bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Background: Type 1 diabetes is one of the most common chronic illnesses among children and
      adolescents. Although, intensive medical care is provided for these patients, some of them
      have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the
      USA achieve the recommended average blood sugar concentration (HbA1c<7.5%). This is a major
      problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type
      1 diabetes and causes several serious complications, for example kidney failure, blindness,
      and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes
      (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1
      diabetes Management.

      Aim: The aim of this project is to determine the most important risk factors for poor
      metabolic control in children and adolescents with type 1 diabetes in a cross-sectional
      design.

      Method: The sample consists of children and adolescents (school age: 7-18 years), who were
      diagnosed with type 1 diabetes over a year ago, and who are in care at the University
      Children's Hospital of Zurich. Structured interviews are conducted with the patients and the
      parents are asked to fill out some questionnaires. Additionally, hair samples are collected
      to investigate the cortisol levels of the past 3 months. The collected data is used to
      investigate the impact of different psychosocial risk factors including personality and
      self-efficacy of the patients, stress, social support, family environment, education, and
      parental factors on the metabolic control (HbA1c) in pediatric patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic - University Children's Hospital Zurich
      
Keywords: type 1 diabetes; metabolic control; psychosocial risk factors; cortisol; children; adolescents
Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults
Condition: Influenza; Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Over the past decade, avian influenza (AI) has become a major health concern. The development
      of safe and effective vaccines against avian strains infecting people is important. The
      purpose of this study is to determine the safety of and immune response to a new AI vaccine
      in healthy adults against the H7N3 strain of avian influenza.
    

Detailed description: 
      The current pandemic risk associated with avian influenza H7N3 infection is significant as an
      increasing number of humans are infected. H7 influenza transmission usually occurs in humans
      when they are exposed through direct contact to infected poultry or surfaces and objects
      contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype
      emerges that infects humans, causes serious illness, and spreads easily between humans. The
      development of a safe and effective vaccine is necessary, should a pandemic occur. The
      purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated AI
      virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann
      Arbor/6/60 ca).

      This study will last approximately 90 days. Participation in this study includes two 12-day
      hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center. All
      participants will receive two doses of vaccine in nasal spray form, at study entry and
      sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to
      the isolation unit 2 days prior to each vaccination. A targeted physical exam, vital signs
      measurement, and a nasal wash will occur daily following each vaccination until discharge.
      Participants will be discharged after three consecutive nasal washes on or after Day 6 are
      negative. Blood and urine collection will occur at selected timepoints throughout the study.
      A follow-up outpatient visit will occur approximately 4 weeks following each vaccination.
    

Intervention name(s): Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Intervention type(s): Biological
Intervention description(s): Vaccine given by nasal spray
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird Flu
Autologous Fibroblast Transplantation in Facial Deformities
Condition: Nasolabial Folds; Glabellar Crease; Deep Wrinkles of the Forehead; Acne Scars
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Phase 2

Summary: 
      Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct
      sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good
      and radiant skin. However despite all the care taken passage of time will bring about
      conditions that will automatically lead to skin aging, which may require certain therapeutic,
      care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a
      critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is
      the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of
      skin fibroblast along with differentiation of stem cells in the skin tissue is the best
      method for healing.
    

Detailed description: 
      Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested
      from the patient's normal skin. Biopsies from behind a patient's ear are the source of
      fibroblasts, which are isolated, expanded through cell culture, and used for the correction
      of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of
      the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at
      least 85%.

      Each single use container of autologous cultured fibroblasts has approximately 20 million
      cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified
      Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain
      gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell
      product
    

Intervention name(s): Fibroblast; fibroblast and gel
Intervention type(s): Biological; Biological
Intervention description(s): 20 million cell in three injection; 20 million cell in three injection plus filler
Other intervention name(s): cell alone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibroblast; Cell transplantation; Facial deformities
Adderall XR and Processing Speed in Multiple Sclerosis (MS)
Condition: Impaired Processing Speed; Cognitive Impairment; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis
      (MS) and can occur independently of physical disability. It is the most common reason, along
      with physical fatigue, for MS patients to stop working. The most frequent complaint is
      problems with multi-tasking or thinking quickly, which corresponds to impairment in the
      cognitive domain of processing speed. Currently there is treatment available to prevent
      relapses and physical disability but there are no medications that have been shown to treat
      cognitive impairment. Amphetamines have been beneficial for selective attention and
      processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain
      injury. This is study will determine whether Adderall XR improves objective measures of
      processing speed and attention in MS patients impaired in this cognitive domain, by comparing
      two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is
      administered. The results of this study will help provide data to design a larger study to
      determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive
      impairment in MS patients.
    


