bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance
Condition: Healthy Nutrition; Eating Behavior
Study type: Interventional

Summary: 
      The purpose of this study was to examine the effectiveness of the Mole's Veggie Adventures
      mobile application in increasing fruit and vegetable acceptance among 3-6-year-olds.
    

Detailed description: 
      After the parents of the participating children had signed an informed consent and filled in
      the baseline questionnaires, the participating early childhood education and care (ECEC)
      centers (in Finland) or groups within the ECEC centers (in Poland) were randomly allocated
      into intervention and control arms. Researchers visited the intervention arm groups and
      introduced the application to the ECEC professionals. The ECEC professionals were instructed
      to use the application with a tablet computer at least one to two times a week during the
      intervention period (3-4 weeks) and to record the number of tasks completed by their group in
      a logbook. In addition, the research team recommended that each group focuses on at least six
      vegetables or fruits during the intervention period. The control arm groups were instructed
      to continue their normal routines during the intervention period and to refrain from
      introducing any novel food education methods during the intervention period.
    

Intervention name(s): Intervention arm
Intervention type(s): Behavioral
Intervention description(s): The intervention arm groups were instructed to use the Mole's Veggie Adventures mobile application for 3-4 weeks.
Other intervention name(s): Mole's Veggie Adventures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Games for health; Mobile application; Smartphone application; Randomized trial
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Condition: Healthy; RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aims of the study are:

        -  To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i)
           local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of
           ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations
           after intravenous administration.

        -  To further determine the safety and local and systemic tolerability of ALX-0171.

        -  To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of
           ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).
    


Intervention name(s): ALX-0171; ALX-0171; ALX-0171
Intervention type(s): Biological; Biological; Biological
Intervention description(s): single dose of 200 mg ALX-0171 via oral inhalation; repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days; Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
Intervention MeSH terms: Gontivimab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism of Action of Vichy Catalan Water
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated
      mineral waters are reported to have beneficial digestive and hypocholesterolemic properties.
      The aim of this study was to investigate the effects of the consumption of a
      sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral
      content water as a control water (CW), on postprandial serum triacylglycerols (TAG),
      cholecystokinin (CCK), and gallbladder volume.
    


Intervention name(s): Bicarbonated mineral water; Mineral water low in mineral content (control)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers fasted overnight consumed:
0.5 L of the bicarbonated mineral water without meal or, 0.5 L of the bicarbonated mineral water with meal; Volunteers fasted overnight consumed:
0.5 L of the control water without meal or, 0.5 L of the control water with meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular risk; Cholecystokinin; Gallbladder emptying; Lipid absorption; Postprandial triacylglycerols; Sodium-bicarbonated mineral water
Compatibility of Different Injury Prevention Exercises in Athletes
Condition: Injury Prevention
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This investigation is aimed to examine the effects of two different exercise-oriented
      protocols on the knee torque-angle relationship of the knee flexors.

      Thirty two young soccer players were be randomly assigned to three groups:
      hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The ECC
      and UNS groups performed eighteen sessions over 6 weeks of an injury prevention protocol,
      using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque
      relationship was measured before and after the training intervention. Voluntary isometric
      torque was recorded at six test angles, with participants prone (35º-100º; 0º on full
      extension).
    

Detailed description: 
      This study utilized a three parallel-groups randomized controlled design, where 3
      between-participant conditions, ECC, UNS and C, were tested. Once considered eligible for the
      study, all participants were familiarized with the testing procedures. Participants attended
      the laboratory for a pre-training test session, where body mass, height and muscle functional
      parameters were recorded. Two days after their pre-test, participants including in ECC or UNS
      started a 6 weeks (18 sessions) training program while the control group did not perform any
      type of resistance training.

      Nevertheless, during the 6 weeks intervention period all three groups continued with their
      normal recreationally physical activity consisting in 2 to 3 sessions per week of soccer
      training or friendly matches. Two days after the end of the intervention period muscle
      function was re-tested.
    

Intervention name(s): Eccentric hamstring exercises; Unistable exercises; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Three exercises: 3 sets of 8 repetitions with 1 minute of rest between sets and 2 minutes of rest between exercises; Three exercises: 3 sets of 8 repetitions with 1 minute of rest between sets and 2 minutes of rest between exercises; Only soccer training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: training, soccer, eccentric, lengthening, unstable, squatting
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)
Condition: Atrioventricular Nodal Reentry Tachycardia
MeSH terms: Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia
      are compared: The standard technique of radiofrequency energy delivery is compared with the
      new approach of cryo-energy application.
    

Detailed description: 
      The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering
      catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy
      of this approach is very high.

      However, the potential complication of higher degree AV conduction block, requiring in some
      instances implantation of a pacemaker, is a major drawback of this approach.

      We want to compare in this randomized study the safety and efficacy of standard RF ablation
      with the cryo-ablation technique. This relatively new technique is thought to offer more
      safety concerning higher degree AV conduction block.
    

Intervention name(s): RF-ablation; cryo ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia; Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns
Condition: Growth; Learning; Toddlers
Study type: Interventional

Summary: 
      This open-label clinical trial will gain evidence of the effect of an oral Nutritional
      Supplement (NS) to help improve catch-up growth and support learning skills in children with
      growth concerns.
    


Intervention name(s): Fortified Cow's Milk-Based Oral Nutritional Supplement
Intervention type(s): Other
Intervention description(s): The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5
      years after adjuvant radiotherapy in women with right sided breast cancer vs left sided
      breast cancer.
    

Detailed description: 
      This study reviews case series of patients with a history of breast cancer treated with
      radiotherapy for at least five years. The study measures atherosclerosis by using coronary
      and carotid artery calcium scoring.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        breast cancer patients after radiation treatment
      
Keywords: coronary calcium scoring; breast cancer patients; radiation treatment
Effect of Heatwave Over Glycemic Control in Patients With T1D
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Observational study about effect of the greatest Spanish heatwave over glycemic contro in
      adult patients with type 1 Diabetes mellitus.
    

Detailed description: 
      Cross-sectional retrospective analysis of all patients with T1D in Castilla-La Mancha
      (south-central Spanish region) using intermittently scanned continuous glucose monitoring
      (isCGM). Glycometric data obtained through deidentified downloads from isCGM´s webpage.
      Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the
      heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results
      are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon
      signed-rank test were used for the analysis of differences. Comparisons between proportions
      were analyzed using a chi-squared test. A P value < 0.05 was considered statistically
      significant. The protocol was approved by the reference Castilla-La Mancha Public Health
      Institute Ethic Committee.
    

Intervention name(s): Intermittenly scanned continuous glucose monitoring
Intervention type(s): Device
Intervention description(s): Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)
Other intervention name(s): FreeStyle Libre; isCGM; FSL
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult type 1 diabetes patients using intermittently scanned continuous glucose monitoring
        during and after the greatest Spanish heatwave.
      
Keywords: Diabetes; Type 1 diabetes
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of
      A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220
      mcg (T2), in healthy male and female adult volunteers.
    

Detailed description: 
      This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK
      study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of
      age.

      All candidates will be screened and only those who satisfy all enrollment criteria will be
      enrolled into this study. Each study subject will participate in a screening visit and four
      (4) study visits with one (1) randomized study treatment given in each visit.

      PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety
      evaluation will be conducted at the end of Study Visit-4.
    

Intervention name(s): A006 DPI; A006 DPI; Proventil® MDI; Proventil® MDI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose 110 mcg, 1 inhalation; Single dose 220 mcg, 1 inhalation; Single dose 90 mcg, 1 inhalation; Single dose 90 mcg, 2 inhalations
Other intervention name(s): Albuterol; Albuterol DPI; Albuterol; Albuterol DPI; Proventil®; Proventil®
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Albuterol
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Importance of effective postoperative pain management is well known. The undesired effects of
      pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean
      delivery, interaction between the mother and her newborn baby can be provided earlier. Many
      regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is
      to compare the postoperative analgesia effects of transversus abdominis plane block and
      rectus sheath block after elective cesarean delivery.
    


Intervention name(s): Transversus abdominis plane block; Rectus sheath block
Intervention type(s): Procedure; Procedure
Intervention description(s): Transversus abdominis plane block will be performed bilaterally after the surgery.; Rectus sheath block will be performed bilaterally after the surgery.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative pain; Transversus abdominis plane block; Rectus sheath block; Cesarean delivery
Itch Relieving Effect of Botox: a Study in Healthy Subjects
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if Botox is effective in the treatment of an
      experimentally induced itch that mimics chronic itch in healthy volunteers.
    

Detailed description: 
      Several studies have shown that botulinum toxin type A (BoNT/A) has an antipruritic effect
      due to the inhibition of acetylcholine and other pruritic factors, such as substance P and
      glutamate. For instance, subcutaneous BoNT/A improves itch accompanied to hand eczema,
      dermatitis, lichen simplex, and rhinitis. Furthermore, a double-blind, placebo-controlled
      study showed that BoNT/A reduced histamine itch intensity in healthy men. Since acetylcholine
      has been shown to mediate itch in atopic dermatitis, this study aims to test the itch
      relieving effect of BoNT/A on a non-histaminergic model for chronic itch. This
      non-histaminergic model using the plant cowhage induces itch by activating protease activated
      receptor 2 (PAR2) receptors, which play a role in the itch of atopic dermatitis, also making
      this model better suited to test the efficacy of BoNT/A to relive chronic itch.
    

Intervention name(s): Botox; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.; 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Itch; Botox; Healthy Volunteers
Pharmacokinetics of Enrofloxacin in Plasma and Urine
Condition: Healthy
Study type: Interventional

Summary: 
      Antibiotics like enrofloxacin are widely used in animal farming to treat and prevent
      bacterial infections. A previous study in poultry farms has shown that yardmen show
      significant concentrations of administered antibiotics in their urine. It is currently
      unclear how poultry yardmen are exposed to the administered antibiotics. The objective of
      this exemplarily study is to obtain information on the pharmacokinetics of the different
      uptake routes (oral, inhaled or dermal).
    

Detailed description: 
      Study subjects will be exposed to enrofloxacin at a concentration level representative for
      occupational exposure of yardmen at poultry farms.

      As three uptake-routes, oral, inhalation and dermal, are conceivable all three cases will be
      investigated. After administration blood and urine samples will be analysed for enrofloxacin
      and its main metabolite ciprofloxacin at several time points. The objective of this
      exemplarily study is to obtain information on the pharmacokinetics of the different uptake
      routes. If different exposure routes are characterized by different pharmacokinetics, such
      studies can be used to obtain a better understanding of general routes of exposure in
      occupational environments. On the basis of the results mitigation strategies can be
      developed, reducing the risk of exposure.
    

Intervention name(s): Enrofloxacin
Intervention type(s): Drug
Intervention description(s): dermal application, inhalation rsp. oral administration of Enrofloxacin
Intervention MeSH terms: Enrofloxacin
Intervention model: Single Group Assignment
Intervention model description: The subjects are exposed to 250 µg of enrofloxacin on three different dosing days that are separated by at least 7 days. On the first dosing day, enrofloxacin is administered via the dermal route. On the second dosing day, enrofloxacin is administered via inhalation of 5 mL solution in a concentration of 50 µg/mL by an ultrasonic nebulizer. On the third dosing day, enrofloxacin is administered orally as a 20 mL solution in a concentration of 12.5 µg/mL.
Masking: None (Open Label)
Primary purpose: Basic Science
Feedback and Psychotherapeutic Competencies
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The purpose of the current study is to examine the influence of feedback on psychotherapeutic
      competency. The present randomized controlled study compares a feedback condition with a
      non-feedback condition. Therapists in the feedback condition receive feedback after every
      fourth session. The feedback is given by two trained and independent raters. The raters are
      licenced and experienced psychotherapists. Therapists in the non-feedback condition receive
      no feedback during the psychotherapy.
    


Intervention name(s): No feedback; Feedback after every fourth session
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapists will receive no feedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Feedback; Therapeutic competencies; Training
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Condition: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomized-controlled, cross-over trial the investigators test the effect of
      long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases
      of 2 weeks on exercise performance and quality of life and many physiological parameters in
      patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.
    


Intervention name(s): long term oxygen therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic
      countries because migration of people infected with T. cruzi. Current methods for diagnosis
      of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce
      severe side-effects, and their effectiveness cannot be properly evaluated. Reliable
      biomarkers for prognosis, early diagnosis and effectiveness of treatment will be
      investigated.
    


Intervention name(s): Benznidazole
Intervention type(s): Drug
Intervention MeSH terms: Benzonidazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Migrants from Latin America visiting the Tropical Medicin Clinic
      
Biospecimen description: 
      Whole blood