bioihbjkbjnl/mcl2 huggingface dataset:
Cook Like A Boss Online: A Virtual One-week 'Camp-style' Cooking Intervention
Condition: Perceptions, Self
Study type: Interventional

Summary: 
      Cook Like A Boss Online is a public engaging virtual cooking camp styled intervention
      evaluating an adapted theory-driven co-created intervention designed to improve perceived
      cooking competence.
    

Detailed description: 
      Cook Like A Boss Online is a virtual cooking camp styled intervention, providing engaging
      virtual cooking activities for children to take part in safely from their homes during the
      COVID-19 pandemic. The online intervention is adapted from the original theory-driven,
      age-appropriate and co-created 'Cook Like A Boss' intervention (Dean et al., 2022), into
      daily cooking videos emailed to parents for children to cook along to, aiming to improve
      perceived cooking competence and wellbeing. Children aged 9-12 years will be recruited from
      across the island of Ireland (Republic of Ireland and Northern Ireland) to take part in the
      intervention. Due to the uncertainty of the pandemic and the need for the intervention to run
      five days consecutively (i.e. over a school holiday), it is deemed unethical to have a
      delayed intervention control group and all children will be provided the opportunity to take
      part in the intervention. Study outcomes include perceived cooking competence, perceived
      motor competence, wellbeing and process evaluation measures and will be collected at baseline
      and post intervention.
    

Intervention name(s): Cook Like A Boss Online - virtual week long cooking camp
Intervention type(s): Behavioral
Intervention description(s): The original Cook Like A Boss camp style intervention, was based on the Cook-Ed Model (Asher et al., 2020) and underpinned by SLT and ELT (Bandura & McClelland, 1977; Kolb, 1984). The content was developed to ensure it was age-appropriate in line with the guidelines (Dean et al., 2021a) and included co-creation. The camp was designed to introduce the children to a range of food and skills and to nurture an initial interest in cooking. The adapted online version of the camp included five daily videos of the original chef performing the recipes. Minor adaptions included the removal of cooking pasta from scratch due to equipment concerns, reordering the days, and chef suggestions around alternative equipment/ingredients to use. The five daily videos were: 1) Introduction & flatbreads; 2) Chicken Chowder; 3) Baking day; 4) Chilli non Carne; 5) Honey Chilli Chicken
Intervention model: Single Group Assignment
Intervention model description: Cook Like A Boss Online is a single-group pre post intervention design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cooking; perceived motor competence; Childhood Wellbeing; Childhood Health; Children; Food Education
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
Condition: Contraception
Study type: Interventional

Summary: 
      The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The
      GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the
      GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by
      reducing failed insertions and perforations. We now need to know how easy it is for doctors
      to see and measure the distance of the anchor to the outside of the uterus. The purpose of
      this open, prospective, observational study is to assess the feasibility of measuring the
      distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz
      and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of
      insertion, the acceptability of the device to Canadian women and any complications. We will
      also compare expulsion rates in post-abortion and other women.
    


Intervention name(s): GyneFix Viz
Intervention type(s): Device
Intervention description(s): insertion of GyneFix Viz and measurment of the SA distance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intrauterine device, contraception
Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543
      on oral contraceptive pharmacokinetics in healthy female subjects.
    


Intervention name(s): CTP-543; Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Drug; Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oral contraceptive; Drug-drug Interaction; CTP-543
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7
      inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)
    

Detailed description: 
      In the present study, E4/DRSP will be administered alone (Treatment A) and in combination
      with VAL (Treatment B) following two sequences A-B or B-A.
    

Intervention name(s): E4/DRSP; VAL
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): E4 and DRSP combined tablet; Valproic acid; Depakote®
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estetrol; Drospirenone; Uridine diphosphate glucuronosyltransferase-2B7; Drug-drug interaction; Valproic acid
Short Course Terlipressin for Control of Acute Variceal Bleeding
Condition: Hemorrhage; Esophageal Varices; Portal Hypertension
MeSH terms: Hypertension, Portal; Esophageal and Gastric Varices; Hypertension; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as
      72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been
      controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to
      moderate risk variceal bleed patients and hence can save cost and may decrease length of
      hospital stay especially in the I.C.U or high dependency units.
    

Detailed description: 
      The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal
      band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide.
      The risk of re-bleeding is highest during the initial 5 days from first presentation.
      Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove
      that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin
      is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled
      with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin
      and may also help in decreasing the length of hospital stay in future.
    

Intervention name(s): Terlipressin; Terlipressin & then Dummy
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours; 2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
Other intervention name(s): Novapressin; Novapressin
Intervention MeSH terms: Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Esophageal varices; Portal Hypertension; Melena; Hematemesis; Gastrointestinal Hemorrhage; Terlipressin; Efficacy; Safety
HIV Testing in Non-traditional Settings Study
Condition: HIV
Study type: Observational

Summary: 
      Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in
      the UK remain undiagnosed - that is, they are living with the infection but do not know this.
      The majority of HIV testing in the UK to date has taken place in sexual health clinics and in
      antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds
      in more general healthcare settings in parts of the country with relatively high rates of HIV
      (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the
      utility, feasibility and acceptability, to patients and staff, of offering routine HIV
      testing in four general medical settings, all set in areas of high HIV prevalence. The
      settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.
    


Intervention name(s): Questionnaire; Focus Group Discussion; HIV test (serum or salivary); Semi-structured telephone interview
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting; FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting; An HIV test offered to all 16-65 year olds (not known already to be HIV-positive) accessing the healthcare setting during the twelve week pilot period; Telephone interview administered to patients offered an HIV test during the pilot period
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        For patient pre-study and intra-study: All patients aged 16-65 (not know already to be HIV
        positive) attending the healthcare setting (Primary Care centre, Emergency Department,
        Acute Care Unit, Medical Outpatient Clinic) before or during the twelve week HIV testing
        pilot programme

        For Staff pre-study and post-study: All members of staff (HCP, Allied Health Professionals
        and Admin/Clerical) working within the healthcare settings examined before and during the
        implementation of the HIV testing programme
      
Keywords: HIV; testing; non traditional settings; acceptability; feasibility
Effects of Almonds on Cardiovascular Risk Factors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this research is to build the evidence base for approval of FDA health claims
      related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled
      feeding study was designed to compare the effects of two blood cholesterol lowering diets
      that meet the American Heart Association recommendations. The nutrient profiles of the
      control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for
      protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25
      men and women with moderately elevated LDL-C. The investigators hypothesize that a
      cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than
      a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response,
      effect on LDL particle size, abdominal adiposity and vascular health.
    


Intervention name(s): Almonds
Intervention type(s): Other
Intervention description(s): 1.5 oz almonds/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular disease; cholesterol; low-density; lipoprotein; high-density lipoprotein; triglycerides
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
Condition: Keratosis, Actinic; Actinic Lesion; Solar Keratosis/Sunburn; Hyperkeratosis; Hyperkeratotic Callus; Hyperkeratotic; Lesion; Hyperkeratotic Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Sunburn
Study type: Interventional

Summary: 
      In this clinical one-site investigation the performance and safety of a skin preparation
      device will be evaluated for removing hyperkeratotic skin prior to further medical treatment.
      Comfort and pain during skin preparation, as well as performance and safety of device, will
      be compared to comparators on separate skin areas for every subject.
    


Intervention name(s): Investigational Skin Preparation Device; GMDN 47102 / Electrode Skin Abrasive Pad; UMDNS 13-230 / Biopsy punch (Dermal Curette)
Intervention type(s): Device; Device; Device
Intervention description(s): Removal of hyperkeratotic skin with Investigational Skin Preparation Device; Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation; Removal of hyperkeratotic skin with Disposable Dermal Curette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.
Condition: Rectal Neoplasm Malignant
MeSH terms: Rectal Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus
      5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced
      rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8
      weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter
      preservation, quality of life, OS and DFS.
    

Detailed description: 
      Patients harbouring rectal adenocarcinoma T3-4 or N>0 M0 within 10 cm to anal verge were
      randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5
      weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks,
      both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage
      before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal
      ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was
      planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative
      margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's
      Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients
      before and after CRT, after surgery and during follow-up.
    

Intervention name(s): Capecitabine Oral Product; 5Fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): Neoadjuvant Capecitabine concomitant to external beam radiotherapy; Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy
Other intervention name(s): Xeloda; 5-Fu
Intervention MeSH terms: Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomization
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of GSK233705 in Healthy Japanese Male Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the
      safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705
      from a novel dry powder device in healthy Japanese male subjects.
    


Intervention name(s): GSK233705; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Long acting muscarinic receptor antagonist; Matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Condition: Stage III Oral Cavity Squamous Cell Carcinoma; Stage IVA Oral Cavity Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally
      advanced or aggressive cancers, and to improve the chance of eradication of the locoregional
      lesions by radical surgery and/or radiotherapy. However, there are still debates on the
      clinical value of induction chemotherapy for patients with advanced and resectable oral
      squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of
      TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with
      locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival
      rate, local control, and safety.
    

Detailed description: 
      The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction
      chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is
      locoregional control rates (1, 2 years), and the safety.
    

Intervention name(s): TPF induction chemotherapy
Intervention type(s): Drug
Intervention description(s): Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.
Other intervention name(s): Followed by surgery and radiotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral squamous cell carcinoma; Induction chemotherapy; Surgery; Radiotherapy
Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
Condition: Visual Outcomes; Quality of Life
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Hypothesis :

      Phacoemulsification is superior to SICS with regards to:

        -  Immediate unaided high and low contrast visual performance

        -  Its impact on quality of life.
    

Detailed description: 
      Phacoemulsification procedure

        -  Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)

        -  Anaesthesia: topical

        -  Incision: temporal clear corneal 2.2 mm single plane

        -  CCC and hydrodissection, sculpting and division using step by step chop in situ and
           lateral separation, I/A.

        -  Single-piece AcrySof IOL (SN60WF) in the bag

      SICS procedure

        -  Anaesthesia: peribulbar

        -  Incision: superior scleral tunnel 6.5 to 7 mm

        -  CCC and hydrodissection

        -  Nuclear expression: blumenthal technique using anterior chamber maintainer, manual
           cortical clean-up

        -  Single-piece PMMA (MZ60BD) in the bag
    

Intervention name(s): phacoemulsification and SICS; manual small incision surgery; phacoemulsification
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): SICS with rigid IOL implantation Phaco with foldable IOL implantation; cataract surgery
Other intervention name(s): ECCE; Manual SICS; exrtracapsular cataract surgery; extracapsualr cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phacoemulsification; manual small incision cataract surgery; visual acuity; contrast sensitivity; quality of vision
A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to prove reasonability of registration in Russian federation
      this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy
      rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by
      additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to
      8 weeks (maximum 9 infusions).
    


Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
Other intervention name(s): Remicade; SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The principal research objective is to determine whether inorganic nitrate in the form of
      beetroot juice compared to placebo control prevents the systemic inflammation that underlies
      typhoid vaccine-induced endothelial dysfunction
    

Detailed description: 
      We wish to determine in a prospective manner whether inorganic nitrate affects the
      endothelial dysfunction induced by systemic inflammation. At baseline we will measure
      flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic
      stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive ~8 mmols of
      dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on
      availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or
      Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation
      that is associated with vascular dysfunction. All vascular function measures will be repeated
      at 8 hours and 32 hours after vaccine administration.
    

Intervention name(s): Typhoid vaccine; Concentrate beetroot Juice; Concentrate beetroot Juice (Placebo)
Intervention type(s): Biological; Dietary Supplement; Dietary Supplement
Intervention description(s): The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution; 140 ml containing ~8 mmol of inorganic nitrate; 140 ml which is nitrate-depleted
Other intervention name(s): Typhim Vi®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention