bioihbjkbjnl/mcl2 huggingface dataset:
Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if different doses of an experimental HIV vaccine are
      safe and to study how the immune system responds to the vaccine. The vaccine will be tested
      in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that
      HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.
    

Detailed description: 
      This study was designed to evaluate the safety and immunogenicity of an alphavirus replicon
      HIV subtype C gag vaccine. This vaccine utilizes a propagation-defective replicon vector
      system derived from an attenuated strain of Venezuelan Equine Encephalitis (VEE) virus. The
      vaccine replicon expresses the gag gene from a South African subtype C isolate of HIV-1.

      This study evaluated the AVX101 vaccine in healthy, HIV uninfected volunteers in both the
      United States and South Africa. Participants will be randomized to receive either vaccine or
      placebo at study entry and again at Months 1 and 3. The study was originally designed to
      enroll four groups of participants in both the US and South Africa, with successive groups
      receiving increasing doses of the vaccine, but was later amended to enroll only two groups.
      Twelve US participants (US Group 1) were randomized to receive either vaccine or placebo.
      After a review of initial safety data from this group, 12 South African participants (SA
      Group 1) were randomized to receive the same vaccine dose as US Group 1 or placebo, while 12
      US participants (US Group 2) were randomized to receive the next higher vaccine dose or
      placebo. Review of safety data from SA Group 1 and US Group 2 was used to inform the decision
      to begin enrollment into SA Group 2 .

      Participants had nine study visits over 12 months. Study visits included clinical evaluation,
      urine and blood tests, and HIV tests. After each injection, participants were asked to record
      their temperature and any symptoms each day for 7 days and report them to the clinic staff.
    

Intervention name(s): AVX101; placebo
Intervention type(s): Biological; Other
Intervention description(s): Alphavirus replicon particle vaccine expressing HIV Gag antigen; phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; AIDS Vaccines; Gene Products, gag; HIV-1; Dose-Response Relationship, Immunologic; Injections, Subcutaneous
Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet
      little is known about the genetic factors that influence response to this therapy. This study
      seeks to quantify response to ICS therapy in African American and white patients, as well as
      look for genetic markers that predict treatment response.
    

Detailed description: 
      Inhaled corticosteroids (ICS) are considered first-line therapy for the management and
      control of patients with persistent asthma. Use of inhaled steroids has been associated with
      improved lung function, diminished symptoms, and fewer exacerbations. However studies show
      considerable inter-subject variability in ICS response. It has also been estimated that
      corticosteroid resistance accounts for half of all asthma-related health care costs.
      Therefore, identifying factors associated with ICS response is both clinical and economically
      important. African-American patients have been understudied with respect to genetic
      predictors of asthma controller medication response, and to date there have been no
      sufficiently powered genome-wide association studies of ICS treatment response among African
      American individuals with asthma. This issue is of particular importance, since
      African-American individuals are disproportionately affected by asthma-related complications.
      In this proposal, we seek to identify novel genetic loci associated with ICS treatment
      responsiveness (defined by the change in Asthma Control Test score) among African American
      individuals treated with beclomethasone dipropionate (BD) for 6 weeks. We will attempt to
      validate loci identified in the discovery set by 1) reassessing these variants for their
      interaction with ICS treatment on asthma exacerbations in a separate group of African
      American individuals with asthma, and 2) by reexamining the genetic association with change
      in asthma control among similarly treated (i.e., treatment with 6 weeks of BD) European
      Americans with asthma.
    

Intervention name(s): beclomethasone dipropionate
Intervention type(s): Drug
Intervention description(s): 160 mcg twice a day (320 mcg per day total)
Intervention MeSH terms: Beclomethasone
Intervention model: Single Group Assignment
Intervention model description: Discovery set for ICS treatment response biomarker analysis
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inhaled corticosteroids; Asthma; Pharmacogenomics; Genome wide association study; Admixture mapping; Continental population groups
Treatment of Temporomandibular Disorders
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional

Summary: 
      The aim of the present study was to carry out a pilot project comparing the effectiveness of
      two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female
      individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were
      randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2)
      transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten
      sessions were held for each patient and two measurements (baseline and 10th session) were
      performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum
      opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be
      carefully selected.
    


Intervention name(s): Transcutaneous electrical nerve stimulation; Physiotherapy
Intervention type(s): Device; Other
Intervention description(s): Sensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually.; Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial Pain; Temporomandibular Joint Disorders; Transcutaneous Electric Nerve Stimulation; Adolescent
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings
      of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence
      of exercise and metabolically demanding cognitive tasks.
    

