bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Since influenza vaccines are normally administered every year because of the frequent change
      in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted
      influenza vaccine need to be re-evaluated after repeated vaccine administration. In this
      study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007
      season's formulations of Fluarix or the adjuvanted vaccine.
    


Intervention name(s): Fluarix; adjuvanted influenza vaccine
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza,; improved vaccine,; influenza disease; elderly
Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical trial is to assess the feasibility and the security of the
      intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment
      of Amyotrophic Lateral Sclerosis patients.
    

Detailed description: 
      Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis
      due to the continued loss of motoneurons that leads them to death in less than 5 years. No
      treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear
      cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps
      of trophic factors that keep the motoneurons functional. Moreover, the clinical trial (Study
      NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the
      safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis
      in humans, found that this procedure is feasible and safe. Continuing with that study, we
      have designed a phase I/II clinical trial to check the feasibility of the intraspinal and
      intrathecal infusion of autologous bone marrow stem cells.
    

Intervention name(s): Laminectomy and bone marrow stem cells transplantation; Intrathecal infusion of autologous bone marrow stem cells; Intrathecal infusion of placebo (saline solution).
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation; Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.; Patients were infused 2 ml of saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Bone marrow; Stem cells; Autologous; Safety
ARB, ACEi, DRi Effects on COVID-19 Course Disease
Condition: Hypertension; COVID-19
MeSH terms: COVID-19; Hypertension
Study type: Observational [Patient Registry]

Summary: 
      It is supposed to monitor hypertensive patients who are infected or have clinical
      manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be
      considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.
    

Detailed description: 
      POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open
      prospective randomized two medical centres trial in subjects suffering from COVID-19 who have
      been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.

      COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to
      12 weeks and up to 24 weeks.

      Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the
      disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features.
      Subanalysis in patients with CKD is additionally performed for those who have CKD.
    

Intervention name(s): Angiotensin converting enzyme inhibitor; Angiotensin Receptor Blockers; Direct renin inhibitor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): routine drug intake; routine drug intake; routine drug intake
Other intervention name(s): no other drug as RAS inhibitor; no other drug as RAS inhibitor; no other drug as RAS inhibitor
Intervention MeSH terms: Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Renin Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at
        the onset and COVID-19 course during 3 weeks
      
Keywords: ACEi, ARB, DRI; Clinical features; CKD
Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL)
      cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in
      HIV-infected individuals, and has been associated with HIV infection itself and
      antiretroviral therapy (ART). These abnormalities are well-established markers of
      cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk
      of CVD associated with ART exposure over and above that conveyed by traditional
      cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual
      clinical strategy remains to add a statin treatment.

      Recent studies suggested ART switch can represent an interesting alternative to statins to
      reduce lipid plasma levels.

      The purpose of this study is to evaluate the frequency with which the replacement of LPV/r
      (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV
      (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate
      the necessity to administer statins.

      A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on
      antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.

      At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will
      replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore
      for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined.
      Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will
      be measured at baseline, at drug switch and at the end of the study

      Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for
      study drug will be done at week-4 and week-12, Returned study medication will be counted and
      the amount notified on the Case Report Form (CRF).
    


Intervention name(s): stop statin and switch to an antiretroviral drug with less impact on lipid metabolism
Intervention type(s): Drug
Intervention description(s): Switch from a boosted PI or efavirenz based ART regimen to etravirine 400 mg/day once daily for patients in need of lipid lowering drugs (statin) after one month wash out of statin
Intervention MeSH terms: Anti-Retroviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infection; lipid lowering drugs; etravirine; patient; statin treatment; EFV or boosted PI antiretroviral treatment
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
Condition: Malignant Neoplasm; Postmenopausal
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This research is being done to compare the physical and quality of life benefits of two
      different types of exercise- tai chi versus strength training- for female cancer survivors
      who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to
      participants in a group that performs flexibility and relaxation exercises, which is expected
      to have different benefits than either tai chi or strength training.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare the relative efficacy of tai chi and strength training to prevent falls in female
      cancer survivors.

      II. Determine the mechanism by which tai chi and strength training each reduces the risk of
      falls.

      III. Determine how well the benefits of each intervention persist after structured training
      stops.

      SECONDARY OBJECTIVE:

      I. Evaluate the effect of the intervention on physical functioning.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

      ARM I: Patients attend strength training classes for 1 hour 2 days per week.

      ARM II: Patients attend tai chi classes for 1 hour 2 days per week.

      ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per
      week.

      In all arms, treatment continues for 6 months.

      After completion of study treatment, patients are followed up for 6 months.
    

Intervention name(s): Exercise Intervention; Exercise Intervention; Exercise Intervention; Questionnaire Administration
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Undergo strength training classes; Undergo tai chi classes; Undergo stretching and relaxation classes; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      This current project investigates the effect of a single session of right dlPFC repetitive
      transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol
      dependent patients and healthy controls.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Repetitive Transcranial Magnetic Stimulation; Emotion Regulation; Craving
Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
Condition: Trigger Points
Study type: Interventional

Summary: 
      Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in
      both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into
      active trigger points, therapy seems warranted. Besides other modalities, self-massage using
      foam rollers (self-myofascial release) has been applied as a treatment. However, there is no
      data on the efficacy of this method concerning LMTRP. Thus, the present study aims to
      evaluate the effects of different forms of self-myofascial release on LMTRP pain.

      Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s
      static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic
      self-myofascial release rolling back and forth on the calf muscles for 90s using a foam
      roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in
      a familiarization session with the foam roller one week prior to treatments. As an outcome,
      pressure pain threshold is assessed with an algometer. The investigators hypothesize, that
      static compression can reduce pressure pain of LMTRP more effective than dynamic
      self-myofascial release. The investigators further expect that placebo treatment will be the
      least effective method.
    


Intervention name(s): Static compression of LMTRP; Dynamic self-myofascial release of calf; Placebo laser acupuncture of LMTRP
Intervention type(s): Other; Other; Device
Intervention description(s): Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).; Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).; Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement
Condition: Skin Photoaging
Study type: Interventional

Summary: 
      Skin moisturizing and elasticizing efficacy of an amino acid food supplement
    

Detailed description: 
      Primary end point of this study was to evaluate the moisturizing and elasticizing activity of
      "Nutrakos®" Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas
      (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product
      will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An
      additional aim of this study was to evaluate the product tolerance both by investigator and
      volunteers.
    

Intervention name(s): Nutrakos®
Intervention type(s): Dietary Supplement
Intervention description(s): "Nutrakos®" Amino Acid Food Supplement supplies a specific mixture of amino acids that has been proven to induce synthesis of collagen and elastin, the main proteins of derma structure in fibroblasts and keratocytes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Interaction Between Aspirin and Nexium
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the interaction between aspirin and Nexium in healthy
      volunteers.
    


Intervention name(s): Aspirin; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 81mg Tablet oral, once daily; 20 mg Tablet oral, once daily
Other intervention name(s): Nexium
Intervention MeSH terms: Aspirin; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nexium; aspirin; peptic ulcers; pharmacodynamic (PD); Esomoeprazole
Examination of Low Wattage and High Wattage E-Cigarettes
Condition: Smoking, Cigarette; Smoking, Tobacco; Nicotine Dependence; Exposure to Toxic Agent
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The overall aim of the proposed study is to evaluate the effect of switching from
      conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and
      continued use, as well as biomarkers of toxicant exposure and effects.
    


Intervention name(s): Low wattage E cigarette device; High wattage E cigarette device; Usual brand cigarette
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.; The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.; The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus.
Condition: Neck Pain; Shoulder Pain; Myofascial Pain
MeSH terms: Shoulder Pain; Neck Pain
Study type: Interventional

Summary: 
      Participants will be 18-59 years old who are recruited through a convenience sample from the
      UMHB/Belton community. There will be a randomized control trial consisting of three groups.
      Each participant will be assigned based on their order of entry to the study group assignment
      and then randomly organized via computer generation into 3 groups of 20 participants
      including a control group, a dry needling group (DN), and a dry needling E-stim group
      (DN-ES), resulting in approximately 60 total participants. Participants in the DN and DN-ES
      groups will be treated four times; at weeks 0, 2, 4 and 6 of the study. Data will be
      collected at weeks 4, 6 and 12 in all groups.
    

Detailed description: 
      Interventions per group:

      Control: none

      DN: 20-30 seconds of DN per trigger point in each involved trapezius muscle, needles rest in
      situ 10 min, needles removed.

      DN-ES: 20-30 seconds of DN per trigger point (TrP) in each involved trapezius muscle, DC ES
      attached to needles crossing the most reactive TrP and current set to strong, but comfortable
      intensity at 10 MHz for 10 min, needles removed.
    

Intervention name(s): Dry Needling (DN); Dry needling with Intramuscular electrical stimulation (DNES)
Intervention type(s): Procedure; Procedure
Intervention description(s): One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). After several twitches occur, the researcher will leave the needles as they are, and the subject will lie on a treatment table without moving arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.; One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject lies on a treatment table without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental There will be three groups in this study; control, DN alone and DN/IES. Each group will have approximately 20 subjects, resulting in approximately 60 subjects total. Subjects will be randomized into one of the three groups via block randomization method based on order of entry into the study.
Masking: None (Open Label)
Primary purpose: Treatment
Service Development: Assessing Non-attendance Rates in Outpatient Clinics
Condition: Asthma; Sleep Apnea Syndromes; Tuberculosis; COPD
MeSH terms: Tuberculosis; Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Many studies have shown a high non-attendance rate in hospital outpatient clinics. The
      investigators have found a non-attendance rate of 25% in their asthma clinics and would like
      to investigate whether a reminder phone call will improve attendance rates. Patients will be
      randomised into two groups; one group will receive a reminder phone call one week prior to
      their hospital consultation and the other group will be managed in the standard manner (i.e.
      no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a
      respiratory nurse specialist and a research officer for two asthma clinics based on a
      Wednesday morning and a Thursday afternoon.
    

Detailed description: 
      Many studies have shown a high non-attendance rate in hospital outpatient clinics. The
      investigators have found a non-attendance rate of 25% in their asthma clinics and would like
      to investigate whether a reminder phone call will improve attendance rates. Patients will be
      randomised into two groups; one group will receive a reminder phone call one week prior to
      their hospital consultation and the other group will be managed in the standard manner (i.e.
      no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a
      respiratory nurse specialist and a research officer for two asthma clinics based on a
      Wednesday morning and a Thursday afternoon.

      To have an 80% chance of detecting a 10% reduction in non-attendance rates (at 5%) 500
      patients are required for this study. The rate of non-attendance will be monitored for all
      the patients in both groups and some demographic information will be recorded for each
      patient(age, sex, diagnosis and home postcode).
    

Intervention name(s): Telephone reminder call
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telephone reminder