cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)

This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment.
2. Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

1. Known hematocrit \<30% or \> 52%;
2. History of medical conditions - other than risk of cardiovascular disease - that may elevate CRP as listed in Appendix B (e.g., tissue damage, infection, inflammation, malignant neoplasia)
3. Vulnerable populations deemed inappropriate for study by the site's principal investigator.
Effectiveness of Motivational Interview in Patients With Dyslipidemia

Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with dyslipidemia
* To sign informed consent.

Exclusion Criteria:

* Secondary hypercholesterolemia.
* Familial hypercholesterolemia.
* Deficiency syndromes family high density lipoprotein.
* Subjects with a history of cardiac or cerebrovascular events.
* Other chronic health problems such as diabetes or severe COPD.
* Subjects with current diagnosis of cancer.
* Patients with hepatic or renal disorders .
* Subjects heavy drinkers.
* Patients with long standing sick leave (more than 6 months).
* Pregnant or breastfeeding.
Glucocorticoids in Patients With IgG4-RD

This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-70 years old with informed consent
* Patients with IgG4-RD:

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L)
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
  4. exclusion of other diseases.

Exclusion Criteria:

* Previously or currently received glucocorticoid and(or) immunomodulator
* Pregnancy or lactating
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
* Measurable disease per RECIST 1.1
* Somatostatin receptor positive (SSTR+) disease
* Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)

Exclusion Criteria:

* Known hypersensitivity to edotreotide or everolimus
* Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
* Prior exposure to any peptide receptor radionuclide therapy (PRRT)
* Prior therapy with mTor inhibitors
* Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
* Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
* Indication for surgical lesion removal with curative potential
* Planned alternative therapy (for the period of study participation)
* Serious non-malignant disease
* Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
* Pregnant or breast-feeding women
* Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.


Eligibility Criteria:
Inclusion Criteria:

* 20-45 years healthy male subjects
* Body weight :50-90kg, BMI between 18.5-25
* Blood glucose level of 70-110mg/dL on the FPG test

Exclusion Criteria:

* have a family history of diabetes
* Serum AST(SGOT), ALT(SGPT)\>1.25 times upper limit of normal
* Creatinine clearance rate\<80mL/min
* show SBP =\<100mmHg or \>=150mmHg, or DBP=\<65mmHg or \>=95mmHg, or tachycardia (PR\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
* can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects
Biphasic Material With PRF in Lateral Sinus Floor Augmentation

A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment.

The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability.

The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.

Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP.

platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.

Eligibility Criteria:
Inclusion Criteria:

* Residual bone crest height \< 5 mm and width≥6 mm in the planned implant site.
* Healed bone crest (at least 6 months elapsed from tooth loss/extraction);

Exclusion Criteria:

* Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies
Evaluation of Premixed Verses Powder/Liquid Bioceramic MTA in Indirect Pulp Capping.

Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars

Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth.

Although it has good properties, MTA has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians.

Researchers and manufacturers have made progress in overcoming these problems in recent years, new and improved products are becoming available such as the premixed bioceramic putty.

The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Upon setting, they become hard and expand slightly providing with superior long-term seal.

Premixed Bio-ceramics (BC) are highly alkaline materials (pH = 12.7), they release calcium and have antibacterial activity. Their biocompatibility is higher than that of MTA, this is attributed to the absence of heavy metals from the premixed BC components.

The premixed bio-ceramic putty (Well-Root™ PT) has been developed for the management of pulp capping procedures with the advantage of uniform homogenous consistency and lack of waste. It is radiopaque material based on a calcium aluminosilicate composition.

It has excellent biological \& physical properties and does not shrink during setting. Well-Root™ PT does not create an inflammatory response and promotes mineralization.

Eligibility Criteria:
Inclusion Criteria:

* Medically fit and cooperative children.
* Pediatric patients aged 6-8 years.
* Deep caries with reversible pulpits in immature first permanent mandibular molars indicated for indirect pulp capping.
* Absence of clinical signs and symptoms of pulpal exposure.
* Absence of radiographic signs and symptoms of pulp degeneration.
* Positive parental informed consent.

Exclusion Criteria:

* Clinical symptoms of irreversible pulpitis requiring endodontic treatment.
* Clinical symptoms of pulp exposure.
* The presence of fistulas or swelling.
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults

Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Male or female
* Non-smoker
* 18-65 years old
* BMI \> 18.5 and \< 30.0
* With medically acceptable form of contraception (female only)
* With signed informed consent

Exclusion Criteria:

* Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure \< 90 or \> 140 mmHg,
* Diastolic blood pressure lower \< 50 or \> 90 mmHg, or heart rate \< 50 or \> 100 BPM)
* Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and
* Hemoglobin \< 128 g/L (males) or \< 115 g/L (females) and hematocrit \< 0.37 L/L (males) or \< 0.32 L/L (females))
* History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
* Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
* Positive pregnancy test, breastfeeding or lactating
* Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
* Participation in an investigational study within 30 days prior to dosing
* Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of \> 499 mL (within 56 days) prior to dosing.
An Evaluation of Zinc Status Biomarkers

The purpose of this study is to determine the effect of a moderate decrease in dietary zinc on DNA strand breaks and other cellular zinc biomarkers.

