bioihbjkbjnl/mcl2 huggingface dataset:
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
Condition: Rheumatoid Arthritis; Diabetic Neuropathy; Fibromyalgia; Irritable Bowel Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Irritable Bowel Syndrome; Diabetic Neuropathies
Study type: Interventional

Summary: 
      CT-100 is a platform that provides interactive, software based therapeutic components that
      may be used as part of a multimodal treatment in supplementary or standalone prescription or
      nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click
      Therapeutics, Inc. (Click).
    

Detailed description: 
      The Study App (CT-100-002) contains a class of Digital Neuro-activation and Modulation
      (DiNaMo™) mechanisms of action that are part of the Click Neurobehavioral Intervention (CNI)
      Platform™. DiNaMo™ provide interactive, software based therapeutic components that may be
      included in a multimodal treatment for developing future digital therapeutics.

      Chronic pain is a transdiagnostic condition which manifests in patients with diverse
      underlying pathologies such as rheumatoid arthritis, diabetic neuropathy, fibromyalgia, and
      irritable bowel syndrome. This basket study aims to evaluate the efficacy, safety, and
      tolerability of CT-100-002 on measures of pain, pain-related functioning, and mood across
      multiple indications. The study results will further future clinical development of digital
      therapeutics comprising DiNaMo™ mechanisms of action.
    

Intervention name(s): DiNaMo Study App; Placebo App
Intervention type(s): Device; Device
Intervention description(s): Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy; Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet
      with that of a standard diet in treating patients who have prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the inhibition of growth of human prostate cancer cell lines by serum from
           patients with prostate cancer before and after being fed a low fat, high fiber diet.

        -  Determine the underlying mechanism through which a low fat, high fiber diet affects the
           growth of prostate cancer cell lines.

        -  Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell
           lines through androgen-dependent and/or androgen- independent mechanisms in these
           patients.

        -  Determine the growth factors, hormones, and/or binding proteins that may be responsible
           for affecting the growth of prostate cancer cell lines in these patients.

      OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.

        -  Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.

        -  Arm II: Patients receive a control diet containing the standard amounts of fat and
           fiber.

      PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within
      6 months.
    

Intervention name(s): therapeutic dietary intervention
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Prevention
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer
Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with
      moderate to severe hidradenitis suppurativa (HS).
    


Intervention name(s): BDB-001 Injection; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple IV infusions of BDB-001 Injection diluted in sodium chloride; Multiple IV infusions of Placebo Injection diluted in sodium chloride; Multiple IV infusions of Placebo Injection diluted in sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass
Condition: Bariatric Surgery; Alcohol Consumption; Cognitive Function
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster
      resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol
      effects after gastric bypass we suggest that also general cognitive function is stronger
      impaired.

      Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8
      normal weight subjects) in the study. Each participant had to drink 250 ml white wine.
      Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions
      were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm.
      During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes
      with breathalyser "Dräger Alcotest 7510".
    


Intervention name(s): 250 ml alcohol consumption
Intervention type(s): Behavioral
Intervention description(s): Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
AZ, MZ, and the Pulmonary System Response to Hypoxia
Condition: Altitude Sickness; Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Altitude Sickness; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ)
      and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction.
      The first objective is to assess the effects of AZ and MZ on the control of breathing in
      normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon
      dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In
      addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic
      ventilatory response will be measured with each drug. The second objective is to assess the
      effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary
      pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.
    


Intervention name(s): Acetazolamide; Methazolamide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acetazolamide; Methazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Acetazolamide; Methazolamide; Control of breathing; Hypoxic pulmonary vasoconstriction
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Condition: Growth in Premature Infants
MeSH terms: Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      We hypothesize that premature infants who receive their mothers' expressed breast milk
      supplemented with liquid protein early in their hospitalization will have a growth velocity
      in the first 28 days of life that is 20% greater than the growth velocity of premature
      infants that do not receive protein fortification.
    


Intervention name(s): liquid protein supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.
Other intervention name(s): Abbott liquid protein supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding
Condition: Variceal Rebleeding
Study type: Interventional
Phase: Phase 4

Summary: 
      Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study
      was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide
      mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.
    

Detailed description: 
      Bleeding from esophageal varices is a severe complication of portal hypertension. After
      initial control of acute variceal bleeding, patients have up to a 70% risk of rebleeding. Of
      those do rebleed, there is a 20%-35% mortality rate. Therefore, preventive procedures are
      required for patients surviving an episode of acute variceal bleeding. Both endoscopic
      injection sclerotherapy (EIS) and propranolol have been well documented to be effective for
      the prevention of variceal rebleeding. In recent years, endoscopic variceal ligation (EVL)
      has replaced EIS as the endoscopic treatment of choice in the management of bleeding
      esophageal varices. On the other hand, the addition of isosorbide-5-mononitrate (ISMN) has
      been shown to be even more effective than propranolol alone in the reduction of portal
      pressure and in the prevention of variceal rebleeding. A controlled trial showed that the
      combination of nadolol and ISMN was better than EIS in terms of prevention of variceal
      rebleeding and complications. The combination of nadolol and ISMN has been shown to be better
      than EVL in preventing variceal rebleeding. However, our study showed a contradictory result.
      On the other hand, carvedilol is shown to be superior to propranolol to reduce the portal
      pressure. This study was undertaken to compare the effectiveness and complication rates of
      nadolol and ISMN with carvedilol in the prevention of rebleeding from esophageal varices.
    

Intervention name(s): carvedilol; nadolol + ISMN
Intervention type(s): Drug; Drug
Intervention description(s): 6.25mg per day, increase to 6.25mg bid; nadolol 40-80mg ISMN 10-20mg
Intervention MeSH terms: Nadolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: beta blocker; variceal rebleeding; efficacy and safety in reducing variceal rebleeding
24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Electrolyte Imbalance
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Association between excretion pattern and development trajectory of urinary electrolytes
      (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine
      phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol)
      and adverse prognosis in patients with chronic kidney disease
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Age ≥ 18 years, chronic kidney disease patients without kidney replacement therapy who had
        24-h urine eletrocyte tests.
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety,
      pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel
      monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male
      volunteers.
    

Detailed description: 
      IL-17 is a new potential therapeutic target which plays important role in pathogenesis of
      several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - SLE and
      MS. BCD-085 is a novel humanized monoclonal antibody against human IL17 developed by JCS
      BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-085-1 study is the
      first-in-human clinical trial which is intended to evaluate tolerability, safety,
      pharmacokinetics and immunogenicity of BCD-085 when used as a single step-by-step escalating
      subcutaneous dose in healthy male volunteers. During this study it is expected to determine
      diapason of safety doses of BCD-085 (incl. MTD) which thereafter can be evaluated in phase 2
      studies.
    

Intervention name(s): humanized monoclonal antibody against human IL-17
Intervention type(s): Drug
Other intervention name(s): BCD-085
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interleukin-17; maximum tolerated dose; novel monoclonal antibody
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Condition: Hypogonadism; Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 1

Summary: 
      The combination of testosterone and dutasteride is intended for use in hypogonadal men. This
      study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone
      administered with and without dutasteride
    


Intervention name(s): Nanomilled testosterone; commercially available dutasteride; Nanomilled dutasteride
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): commercially available dutasteride; Nanomilled testosterone
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testosterone; Men; Hypogonadism; Dutasteride; DHT; Androgen deficiency
Perioperative Anxiety in Children
Condition: Nurse's Role
Study type: Interventional

Summary: 
      The study was conducted to evaluate the effect of preoperative patient education given by
      three different methods on the level of perioperative anxiety in children aged 4-7 years. The
      research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University
      Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients,
      22 patients in each group, who met the inclusion criteria and were included in the stratified
      randomization method, were included in the planned quasi-experimental study. Research data
      were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool
      Children" administered before and after the surgery.
    

Detailed description: 
      Pre-operative patient education was given to the children in the first experimental group by
      the service nurse. The children in the second experimental group were given pre-operative
      patient education by the service nurse, in addition, patient visits were provided by the
      operating room nurse and the operating room environment was explained through play. The
      children in the third experimental group were given pre-operative patient education by the
      service nurse, after which they listened to the mother's voice recording and loving words
      until they went to the operating room. It was determined that 69.7% of the mothers of the
      children participating in the study were 30 years and older, 81.8% were married, 37.9% were
      undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of
      those who had no previous surgery experience were found significantly higher than those who
      had previous surgery experience (p<0.05). In terms of affecting the anxiety level, there was
      a significant difference between the preoperative methods (p<0.05). It was determined that
      the education given by both the service nurse and the operating room nurse together was more
      effective than other methods in reducing the anxiety levels of children, and there was a
      statistically significant difference between them. (p<0.05)
    

Intervention name(s): Preoperative patient education given with three different methods
Intervention type(s): Other
Intervention description(s): To determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; child sick; surgical nursing
Immunogenicity and Safety of Adacel Polio Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is designed to meet the requirements of the Taiwanese Health Authorities
      for registration of ADACEL POLIO in Taiwan.

      Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples
      will be taken for antibody titration. The expected total duration of follow-up for each
      subject will be 28 days.
    


Intervention name(s): TdcP-IPV vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): ADACEL POLIO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis
Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars
Condition: Scar
Study type: Interventional

Summary: 
      This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex
      laser or no treatment results in a better outcome in the quality of the surgical scar using
      the multiplex cynergy laser, starting treatment the day of suture removal.
    

Detailed description: 
      This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex
      laser or no treatment results in a better outcome in the quality of the surgical scar using
      the multiplex cynergy laser, starting treatment the day of suture removal.

      Patients will be offered the opportunity of enrolling in the trial before their surgery. If
      they qualify and agree to participate they will sign informed consent and Health Insurance
      Portability and Accountability Act (HIPAA) form.

      The surgical defect should be closed primarily, with the minimal scar length being 3cm. The
      scar will be randomized into 3 equal thirds, each third will randomly receive either: no
      treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be
      performed over a period of 3 weeks (one treatment session performed every week), and the
      patient will come in for a final follow up visit, for a final assessment of the scar using
      the Patient and Observer Scar Assessment Scale (POSAS) system.
    

Intervention name(s): 595/1064nm Multiplex Laser; 595nm PDL
Intervention type(s): Device; Device
Intervention description(s): The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.; One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant scar was randomized to the 3 treatment arms.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pain Evaluation of Venous Cannulation to Predict Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The investigators have recently reported a relationship between pain induced by peripheral
      venous cannulation and postoperative pain. The purpose of this study is to validate this
      method of postoperative pain prediction in a larger cohort subjected to different types of
      surgery.
    

Detailed description: 
      -  The investigators will study all adult (>18 years old) patients going through surgery at
           the site during a defined period of time. Before induction of anesthesia participants
           will be asked to assess (in VAS units) the pain intensity associated with peripheral
           venous cannulation. The maximum level of postoperative pain intensity will be recorded
           in the post-anesthesia care unit.

        -  After the endpoint of the study, the patient records will be reviewed, and de-identified
           relevant data be recorded and analyzed in the Statistical Package for the Social
           Sciences (SPSS) software.

        -  Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation
           assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those
           scoring < 2.0 - corresponding to a difference in maximum postoperative pain intensity of
           almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80
           % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain
           intensity level between patients scoring above or below 2.0 VAS units, respectively,
           would require 55 patients in each group subjected to the same kind of surgery. With 4
           groups of cases and controls 440 patients would need to be included. As the study is
           strictly observational, 600 patients will be included to make up for possible missing
           data.

        -  Statistics: The Mann-Whitney U- test will be used to compare differences in
           postoperative pain intensity levels, and the Pearson Chi-square test to compare
           proportions of patients with moderate or severe postoperative pain, in patients
           differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic
           regression analysis will be used to adjust for gender and age and to evaluate the
           predictive ability of proposed method.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for elective surgery at Hallands Hospital Halmstad