bioihbjkbjnl/mcl2 huggingface dataset:
Improved Quality of the Treatment and Increased Compliance in Asthmatics Through the Dialog Tool Soren - Between Patient and Caregiver
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of the study is to assess if a dialog tool can improve compliance and asthma
      control in patients with asthma.
    


Intervention name(s): Dialog tool for caregivers
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Asthma; dialog tool; compliance
Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow
      and may help a person's immune system recover from the side effects of the chemotherapy used
      in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace
      immune cells that were destroyed by chemotherapy.

      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation,
      chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase
      chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow
      transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this
      regimen in these patients.

      OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are
      treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative
      chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative
      regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone marrow
      transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180, and
      interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6
      months for 2 years, and then annually for 3 years.

      PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.
    

Intervention name(s): recombinant interferon alfa; sargramostim; autologous bone marrow transplantation
Intervention type(s): Biological; Biological; Procedure
Intervention MeSH terms: Interferons; Interferon-alpha; Sargramostim
Primary purpose: Treatment
Keywords: relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia; Philadelphia chromosome negative chronic myelogenous leukemia
Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      This is a study of the genetics of malaria transmission by the mosquito vector in Africa,
      Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected
      with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by
      microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that
      control mosquito resistance to malaria parasites.
    

Detailed description: 
      A standard diagnostic blood smear from a drop of blood will be carried out on 20 study
      subjects once per month. One malaria-positive subject from among the 20 will be asked to
      donate 5cc of blood, also no more frequently than once per month. The blood will be placed in
      a water-jacketed heated membrane feeding device that will be positioned on top of a cage of
      mosquitoes. The mosquitoes are attracted to the warmth and drink the blood through the
      artificial skin-like membrane. The goal of the research is to study the infected mosquitoes.
      No studies will be carried out on the human subjects. The point of human subjects involvement
      is to obtain the naturally malaria-infected blood for feeding of mosquitoes. After blood
      feeding, the mosquitoes are held in an environmental chamber for one week, at which time they
      are dissected to count numbers of malaria parasites developing on the mosquito stomach wall.
      This number constitutes the quantitative phenotype, and we extract genomic DNA from the
      carcass for genetic marker typing, which constitutes the genotype. Genetic linkage analysis
      identifies markers near genes that control parasite number, thus resistance or susceptibility
      to parasite infection.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
Baby Dvd Effects on Cortisol
Condition: Infant Development
Study type: Interventional

Summary: 
      The investigators will do an experiment where 9-12 month old infants are randomized to 30
      minutes of block play or 30 minutes of watching a baby DVD.
    


Intervention name(s): block play; baby dvd
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 minutes of block play; 30 minutes of dvd viewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Salivary cortisol measured after DVD watching or block play
Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      We evaluated the effect of two weeks of intensive supervised physical activity in serum
      fibroblast growth factor 21 (FGF21) levels.
    

Detailed description: 
      Comparative and longitudinal study. Anthropometric and biochemical evaluation were done
      before, 1hr and 4hr after a bout of exercise and repeated after two weeks of daily supervised
      exercise. We studied sedentary young healthy women. A treadmill exercise test (following the
      Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks. The
      Department of Endocrinology and Metabolism at the INCMNSZ performed all biochemical
      laboratory measurements using standardized procedures.
    

Intervention name(s): Supervised Exercising
Intervention type(s): Other
Intervention description(s): A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.
Other intervention name(s): Bruce's protocol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Fibroblast growth factor 21 (FGF21); Exercise; Metabolic equivalents (METs); Lipolysis; Glucose; Free fatty acids (FFAs); Epinephrine
Study to Evaluate the Effect of Naltrexone and Bupropion Combination on the Pharmacokinetics of Metformin in Healthy Participants
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of multiple oral doses of
      naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.
    

Detailed description: 
      The drug being tested in this study is naltrexone HCl and bupropion HCl Extended- Release
      fixed dose combination (NB) . This study will evaluate the potential effect of multiple oral
      doses of extended-release combination of naltrexone/bupropion on the PK of a single oral dose
      of metformin in healthy participants with normal renal function (defined as creatinine
      clearance [CrCl] greater than equal to [>=] 90 milliliter per minute [mL/min]/1.73 meter
      square [m^2]).

      The study will enroll approximately 30 participants. Participants will receive:

      Metformin 850 mg as a single dose alone and in combination with multiple doses of
      Naltrexone/Bupropion Naltrexone 8 mg/Bupropion 90 mg + Naltrexone 16 mg/Bupropion 180 mg as
      multiple doses alone and in combination with a single dose of metformin

      All participants will be asked to take 1 tablet of metformin in the morning on Day 1 and Day
      14, 1 tablet of naltrexone/bupropion twice daily from Day 3 through Day 5, and 2 tablets of
      naltrexone/bupropion twice daily from Day 6 through Day 15.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is 73 days. Participants will be admitted on Day -1 (check in) and
      remain confined to the clinic until Day 16 and will be contacted by telephone 30 (±2) days
      after last dose of study drug for a follow-up assessment. Serial blood samples will be
      collected for PK assessments. Safety will be monitored throughout the study.
    

Intervention name(s): Naltrexone/Bupropion; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone/Bupropion extended-release tablets.; Metformin immediate-release tablet.
Intervention MeSH terms: Metformin; Naltrexone; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Therapy
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This is a prospective, open label, single arm, and observational and multicenter study to
      assess the correlation between PEST and SCORAD scores in the management of AD with the
      Ceradan® regimen.
    

Detailed description: 
      All eligible patients shall apply permitted topical steroid(s) according to standard local
      practice

      For the entire study period, patients should apply Ceradan Cream® liberally twice daily or
      more, if required and use a non-soap based wash once or twice daily.

      At the screening visit, patients will receive a diary card and will be asked to track their
      atopic dermatitis symptoms for 12 weeks.

      Retrospective information on other topical treatments used will be collected at baseline.
    

Intervention name(s): Ceradan Cream; Ceradan Wash
Intervention type(s): Other; Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children Aged Six Months to Six Years with Atopic Dermatitis
      
Keywords: Children; Atopic Dermatitis; Ceradan; PEST; SCORAD
The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity
Condition: Covid19; Breathing Exercise; Cardiovascular Diseases
MeSH terms: COVID-19; Respiratory Aspiration; Cardiovascular Diseases
Study type: Interventional

Summary: 
      Objective propose: to investigate the effect of home based breathing exercise and chest
      mobilization on the cardiorespiratory functional capacity of Covid-19 survivors with
      cardiovascular comorbidity.

      Breathing exercise and chest mobilization are proven to increase lung functional capacity in
      Covid-19 survivors. It is hypothesized that breathing exercise and chest mobilization in
      Covid-19 survivors will give benefits to Covid-19 survivors with cardiovascular disease.
    

Detailed description: 
      Lung restrictive disorder is one of the reasons that induce chronic fatigue in COVID-19
      (Corona Virus Disease-19) survivors. It also gives a significant effect on cardiovascular
      patients who are in the second phase of cardiac rehabilitation. Breathing exercise and chest
      mobilization are proven to increase lung functional capacity in Covid-19 survivors. On the
      other hand, there is still no research that shows the effectiveness of Breathing exercises
      and chest mobilization in Covid-19 survivors who are suffering from cardiovascular problems.

      Patients in National Cardiac Center Hospital, Jakarta, with a history of Covid-19 and have
      cardiovascular disease are recruited. They will undergo pre and post-exercise examinations
      such as blood sampling, do 6 minutes walking test, Peak Cough Flow and Peak Flow Rate test,
      measuring the chest dimension, treadmill, and answer the European Quality of Life Five
      Dimension (EQ-5D) questions. With randomization, patients will be determined to treatment or
      control group. They will be prepared about what exercises should they do at home. Subjects
      will be supervised digitally and regularly through Zoom meetings. Exercises will be done for
      3 months.
    

Intervention name(s): Breathing and chest mobilization exercises; Second phase cardiac rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients walk regularly 5 times per week and increase the distance day by day according to their improved ability. Patients also do breathing and chest mobilization exercise 3 times per week. It is a recorded moderated exercise for 30 minutes duration. Patients can access the video as a home-based activity through an online videos platform and will be supervised.; Independently, patients walk regularly 5 times per week and increase the distance day by day according to their improved ability without breathing and chest mobilization exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients
Condition: Pain, Postoperative; Anesthesia, Regional
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to investigate the analgesic effects of thoracal paravertebral block
      in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to
      the study group. Conventional analgesia methods were applied to the control group.
    

Detailed description: 
      Randomization was divided into two groups by using closed envelope method. Postoperative pain
      scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain
      = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a
      deep Breath) were evaluated. Patients with VAS> 4 received additional analgesics.
    

Intervention name(s): paravertebral block
Intervention type(s): Procedure
Intervention description(s): paravertebral block group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paravertebral block group and Control group
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Pain management; Analgesia; paravertebral block; nephrolithotomy
Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
Condition: Bipolar I Disorder; Current Episode Depressed
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether creatine monohydrate is effective as an
      adjuvant treatment for bipolar depression.
    

