bioihbjkbjnl/mcl2 huggingface dataset:
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
Condition: Candidiasis
MeSH terms: Candidiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The most common etiology of infection-related death or neurodevelopmental impairment in
      neonates with birthweight <750 g is invasive candidiasis. Over 70% of the premature neonates
      who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment.
      Fluconazole has been commonly used off-label in the neonatal intensive care unit, but
      definitive recommendations for its use in the nursery have been hampered by the limited
      number of well-designed trials. In neonates weighing <750 g, appropriate dosing is not known,
      definitive safety and long-term follow up trials have not been completed, and there have not
      been well-powered trials conducted to establish the efficacy of the product using mortality
      as part of the primary endpoint. Three recent proof-of-concept studies suggest that
      fluconazole will be safe and effective, and a recently completed pharmacokinetic study is
      providing data to give preliminary dosing guidance. The next logical step in drug development
      is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy
      of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment.

      362 neonates, with a birthweight <750g, were randomized at 33 US centers, to twice weekly
      fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint
      will be Candida-free survival at study day 49. The research will establish definitive dosing,
      safety, and efficacy of fluconazole; it will also provide critical information on the effects
      of fluconazole on neurodevelopmental impairment and antifungal resistance.

      Potential Impact:

      Approximately 17,000 neonates are born <750 grams each year in the United States. Over 5000
      will die or develop invasive Candida infections. Demonstrating safety and efficacy of
      fluconazole in preterm neonates will improve the survivability and long term outcomes for
      these neonates.
    

Detailed description: 
      362 subjects were randomized to the study at 33 US sites. Final study visits of Month 18-22
      corrected age long term follow up were completed. Study database is locked.
    

Intervention name(s): fluconazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses; normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses
Other intervention name(s): Diflucan
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Candida; Neonate; Fluconazole; Prophylaxis; Colonization; Resistance
BRCA1 and BRCA2 Mutation in Romanian Population: a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival
Condition: To Determine the Prevalence, Penetrance of BRCA1 and BRCA2 Mutations in Romanian Womens With Breast or Ovarian Cancer
Study type: Observational

Summary: 
      Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with
      breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by
      specific criteria for high-risk status including age at disease onset.

      Secondary objective Considering the fact that BRCA testing is not a routine procedure in
      Romania and mutation prevalence varies in different populations, we intend to look for the
      founder mutation in our population, running full BRCA genes sequencing to a representative
      population sample. This would allow a more targeted approach to real-life practice and would
      ensure personalized solutions for every patient in need.
    


Intervention name(s): NGS BRCA 1 and BRCA 2 full sequencing; Multiplex ligation-dependent probe amplification (MPLA) BRCA1 BRCA2
Intervention type(s): Genetic; Genetic
Intervention description(s): Firstly many pairs of probes, containing: a universal primer sequence, a specific hybridisation target sequence and a stuffer DNA region to vary the size of the resulting product, are hybridised adjacent to each other on the target DNA strand .The two adjacent probe sequences are ligated to form a continuous section of DNA.The ligated probes are then amplified using PCR. The amplified fragments are analysed by capillary electrophoresis to detect the different fragment lengths. These data can be analysed to show the relative copy number of each fragment that is present in the sample.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Womens who have been diagnosed with breast/ovarian cancer , carriers of a high risk of
        gBRCA mutations based on prespecified inclusion criterias
Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
Condition: Type 1 Diabetes Mellitus; Adolescent Behavior; Parent-Child Relations; Communication
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people
      with T1D are diagnosed at a young age; their parents have to manage their child's condition.
      Eventually, the child must begin to take steps to transition to self-management. During the
      transition from parent to adolescent self-management, difficulties arise because adolescents
      may not be fully aware of, or want, to take responsibility for all the necessary tasks to
      successfully manage their T1D. Though there are other apps on the market to help with
      diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app
      allows for monitoring the patients' T1D by linking their self-management information to their
      parents' cell phone, and thus also helps to bridge communication gaps. Prior research
      suggests that these are critical gaps that must be filled in order for successful transition
      in care to occur, the proposed app will help fill some of these gaps.
    


Intervention name(s): MyT1DHero
Intervention type(s): Device
Intervention description(s): A mobile phone application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Kava is a dietary supplement on the US market and is experiencing a resurgence of its use.
      Its pharmacokinetic information, however, is lacking which is important for its future
      effective usage as a dietary supplement or potentially as a botanical therapeutics. This
      phased trial, based on the recommendation from NIH, is to collect pharmacokinetic data of
      kava in healthy subjects.
    

