bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Evaluation of an Interactive Health Game
Condition: Health Behavior; Health Attitude
Study type: Interventional

Summary: 
      Broad, diverse, and innovative efforts are needed to address the growing dual public health
      challenges of obesity and diabetes, especially for those at increased risk like minority
      older adults. The emerging field of health games offers an innovative opportunity to reach
      populations to provide healthy eating and physical activity messages. Little research has
      focused on the use of health games specifically tailored for older adults. This study builds
      upon a health game designed to provide knowledge, facilitate movement, enhance motivation,
      and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study
      will adapt, implement, and evaluate the feasibility, acceptability, adherence, and
      preliminary outcomes of the game among overweight/obese African American older adults.
    


Intervention name(s): Healthy eating workshop and interactive health game; Healthy eating workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop and interactive health game. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.; The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat
      doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in
      adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on
      limited background standard of care treatment, in order to estimate the optimal dose.

      BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder
      Index 4, with sustained reduction of oral corticosteroids, in the same participant
      population.
    


Intervention name(s): BOS161721; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SC administration; SC administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adults; BOS161721; standard of care; moderately to severely active Systemic Lupus Erythematosus
Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
Condition: Male Subjects With Type II Diabetes (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a phase I, first time in human (FiH), randomized, single-blind,
      placebo-controlled, SAD study in male patients with T2DM, performed at a single study center.
      The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65
      years will be included
    

Detailed description: 
      Part A will assess the safety and tolerability of SAD of intradermal (ID) injection of
      AZD8601 (modified VEGF-A RNA) and Part B will evaluate the pharmacodynamic effects of ID
      injection of AZD8601 in forearm skin. AZD8601 is a VEGF-A modified RNA under development as a
      novel modality for local production of human VEGF-A protein and is developed for the
      treatment of diabetic patients with ulcers. Each patient in Part A will be involved in the
      study for 7 to 8 weeks. Each patient in Part B will be involved in the study for 5 to 6
      weeks.

      Safety and tolerability variables includes Adverse events (AEs), Vital signs (BP, pulse),
      ECG, Hematology, Clinical chemistry, Urinalysis.

      The study will include patients with T2DM that are on stable doses of 1 to 2 anti-diabetic
      medications. The T2DM patients may also be on medications for comorbidities such as
      hypertension, dyslipidemia, hyperuricemia, thyroid disorders, benign prostate hyperplasia
      etc. (e.g. diuretics, statins, allopurinol, thyroxin), but must be healthy otherwise.
    

Intervention name(s): AZD8601+Placebo (SAD); AZD8601+Placebo; Placebo+Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Six subjects are randomized to receive one treatment of AZD8601 and one treatment of Placebo.
Single ascending dose (SAD) with a sequential cohort design and three dose levels of AZD8601 are planned to be investigated. Subjects will receive 0.004 mg per injection of AZD8601/placebo with a total proposed dose of 0.024 mg.; Subjects will receive dose with sufficient vascular endothelial growth factor (VEGF)-A protein production and a good safety profile as determined in Part A and the total dose per patient will not exceed the maximum dose given in Part A.; Subjects are randomized to receive 2 placebo treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Safety; Tolerability; AZD8601; Type II Diabetes
Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to
      evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra®
      (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are
      planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip
      of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).

      The study has a screening period of 7 days. PK blood samples will be collected from subjects
      to determine the serum concentration of tocilizumab, thus to evaluate the change and
      similarity of the pharmacokinetics of the three study drugs.

      The investigator will perform safety evaluation for vital signs, physical examinations,
      injection site reaction, ECG, clinical laboratory tests and adverse events throughout the
      study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
    


Intervention name(s): BAT1806 injection
Intervention type(s): Drug
Intervention description(s): Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
Other intervention name(s): Actemra(EU-licensed); Actemra(US-licensed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Blod Pressure; Glucagon-like Peptide-1; Human Physiology; Blood Flow
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes and high blood pressure are risk factors for developing heart disease. An increase
      in the number of diabetes patients is expected. This increases the number of patients with
      heart disease, and since the vast majority with diabetes die from heart disease, it is
      extremely important to investigate how these diseases can be prevented and treated.

      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can
      expand blood vessels, thus lowering blood pressure, but it is not known whether the effects
      is found in humans, which we will investigate.

      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is
      solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1
      has an effect on the muscles which increases the uptake of sugar. We investigate whether
      GLP-1 enhances the absorption of sugar in the leg.

      The investigators also examines whether these effects are greater in people with diabetes
      then in healthy.
    


Intervention name(s): human glucagon-like peptide 1 (7-36)amide; human glucagon-like peptide 1 (9-36)amide
Intervention type(s): Other; Other
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Blod pressure; Glucagon-like peptide-1; Human physiology; Blood flow
Digital Health Literacy Intervention for Disadvantaged Women During Corona
Condition: Health Literacy
Study type: Interventional

Summary: 
      The aim is to deliver a digital health literacy intervention to disadvantaged women to
      improve their health behaviors with regard to (i) hygiene and sanitation, and (ii)
      coronavirus awareness and prevention in four provinces of Pakistan through women community
      health workers.
    

Detailed description: 
      There is a need to continue primary healthcare services through digital communication for
      disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of
      coronavirus pandemic, social distancing, and lockdown of communities. This project will be
      the first of its kind in aiming to provide women with a smartphone and digital access for a
      digital health literacy intervention through community healthcare workers. The majority of
      poor women in Pakistan who are dependent on primary health services: 1. suffer from health
      challenges more than men due to multiple social and structural disadvantages, 2. are the
      dominant care-providers and nurturers in the home, and 3. need support in understanding
      public health messages during health crises due to low health literacy and awareness. The
      digital health literacy intervention will be delivered in target two areas: (i) hygiene and
      sanitation, and (ii) coronavirus awareness and prevention. Women will be sampled from
      disadvantaged areas across the four provinces of Pakistan- Baluchistan, KPK, Punjab, and
      Sindh. A target of 1,000 women will comprise the sample with 500 women each assigned to the
      control and experiment group.
    

