bioihbjkbjnl/mcl2 huggingface dataset:
A Study of AZD8233 in Participants With Dyslipidemia
Condition: Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study
      aims to evaluate the dose-dependent reduction in LDL-C after SC administration of multiple
      doses of AZD8233 as well as the associated adverse effects profile. The data generated will
      be used to guide choice of doses, dosing regimens, and sample sizes, as well as safety and PD
      monitoring in the further clinical development program.
    

Detailed description: 
      This is a randomized parallel, double-blind, placebo-controlled, dose-ranging Phase 2b study
      in approximately 108 participants with dyslipidemia. The primary objective of the study is to
      investigate the effect of AZD8233 on LDL-C across different dose levels. The study will be
      conducted at up to 25 sites in up to 4 countries.

      The screening period starts up to 42 days before the randomization visit and ends on Day -1.
      Eligible participants will attend 7 visits during the treatment period and 7 additional
      visits during the safety follow up period. Eligible participants are randomized across four
      different treatment arms in a 1:1:1:1 ratio for a 12-week treatment period. The planned
      treatment arms are AZD8233 low dose, AZD8233 medium dose, AZD8233 high dose, and Placebo.
      Participants will be dosed SC on Days 1, 8, 29, and 57.
    

Intervention name(s): AZD8233; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.; Placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dose Range Finding; AZD8233; Efficacy; PK; PD; Immunogenicity; Safety; Tolerability
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
Condition: Tumors
Study type: Interventional

Summary: 
      This study is a clinical trial of prospective, two-center, single-arm objective performance
      criteria. This trial will be conducted in 2 clinical trial sites with a total of 47 subjects
      enrolled. All of subjects will be treated with radiation therapy using the medical device
      Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective
      performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy
      system for oncology patients, providing a clinical basis for the medical device registration.
    

Detailed description: 
      Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen,
      spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to
      enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period
      after the last treatment is divided into short-term follow-up and long-term follow-up, in
      which short-term follow-up will be 3 months after the end of the last treatment. Total
      expected participation for each subject from screening to the completion of short-term
      follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after
      the end of short-term follow-up until the 5th year after the end of the last radiotherapy
      session.
    

Intervention name(s): Proton Therapy System (ProBeam)
Intervention type(s): Radiation
Intervention description(s): All of subjects (tumor patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors) will be treated with Proton radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam). The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months ( for this trial). Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.
Intervention model: Single Group Assignment
Intervention model description: a clinical study of prospective, single-arm objective performance criteria
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nervous system; head; neck; chest; abdomen; spine
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
Condition: Pediatric Hypertension With or Without CKD
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess efficacy, safety and tolerability of valsartan when comparing two doses of
      valsartan in reducing and controlling blood pressure in children with hypertension with or
      without CKD.
    


Intervention name(s): VAL489; VAL489 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Valsartan 3mg/kg oral solution; Valsartan 3 mg/kg oral solution
Other intervention name(s): Diovan; Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; CKD; Pediatric
Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make
      tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine
      after surgery may kill any remaining tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine
      together with radiation therapy works in treating patients with nonmetastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the safety and feasibility of concurrent capecitabine and standard
           external-beam irradiation in patients with high-risk early stage breast cancer.

      Secondary

        -  To determine the effects of concurrent treatment on cosmesis and wound healing at 1
           year.

        -  To determine the short-term (1-year) risk of recurrence of breast cancer in these
           patients.

      OUTLINE: This is a multicenter study.

      Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently
      receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately
      6-7 weeks.

      After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6
      months, and 12 months.
    

Intervention name(s): capecitabine; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; male breast cancer; recurrent breast cancer
Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce
      the risk of diabetes-related complications. Despite technological advances such as the use of
      insulin delivery devices and continuous glucose monitoring, the average glycemic control in
      T1D is poor. Though dietary management plays a major role in the overall management of T1D,
      and it is often classified as the most challenging aspect of treatment, the 2019 Standards of
      Medical Care in Diabetes for children and adolescents do not clearly address dietary
      management. As carbohydrate is the macronutrient with the greatest impact on blood glucose,
      it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose
      excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have
      gained popularity, and observational studies report positive glycemic outcomes. However, to
      date, scientific evidence from randomized trials on the impact of LCD in children with T1D is
      lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and
      safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will
      evaluate the efficacy of LCD on glycemic control.
    

Detailed description: 
      The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of
      LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit)
      during the 6 month-duration of the study. Participants will be randomized to an intervention
      group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.

      During the screening visit, participants will be assessed by a dietitian to categorize their
      existing dietary regimen before randomization to either the LCD or the standard diet. In
      addition, participant's insulin regimen (either pump settings or multiple dose insulin
      injection therapy) will be reviewed for insulin dose adjustments as needed over a 2
      week-period.
    

Intervention name(s): Low carbohydrate diet
Intervention type(s): Other
Intervention description(s): 25-35% of carbohydrates from total energy intake
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
Masking: None (Open Label)
Primary purpose: Other
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a
      bowel preparation prior to colonoscopy in pediatric patients.
    


Intervention name(s): BLI800 - Dose 1; BLI800 - Dose 2
Intervention type(s): Drug; Drug
Intervention description(s): BLI800 oral solution; BLI800 oral solution
Other intervention name(s): BLI800; BLI800
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colonoscopy; pediatric
Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is a randomized controlled trial which aims to compare the effect of weight
      bearing exercises and non-weight bearing exercises on the dynamic balance in knee
      osteoarthritis patients as 60 patients will divided in three groups where one group is
      control group and others two groups one of them perform weight bearing exercises and the
      other perform non weight bearing exercises.
    