Detailed description: 
      Kava is used in the South Pacific Islands for relaxation and socialization. It is available
      in the US as a dietary supplement, and was used in Europe in the 1990s to treat mild to
      moderate anxiety. Some clinical trials suggested kava's efficacy in treating generalized
      anxiety disorder (GAD), although a recent meta-analysis was inconclusive. While the
      mechanisms behind kava's anxiolytic activity are not well-established, its clinical use shows
      no signs of addiction or withdrawal. Kava thus is a promising and potentially novel
      anxiolytic with a unique mechanism of action. Although kava has been extensively consumed by
      humans for centuries, its pharmacokinetics have never been characterized in humans. Such
      knowledge is essential for its future studies of its anxiolytic potential and dose
      optimization. This study will characterize kava pharmacokinetics, which will set a solid
      foundation for its future clinical development. To establish kava pharmacokinetics, each
      participant will take three 75 mg kava capsules in a single dose and the absorption,
      distribution, metabolism and excretion of kava will be assessed, corresponding to the
      pharmacokinetic curve. Serum liver biochemistries will then be monitored for up to three
      months to test liver function response to kava.
    

Intervention name(s): Kava Dietary Supplement
Intervention type(s): Drug
Intervention description(s): Participants will be given three 75mg kava capsules.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: kava; dietary supplement; anxiety; generalized anxiety disorder (GAD)
Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The primary objective of this study is to analyze smart phone-based Transdermal Optical
      Imaging (TOI) features to develop a model that can discern hypohydration from euhydration
      status including 1) a small feasibility study for 24-hour data collection in the general
      population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise
      study in moderately active participants in both dehydrated and euhydrated states (EXERCISE).
      TOI data will be collected alongside standard reference measures of hydration status.

      This is an exploratory pilot proof of concept study with each subject serving as their own
      control.
    


Intervention name(s): GENPOP Passive dehydration (75% reduction in fluid intake; GENPOP Ad lib fluid intake; EXERCISE without fluid replacement; EXERCISE with fluid replacement
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Over 24-hours; Over 24 hours; 90-min standard cycling exercise trial in heat chamber; 90-min standard cycling exercise trial in heat chamber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hydration; dehydration; euhydration; hypohydration; exercise; Transdermal Optical Imaging; TOI
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Condition: Sinonasal Malignancies; Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
MeSH terms: Carcinoma, Squamous Cell; Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and
      efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and
      carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local
      control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial
      includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal
      malignancies.
    

Detailed description: 
      Local control in sinonasal malignancies is dose dependent. However, dose escalation at
      acceptable toxicity is technically demanding even with modern radiotherapy techniques.
      Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher
      doses at comparable or reduced side-effects.

      Methods/ design:

      The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in
      the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12)
      boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or
      squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE
      carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

      Study objectives:

      Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local
      control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and
      late toxicity at 2 years post RT)are secondary endpoints.
    

Intervention name(s): carbon ion boost
Intervention type(s): Radiation
Intervention description(s): 8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMRT; carbon ion therapy; paranasal sinus; nasal cavity; adenocarcinoma; squamous cell carcinoma
Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease
Condition: Virtual Reality; Rehabilitation; Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Virtual-reality-based interactive treadmill system will be applied to the Parkinsons' disease
      patients who can walk (Hoehn and Yahr stage 2 to 4). Subjects will be randomly allocated to
      either VR-based treadmill training group or treadmill training without VR-based interaction.
      The training will be provided for 3 sessions (30min/session)/week for 4weeks, the total of 12
      sessions. The outcomes will be measured at baseline, immediately after the completion of the
      intervention and 1 month after the intervention.
    


Intervention name(s): Virtual reality-based interactive treadmill training; Treadmill training without VR-based interaction
Intervention type(s): Device; Device
Intervention description(s): During the 30-min training session, VR based interaction and feedback will be provided; the foot location will be visualized in the VR screen (semi-immersive condition), the obstacles will be seen in the screen from which subjects has to avoid, gait speed will be visualized, slopes of the treadmill will be changed according to the slope changes in VR and distractors will be added. Dual tasks will also be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of VR-based training.; Treadmill training without VR-based interaction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chemoprevention With Folic Acid
Condition: Colon Cancer; Adenoma; Colonic Polyps
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      Colorectal neoplasia is the second most common cancer in the United States and other Western
      countries with about 140,000 newly diagnosed cases per year in the United States with a
      mortality rate of about 40%. The identification of a specific natural or synthetic compound
      with the ability to reverse or suppress the process of colon carcinogenesis would have
      profound implication in the development of colorectal adenomas and their subsequent
      transformation to colon cancer. Furthermore, the establishment of a correlative relationship
      between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence
      would provide pivotal data required to elucidate cell signaling mechanisms in future colon
      cancer chemoprevention trials.
    


