bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo controllled parallel design study to
      evaluate the use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on
      quality of life in adults with chronic pain. Eligible participants that provide informed
      consent and pass the screening visit procedures will be randomized in a 4:1 ratio to active
      product or placebo at the baseline visit (V2) and will return after 3 and 6 weeks of
      supplementation for study assessments.
    

Detailed description: 
      A newly developed biomarker test panel, named the Foundation Pain Index (FPI), has been
      demonstrated to have applications in the potential medical care of individuals living with
      chronic pain. The research to date has demonstrated a nutritional link to pain amongst other
      potential causes or collaterals related to pain. The current research points to nutritional
      deficiencies, metabolic abnormalities and oxidative stressors as all being related to pain
      and potential pain management. Preliminary research has found that the novel biomarker
      testing platform allows for the treating physician to utilize non-opioid means for helping to
      manage quality of life and pain medication usage (opioid and non-opioid). Using the FPI, a
      systems biology approach will be taken to identify potential biomarkers related to pain and
      pain management.

      The present study is designed to determine if individuals with chronic pain can benefit from
      the FPI and the nutritional supplement BioPlete™

      A total of 30 participants will be randomized in a 4:1 ratio for the study, with 24
      participants in the Test Product arm and 6 participants in the placebo arm. The study
      duration for this trial can last up to a total of approximately 2.5 months (73 days) in
      duration.
    

Intervention name(s): BioPlete™ Advanced Formula; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal; 2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This retrospective database study analyzed resource utilization and costs associated with
      sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy
      among adults with a diagnosis of diabetes who were continuously enrolled in a large US
      healthcare plan.
    


Intervention name(s): Rosiglitazone + Metformin; Sitagliptin + Metformin
Intervention type(s): Drug; Drug
Intervention description(s): At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG; At least 180 days of continuous therapy with STG+MET after the first Rx for STG
Other intervention name(s): Avandia(TM); Januvia(R)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Rosiglitazone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults continuously enrolled in a large US health insurance plan with a diagnosis of
        diabetes who are currently receiving Metformin
      
Keywords: Retrospective; Type 2 Diabetes; Cost Analysis; Rosiglitazone; Sitagliptin
Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"
Condition: Diabetic Neuropathic Ulcer
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical trial is to investigate the efficacy (by monitoring the wound
      surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of
      two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically
      administered to the wound matrix of patients with diabetic neuropathic ulcer.
    

Detailed description: 
      This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
      and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in
      patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will
      be expanded in vitro. The Investigational medicinal product (IMP) containing the
      ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit
      10) on the wound surface of DFU.

      Patients are followed up for efficacy for a period of three months starting after the first
      IMP application which allows to distinguish actual wound healing from transient wound
      coverage.

      The wound healing process will be documented by standardized photography. The wound size
      reduction evaluation will start two weeks after the first IMP application. The quality of the
      wound healing process will be assessed on the basis of formation of granulation tissue,
      epithelialization and wound exudation.

      Pain will be assessed using a numerical rating scale and quality of life will be investigated
      with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-DFU
      three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.
    

Intervention name(s): allo-APZ2-DFU
Intervention type(s): Biological
Intervention description(s): Suspension of ABCB5-positive mesenchymal stem cells
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment Interventional, single arm, multicenter, phase I/IIa clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic neuropathic ulcer; ABCB5; allogeneic; mesenchymal stem cells; skin ulcer; advanced therapy medicinal product; somatic cell therapy; phase I/IIa; Diabetic Foot Ulcer
Interleukin 20 and Periodontal Tisuue Destruction
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Periodontitis is an inflammatory disease that causes destruction of periodontal tissues.
      IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory
      cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role
      in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to
      evaluate the effect of IL-20 on periodontal destruction.

      In the study, a total of 60 participants were included, 30 of whom were systemically and
      periodontally healthy (control group) and 30 of whom were systemically healthy and had
      periodontitis (periodontitis group). GCF and serum samples were collected from the
      participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α,
      IL1β/IL-10, RANKL/OPG and MMP8 levels
    


Intervention name(s): biochemical analysis
Intervention type(s): Other
Intervention description(s): GCF and serum samples were collected from the participants for biochemical analysis.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study included individuals who applied to Recep Tayyip Erdogan University, Faculty of
        Dentistry, Department of Periodontology for treatment
      
Biospecimen description: 
      serum and gingival crevicular fluid
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study it is intended to compare the blood pressure lowering effect of the combination
      of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the
      combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in
      patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The
      Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and
      candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.
    