Detailed description: 
      Supplementation with vitamins and minerals has been shown to enhance energy production,
      metabolism, and mood state. It is thought that they may also aid recovery from challenging
      physical and psychological tasks following both acute and chronic supplementation. The
      present study will investigate the effects of a multivitamin/mineral supplement (Supradyn®
      Energy 3RDA) following a single intake and following daily intake for 4-weeks on subjective
      ratings of 'fatigue/stress', metabolism and blood biomarkers of cell damage following both
      exercise and demanding cognitive tasks, in healthy young male and female volunteers.
    

Intervention name(s): Supradyn® Energy 3RDA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Multivitamin/mineral containing co-Q10; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Multivitamin/mineral; Exercise; Fatigue; Stress; Arousal; Energy expenditure; Recovery biomarkers; Cognition
Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This is a pilot feasibility study to examine the impact of providing a non-therapeutic
      resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS
      (PwMS).

      Cognitive difficulties are a prominent feature in PwMS and prove to be a challenge for PwMS
      and the close family members that care for them. This study is a pilot telehealth program
      that aims to address these needs and improve the overall well-being of adults with MS and
      their Support Partners.

      A manualized program was developed utilizing the previous research study conducted
      literature, and the expertise and experience of the research study team. Funding was sought
      and obtained for 30 pairs to participate in the pilot. The 6-session program will address
      needs identified by this population and improve knowledge of cognition in PwMS.

      Study Objectives:

      Primary Objective:

      To conduct an evaluation of the feasibility of the resilience program by examining:

        1. Recruitment (i.e. willingness to participate in program)

        2. Participation rates and attrition

        3. Participant satisfaction of the program.

      Secondary Objective (Support Partner):

      To assess the potential long-term benefits of the program to Support Partners of PwMS.
      Program benefits will be assessed using the following outcomes:

        1. Sense of Competencies

        2. Understanding of cognitive impairment in MS

        3. Caregiver burden

        4. Positive Emotions.

      Secondary Objective (PwMS):

      To assess the potential long-term benefits of the program to PwMS. Program benefits will be
      assessed using the following outcomes:

        1. Relationship Satisfaction

        2. Perceived Support.
    


Intervention name(s): Resilience-Based Program for Support Partners of PwMS
Intervention type(s): Behavioral
Intervention description(s): Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. The MyHealios Resilience Program for PwMS and their Support Partners has been designed to be interactive and include skills-based activities led by the Resilience coach. This includes skills of communication, problem solving, and learning about resilience and cognition in MS.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Resilience; Telehealth; Well-being; Support; Caregiving
Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
Condition: Fever
MeSH terms: Infections; Respiratory Tract Infections; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      Currently, paracetamol, ibuprofen and nonsteroidal antiinflammatory drugs are widely used by
      emergency physicians in Turkey for the treatment of fever . The objective of the study is
      compare the efficacy of intravenous ibuprofen and paracetamol in the treatment of patients
      with upper respiratory tract infections presenting with fever in the emergency department
    

Detailed description: 
      This is the randomized double blinded clinical trial to compare the efficacy of these two
      drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency
      Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency
      physicians and emergency service nurses) were trained before the study. When intravenous
      drugs (Paracetamol and İbuprofen) was being recommended, an eligibility checklist was
      completed by the attending physician. patients who presented to the emergency department with
      upper respiratory tract infection and had a temperature above 38.0 ° C were measured by a
      fever gauge included into the study First Group: 1000 mg of paracetamol ( parol 10mg/ml
      solution Mefar, Turkey) intravenous (IV) was given 100 patients

      Second Group:

      Ibuprofen 400 mg ( intrafen 400mg/4ml solution -Gen ilaç san., Turkey) intravenous (IV) was
      given 100 patients which determined to be applied as a group. Drug packs prepared in 150 ml
      serum physiology were numbered by an independent nurse, who not involved in the study
      Randomization was achieved by using computer software to generate random numbers. During the
      intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an
      automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms).
      Patients in both groups received two types of medication in a similarmanner, thus ensuring
      double blind.
    