Intervention name(s): Folic Acid
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
Condition: Healthy
Study type: Interventional

Summary: 
      This is a single site, blinded, randomized, controlled study designed to examine
      phytochemical absorption, metabolism and excretion, as well as vascular health and satiety,
      after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Eligible
      participants will attend 6 in-person clinic visits for comparative testing of the 4 bean
      varieties versus lentils and rice.
    

Detailed description: 
      This is a single site, blinded, randomized, controlled study designed to examine
      phytochemical absorption, metabolism and excretion, as well as vascular health and satiety,
      after ingestion of 4 different bean varieties (pinto, navy, red kidney, black).

      Recruitment will consist of a total of 8 volunteers. Volunteers will be recruited through
      advertisement from the local community.

      The study will be conducted at the I.H. Asper Clinical Research Institute,located at the St.
      Boniface Hospital. Participants will be asked to provide written informed consent prior to
      participation in the study. Participants who have provided written consent will be asked to
      attend an in-patient visit to provide a fasting blood sample. Should the participant be
      eligible to participate, they will be scheduled for six study visits to assess the
      bioavailability, metabolism and excretion of phytochemicals present in beans compared to
      lentils and white rice.

      Uptake, metabolism and excretion of phytochemicals present in different varieties of beans
      during acute phase testing in healthy individuals will be examined. Possible relationships
      between phytochemical composition of the beans, arterial function and satiety will be
      investigated as the secondary objective.
    

Intervention name(s): Navy Beans (cooked); Red Kidney Beans (cooked); Pinto Beans (cooked; Black Beans (cooked); Lentils (cooked); White Rice
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): One time consumption of 3/4 cup of cooked navy beans.; One time consumption of 3/4 cup of cooked red kidney beans.; One time consumption of 3/4 cup of cooked pinto beans.; One time consumption of 3/4 cup of cooked black beans.; One time consumption of 3/4 cup of cooked lentils.; One time consumption of 3/4 cup of cooked white rice.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Keywords: Beans, Lentils, Bioavailability, Phytochemical Absorption
A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of an oral solution of
      CDX-6114 when administered as a single dose in healthy volunteers
    

Detailed description: 
      This is a second Phase 1, double-blind, placebo-controlled study in approximately 24 healthy
      volunteers who are 18 to 55 years old. Three cohorts are planned each consisting of 8
      subjects; the cohorts as planned are 7.5, 15.0 and 22.5 g of CDX-6114 (or matching placebo)
      in oral solution. Increasing doses of CDX-6114 will be assessed sequentially un til the final
      dose is evaluated or any of the stopping criteria are reached. Subjects will each receive
      either a single dose of CDX-6114 or matching placebo, with food, and will then be followed
      for a total of 22 days (3 weeks).
    

Intervention name(s): CDX-6114; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CDX-6114 will be administered as a single, oral dose solution at dose levels of 7.5, 15.0 and 22.5g; Phosphate Buffer Diluent oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose-escalating, Randomized, Double-Blinded,. Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
Condition: Post-Hysterectomy Vaginal Vault Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse; Depression
Study type: Interventional

Summary: 
      To find out the Effects of deep breathing exercises with and without Progressive Muscle
      Relaxation Technique on depression and Quality of life in females with hysterotomy
    


Intervention name(s): Deep breathing excercises; Deep breathing exercises +and progressive muscle relaxation techniques
Intervention type(s): Other; Other
Intervention description(s): Deep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve; Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression, Hysterectomy, Progressive muscle relaxation technique
Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT
Condition: Acute Post-operative Pain; Cholecystectomy, Laparoscopic; Pain Assessment Pain Intensity; Pain Intensity
MeSH terms: Pain, Postoperative; Pain
Study type: Interventional

Summary: 
      evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain
      management.
    

Detailed description: 
      Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern,
      leading to extended hospital stays or readmissions. In majority of patients, postoperative
      pain medications are required. A standardized strategy is needed to offer effective pain
      relief postoperatively. The majority of pain in the early postoperative period is due to
      elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to
      evaluate the two final steps we added to optimize postoperative pain management. Patients and
      methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder
      stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A;
      interventional contained 402 patients. Group B; control contained 402 patients.
      Post-operative data to be compared were made in terms of operative time, shoulder pain, upper
      abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay.
      Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.
    

Intervention name(s): active gas aspiration
Intervention type(s): Procedure
Intervention description(s): sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites
Other intervention name(s): application of Bupivacaine soaked sponge
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention