-101 scale
        [74]. For the purposes of this study NP is defined as;
Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
Condition: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to provide data on the immune response and safety of administering
      vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to
      controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The
      data of this study will support the labels for ozanimod in multiple sclerosis (MS) because
      the effect of ozanimod on the vaccination response of MS participants is of interest to
      participants and prescribers.
    


Intervention name(s): Tetanus, diphtheria, and acellular pertussis vaccine; Pneumococcal polysaccharide vaccine; Seasonal influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Tdap; PPSV23; Seasonal influenza vaccine
Other intervention name(s): Tdap; PPSV23
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Ozanimod; Relapsing-remitting multiple sclerosis
Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
Condition: Impulse Control Disorders
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 or
      placebo when dosed for 5 days in adults with tobacco use disorder who voluntarily abstain
      from the use of cigarettes.
    

Detailed description: 
      This study is a Phase 2A, randomized, double-blinded, placebo-controlled, two-period
      crossover study to evaluate the effect of two doses of SXC-2023 on measures of impulsivity
      and inhibitory control, urge for cigarettes, and mood in non-treatment seeking smokers who
      are abstaining from smoking. The study consists of a screening period of up to 30 days, a 5
      day randomized double-blind treatment period, a 9 day washout period, followed by a second 5
      day randomized double-blind treatment period, with a safety follow-up period 7 days after the
      last dose of study medication.
    

Intervention name(s): SXC-2023; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): SXC-2023 oral capsules; Matching Placebo oral capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SXC-2023; Cognitive Control; Impulsivity; Delay Aversion; Top Down Processing; Behavioral Addiction
An Interprofessional Intervention to Reduce Smoking Rates
Condition: Smoking, Cigarette
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of an experimental process to aid
      Spanish-speaking patients in quitting smoking with the help of pharmacists and behavioral
      health psychologist trainees and clinicians.
    


Intervention name(s): Pharmacy and Behavioral Health Team; Motivational Interviewing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.; Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine
      compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the
      non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months.
      The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control
      vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
    

Detailed description: 
      This study is a randomized, double-blind, single-center, controlled phase III clinical trial
      in children aged 36-71 months, and bridging trial between agegroup of 6-35 and 36-71 months.
      The purpose of this study is to evaluate the immunogenicity and safety of the experimental
      EV71 vaccine in children aged 36-71 months. The primary objective of this study is to
      evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71
      vaccine in children aged 36-71 months, and the non-inferiority of EV71 vaccine used in
      children aged 36-71 months compared to 6-35 months. The secondary objective is to evaluate
      the safety of the experimental vaccine used in children aged 36-71 months. The experimental
      vaccine is manufactured by Sinovac Biotech Co., Ltd, and the control vaccine is manufactured
      by Institute of Medical Biology Chinese Academy of Medical Sciences. 600 children aged 36-71
      months will be randomly assigned in to receive the experimental vaccine or control vaccine,
      and 300 children aged 6-35 months will receive the experimental vaccine.
    

Intervention name(s): 36-71 months old children-experimental EV71 vaccine.; 36-71 months old children-control EV71 vaccine.; 6-35 months old children-experimental EV71 vaccine.
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.; Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.; Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
Condition: Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic
      patients with secondary failure to oral hypoglycemic agents, a randomized double blind,
      single centre, study of 3 months duration was carried out.
    


Intervention name(s): Mersina
Intervention type(s): Drug
Intervention description(s): capsule, 3g/day, 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ayurvedic formulation; type 2 diabetes mellitus; secondary failure to oral hypoglycemic agents; antidiabetic
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive
      loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA)
      deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that
      crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the
      major DA metabolising enzyme in man.

      Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and
      safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a
      stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.

      The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary
      recording period.
    


Intervention name(s): Safinimide 50-100 mg/day; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of the consumption of two microalgae
      Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic
      syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein
      A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.
    

Detailed description: 
      A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to
      evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and
      Arthrospira platensis (Spirulina).

      The investigators included 30 participants between 18 and 65 years (BMI ≥25 and <40 kg / m2).
      All volunteers will be randomized into 3 study groups, and participants will receive the 3
      different study products during 30 days.
    

Intervention name(s): Experimental: Group 1: Spirulina platensis; Experimental: Group 2: Chlorella vulgaris; Placebo Comparator: Group 3: Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 16 g/day (two doses of 8g); 16 g/day (two doses of 8g); 16 g/day (two doses of 8g)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: microalgae; lipid profile; metabolic syndrome; pilot
Neurostimulation for the Relief of Acute Bronchoconstriction
Condition: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to validate design for the Resolve™ Stimulator and Proximity
      Electrode and the associated procedure to quickly and safely place an electrode into the
      neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or
      other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm
      that the electrical signal being delivered via this electrode rapidly counters
      bronchoconstriction and improves airway flow.
    

Detailed description: 
      The present study is to evaluate the safety of a new neurostimulator device, the Resolve
      Stimulator and Proximity Lead™, which comprises an external electrical signal generator
      coupled to temporary electrode that is percutaneously inserted in the neck.

      Sponsor believes, based on animal testing data provided as well as consultations with
      physicians who regularly treat patients suffering from attacks of acute bronchoconstriction
      in ER and inpatient hospital settings, that this device could be used in the skilled care
      hospital setting to help rapidly relax the smooth muscle in the airway, relieving a
      clinically significant portion of the bronchoconstriction suffered by patients experiencing
      moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to
      restore the patient to his or her baseline respiration status.
    

Intervention name(s): Resolve Stimulator and Proximity Lead
Intervention type(s): Device
Intervention description(s): An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bronchoconstriction; neuromodulation; neurostimulation; vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; non invasive; gammacore
A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of gastric pH changes induced by
      famotidine on the drug levels of BMS-986256.
    


Intervention name(s): BMS-986256; Famotidine
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Pepcid
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; BMS-986256; Famotidine; Gastric pH
HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is
      assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is
      assigned to receive MST therapy without GVHD prophylaxis.
    

Detailed description: 
      The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first
      complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST)
      can improve survival in AML-CR1 patients. However, a comparison study between the MST and
      nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1
      patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled
      in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with
      GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy
      without GVHD prophylaxis.
    

Intervention name(s): HLA mismatched stem cell; HLA matched stem cell; cyclosporine A; Mycophenolate mofetil; Ara-C; fludarabine; anti-lymphocyte globulin; cyclophosphamide
Intervention type(s): Genetic; Genetic; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy; HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen; The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil; The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil; 2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose; 30 mg/m2/d for 5days; 1.5-2 mg/kg/d for 4 days; 40 mg/kg/d for 2 days
Other intervention name(s): microtransplantation; nonmyeloablative transplantation; GVHD prophylaxis; GVHD prophylaxis; conditioning reginmen; NST conditioning reginmen; NST conditioning reginmen; NST conditioning reginmen
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Cyclophosphamide; Fludarabine; Cyclosporins; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myeloid Leukemia; microtransplantationHLA-mismatched microtransplantation; nonmyeloablative stem cell transplantation; graft-versus-host disease
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect and side-effects of injections with
      botulinum toxin in neck muscles in cervicogenic headache compared to injections with sodium
      water.
    

Detailed description: 
      Cervicogenic headache is a unilateral headache stemming from the neck. Usually, there are no
      pathological findings on x-ray or MRI of the neck. It is supposed that pain may stem from
      various structures in the upper part of the cervical spine. Regardless of the source, it is
      often believed that the neck muscles may be involved in the pain generation, either primarily
      or secondarily.

      Treatment of cervicogenic headache is often difficult. The effect of drugs is usually
      limited. Various surgical techniques such as radiofrequency generation of the facet joints in
      the neck have been tried, but with little success (4).

      Botulinum toxin injection in muscles have for several years been used in conditions with
      pathologically increased muscle activity, such as spasticity and dystonias. Gradually, it has
      also been used in many pain conditions, among them headaches. One case history (5) and a
      randomized placebo controlled, double-blind study (6), have shown effect in cervicogenic
      headache. The latter study had some methodological weaknesses, since it was small, only 26
      patients, and the placebo group had prior to treatment only half as much pain as the group
      receiving botulinum toxin treatment. In addition, pain was not registered daily, but only
      before (prior) treatment and after 3 or 4 weeks. A review considers the documentation on
      treatment with botulinum toxin in idiopathic and cervicogenic headaches to be inconclusive
      (7).

      In our Department, we have tried this treatment on a few patients with typical cervicogenic
      headache with excellent effect and without side-effects. Therefore, it would be of
      considerable interest to perform a larger study with good scientific quality and a higher
      statistical power than the above-mentioned one.

      As the basis for our study we would adopt a conservative hypothesis (H0): Botox injections in
      cervical muscles is not superior to placebo in alleviating pain in unilateral cervicogenic
      headache.
    

Intervention name(s): Botulinum toxin; Placebos
Intervention type(s): Drug; Drug
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Injection; Headache; Cervical muscles
A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as
      evaluate pharmacokinetics
    

Detailed description: 
      This trial will be conducted in order to provide an evaluation of the potential of
      ferumoxytol to cause cardiac arrhythmia in accordance with the International Conference on
      Harmonization (ICH) E14 guidance. The purpose of this trial is to define the effects of
      ferumoxytol on electrocardiogram (ECG) data. Pharmacokinetics will also be evaluated at
      multiple time points as specified. Subject safety will be monitored throughout the study.
    

Intervention name(s): ferumoxytol; moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Ferrosoferric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: anemia; intravenous iron; pharmacokinetics; QTc