Intervention name(s): Adderall XR 5mg; Adderall XR 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Impairment; Multiple Sclerosis; Processing Speed; Treatment
A Survey Exploring Health and Screening Tests in People Treated for Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Observational

Summary: 
      A survey of health beliefs and cancer screening behaviour and intentions in Hodgkin lymphoma
      survivors
    

Detailed description: 
      A survey of Hodgkin lymphoma survivors registered in a follow-up database, examining health
      beliefs (using Health Belief Model) around breast, bowel and lung cancer screening, previous
      screening uptake and future uptake intentions
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of Hodgkin lymphoma survivors registered in a clinical follow-up database at The
        Christie Hospital
Assessment of a Novel Tracheostomy Tie
Condition: Tracheostomy Complication
Study type: Interventional

Summary: 
      Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be
      securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged
      as needed. However, the process of ties exchange is always risky and complicated. A novel
      tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of
      cleaning. This study is to determine if the new device is better than the old one.
    

Detailed description: 
      Tracheotomy is a common procedure for multiple medical indications. Nursing staff must
      understand the immediate postoperative and long-term management of tracheostomy patients. To
      provide safe and competent care, tracheostomy tubes must be taken care of carefully,
      including cleaning or changing the inner cannula, caring for the stoma, suctioning at least 3
      times a day, and replacing tracheostomy ties according to facility-specific policy as needed.
      However, to avoid inadvertent dislodgement of the tracheostomy tube, the process of ties
      exchange is always risky and complicated, which request one person to hold the tube in place
      while a second person performs the tie exchange.

      The investigators designed a novel tracheostomy tie to ensure the safety during exchanging
      and conveniences of cleaning, the primary feature of which is double belts and easy to
      operate. This randomized controlled trial is to determine if the new device is better than
      the traditional one.

      Sixty tracheotomy patients without an existing neck injury will be recruited . Patients in
      experimental group wear a novel tracheostomy tie. The traditional one was used in control
      group. Difficulty level of exchanging or cleaning the tracheostomy ties, degree of comfort,
      skin breakdown and the actually frequency of exchanging will be evaluated.
    

Intervention name(s): novel tracheostomy bi-ties; traditional Tracheostomy ties
Intervention type(s): Device; Device
Intervention description(s): The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.; Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: tracheostomy ties
The Mechanism of MicroRNAs Network in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational [Patient Registry]

Summary: 
      MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and
      the clinical validation in diagnosis AD.
    


Intervention name(s): MicRNAs test
Intervention type(s): Diagnostic Test
Intervention description(s): plasma micRNAs concentration
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        age between 60 to 90 years old.
      
Keywords: MicroRNAs; Alzheimer's Disease; Validation
TACE Combined With Donafenib and Tislelizumab in Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      Most hepatocellular carcinoma (HCC) are found in the intermediate or advanced stage. The
      patients lose the opportunity of curative surgical resection. In clinical practice,
      unresectable HCC is often encountered with large tumor lesions and insufficient remaining
      liver volume. It is expected that the benefit of direct surgical resection will not exceed
      that of non-surgical treatment if the tumor is limited in scope but with unclear boundaries,
      surrounding small foci, or adjacent to important vascular structures, or combined with
      secondary or higher portal vein tumor thrombus. These patients account for a significant
      proportion of unresectable HCC, but have the potential for surgical resection. If the
      investigators can make full use of the existing HCC treatment, the patients hope to obtain
      radical surgical resection opportunities and better long-term survival after tumor shrinkage
      and tumor necrosis boundary becomes clear.

      Transcatheter arterial chemoembolization (TACE) has been the standard arterial treatment for
      advanced HCC. Donafenib is a multikinase inhibitor that is the first-line treatment for
      hepatocellular carcinoma. Tislelizumab is an immune checkpoint inhibitor and a first-line
      treatment for HCC. This study investigated the efficacy and safety of TACE combined with
      donafenib and tislelizumab in the treatment of unresectable HCC.
    


Intervention name(s): Transarterial chemoembolization combined with Donafenib and Tislelizumab
Intervention type(s): Drug
Intervention description(s): Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Donafenib and Tislelizumab
Intervention MeSH terms: Tislelizumab
Intervention model: Single Group Assignment
Intervention model description: Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Donafenib and Tislelizumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma
Maintenance Therapy for Small-cell Lung Cancer
Condition: Progression Free Survival
MeSH terms: Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study involves patients treated with cisplatin and etoposide (induction therapy),
      followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this
      study is to determine if this type of treatment will delay the growth of the tumor and if so,
      for how long. The primary endpoint is progression free survival and second endpoints are
      toxicities, overall survival.
    

Detailed description: 
      Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of
      malignancy, short doubling time, early and widespread metastasis, is sensitive to
      chemotherapy and radiotherapy, and has a high initial response rate, but is prone to
      secondary drug resistance and relapse. The treatment is mainly based on systemic
      chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy
      could prolong progression free survival.
    

Intervention name(s): cis Platinum, etoposide, S1
Intervention type(s): Drug
Intervention description(s): cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
Intervention MeSH terms: Etoposide; Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196),
      acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with
      omeprazole.
    

Detailed description: 
      This is a 3-part study. Each part of the study will compare the effect of an acidic
      formulation of ACP-196, acidic beverage (orange drink), or grapefruit juice on the PK profile
      of ACP-196 alone and when coadministered with omeprazole. Participants will be enrolled into
      Part 1 of the study first and then subsequent participants will be randomized in a 1:1 ratio
      to either Part 2 or Part 3 of the study. Participants will be screened within 28 days before
      the dose. Participants will be contacted approximately 14 days after the last dose of study
      drug administration to determine if any adverse event has occurred since the last dose of
      study drug.
    

Intervention name(s): ACP-196; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): In Parts 1, 2, and 3, participants will receive oral Dose 1 of ACP-196 (reference or acidic formulation as applicable) on Day 1, Day 3, Day 8, and Day 10.; Participants will receive omeprazole in all parts as: on Day 8 and Day 10 with water in Part 1; on Day 8 with water and on Day 10 with acidic beverage in Part 2; on Day 8 with water and on Day 10 with grapefruit juice in Part 3.
Other intervention name(s): Acalabrutinib
Intervention MeSH terms: Acalabrutinib; Omeprazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acalabrutinib; ACP-196; Healthy volunteers; Pharmacokinetics; PK; Acidic Formulation; Acidic Beverage; Grapefruit Juice; Omeprazole; Fixed-sequence
Postpartum Intrauterine Device Study
Condition: Contraception; Intrauterine Devices; Pilot Study; Africa
Study type: Interventional

Summary: 
      The purpose of this non-blinded randomized clinical trial is to pilot the design of a
      randomized clinical trial to be conducted in Malawi to investigate immediate postpartum
      insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to
      placement at the 6-week postpartum visit.

      The investigators hypothesize that it will be feasible to enroll 140 women into this study,
      and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.
    

Detailed description: 
      Women will be enrolled into the study during prenatal care. After delivery, if they meet
      secondary eligibility criteria, they will be randomized to receive the IUD immediately
      postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks
      after IUD insertion, and be assessed at those time points for satisfaction with the method
      and IUD expulsion.
    

Intervention name(s): Copper T380A Intrauterine Device
Intervention type(s): Device
Intervention description(s): the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Postpartum Contraception; Intrauterine device; feasibility; IUD; Immediate postpartum IUD
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to
      evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01
      in healthy volunteers.
    


Intervention name(s): CT-L01 12.5/500 mg; Alogliptin Benzoate 12.5 mg; Metformin HCl XR 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC tablet, 2 tablets at a time, oral administration; Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration; Metformin HCl XR 500 mg 2 tablets, at a time, oral administration
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Complementary and alternative medicine has been employed over thousands of years to relieve
      knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been
      used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may
      explored its mechanism. However, presently, there is a lack of large-sample, multicenter,
      randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA.
      Therefore, the investigators designed a randomized, placebo-controlled, double-blind,
      multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the
      treatment of KOA.
    


Intervention name(s): glucosamine sulfate; Xinfeng capsule
Intervention type(s): Drug; Drug
Intervention description(s): glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks; Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Xinfeng capsule; Knee osteoarthritis; Randomized controlled trials; Double-blind
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
Condition: Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the neurophysiological changes following single
      doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male
      subjects.
    


Intervention name(s): EVT 101; EVT 101; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 mg capsule, single oral dose; 15 mg capsule, single oral dose; Placebo capsule, single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science