Intervention name(s): stretching exercises; Transcutaneous electrical nerve stimulation; weight bearing strengthening exercises; Non-weight bearing strengthening exercises
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): stretching exercises for Hamstring, quadriceps and calf muscle for both lower limbs of the same patients. each exercise was repeated 5 times and each repetition hold for 30 seconds in the same session.; it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.; strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of weight bearing from standing position each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.; strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of non-weight bearing from lying and setting positions each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.
Other intervention name(s): TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
UPnRIDE Power Standing Wheelchair for SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      People with higher level of spinal cord injury have limitations to using exoskeletal-assisted
      walking devices due to restrictions of trunk stability, functional use of the upper
      extremities and hand grip. With increasing sedentary time in wheelchairs, people with SCI
      have a high risk for developing secondary complications. A powered wheelchair has recently
      been developed for use in persons with spinal cord injury that provides a solution for
      placing the user in an upright, standing position while maintaining the overground mobility
      features of the powered wheelchair; providing the ability to engage in society in either a
      standing or seated position. The purpose of this study is to verify user performances of the
      upright powered wheelchair and to identify obstacles that are difficult, or prevent use.
      Additionally, the option to have upright posture throughout the day may have the potential to
      improve some of the secondary medical conditions associated with the extreme sedentary
      lifestyle.

      This study will determine change from baseline after 12 weeks of use for safety, tolerance,
      medical, physical and quality of life outcomes. The intervention will consist of 3.5 hours
      per session, 3 times per week for 12 weeks. During each session, participants will be asked
      to stand at least 5 minutes during every 15 minutes. To our knowledge, there is no existing
      empirical data on intermittent standing during the day in persons with higher levels of SCI
      who cannot otherwise stand and whether this approach will improve health related outcomes.
    


Intervention name(s): UPnRIDE power wheelchair
Intervention type(s): Device
Intervention description(s): The intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Corneal ectasia is a relative weakness in the structure of the cornea, which produces a
      progressive change in its shape which results in visual distortion. It is known that collagen
      cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to
      prevent progressive ectasia. Corneal collagen cross-linking with riboflavin on corneas
      thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent
      progression of the disease.

      The purpose of this study is to determine whether corneal collagen cross-linking with
      riboflavin in a hypotonic solution, with UV light, on corneas less than 400 microns thick,
      leads to stabilisation of corneal ectasia.
    

Detailed description: 
      When cross-linking corneas of > 400 microns, riboflavin in a solution with high molecular
      weight dextran T500 is used to prevent corneal swelling during the administration of the
      drops and the UV treatment. However if riboflavin is applied to a cornea in a hypotonic
      solution (saline), then transient corneal oedema is created with thickening of the corneal
      stroma. In this way it is thought that the temporarily thickened cornea can be treated with
      UV whilst still providing a sufficient thickness to absorb the UV to an extent that
      endothelial cell damage is avoided.
    

Intervention name(s): Collagen cross-linking with hypotonic riboflavin
Intervention type(s): Procedure
Intervention description(s): Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).
Other intervention name(s): Medio-Cross® hypotonic solution
Intervention MeSH terms: Riboflavin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: keratoconus; collagen cross-linking; riboflavin; UV light
Pilot Study of the HWL Program
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of the project is to test a remotely delivered, standalone behavioral weight loss
      intervention designed to help adults initiate the important dietary, physical activity (PA)
      and behavioral changes necessary to achieve weight loss.
    

Detailed description: 
      The Weight Management Center currently offers a remotely delivered (smart phone, tablet,
      computer) program to assist patients with maintaining weight losses already achieved, which
      includes multi-channel self-monitoring and asynchronous individually recorded feedback from
      clinical staff. The goal of the presently proposed project is to build on this existing
      maintenance-focused program to create a remotely delivered, standalone behavioral weight loss
      intervention designed to help participants initiate the important dietary, physical activity
      (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home
      Weight Loss (HWL) program by repackaging existing clinical educational materials as
      instructional lifestyle change modules to be delivered remotely for participant weight loss

      The aim of the proposed project are to pilot test the effects of the HWL program among a
      sample of overweight and obese adults (N=30). The digital platform currently used in the
      maintenance program will be used for the HWL program
    

Intervention name(s): Home weight loss program
Intervention type(s): Behavioral
Intervention description(s): Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
Intervention model: Single Group Assignment
Intervention model description: Single group pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telehealth; Remote weight loss; Self-monitoring; Diet; Physical activity
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
Condition: Febrile Neutropenia; Hematological Diseases
MeSH terms: Neutropenia; Febrile Neutropenia; Hematologic Diseases; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic
      refractory fever. The investigators evaluate efficacy and safety of micafungin sodium
      (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a
      control and this study is prospective, randomized, non-inferiority trials.

      Therefore, this study was planned for review of the safety and efficacy in korean patients.
    


Intervention name(s): Micafungin sodium; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Treatment period (active treatment): an average 14 days
Dosage:
- Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day)
Administration Method:
Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever.; Treatment period (active treatment): an average 14 days
Dosage:
- Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day)
Administration Method:
Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever.
Other intervention name(s): Mycamine®; Sporanox®
Intervention MeSH terms: Itraconazole; Micafungin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2
      Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
    


Intervention name(s): sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day; comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.; Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
Other intervention name(s): Januvia
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
      to baseline in subjects with partial onset seizures not fully controlled despite their
      treatment with 1 to 3 concomitant anti-epileptic drugs.

      Also to evaluate the safety and tolerability of YKP3089.
    


Intervention name(s): YKP3089; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, dose to be titrated Tablet, dose to be titrated; Placebo capsule Placebo tablet
Other intervention name(s): cenobamate
Intervention MeSH terms: Cenobamate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: partial onset seizures; treatment resistant; partial epilepsy