Assessing the zinc status of humans has proven to be difficult because of the unique physiological features of zinc homeostasis. Animal and human studies show that a small, vulnerable pool of cellular zinc is sensitive to changes in dietary zinc. The protein, Metallothionein (MT), is made within cells to stabilize this transient zinc pool and to provide a means to 'park' a small zinc reserve. The overall goal is to develop a new method for measuring MT in cells and to assess other cellular responses to changes in small changes in dietary zinc. Culture models of zinc deficiency and excess have been developed and used to test the response of cellular MT levels and mineralization to changes in zinc availability. In Phase II, the changes in the expression of leukocytic zinc transporters and the cellular in vitro uptake of isotopic zinc will be measured. Healthy men will be recruited to participate in a 6-week feeding trial to be followed by a 3-week recovery period. The results of this study will determine if potential new cellular zinc biomarkers respond to changes in zinc status when the men are fed an additional 4 mg zinc/d incorporated into a rice-based meal. These findings will provide essential, new information for designing an efficacy trial of biofortified rice and the zinc status of infants and young children.

Eligibility Criteria:
Inclusion Criteria:

* willing to limit food and beverage intake to that provided by the study
* willing to discontinue consumption of alcoholic beverages during the study
* has an operative understanding of English
* no plans to move from the area during the study period

Exclusion Criteria:

* chronic or acute metabolic disease (i.e., diabetes or asthma)
* taking medications for a metabolic disorder
* evidence of alcohol abuse or use of illicit drugs
TAF for HIV-HBV With Renal Dysfunction

The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection.

The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.

Rationale:

Tenofovir alafenamide (TAF) has been shown to cause less renal complications than tenofovir disoproxil fumarate (TDF) while having the same virological efficacy against HIV and HBV infections. In a recent study from the USA and Japan, over 90% of HIV/HBV-coinfected individuals had a suppressed HBV viral load 48 weeks after TDF was replaced by TAF. Thus, TAF might be a valuable treatment option for HIV/HBV-coinfected individuals with TDF-toxicity, especially in the context of resistance to lamivudine and entecavir. However, the safety and efficacy of TAF has not been evaluated to date in HIV/HBV-coinfected patients with renal dysfunction.

Primary objectives:

* To evaluate changes in glomerular and tubular renal function after switch from TDF to TAF in HIV/HBV coinfected patients with renal dysfunction
* To assess the HBV virological efficacy of TAF in HIV/HBV coinfected patients with renal dysfunction switching from TDF to TAF.

Secondary objectives:

* To assess the percentage of and reasons for treatment interruptions
* To describe toxicity events including liver-related complications
* To evaluate changes in liver fibrosis

Intervention:

In eligible patients willing to participate and who have signed an informed consent TDF will be replaced by TAF on day 1 of the study.

Products:

* Tenofovir alafenamide/emtricitabine (TAF/FTC) Dose: one tbl. once per day in addition to at least one third compound OR
* Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) Dose: one tbl. once per day

Study Population: eligible patients from all 7 centers of the Swiss HIV Cohort Study will be considered.

Eligibility Criteria:
Inclusion Criteria:

* HIV/HBV-coinfection
* Suppressed HIV-viremia (\<200 cp/ml)
* On TDF-containing ART since at least 6 months
* eGFR \> 30 ml/min and \<90 ml/min
* Written informed consent

Exclusion Criteria:

* Study drug considered by the treating physician not a valid option for the patient
* Pregnancy
* Decompensated liver cirrhosis
Sensory Awareness Program

Few alternatives to addictive medical treatment exists for persons with severe mental health problems (SMHP) and anxiety, often connected to high risk of suicide. Access to effective interventions that depart in individuals' needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users. Service users are often unaware of sensory needs, connected to anxiety outburst. The Sensory Awareness Program (SAP) is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors. SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies. International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services (MHS), and also to empower users. However, much research to date focus on using sensory strategies within wards. International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life. Earlier studies further show that users' unawareness of sensory needs triggers anxiety, and that anxiety itself is the main contributing factor for disrupting everyday life. Also, staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement.

The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual (TAU) among 200 outpatients. The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety (primary outcome) at three months follow-up. Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group. The implementation process of the SAP will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Be assigned to a MHS
* Age over 18
* Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder)
* Experience anxiety

Exclusion Criteria:

* Acutely mentally unwell
* Cognitively impaired
* Non-Swedish speaking
Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children

Food protein-induced enterocolitis syndrome (FPIEES) is a particular non-Immunoglobulin E-mediated food allergy.

A retrospective descriptive single-center study was conducted. Subjects included were children with acute FPIES who consulted the allergy department of the Nancy Regional University Hospital between November 2013 and June 2016.

As it is a descriptive study, the Primary Outcome is not a Measure. Therefore it is not possible to include the name of the measurement or measurement tool used to assess the measure in the primary outcome measure title.

Eligibility Criteria:
Inclusion Criteria:

* Child from 0 to 17 years with acute FPIES

Exclusion Criteria:

-
Calcium and Gut Hormones

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women age between 18-65 yrs.
* Able to consume provided supplement.
* Weight stable for the past 3 month (no change within 3%)

Exclusion Criteria:

* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
* Not between the ages of 18-65 years
* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
* Taking medications that may influence your metabolism
* Plans to change your lifestyle (diet and/or physical activity) during the study period
* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
* Current smoker