bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
Condition: Anxiety
Study type: Interventional

Summary: 
      Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a
      disorder and serious enough to require treatment affects up to 10% of all youth by the age of
      16. Anxiety disorders can have serious negative effects on a young person's personal
      relationships, school performance, and family life. These disorders may not be discovered by
      youth, parents and health care providers. Even if anxiety disorders are discovered, youth may
      not get the right therapy. Anxious youth can become sick if their anxiety is not treated
      properly.

      The investigative team will carry out research to test Breathe, their new Internet-based
      treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe
      includes information materials and personalized homework assignments to help anxious youth
      learn ways to manage anxiety.

      This study is a pilot randomized controlled trial (RCT) with two groups, an
      Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a
      resource webpage (control group; considered treatment as usual for youth waiting for
      services). The investigators will evaluate several methodological processes and outcomes
      through the following objectives:

        1. To evaluate the change in youths' anxiety (primary outcome) from pre- to post-
           intervention.

        2. To estimate recruitment and retention rates for a full-scale RCT.

        3. To estimate a sample size for a full-scale RCT.

        4. To define the minimal clinically important difference (MCID) for the primary outcome
           measure.

        5. To measure intervention acceptability.

        6. To determine the use of co-interventions during the trial.

        7. To conduct a preliminary economic analysis.
    


Intervention name(s): cognitive behavioural therapy; Internet-based resource page
Intervention type(s): Behavioral; Other
Intervention description(s): Internet-based CBT; Static webpage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
Condition: Cicatrix, Hypertrophic; Rehabilitation
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic; Cicatrix
Study type: Interventional

Summary: 
      This study explores the smart scar care pad's potential therapeutic effect in treatment
      hypertrophic scar while elucidating the adverse effects if there is any. Half of the
      participant receives traditional treatment of pressure garment and the other half receives
      the smart scar care pad together with pressure garment.
    


Intervention name(s): SSCP; SPMS
Intervention type(s): Other; Other
Intervention description(s): Insert; Pressure therapy
Other intervention name(s): The Smart Scar Care PAd; The Smart Pressure Monitored Suit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insert; pressure therapy; silicone gel
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Condition: High Complex Anal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and
      cutting seton (CS) in the treatment of high complex anal fistula.
    


Intervention name(s): Decomprssion and drainage seton; Cutting seton
Intervention type(s): Procedure; Procedure
Intervention description(s): Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.; Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To detect the effect of kinesio -tape on balance in children with spastic diplegia.
    

Detailed description: 
      The use of Kinesio Taping might influence the cutaneous receptors of the sensory motor
      system, resulting in the improvement of voluntary control and coordination in a physiotherapy
      program for children with CP. (Yasukawa et al., 2006).

      The study will be conducted To investigate the effect of kinesiotape applied on dorsi fexors
      muscles on improving balance in spastic diplegic children .
    

Intervention name(s): kinesio taping
Intervention type(s): Other
Intervention description(s): apply kinesio taping on dorsi flexors muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: children rranged from 4 years uo to 10 years with Spastic diplegia
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study looks at the blood levels of a new study medicine in people with normal and
      impaired kidney function. Participants will get the study medicine called NNC0174-0833. This
      is an experimental medicine and has not been approved by the US FDA. It is being developed as
      a new medicine for weight management. Participants will get 1 injection of the study medicine
      by a study nurse at the clinic. The injection will be with a needle in a skin fold in the
      stomach area. The study will last for about 9 weeks. Participants will have about 7 visits
      with the study staff or the doctor. At the visits, participants will have clinical checks
      done and blood samples taken. Participants will be collecting their urine several times
      during the study. Participants will be asked about their health, medical history and habits.
      People who are already in another research study cannot take part. Only women who are not
      able to become pregnant can take part in the study. Only men who do not plan to father a
      child during the study or 6 weeks following the dose administration can take part in the
      study.
    


Intervention name(s): NNC0174-0833
Intervention type(s): Drug
Intervention description(s): A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Harmonized Micronutrient Project
Condition: Genomic
Study type: Interventional

Summary: 
      The purpose of this trial is to better define how individuals with different genetic make-ups
      will require different interventions to improve their methylation potential and nutrient
      status.
    

Detailed description: 
      Despite the increasing incidence of overweight and obesity among children, nutritional
      deficiencies are still a concern.

      A low intake of vitamins and minerals is associated with a reduction in the antioxidant
      capacity. Some vitamins are associated with chronic diseases including overweight and
      obesity.

      S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are the substrate and product of
      essential reactions; the SAM:SAH ratio has been associated with health and is an indicator of
      cellular DNA methylation potential.

      Low level of this ratio may affect short and long term health. In this explorative knowledge
      building open interventional study, subject to be enrolled are children or adolescents 9 to
      13 years of age per year (n=180 per year, over 2 years). The study consists of 6 weeks
      nutritional intervention followed by a 6 weeks follow up.

      In this study, genomics, proteomics, lipidomics analysis will be performed, in addition to
      biochemistry, hematology and vitamins analysis.
    

Intervention name(s): micronutrient supplementation
Intervention type(s): Dietary Supplement
Other intervention name(s): Nestrovit: white chocolate bar with vitamins and minerals
Intervention MeSH terms: Micronutrients; Trace Elements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: micronutrient; genomic; SAM/SAH ratio
Behavioral Treatment of Weight Gain in CF
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study examines the efficacy of two treatments to help children with cystic
      fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended
      daily allowance of energy and the effect of these treatments on weight gain and maintenance.
      One treatment provides children with CF and their parents nutrition education about the best
      foods for meeting their dietary needs. The second treatment gives children with CF and their
      families similar nutritional information plus behavioral parenting methods for motivating
      children to eat the recommended foods. Children with CF and their families are seen weekly
      for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then
      followed for 2 years after treatment in order to better understand how long the treatments
      are effective and to determine the health benefits of better nutrition status and weight
      gain.
    


Intervention name(s): Behavioral Treatment
Intervention type(s): Behavioral
Primary purpose: Prevention
Keywords: Nutrition; Behavior Therapy; Cystic Fibrosis
Study of HBV-001 D1 in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and
      tolerability of HBV-001 D1 in healthy adult subjects.
    

Detailed description: 
      This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and
      tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two
      dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts.
      Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.
    

Intervention name(s): DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel); Placebo for DEN1-80E
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.; 3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.
Other intervention name(s): HBV-001 D1
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue fever; Dengue hemorrhagic fever; Dengue shock syndrome; Vaccine; Hawaii Biotech
Phase 1 Study Assessing the Safety and Tolerability of CTX-4430
Condition: Pulmonary Inflammation
MeSH terms: Pneumonia; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules taken
      orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat lung
      inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1
      assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will include
      several dosages. During the single-dose part of the study, following a 14-day washout period,
      two cohorts will be assessed for potential effects on tolerability when fed at the time of
      dosing. For both parts of the study, blood samples will be collected for PK assay validation.
    


Intervention name(s): CTX-4430; Mannitol; Placebo; CTX-4430; Placebo; Mannitol
Intervention type(s): Drug; Other; Drug; Drug; Drug; Other
Intervention description(s): Ascending single oral doses of CTX-4430 will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross-over, fed a high fat diet and administered different single oral doses of CTX-4430; excipient blended with CTX-4430 in capsules; Single oral doses of placebo will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross over, fed a high fat diet and administered single oral doses of placebo; Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.; Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.; excipient blended with CTX-4430
Other intervention name(s): osmitrol; osmitrol
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The overall aim of this study was to assess the effects of nutritional supplementation and
      education on the healing of foot ulcers in diabetic patients. The hypothesis was that
      improving dietary intake can promote wound healing by improving nutritional status, blood
      flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.
    


Intervention name(s): glucose control nutritional shake, nutrition education
Intervention type(s): Dietary Supplement
Intervention description(s): Participants in the treatment group were educated about improving their diet by consuming more low-fat high-quality protein sources, vegetables, complex carbohydrates and less simple carbohydrates. They were also instructed to consume two servings (474 ml) of a commercially produced Glucose Control Nutritional Shake between meals throughout the day for 12 weeks or until complete healing. The supplements provided a total of 500 kilocalories, 28 grams of high-quality protein and essential vitamins and minerals.
Other intervention name(s): Nutrition education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DFU, wound healing, nutrition education,supplementation
Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis
Condition: Acute Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to
      placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal
      and paranasal sinuses).
    

Detailed description: 
      Acute rhinosinusitis is one of the most common diseases worldwide with a prevalence of 6-15%
      and a large impact on quality of life and socioeconomics. The majority of infections are of
      viral origin, while acute bacterial infection occurs in only 0.5-2% of cases. Currently
      available treatment includes a variety of remedies, like analgesic, inhalation with water
      steam of diluted drugs, nasal douche or spray, decongestant and mucolytic remedies as well as
      antibiotics.

      Sinusitis Hevert SL is registered since 2003 for the treatment of inflammation of the nose
      and throat region and the sinuses (sinusitis) and contains eleven homeopathic single
      substances which are classically used in homeopathy for this condition, but has not been
      evaluated in a randomized controlled clinical trial. In this multicenter, randomized,
      double-blind, placebo-controlled, parallel group phase IV study the efficacy and safety of
      Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated
      rhinosinusitis shall be demonstrated.
    

Intervention name(s): Sinusitis Hevert SL Tablet; Placebo for Sinusitis Hevert SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets; 1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Microbiome of Donor Iron Deficient Study
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Observational

Summary: 
      The goal of this pilot study is to test whether the microbiome is affected by intravenous
      iron repletion.
    

Detailed description: 
      The colonic microbiome, the community of bacteria living in our gut, is essential in human
      health and disease. Iron is an essential nutrient for both bacteria and humans. In the United
      States, of the donors who provided the ~15 million units of red blood cells that were
      collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly
      prevalent in first-time donors, its prevalence is even higher in these particularly
      altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors,
      respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency
      from blood donation is associated with fatigue, restless leg syndrome, decreased physical
      endurance and work capacity, and impaired concentration, attention, and other neurocognitive
      functions; however, these conclusions are not based on definitive studies and have not yet
      changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized
      controlled trial, recruiting 60 healthy regular donors who meet donation standards, while
      exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary
      study, we will determine what effect donor iron deficiency and IV iron repletion have on the
      gut microbiome.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with iron deficiency from blood donation will be recruited over 5 years in the
        associated randomized controlled trial conducted at Columbia University Medical Center.
      
Biospecimen description: 
      Stool collection
    
Keywords: Blood donation; Iron repletion; Transfusion
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma; Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab
      to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended
      dose for the Phase II clinical trial.
    


Intervention name(s): SyB L-0501; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).; The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
Other intervention name(s): Bendamustine hydrochloride
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; Mantle cell Lymphoma; Transformed lymphoma, transformed to diffuse large B-cell lymphoma; Follicular Lymphoma
OTO-313 in Subjects With Subjective Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics
      (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the
      treatment of subjective tinnitus.
    


Intervention name(s): OTO-313; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single intratympanic injection of gacyclidine; single intratympanic injection of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tinnitus, intratympanic injection, gacyclidine
To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis
Condition: Renal Dialysis
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate
      the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular
      dialysis. Eligible subjects with written consent were randomized into one of the two groups:
      A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the
      study subjects were asked to take the investigational products orally for 90 days in order to
      evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of
      inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax
      senticosus and placebo.
    


Intervention name(s): Eleutherococcus senticosus; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): taken orally once/day for 90 days; taken orally once/day for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention