bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Condition: Focus: Nutritional Requirements for Infants
Study type: Interventional
Phase: Phase 1

Summary: 
      The immune system of newborn infants is immature with low activity of both innate and
      acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary
      fatty acids are one nutritional factor noted to play a role in immune function. The omega-6
      long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA
      (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The
      balance or relative amounts of ARA and DHA have been associated with immune response. Some
      commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and
      DHA has not been determined with respect to immune function. This study will assess two
      levels of ARA and the impact on immune response in healthy, term infants and whether genes
      that influence essential fatty acid metabolism alter the nutritional requirement of infants.
    


Intervention name(s): Arachidonic acid (25 mg/100 kcal ); Arachidonic acid (34 mg/100 kcal); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nutrient; nutrition; arachidonic acid; essential fatty acids
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
Condition: Distal Radius Fracture; Wrist Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      A prospective, randomized study investigating the possible benefits of immediate mobilization
      and frequent physiotherapy following a wrist fracture treated by volar plating.

      The current study will test the following null hypothesis:

      There is no significant difference between patients who receive a cast for the first 2 weeks
      postoperatively and then instructions in home exercises and patients who receive a cast for
      2-3 days postoperatively and then have frequent sessions with a physiotherapist following
      volar locked plating for a extraarticular distal radius fracture, as evaluated by
      self-reported satisfaction after 3 months.
    

Detailed description: 
      The study will focus on patients treated with volar locked plating following an
      extraarticular distal radius fracture.

      In a prospective manner the investigators intend to analyze hand function, x-ray and other
      parameters in order to investigate whether early mobilization and a targeted program of
      physiotherapy postoperatively leads to a better functional result and earlier return to a
      normal activity level. The investigators analysis will also focus on the safety of early
      mobilization with regards to possible detrimental effects on the osteosynthesis, bony union,
      associated soft-tissue injuries and functional outcome. The investigators also intend to
      assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit
      evaluation.
    

Intervention name(s): Early mobilization; Late mobilization
Intervention type(s): Other; Other
Intervention description(s): Early weightbearing and physiotherapy; Late mobilization, none-weightbearing and home exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal radius fracture; Wrist fracture; Physiotherapy; Immobilization; Volar locking plates; Mobilization
Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor（CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL
Condition: MRD-positive; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T
      for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic
      leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and
      cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.
    

Detailed description: 
      Participants with MRD-positive B cell acute lymphoblastic leukemia can participate if all
      eligibility criteria are met. Tests required to determine eligibility include disease
      assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws. Participants
      receive chemotherapy prior to the infusion of CD19/CD22 CAR+ T cells. After the infusion,
      participants will be followed for side effects and effect of CD19/CD22 CAR+ T cells. Study
      procedures may be performed while hospitalized.
    

Intervention name(s): anti-CD19/CD22 CAR-T cells; Fludarabine; Cyclophosphamide
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs; 30mg/m2/d; 300mg/m2/d
Intervention MeSH terms: Cyclophosphamide; Fludarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD19/CD22; Bispecific CAR-T; leukemia; MRD-positive; B-ALL
Nasotracheal Intubation Over a Bougie
Condition: Nasotracheal Intubation; Nasal Bleeding
MeSH terms: Epistaxis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether nasal intubation over a bougie placed via a
      nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind
      nasal endotracheal tube passage.
    

Detailed description: 
      Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic
      Techniques," CVT) are known to be associated with significant trauma to the patient's nares
      and the endotracheal tube itself. The investigators propose an alternative technique
      (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or
      NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which
      promises to not only be less traumatic to the patient and the endotracheal tube, but also to
      take less time to perform and have a higher first-attempt success rate than conventional
      methods. The investigators propose a randomized prospective interventional study comparing
      this new technique with conventional technique to see if a significant difference exists.
    

Intervention name(s): Nasotracheal intubation over a bougie; Conventional Nasotracheal Intubation
Intervention type(s): Procedure; Procedure
Intervention description(s): Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps; Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
Other intervention name(s): Abrons technique for nasotracheal intubation; Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet; NIB; CVT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nasotracheal Intubation
Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion
Condition: Cardiovascular Diseases in Old Age
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of this study was to determine the chronic effects of beetroot juice
      supplementation on the acute (90-minute post nitrate consumption) efficacy of converting
      dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults.
      the investigators were also interested in determining the effect of this intervention on
      fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of
      participants classified as "non-responders" was determined based on increases in plasma
      nitrite achieved using tolerable volumes of beetroot juice by other studies.
    


Intervention name(s): BRJ Nitrate; BRJ Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.; Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: beetroot juice; dietary nitrate; plasma nitrite
MR Characterisation/Localisation of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in
      detecting, localising and characterising satellite lesions in relation to an index breast
      tumour in order to improve definition of clinical target volume after local excision.

      Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for
      localising unsuspected multifocal and multicentric lesions in women diagnosed with early
      breast cancer.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with confirmed breast cancer
A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni
Condition: Schistosoma Mansoni
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the comparative efficacy of artesunate plus
      sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children
      infected with S.mansoni in western Kenya.
    

Detailed description: 
      Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In
      the absence of a vaccine, the major control strategy is the reduction of morbidity by
      chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue
      to show that schistosome worms have developed reduced susceptibility to Praziquantel. These
      observations indicate the need for research to monitor the trends in efficacy of praziquantel
      and the need for research to develop novel antischistosomal drugs. Randomized controlled
      trials have also shown that Artemisinin derivatives (artesunate, artemether) have
      antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to
      conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate
      plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school
      children infected with S.mansoni in Rarieda district in western Kenya. To do this we will
      screen about 1000 school children by examination of stool for schistosome eggs. Eligible
      children will be randomized to receive either artesunate plus
      sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks
      after treatment, the participants will be assessed for cure and egg reduction.Our study may
      provide vital information regarding an alternative treatment for S. mansoni infection in
      children.
    

Intervention name(s): Artesunate+Sulfamethoxypyrazine/pyrimethamine; Praziquantel
Intervention type(s): Drug; Drug
Other intervention name(s): Co-arinate FDC; Biltricide
Intervention MeSH terms: Artesunate; Pyrimethamine; Sulfalene; Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosoma mansoni; Praziquantel; Artesunate + Sulfamethoxypyrazine/pyrimethamine; Randomized open-label controlled clinical trial
The Effects of Cilnidipine on Metabolic Syndrome Improvement
Condition: Hypertension; Metabolic Syndrome X
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with
      hypertension, and these metabolic abnormalities are reported to be related to insulin
      resistance. Therefore, whenever treating such patients, antihypertensive agents that may have
      the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine)
      is expected to improve metabolic syndrome as well as insulin resistance by its dual effects
      on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects
      of CinalongTM on insulin resistance and other metabolic related factors.
    

Detailed description: 
      -  Multi-center, randomized, prospective, double blind, active control, parallel study

        -  Superiority study (Treatment group - Cilnidipine/Control group - Nifedipine)

        -  Measure the effects of Cinalong(TM) after 3 month and 12 month-application
    

Intervention name(s): Cilnidipine
Intervention type(s): Drug
Intervention description(s): 10~20mg, qd, po for 3 months or 12 months.
Other intervention name(s): Cinalong
Intervention MeSH terms: Cilnidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: metabolic syndrome; Hypertension; CCB; cilnidipine
A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
Condition: Fasting; Chronic Disease; Autoimmune Diseases; Metabolic Disease; High Blood Pressure; Fatty Liver; Kidney Stone; Gall Stone; Hysteromyoma
MeSH terms: Fatty Liver; Gallstones; Kidney Calculi; Hypertension; Metabolic Diseases; Autoimmune Diseases; Chronic Disease
Study type: Observational

Summary: 
      Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to
      treat metabolic and autoimmune diseases in mice. However, clinical trials performing
      prolonged fasting with more than 7 days have not been reported. Investigators conduct an open
      label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day
      fasting-like diet in the treatment of metabolic and autoimmune diseases.
    

Detailed description: 
      Although fasting has been proved an effective approach to treat metabolic and autoimmune
      diseases in mice, prolonged fasting is difficult to implement in human-beings for the safety
      and feasibility reasons.

      In this clinical trial, we will recruit metabolic and autoimmune diseases and then follow a
      traditional Chinese 21-day fasting-like diet process with extremely low calorie intake (about
      5% of normal diet) and prolonged fasting-like period. Blood, urine, stool samples will be
      collected on day 0 (baseline), day 4, day 7, day 14, day 21 and day 51 after it started up.
      Therefore we can examine the changes of disease-associated physical indexes and metabolic
      biomarkers pre and post the 21-day fasting-like diet.

      The purpose of the study is to ascertain the impact of the fasting-like diet during the 21
      days. The investigators hypothesize that the 21-day fasting-like diet can reduce the
      biomarkers associated with aging and age-related diseases and benefit for the treatment of
      metabolic and autoimmune diseases.
    

Intervention name(s): the 21-day fasting-like diet
Intervention type(s): Other
Intervention description(s): a fasting-like diet with 400 KJ energy intake per day for 21 days
Other intervention name(s): Bigu
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Of these 144 participants, 55 were male and 89 were female. For detailed information,
        please follow our recent publications.
      
Keywords: fasting-like diet; chronic diseases; autoimmune diseases; metabolic disorder
The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether providing patients with information about
      their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows
      them to make appropriate decisions about heart disease prevention.
    

Detailed description: 
      Background: Low utilization of effective CHD prevention strategies may be due to many
      factors, but chief among them is the lack of patient involvement in prevention decisions. We
      undertook this study to test the effectiveness of an individually-tailored, computerized
      decision aid about CHD on patients' discussions with their doctor and their plans for CHD
      prevention.

      Methods: We conducted a pilot randomized trial in a convenience sample of adults with no
      previous history of cardiovascular disease to test the effectiveness of an
      individually-tailored, computerized decision aid about CHD prevention against a risk factor
      list that patients could present to their doctor.
    

Intervention name(s): Heart-to-Heart Decision Aid
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Keywords: Risk Assessment; Decision Support Technique; Physician-Patient Relations; Prevention and Control
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
Condition: Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, double blind, randomized, placebo-controlled study that will enroll
      approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic
      foot ulcers. The study will be conducted at approximately 12 investigational sites in the
      United States.
    


Intervention name(s): rhuMAb VEGF (telbermin)
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Diabetes; Diabetic; Diabetic Foot Ulcer
A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown
      potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in
      animal and human studies. Furthermore, controlled, single site human studies have shown the
      anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel
      Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with
      Generalized Anxiety Disorder. The primary objectives of this study are to assess the efficacy
      and safety of Sensoril® for patients with moderate or greater severity of symptoms associated
      with Generalized Anxiety Disorder.

      The Primary Efficacy endpoint in this study will be determined by a statistically
      significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale
      scores in the Sensoril® treated group versus those receiving placebo.

      The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo
      results in:

        1. Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last
           value)

        2. Greater remission rates (HAM-A total scores ≤ 7) at week 8

        3. Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety
           cluster scores.

        4. Greater improvements on CGI - severity scores from baseline to last value.

        5. A higher percentage of subjects rated as "much improved" or "very much improved" on the
           CGI - Improvement subscale at the last value.

        6. Serum cortisol and DHEA-S levels will be assessed between the two treatment groups.
           These biomarkers are indices of stress and it is hypothesized that improvement in levels
           of these stress indices will favor the Sensoril® treated group.

      Exploratory Endpoint

      1. Patient reported outcomes for sleep and calmness will be assessed between the two
      treatments.

      Safety Endpoint

      The safety endpoints will be determined by assessments of adverse and serious adverse events,
      physical examination, vital signs, EKG, and clinical laboratory measures. Clinical measures
      with laboratory defined reference ranges and vital signs will be assessed.
    


Intervention name(s): Sensoril®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks; Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
Other intervention name(s): Ashwagandha; Withania somnifera
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study aims to find out the difference in brain activity when performing upper limb
      exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.
    

Detailed description: 
      This study aims to find out the difference in brain activity when performing upper limb
      exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.
      All participants will participate in tasks for upper limb exercise conducted for 26 minutes.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods
      separated by a washout period of 14 days or more.
    

Detailed description: 
      Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods
      separated by a washout period of 14 days or more. In one period, subjects received three
      single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol
      dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg
      OPC was administered alone.
    

Intervention name(s): BIA 9-1067; Paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): BIA 9-1067 50 mg; Paracetamol 1g
Other intervention name(s): OPC, Opicapone; acetaminophen
Intervention MeSH terms: Acetaminophen; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment