bioihbjkbjnl/mcl2 huggingface dataset:
Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis; Depression
MeSH terms: Multiple Sclerosis; Sclerosis; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will determine whether fish oil can reduce depression in people with multiple
      sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant
      medication.

      Study hypothesis: Three months of fish oil supplementation will improve depression scores on
      the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI)
      better than placebo.
    

Detailed description: 
      Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the
      omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low
      risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to
      improve the therapeutic benefits of antidepressants. This study will determine the
      effectiveness of fish oil supplements in reducing depression in MS patients who are taking
      antidepressant medication.

      This study will last 3 months. Participants will be randomly assigned to receive either fish
      oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show
      an improvement in their depressive symptoms will have the option to continue their treatment
      for an additional 3 months. Participants will do no respond to treatment will be excused from
      the study. All participants will remain on their antidepressants and MS medication throughout
      the study. Participants will have weekly study visits. At each visit, participants will be
      asked about their general health, and self-report scales will be used to assess depressive
      symptoms. Medication adherence will be monitored by pill counts and through red blood cell
      fatty acid analysis. Blood collection will occur at study start and at study completion.
    

Intervention name(s): Fish oil concentrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).; soybean oil with 1% fish oil at a daily dose of 6 grams
Other intervention name(s): omega-3 fatty acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatty Acids, Omega-3; Fish Oils; Complementary Therapies
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of Rabeprazole extended
      release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among
      subjects with erosive gastroesophageal reflux disease (GERD).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects
      who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment
      groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe
      erosive GERD.
    

Intervention name(s): Rabeprazole sodium; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
Other intervention name(s): Aciphex
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD; erosive GERD; erosive esophagitis
Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus
      bevacizumab as first line treatment in patients with metastatic and HER2 negative breast
      cancer.
    

Detailed description: 
      A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin
      is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity
      profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus
      bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel
      alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination
      plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast
      cancer. Furthermore, the efficacy of the combination therapy will be correlated with the
      presence of circulating tumor cells (CTCs) in this population.
    

Intervention name(s): Docetaxel; Epirubicin; Bevacizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles; Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles; Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles
Other intervention name(s): Taxotere; Farmorubicine; Avastin
Intervention MeSH terms: Bevacizumab; Docetaxel; Epirubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; chemotherapy; biological therapy
Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare the oral bioavailability of seven prototype slow-release formulations to
      immediate-release tablets
    


Intervention name(s): Formulation B: Pramipexole Slow release (SR) tablet; Formulation C: Pramipexole Slow release tablet; Formulation D: Pramipexole Slow release tablet; Formulation E: Pramipexole Slow release tablet; Formulation F: Pramipexole Slow release tablet; Formulation G: Pramipexole Slow release tablet; Formulation H: Pramipexole Slow release tablet; Pramipexole immediate release (IR) tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Condition: Haemophilus Influenzae Type b (Hib) Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of booster doses of the two vaccines
      used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.
    


Intervention name(s): Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine); Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Intervention type(s): Biological; Biological
Intervention description(s): Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.; Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b (Hib); Vaccine; Booster
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine
      Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants
      will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will
      receive placebo.
    


Intervention name(s): Ammoxetine Hydrochloride Enteric-coated Tablets; placebo enteric-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested.; There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reducing Pain Intensity During Spinal Needle Insertion: Valsalva Maneuver vs. Control Technique
Condition: Undefined
MeSH terms: Pain
Study type: Interventional

Summary: 
      This study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity
      during spinal needle insertion.
    

Detailed description: 
      Spinal anesthesia is one of the regional anesthesia techniques needed to provide motor,
      sensory, and autonomic blocks specifically for lower limbs by delivering local anesthetics
      into subarachnoid space. This technique is not difficult to perform and relatively
      inexpensive. However, spinal anesthesia may cause an intense pain during needle insertion.
      Valsalva maneuver is an attempt to force expiration by pushing a closed airway, such as
      covering nose or mouth. This maneuver can lead to anti-nociceptive stimulation and may
      decrease the pain. Thus, this study was aimed to observe the efficacy of Valsalva maneuver in
      reducing pain intensity during spinal needle insertion.
    

Intervention name(s): Valsalva Maneuver
Intervention type(s): Behavioral
Intervention description(s): Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Condition: Congenital Hyperinsulinism
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to evaluate the safety, tolerability and glucose-raising
      effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
    

Detailed description: 
      There is a significant unmet medical need to develop new therapies aimed at preventing
      chronic recurrent hypoglycemia in congenital HI, the most common cause of persistent
      hypoglycemia in children. RZ358 is a human mAb that allosterically attenuates excessive
      insulin action on target cells. Therefore, RZ358 is ideally suited as a potential therapy for
      hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases
      such as congenital HI. This is a Phase 2, multicenter, open label clinical study designed to
      assess the safety and efficacy of four progressively higher doses of RZ358 in separate groups
      of patients with hyperinsulinemic hypoglycemia due to Congenital HI, not adequately
      controlled with or without current standard of care. A screening period of up to 5 weeks will
      evaluate eligibility. Once enrolled, RZ358 will be administered bi-weekly over 8 weeks, and
      then patients will complete a post-treatment follow-up period of 13 weeks.
    

Intervention name(s): RZ358 Sequential Group Cohort 1; RZ358 Sequential Group Cohort 2; RZ358 Sequential Group Cohort 3; RZ358 Sequential Group Cohort 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks); IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks); IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks); IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoglycemia; Congenital Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pancreatic Diseases; Digestive System Diseases; Hyperinsulinism
A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      In this study we will compare two electronic goniometric gloves to see if they can be used in
      research on joint movement in arthritis.

      One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other
      is a glove that we have specially designed and developed for use in people with arthritis.
      Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.

      We aim to find out if the gloves are accurate and if they can be worn and used without too
      much discomfort by people with arthritis.
    

Detailed description: 
      This is an open pilot study to assess the usability and accuracy of two electronic
      goniometric gloves in measuring finger joint movement in patients with Rheumatoid Arthritis.

      We will use questionnaires to assess pain, stiffness and disability. We will be using an
      inner disposable glove worn under the electronic goniometric gloves as this will be important
      for infection control in clinical use.

      We will calibrate the electronic goniometric gloves using wooden blocks at predefined angles
      using our own software calibration process to optimise the accuracy of the glove for the
      individual patient.

      The patient will flex and extend their fingers repeatedly to get measurements of the minimum
      and maximum angle of flexion in their joints. During these movements we will also capture the
      dynamic characteristics of movement such as maximum velocity. In this study a laptop will be
      used to capture and record all of the measurements from the electronic goniometric glove and
      record the time at which the measurements were taken.

      Each electronic goniometric glove will be refitted for a second set of tests to assess
      variability due to the fitting process. We will record a full set of data from each set of
      movements for later analysis.

      Finally, we will assess usability and establish if patients have a preference between the two
      electronic goniometric gloves.
    

Intervention name(s): Data gloves to perform movements
Intervention type(s): Device
Intervention description(s): Using the electronic data gloves to perform a set routine of movements:
5DT 'dataglove 14 Ultra' Electronic glove (commercially available)
New 'Tyndall/UU' developmental dataglove
Other intervention name(s): 5DT; Tyndall/UU dataglove
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Arthritis; rheumatoid; joints; swelling; measurement; movement; electronic; data; glove; goniometry; outcome; stiffness
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
Condition: Metabolic Disorder; Carbohydrate, Absorption, Intestine
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This study aimed at determining the 4-hours postprandial blood glucose and insulin responses
      to the ingestion of cereal product differing by their SDS content.
    

Detailed description: 
      This study aimed at determining the 4-hours postprandial blood glucose and insulin responses
      to the ingestion of cereal product differing by their SDS content. It is a laboratory-based
      research study with an open cross-over design, including 20 healthy non-smoking voluntary
      subjects, aged from 18 to 45 years. 2 test sessions per subject are included in the study.
      Foods are consumed in a random order according to a randomisation list.
    

