bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Condition: Fatigue; Hypothyroidism
MeSH terms: Hypothyroidism; Fatigue
Study type: Interventional

Summary: 
      This study evaluates the effects of an inhaled blend of essential oils on fatigue scores
      among women who have hypothyroidism. Half of the participants will receive an essential oil
      blend to inhale daily for two weeks while the other half will serve as controls and inhale a
      carrier oil.
    

Detailed description: 
      The inhalation of certain essential oils has been found to increase stamina and reduce
      fatigue among athletes but have not been evaluated for the purpose of reducing fatigue among
      women who experience fatigue as a result of a hypothyroid condition.

      The essential oils used in this study are inhaled mid-afternoon, the time in which women with
      hypothyroidism typically experience the lowest levels of energy during the day, otherwise
      known as the "afternoon slump." The essential oil is administered during this time to
      evaluate both the immediate effects on fatigue as well as the overall effects, with
      measurements at the end of both the first and second week of the study.

      Fatigue is measured on a multi-dimensional scale, a validated instrument that measures not
      only physical fatigue but also emotional and mental fatigue.
    

Intervention name(s): Aromatherapy Blend; Placebo
Intervention type(s): Other; Other
Intervention description(s): The essential oil intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.; The placebo substance is an odorless vegetable oil derived from avocados.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aromatherapy; fatigue; hypothyroidism; essential oils
Physiotherapy in Mutated COVID-19 Patients
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The prospective study was conducted at a single location within the COVID-19 department of a
      city hospital. The study included COVID-19 patients who were hospitalized in the COVID-19
      service and consulted for physiotherapy, were between the ages of 18 and 65, and had the
      capacity and inclination to participate in one daily physiotherapy session five days per
      week.
    

Detailed description: 
      A hospital's COVID-19 service recruited 32 participants for the study. Patients were divided
      into two groups: COVID-19 (n=16; age = 53.81 9.48) and mutation (n=16; age = 55.25 10.12).
      Both groups underwent physiotherapy consisting of mobilization, normal range of motion, and a
      respiratory exercise program (COVID-19 group: 9.945.85 days; mutation group: 7.632.83 days).
      Every patient participated in a once-daily physiotherapy program. The patients' muscle
      strength, mobility, daily activities, exercise capacity, and perception of fatigue were
      assessed. To compare groups, the mixed repeated measures ANOVA model was used.
    

Intervention name(s): Physiotherapy
Intervention type(s): Behavioral
Intervention description(s): Physiotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the non-inferiority, at the assessment
      visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI)
      administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of
      tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.
    


Intervention name(s): pristinamycin; amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days; 50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
Intervention MeSH terms: Amoxicillin; Pristinamycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intervention to Reduce Bisphenol A Exposure in Women
Condition: Environmental Exposure
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a 3-week intervention reduces urinary
      Bisphenol A (BPA) in women with obesity
    

Detailed description: 
      The purpose of this study is reduce BPA exposure in women. The intervention is rooted in
      social cognitive theory, and is applied to environmental health.
    

Intervention name(s): Face-to-Face Meetings; Email Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.; Participants received health and fitness education.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to intervention or control.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
Condition: Hepatitis B; Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Observational

Summary: 
      Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe
      and unlikely to result in vaccine-associated serious adverse events. This post-licensure
      study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.
    

Detailed description: 
      -  The outcomes to be assessed include the occurrence of all seizures (with or without
           fever), medically-attended fever, seizures associated with fever, allergic reactions,
           outpatient visits and hospitalizations for any cause, and all deaths.

        -  Data collection through utilization of automated databases at the study site with subset
           medical record review. The Protocol Posting has been updated in order to comply with the
           FDA Amendment Act, Sep 2007.
    

Intervention name(s): Pediarix; Licensed DTPa containing vaccine; Prevnar®: (Wyeth)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 or more injections; 1 or more injections; Concomitant vaccination
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be conducted by the University of California, Los Angeles (UCLA) Center for
        Vaccine Research (CVR) and the Southern California Kaiser Permanente Health Care Plan
        (SCKP), the largest Health Maintenance Organization (HMO) in California.

        All infants who receive at least one dose of PEDIARIX in the primary series will be
        identified through the automated Kaiser Immunization Tracking System (KITS).
Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat
Condition: Quality of Life; Graft-vs-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Observational

Summary: 
      Psychological well-being and cognitive function will be measured in patients enrolled on the
      primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to
      prevent graft versus host disease following unrelated donor hematopoietic stem cell
      transplantation. Validated questionnaires will be administered to assess patients' level of
      depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality.
      Cognitive testing will include reliable and valid measures of processing speed, attention,
      executive function, episodic memory, and visual learning and memory. The purpose of this
      study is to determine whether these measures are feasible to administer in patients before
      and at early time points after bone marrow transplantation .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled on the primary study NCT01790568. Eligible patients who choose not to
        participate in this add-on study will not be excluded from participating in NCT01790568.
      
Keywords: Bone Marrow Transplantation; Hematologic Malignancies; Adults; Cognition
Effect of Preoperative Music on Anxiety
Condition: Music on Postoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In this study, we are planning to evaluate whether listening to the music of the patient's
      choice preoperatively contributes to postoperative anxiety.
    

Detailed description: 
      Preoperative anxiety can be detected via structured and standardised screening by the State -
      Trait Anxiety Inventory (STAI) I and II.

      117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70
      will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will
      be applied to each patient. The patients will be divided into two groups as preoperative
      music played and not played. The list of patients listening to the music will be played
      through the headphones which are the preference of the patients. The postoperative STAI
      questionnaire will be applied again. results will be evaluated statistically
    

Intervention name(s): music; no music
Intervention type(s): Other; Other
Intervention description(s): The preference of the patients will be listened to preoperatively through the headphones; the patients will not be listened
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: postoperative anxiety; State - Trait Anxiety Inventory
Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole
Condition: Soil Transmitted Helminthiasis; Neglected Tropical Diseases
MeSH terms: Helminthiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Mass drug administration (MDA) of albendazole (ABZ) to school-age and pre-school-age children
      is the currently recommended strategy for controlling soil-transmitted helminthiasis (STH) in
      endemic areas. Recent mathematical modelling suggests that community-wide MDA will be
      required in order to interrupt transmission of STH. DEWORM3 aims to determine the feasibility
      of eliminating STH through expanded and intensified MDA strategies. In order to ensure
      rigorous trial results, it is crucial that the definition of such MDA coverage is informed by
      unbiased, empirical data. The Centro de Investigación Veterinaria de Tandil (CIVETAN) and
      Instituto de Investigaciones en Enfermedades Tropicales Universidad Nacional de Salta
      collaborate on scientific research related to pharmacokinetic studies of ABZ.

      This proposal describes the request for funding from DEWORM3 to conduct a study of the serum
      pharmacokinetic characteristics and urinary excretion of ABZ and its metabolites in
      non-infected human volunteers to better understand the use of urinary analysis of ABZ as a
      measure of MDA adherence in the context of DEWORM3.
    

Detailed description: 
      Objective 1.To characterize the plasma disposition kinetics of ABZ and its main metabolites
      (ABZ sulphoxide and ABZ sulphone) in non-infected human volunteers.

      Objective 2. To characterize the pattern of albendazole (ABZ) and its main metabolites (ABZ
      sulphoxide and ABZ sulphone) urinary excretion in non-infected human volunteers.

      Objective 3. To determine the optimal and the longest period time after treatment where
      either ABZ and/or its metabolites can be measured in urine as an indirect assessment of an
      individual's adherence to treatment.
    

Intervention name(s): Albendazole.
Intervention type(s): Drug
Intervention description(s): Single dose 400mg orally
Intervention MeSH terms: Albendazole
Intervention model: Single Group Assignment
Intervention model description: Pharmacokinetics
Masking: None (Open Label)
Primary purpose: Other
Effects of NAD3 Supplementation on Biomarkers of Aging
Condition: Aging
Study type: Interventional

Summary: 
      This is a randomized, parallel-group, placebo-controlled, clinical trial in middle-aged and
      older male and female subjects from Ohio. Subjects will take an over-the-counter dietary
      supplement or a placebo for 12 weeks. Outcome measures will include body weight, systolic and
      diastolic blood pressure, standard blood chemistries (e.g. chemistry panel, lipid panel, CBC
      with differential), changes in mood, vitality, energy, fatigue, productivity, digestive
      wellness (via anchored Visual Analogue Scales).
    


Intervention name(s): NAD3
Intervention type(s): Dietary Supplement
Intervention description(s): NAD3 is an over-the-counter dietary supplement available online to consumers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: dietary supplement
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The primary objective of the study is to define procedures for the use of CureXcellTM in the
      community through Clalit Health Services. Secondary objective is to evaluate the blinding
      method in a subgroup of patients, which will be used in a future study named: a
      multinational, multi-center, randomized, double blind, placebo controlled study for the
      evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer
      treatment, in diabetic patients with ulcers in the lower extremities.

      Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post
      operative ulcer will be recruited to the study. Patients that have been recruited for the
      study will be treated as required for their medical condition. As required, cultures will be
      taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will
      be referred to catheterization, revascularization, or amputation as required and the decision
      to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct
      treatment to good ulcer care (GUC).
    


Intervention name(s): Activated allogeneic white blood cells
Intervention type(s): Biological
Intervention description(s): The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).
Other intervention name(s): CureXcell
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post
        operative ulcers.
      
Keywords: Chronic ulcers; pressure ulcers; venous ulcers; diabetic foot ulcers; post operative ulcers; hard to heal ulcers
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
Condition: Obesity; Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The proposed study is a randomized clinical trial investigating the effects of a weight gain
      and eating dysregulation prevention intervention among college freshmen women. It will
      compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no
      treatment control group. Appetite Awareness Training approach to increasing eating regulation
      through training individuals to eat in response to their appetite cues rather than external
      or emotional cues.
    

Detailed description: 
      All female freshmen students residing in the university dorms were recruited to participate
      in this study. After completing the baseline assessment, eligible participants were randomly
      assigned to one of the three arms. Those in the AAT condition received guided administration
      of AAT over the course of three weekly group sessions, with an additional booster session
      three weeks after completion (week 6). The standard treatment comparison group received four
      similarly timed group sessions of psychoeducational/nutrition information facilitated by a
      registered dietician. A manualized approach to administration of the intervention was created
      based on the AAT treatment and was strictly followed in order to standardize the
      implementation of the prevention groups. The no-treatment control group only participated in
      the assessments.
    

Intervention name(s): Appetite Awareness; Nutrition Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues; Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Eating Disorders; Appetite regulation; Eating Regulation
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
Condition: Medical Device Complication
Study type: Interventional

Summary: 
      The PrePex is a WHO prequalified medical device for adult male circumcision for HIV
      prevention. The Government of Rwanda was the first country to implement the PrePex and acts
      as the leading Center of Excellence providing training and formal guidelines.

      In support of efforts to scale up male circumcision, readily available data have been applied
      to estimate the potential cost and impact of scaling up medical MC services in Rwanda to
      reach 80 percent of adult, children and newborn males by 2015. Infant and children male
      circumcision ensures that the wound will be healed before sexual activity begins, and thus
      reduces the risk of HIV transmission during healing period.
    

Detailed description: 
      The American Academy of Pediatrics (AAP) published in August 2012 a technical report and a
      policy statement, "Evaluation of current evidence indicates that the health benefits of
      new-born male circumcision outweigh the risks; furthermore, the benefits of newborn male
      circumcision justify access to this procedure for families who choose it. Specific benefits
      from male circumcision were identified for the prevention of urinary tract infections,
      acquisition of HIV, transmission of some sexually transmitted infections, and penile cancer.
      Male circumcision does not appear to adversely affect penile sexual function/sensitivity or
      sexual satisfaction. It is imperative that those providing circumcision are adequately
      trained and that both sterile techniques and effective pain management are used. Significant
      acute complications are rare."

      The primary objective of the study was to assess the safety and efficacy of the PrePex device
      among healthy early infant and children males scheduled for voluntary circumcision. The study
      consisted of 2 phases:

      Phase I included infants age 5-33 days Phase II included children age 4-10 years.

      The study examined the feasibility of performing PrePex circumcision on early infants and
      children male population.
    

Intervention name(s): Male circumcision using a non-surgical device
Intervention type(s): Device
Intervention description(s): Male Circumcision
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrePex; Infants; Early infants; Children; Circumcision; HIV; AIDS; Non surgical
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Condition: Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Manic State; Psychoses, Manic-Depressive
MeSH terms: Mania; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Affective Disorders, Psychotic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of sustained-release
      quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3
      weeks.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate (Seroquel) SR
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder; Bipolar Mania; Manic Depression; Seroquel; Seroquel SR; quetiapine fumarate
Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects
Condition: Congenital Heart Disease; Pediatric Obesity
MeSH terms: Heart Diseases; Heart Defects, Congenital; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      This study is to assess whether a lifestyle intervention with diet, exercise and counselling
      in young patients will have a positive influence on their weight and overall well-being. This
      study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart
      disease, and have been identified being overweight or obese. A total of 40 individuals will
      participate in this study. The study duration will last for 1 year.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: congenital heart disease; smart mobile technology; children; adolescents; lifestyle counselling; nutrition; physical activity