Intervention name(s): Candesartan cilexetil; Hydrochlorothiazide; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 32mg oral; 12.5 mg oral; 25 mg oral
Other intervention name(s): ATACAND; HCTZ; HCTZ
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood pressure reduction; combination therapy; candesartan cilexetil; hydrochlorothiazide
Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for
      the treatment of hepatitis C in Iran. In this study the efficacy of this combination is
      evaluated in 1000 patient with hepatitis C.
    

Detailed description: 
      All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or
      hepatitis B, active drug abuse, on immune suppression and from all genotypes will be
      included. Patients will be treated by a single daily dose of a fixed-dose combination pill of
      400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by
      liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment
      duration will be prolonged to 24 weeks.
    

Intervention name(s): sofosbuvir and daclatasvir
Intervention type(s): Drug
Intervention description(s): A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.
Other intervention name(s): Sovodak
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; sofosbuvir; daclatasvir
What Influences Patient Outcome in Obstructive Airway Disease?
Condition: COPD
Study type: Observational

Summary: 
      The aim of this observational study is to utilise the established record linkage data
      available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        COPD patients within NHS Tayside, UK
Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil
Condition: Healthy; Mildly Elevated Cholesterol Levels
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Plant sterols and fish fatty acids are known to affect the blood lipid profile. This
      randomized, double-blind, placebo-controlled, parallel efficacy study is designed to
      investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of
      plant sterols and different doses of fish fatty acids when combined in a spread format.
    


Intervention name(s): Plant sterols and fish oil; Plant sterols; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4 weeks intervention, 3 times daily; 4 weeks intervention, 3 times daily; 4 weeks, 3 times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dose-response study; blood lipid profile; plant sterols; fish oil
Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
Condition: Infertility, Female; Ovarian Insufficiency
MeSH terms: Infertility; Infertility, Female; Flushing
Study type: Interventional

Summary: 
      The object of this study is to determine the benefit of follicular flushing with a double
      channel needle in a poor responder population for a maximum number of oocytes to be
      retrieved. The investigators compare two methods of oocyte retrieval with or without
      flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm
      Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and
      more the day of ovulation induction will be included, following a randomized protocol in two
      groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G.
      Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all
      follicles are flushed with flushing solution in addition to direct aspiration of the
      follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing
      medium is collected separately from direct fluid aspiration in order to follow up each oocyte
      one by one. First criterion of our comparison is the number of oocyte retrieved. Second
      criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained,
      clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes
      collected in flush medium and oocytes from direct follicle fluid. Then the investigators will
      know the capability of oocyte collected after follicular flushing to be fertilized and to
      increase the success chance of pregnancy for poor responder patients.
    


Intervention name(s): Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
Intervention type(s): Procedure
Intervention description(s): In addition to direct aspiration of the follicular fluid all follicles are flushed with flushing solution, 20CC of flushing medium( Flushing Medium MediCultâ France) is provided for all the procedure and flushing medium is collected separately from direct fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Telehealth & HPV Self-Collection
Condition: Gynecologic Cancer
Study type: Interventional

Summary: 
      This study aims to compare the efficacy and participant experience of telehealth-based,
      self-collected cervical cancer screening to mail-based, self-collected cervical cancer
      screening across the adult female screening lifespan. This will be done by evaluating
      sufficient Human papillomavirus (HPV) sample collection and determining preference for
      self-collection verses provider collection, comparing role of telehealth in pre- and post-
      menopausal women's comfort with self-collection, comparing self-collection completion rates
      for women with and without telehealth visits.
    

Detailed description: 
      This will be a prospective, randomized study of women ages 25 and older, stratified by
      menopausal status (defined as 12 months or greater without menses or time at which both
      ovaries have been surgically removed), who are eligible for cervical cancer screening.
    

Intervention name(s): Receive routine instructions; Telehealth-based instructional visit and receive routine instructions
Intervention type(s): Other; Other
Intervention description(s): Study subjects randomized to this arm will receive a mailed myLab Box kit with instructions on HPV self-collection and postage to be shipped directly to the commercial lab. It should take less than 5 minutes to collect the sample.; Study subjects randomized to this arm will similarly receive a mailed myLab Box kit and also undergo a brief 5-10" telehealth instructional visit via video conference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pap Smear; Human papillomavirus; Telehealth
Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults
Condition: Malaria
MeSH terms: Infections; Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to establish the best dose to safely infect healthy individuals with
      Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.
    

Detailed description: 
      TÜCHMI-001 is a single center, open label, randomized and controlled human pilot study to
      optimize controlled human malaria infection(CHMI) administered by PfSPZ Challenge. Volunteers
      will be inoculated with PfSPZ Challenge. Controls will receive the PfSPZ Challenge by ID
      administration. The remaining volunteers will receive the PfSPZ Challenge by IV
      administration. All volunteers recruited will be healthy adults aged between 18 and 45 years.
      Safety and infectivity data will be collected for each of the regimens and dose-levels.

      Volunteers and clinical investigators will not be blinded to group allocation, however
      laboratory investigators processing blood films and samples for PCR analysis will be blinded
      to group allocation.
    

Intervention name(s): PfSPZ Challenge
Intervention type(s): Biological
Intervention description(s): PfSPZ Challenge are aseptic, cryopreserved P. falciparum sporozoites.
Other intervention name(s): Aseptic, cryopreserved P. falciparum sporozoites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Controlled human malaria infection (CHMI); Malaria challenge; Plasmodium falciparum; PfSPZ Challenge
Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864).
      In the parent trial, patients will be subjected to an 8-week diet intervention phase
      including a low-calorie diet and dietetic counseling, after which patients will be randomised
      to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic
      guidance on re-introducing regular foods and a focus on continued motivation to engage in a
      healthy lifestyle.

      This substudy aims to investigate the impact of, and subsequent change of, joint inflammation
      and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation
      to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
    


Intervention name(s): Liraglutide 3 mg (Saxenda); Liraglutide 3 mg placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liraglutide; Liraglutide 3 mg; Osteoarthritis; Obesity; Ultrasound
Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to compare periodontal treatment with or without the adjunct of an
      enamel matrix derivative in terms of acute-phase responses in healthy patients.
    

Detailed description: 
      Patients with periodontitis will be randomly allocated to two groups. In both groups,
      periodontal root instrumentation will be performed. In the test group, an additional flapless
      application of enamel matrix derivatives will be granted for sites with pockets deeper than 5
      mm.

      Systemic inflammation as measured through blood testing and local parameters of periodontal
      health will be measured at baseline and three months after treatment completion.
    

Intervention name(s): Root Instrumentation; EMD Application
Intervention type(s): Procedure; Device
Intervention description(s): Instrumentation of the root surface in order to achieve debridement; Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety & Efficacy Study of rAAV1-CB-hAAT for Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1 Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant
      adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in
      AAT-deficient adults at three dosage levels [6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector
      genome particles (vg) per kg body weight].

      Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung,
      and Blood Institute
    

Detailed description: 
      The study is a non-randomized, open-label, multi-center, sequential, three-arm, Phase 2
      clinical trial evaluating the safety and efficacy of administration of a rAAV1-CB-hAAT vector
      administered by IM injection. Each participant will receive rAAV1-CB-hAAT on a single
      occasion. Three groups of three subjects each will receive rAAV1-CB-hAAT at dosage levels of
      6 x 10e11 vg/kg, 1.9 x 10e12 vg/kg or 6 x 10e12 vg/kg by IM injection. Subjects in group 1
      will receive a total of 10 IM injections distributed across a single muscle site, subjects in
      group 2 will receive a total of 32 IM injections distributed across three muscle sites, and
      subjects in group 3 will receive 100 IM injections distributed across 10 muscle sites. Each
      injection will be given in a volume of 1.35 mL, at the appropriate vector concentration to
      achieve the desired total vector dose.

      The three groups were enrolled sequentially, with review of safety data by a Data and Safety
      Monitoring Board before enrollment of each higher dosage level group.

      Safety was monitored by evaluation of adverse events, hematology and clinical chemistry
      parameters, histological examination of muscle biopsies, and measurement of serum antibodies
      to AAT. Efficacy was measured by evaluation of serum concentrations of M-specific AAT and
      total AAT, and serum AAT phenotype determined on isoelectric focusing gels. Additional
      information collected included presence of the vector in blood or semen, changes in serum
      anti-AAV antibody titers, and changes in T cell responses to AAV and AAT.
    

Intervention name(s): rAAV1-CB-hAAT
Intervention type(s): Drug
Intervention description(s): Recombinant adeno-associated virus vector expressing human alpha-1 antitrypsin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alpha-1 antitrypsin deficiency; Adeno-associated virus vector; AAV; Gene therapy; Human gene transfer