Intervention name(s): Sandwich biscuit high in SDS; Co-extruded cereal low in SDS
Intervention type(s): Other; Other
Intervention description(s): Consumption of the high SDS product (50g) alone with a glass of water; Consumption of the low SDS product (48.3 g) alone with a glass of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glycemic & insulin response, SDS, cereal product, Nutrition
Active and Healthy Kids in Telemark - a School Based Health Promoting Intervention
Condition: Academic Performance; Physical Fitness; Physical Activity; Nutrition
Study type: Interventional

Summary: 
      The study examine possible changes in physical activity, nutrition, and psychosocial health
      following the intervention "Active and Healthy Kids in Telemark". The intervention schools
      will received the intervention, whereas the control schools will continue as usual.
    

Detailed description: 
      School based, health promoting interventions with focus on increase physical activity and
      improved nutrition seems to be a good solution to the challenges with low physical activity
      level, poor physical fitness, poor nutrition and psychosocial health challenges among
      children and adolescents. Low physical activity levels and physical fitness is recognized as
      one of the major public health challenges in the 21st century, and it negatively affects
      cognitive skills and academic performances. Providing school based health promoting
      interventions makes it easier to reach all children and adolescents regardless of social and
      cultural background, and hence reduce social inequalities in health.
    

Intervention name(s): Activity and diet
Intervention type(s): Behavioral
Intervention description(s): Physical activity: use of physical activity in theoretical subjects (3 x 30 min/week), physically active breaks (5 x 5 min/week), physical education (2 x 45 min/week) Nutrition: focus on school meals
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School; Health; Academic performance; Physical activity
A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
Condition: Inflammatory Response
MeSH terms: Blister
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of
      RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects
      Using a Standardized Blister Model
    


Intervention name(s): RIST4721; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RIST4721 oral solution; Placebo oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Persons with Parkinson Disease (PD) face significant declines in function resulting in
      greater disability. Function can improve through participation in exercise, yet many people
      with PD are physically inactive. Given that people with PD live long lifespans following
      diagnosis; it is essential to include routine exercise into their lives over the long-term.
      Physical therapy is effective in improving function in persons with PD. However,
      participation in on-going physical therapy indefinitely is not a realistic option due to
      limited healthcare resources. Interventions using mobile health technologies allow physical
      therapists to stay connected to patients over time potentially improving their ability to
      meet the changing needs of patients with PD. Innovative approaches using mobile health
      technology may improve outcome; however, the effectiveness of different approaches to improve
      function and reduce disability in PD is unknown.

      The purpose of this study is to compare the effectiveness of two interventions to improve
      function and health-related quality of life in 65 people with PD. In one study group,
      participants receive a home exercise program, in written format, to continue on an
      independent basis. In the other study group, participants are instructed to continue with an
      exercise program, in their home, delivered using videos of the exercises on a computer tablet
      device. This use of mobile-Health technology allows the physical therapist to remotely
      monitor participants' progress and modify the exercise program to meet the changing needs of
      each patient. The long-term objective of this research is to determine the most efficient and
      effective way to improve function that can be widely disseminated to persons with PD.
    


Intervention name(s): Mobile Health Technology; Stretching & Strengthening Exercises; Walking with Pedometer
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Rehabilitation; Telemedicine
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of a single injection of NX-1207
      for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients
      currently undergoing active surveillance. Study participants currently on active surveillance
      will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5
      mg or 15 mg) followed by active surveillance or to no treatment (continued active
      surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate
      biopsy.
    


Intervention name(s): NX-1207 2.5 mg; NX-1207 15 mg
Intervention type(s): Drug; Drug
Intervention description(s): A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.; A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate; Prostate Cancer; Localized Prostate Cancer; T1c Prostate Cancer; Focal Therapy; NX-1207