Intervention name(s): Digital Health Literacy Intervention
Intervention type(s): Behavioral
Intervention description(s): Willing women participants will be provided equipment with instructions for the intervention, including a smartphone and a 4G Wifi gadget. The health literacy intervention, delivered to the experiment group, will last three months and will include a combination of the following four components:
Component 1: Health literacy video tutorial. Component 2: Virtual one-on-one weekly meetings. Component 3: Monthly group virtual meetings and Whatsapp group. Component 4: Provision and guidance of a self-management chart.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The control and experiment group will both be provided a hard-copy of a health literacy booklet and electronically administered the: (a) base-line survey, and (b) the pre-test survey and the post-test survey.
The experiment group will receive a digital health literacy intervention in two target areas: (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: digital health literacy; community healthcare workers; coronavirus; primary healthcare; maternal and child health
Validation of an ERAS Protocol in Gynecological Surgery
Condition: Surgery; Hysterectomy; Gynecologic Disease; Gynecologic Cancer; Anesthesia
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Validation of ERAS interventional measures in elective gynecological surgery, for benign
      either malignant pathology.
    


Intervention name(s): Changes in preoperative care; Changes in intraoperative care; Changes in postoperative care
Intervention type(s): Other; Other; Other
Intervention description(s): Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling; Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.; Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERAS, Fast-track surgery, gynecology
Safety and Efficacy of Propionate for Reduction of LDL Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of the trial is to evaluate a potential impact of food supplements with the
      short chain fatty acid propionate on blood LDL cholesterol level.
    

Detailed description: 
      62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo
      (b.i.d.) or 500mg of propionate (b.i.d.). The primary endpoint is the change (delta) in blood
      LDL cholesterol levels after 8 weeks.
    

Intervention name(s): Calcium-Propionate 500mg; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Calcium-Propionate capsules; Placebo capsules without any active ingredient
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: propionate
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A
      emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.
    

Detailed description: 
      The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
      which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets
      for cancer vaccination against lung cancer. In this phase I trial, the investigators examine
      using a combination of these three peptides the safety, immunogenicity, and antitumor effect
      of vaccine treatment for HLA-A*2402-positive advanced non-small cell lung cancer patients who
      failed to standard therapy.
    

Intervention name(s): HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides
Intervention type(s): Biological
Intervention description(s): Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other intervention name(s): URLC10, CDCA1, and KIF20A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: URLC10; CDCA1; KIF20A; lung cancer; vaccine; HLA-A*2402
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Condition: Vasomotor Rhinitis
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the
      treatment of vasomotor rhinitis
    

Detailed description: 
      randomized, double-blind, placebo-controlled, phase 3
    

Intervention name(s): Pseudoephedrine / Levocetirizine
Intervention type(s): Drug
Intervention description(s): tablet, BID everyday
Other intervention name(s): Cossac L
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vasomotor; pseudoephedrine; levocetirizine
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      Evaluation of the association between risk and severity of asparaginase associated toxicities
      and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated
      in the NOPHO-ALL 2008 protocol.
    

Detailed description: 
      Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge
      toxicity burden and the toxicities are often preventing further treatment. The most common
      asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and
      osteonecrosis.

      In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since
      the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have
      been done before every asparaginase administration and analyzed retrospectively.

      This study evaluate the association between risk and severity of asparaginase associated
      toxicities and asparaginase enzyme activity levels in children with ALL treated in the
      NOPHO-ALL 2008 protocol.
    

Intervention name(s): Asparaginase
Intervention type(s): Drug
Intervention MeSH terms: Asparaginase
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children with ALL, aged 1-17.9 years at time of diagnosis
Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer
Condition: Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
MeSH terms: Head and Neck Neoplasms; Fatigue; Pain, Postoperative
Study type: Interventional

Summary: 
      This study aimed to investigate the effects of progressive muscle relaxation (PMR) on
      postoperative pain, fatigue, and vital signs in patients with head and neck cancers.
    


Intervention name(s): progressive muscle relaxation; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): progressive muscle relaxation; Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: progressive muscle relaxation; head and neck cancer
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects enrolled in this study will be evaluated for immune responses and histological
      changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten
      challenge.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled clinical trial to assess the
      safety, pharmacodynamics, efficacy, and PK, of TIMP-GLIA in subjects with well-controlled
      celiac disease (CD) following an oral gluten challenge. Subjects aged 18 to 70 years
      inclusive, with documented history of biopsy-proven confirmed CD, and on a gluten-free diet
      (GFD) for a minimum of 6 months, will be screened. Subjects who meet all inclusion and no
      exclusion criteria, and provide written informed consent, will be randomized within 45 days
      after Screening to receive 2 intravenous (IV) infusions of TIMP-GLIA, 8 mg/kg up to a maximum
      of 650 mg or placebo (normal saline) in a 1:1 ratio. Treatment with drug or placebo will be
      followed by 14 days gluten challenge.
    

Intervention name(s): TIMP-GLIA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.; Administered intravenously on days 1 and 8.
Other intervention name(s): TAK-101; 0.9% sodium chloride (normal saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Condition: Fibrosis; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to evaluate the impact in safety and efficacy of a new formulation
      of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic
      kidney Disease (CKD).
    


Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled.
Other intervention name(s): 5-methyl-1-phenyl-2-(1H)-pyridone
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nephroprotection; pirfenidone; polymorphisms