Detailed description: 
      Bipolar Depression is associated with high rates of disability and increased mortality.
      Despite its major negative impact, treatment of Bipolar Depression is still controversial and
      only partially efficacious, with over half of patients not responding adequately to available
      treatment. In this context, the use of drugs that modulate energy metabolism has been
      proposed as promising new option as treatment strategies for bipolar depression. The aim of
      our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled
      clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.
    

Intervention name(s): creatine monohydrate; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
Condition: Stenosis Cervix
MeSH terms: Uterine Cervical Dysplasia; Constriction, Pathologic
Study type: Interventional

Summary: 
      Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and
      amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para
      dilatar canal endocervical") placed just after the conization, in order to evaluate the
      safety, efficacy and quality of life.
    

Detailed description: 
      This device has the potential to improve outcomes by means of a significant stenosis
      reduction and maintain patency of the endocervical canal to view the squamo-columnar junction
      (SCJ) of the cervix during follow-up of this patient.
    

Intervention name(s): DUDA device; LEEP
Intervention type(s): Device; Procedure
Intervention description(s): Insertion DUDA device; Loop Electrosurgical Excision Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Intraepithelial Neoplasia; stenosis; cervix; medical device; inventories; Uterine Cervix; Intrauterine Devices; intrauterine; conization; loop electrosurgical excision
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, one treatment, four group, parallel group study to
      investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in
      participants with different levels of hepatic function. Participants with mild, moderate or
      severe hepatic impairment ('Mild', 'Moderate' and 'Severe' groups), and control participants
      with normal hepatic function ('Normal' group) will each receive a single 100 mg dose of
      entrectinib after consumption of a standardized meal.
    

Detailed description: 
      Participants with reduced hepatic function will be assigned to a functional category based on
      assessments at the Screening visit. Each individual will be categorized according to the
      Child Pugh system for classifying hepatic impairment and also according to the National
      Cancer Institute organ dysfunction working group (NCI-ODWG) system. Recruitment will be
      staggered to allow review of pharmacokinetic and safety data from at least three participants
      in each of the Mild and Moderate groups before participants are enrolled into the Severe
      group. Recruitment of the Severe group will only proceed if there is agreement between the
      Sponsor and the Investigator that data from this group are necessary to fulfill the
      objectives of the study and that dosing is not anticipated to present an unacceptable risk to
      those individuals. The control group of participants with normal hepatic function will be
      enrolled after the full complement of participants with hepatic dysfunction has been dosed.
    

Intervention name(s): entrectinib
Intervention type(s): Drug
Intervention description(s): 1x100 milligram (mg) capsule given with approximately 240 milliliter (mL) of water within 30 minutes of consumption of a standardized meal
Other intervention name(s): F06 formulation; Rozlytrek
Intervention MeSH terms: Entrectinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment
The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair
Condition: Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Transversus abdominis plane block is
      superior to placebo or superior to local infiltration in analgesic efficacy after groin
      hernia repair.
    


Intervention name(s): Transversus abdominis plane block; Saline; Local infiltration
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): UL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline; UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose; Ilioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose
Other intervention name(s): postoperative pain, UL-guided block; postoperative pain.; Local wound infiltration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transversus abdominis plane block
Correlation of the Paediatric Tracheal Tube Size
Condition: Pediatric Tracheal Tube Size
Study type: Observational

Summary: 
      In the context of the study a retrospective data collection of all anaesthesia protocols of
      children under the age of 12 which underwent surgery in the Charité - University Medicine
      Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The
      correlation of the tracheal tube sizes with the weight, age and height shall be evaluated.
      This data collection should serve to reevaluate the already published formulas e.g. (Rettberg
      M. et al., 2011).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children under the age of 12 who underwent surgery in the Charité - University Medicine
        Berlin, Campus Virchow - Klinikum in the years 2011/12
Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training
Condition: Improved VO2max and Cardiac Output in Response to Training
Study type: Interventional

Summary: 
      The purpose of this study was to determine if ethnicity alters training responsiveness to a
      low dose of high intensity interval training in inactive women.
    

Detailed description: 
      Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9
      sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of
      cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is
      well-tolerated in inactive individuals. Continuously during each session, heart rate was
      monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity
      enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to
      training, as well as post.
    

Intervention name(s): High intensity interval training
Intervention type(s): Other
Intervention description(s): Repeated, brief, and intense exercise bouts separated by active recovery
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This study was a longitudinal, repeated measures between subjects design.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIIT; Inactive; Women