Intervention name(s): Paracetamol; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients
Other Names:
Perfalgan
Paracerol; 400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients
Other Names:
Dorifen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fever, emergency department, paracetamol, ibuprofen, upper respiratory infection
Effect of Hand-Washing Training in Covid-19
Condition: Chronic Disease; Covid-19 Pandemic
MeSH terms: COVID-19; Chronic Disease
Study type: Interventional

Summary: 
      This study was conducted in order to inform, the women with chronic disease in rural areas,
      about hand-washing and nutrition, and to evaluate the efficiency of the training program. A
      randomized-controlled trial was performed based on CONSORT checklist. 90 women in total were
      included in the study, 45 for each group. The women in the intervention group were given, by
      the researcher, the training on the importance of hand-washing and appropriate food choices.
      The training given to the women in rural areas created significant benefit for them to have
      the appropriate food choices and hand-washing behaviours.
    


Intervention name(s): Training
Intervention type(s): Behavioral
Intervention description(s): After the data was collected, the women in the intervention group were trained on "Hand-Washing and Nutrition during the COVID-19 period". The training on hand-washing and nutrition was given using the "Hand-Washing and Nutrition Training Guide" prepared by the researchers, and the "Hand-Washing and Nutrition Training Manual" covering the content of the training, was distributed to the women at the end of the training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: COVID-19; hand hygiene; chronic disease
Botulinum Toxin for Erectile Dysfunction
Condition: Sexual Dysfunction; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an
      alternative line of treatment in patients with erectile dysfunction - not responding to oral
      PDE5i - through cavernosal smooth muscle relaxation.
    

Detailed description: 
      The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the
      treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.

      The investigators conduct a phase 2 trial to confirm the initial results in a larger group of
      men.70 males will be included in the study. The participants will be subjected for full
      history taking, general and genital examination. Penile duplex will be performed to assess a
      vascular etiology before the treatment and 2 weeks later. The patients will be randomized
      into a treatment group (35 patients) and a control group (35 patients).

      All patients will sign an informed consent. The treatment group will be injected IC with a
      trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler
      assessment, followed, next day by 50 units of BTX-A. The control group will be injected with
      the trimix solution during penile color Doppler assessment followed next day with a normal
      saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.

      Procedure: At least 1 day after the penile color Doppler test, the patient is placed in the
      supine position flaccid and stretched penile length and girth would be measured from tip of
      the penis to the pubic bone will be done. A rubber band will be applied to the base of the
      penis. The skin will be prepped with alcohol swabs followed by the IC injection of 100 units
      of BTX-A. Direct pressure will be applied for 2 minutes. The rubber band will be removed
      after 15 minutes.

      Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and
      answer the the Sexual Encounter Profile questions 1 and 2 (SEP 2 & SEP 3), and the global
      assessment question (GAQ) before and 4 weeks after treatment.
    

Intervention name(s): Botulinum Toxin Type A; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.; The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized double blind placebo control ( RDBPC) study.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Erectile dysfunction; Botulinum toxin A; Botox
Melatonin for Sleep in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Many people with MS report sleep disturbances. However, objective data on sleep quality in
      MS, such as those obtained using actigraphy, remain scant, as do data about optimal
      therapeutic management. Melatonin is frequently used to improve sleep parameters, both in
      healthy and neurological populations. Altered melatonin regulation and signaling has been
      implicated in MS, through observations including (1) MS risk associated with shift work, (2)
      contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of
      endogenous melatonin levels from exogenous corticosteroid administration.

      To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost,
      low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized
      controlled pilot trial.
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will start with 0.5 mg tablets of melatonin with the option of switching to an 'escalation dose' of 3 mg if no relief after 3 days.; Placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep; Melatonin; Sleep disturbance
Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Observational

Summary: 
      The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.
    

Detailed description: 
      The aim is to investigate circadian rhythm in episodic cluster headache patients in- and
      outside of bout. This will be done using actigraphy and a short diary for 2 weeks in each
      period. A secondary outcome is to look at attack occurence and physical activity before and
      during an attack.
    

Intervention name(s): Actigraphy; Diary
Intervention type(s): Device; Other
Intervention description(s): An actigraph from Philips; Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
Other intervention name(s): Actigraph from Philips
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with episodic cluster headache as defined by ICHD III beta
      
Keywords: Cluster headache; actigraphy; circadian rhythm
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A
      total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria
      will be included. The participants will be randomized into one of three groups consuming
      either HMO (two groups) or placebo (one group).

      The primary objective of the study is to establish the effect of HMOs on the faecal
      microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal
      symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and
      depression.
    


Intervention name(s): HMO1; HMO2; Dextropur
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment