cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852

This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects

Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.

Part 2

: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
* Healthy adult, 19 - 55 of age (inclusive)
* Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit
* Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results

Exclusion Criteria:

* History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
* History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension
* Subjects who are positive for Hepatitis B, Hepatitis C, and HIV
* History of relevant allergy/hypersensitivity
* Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug
* Subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period
* Subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit Foods and/or beverages containing grapefruit Products containing caffeine (Coffee, tea, chocolate, caffeine-containing soft drinks)
* Subject who is not willing to use contraception throughout the study
* Subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period
* Subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study
* Administration of any investigational products within 3 months from the first dose of the study drug
* Subject who's serum prolactin is over 3-fold higher than the upper limit of normal range
* Subject who judged not eligible for study participation by investigator
Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.

Eligibility Criteria:
Inclusion criteria:

* Age 18-75 (inclusive
* Blood pressure in hypertensive range (systolic \>= 140 or diastolic \>=90
* Diabetes

Exclusion criteria:

* Pregnancy
* Lack of computer with internet access or phone line
* Lack of English language literacy
* Arm size to large or small for cuff
Glycemic Index and Glycemic Response of Food and Products

The purpose of ths study was to evaluate the glycemic index and glycemic response of food and products that produced in Tiwan. The food and product are in includes local produced fruits, starchy food and bread made from resistant starch.

Low glycemic index (GI) diets have protective and therapeutic potential for diabetic patients and general public. With recent recognition of resistant starch (RS), an indigestible fraction which has postprandial glucose lowering effects, the addition of resistant starch in bread may alter its glycemic effects and thus glycemic index. Therefore, the objectives of this study were to investigate the glycemic index, glycemic reponse of Taiwan local food and effects of resistant starch in bread formulation.

Eligibility Criteria:
Inclusion Criteria:

* 1) healthy weight, stable for 6 months prior to the study, 2) not being on a diet, 3) not taking prescription medication, 4) not a smoker, 5) normotensive and 6) normal fasting glucose

Exclusion Criteria:

-
Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis

The primary objective of this study is to assess the short-term immune response of type-2 diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.

The investigators hypothesize that type-2 diabetes exacerbates the disruption of DC (dendritic cells)-mediated immune homeostasis associated with periodontitis.

Objectives: The primary objective of this study is to assess the short-term immune response of type-2 diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.

Hypothesis: we hypothesize that type-2 diabetes exacerbates the disruption of DC-mediated immune homeostasis associated with periodontitis.

Subject population: Four groups comprising 80 subjects will be selected to participate: type 2 diabetics with GCP (n=20), prediabetics with GCP (n=20), normoglycemics with GCP (n=20) and healthy controls (n=20).

Study design: discovery study nested within a single-arm, single blinded clinical trial.

Experimental periods: Screening/Baseline Visit, Treatment Visit, 24 hours, 30 days and 3 months after treatment.

Intervention: Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.

Primary outcomes:

* Cellular measures: Blood PBMCs- counts of myeloid DC (BDCA-1+CD19-), Plasmacytoid DC (cd123+cd303+) NK (CD56+CD16+), Th17, Treg (CD25+, CD39,CD73,CD127, cd152)
* Molecular measures: (Serum/crevicular fluid/ saliva): Anti-mfa-1 IgG (ELISA), Levels of IDO-1, TGFβ, TNFα, IL-1β, IL-6, IL-2, IL-10, IL-17, IL-23, IFNγ, CXCL12 (SDF1) by Multiplexing Luminex immunoassay \[MAGPIX®\]), performed in triplicate
* Expression on mDCs by custom qrt-PCR array (One step-fast cycle Taqman®, life technologiesTM of: angiopoietin-2, follistatin, GM-CSF, G-CSF, HGF, IL8, IL-6, leptin, PDGF-BB, PECAM-1, VEGF, TGFβ, IDO-1, IL-10, IL-1β, caspase-1, IL-17, IL-23, IL-23R IL-33, IL-12 p70, TRAIL, FOX01, Bcl-2, CXCL12 (SDF-1), CCL19, CCL21 analyzed in triplicate.
* Secondary outcomes: periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 35 and 65 years
2. Subject diagnosed with T2DM (HbA1C ≥6.5), prediabetic (HbA1C ≥5.7 and ≤6.4) and non-diabetic (HbA1C ≤5.6) according to American Diabetes Association, 2013.
3. Subjects with GCP (PPD ≥5 mm in ≥10 teeth and BOP in ≥30% of sites) and without GCP (PPD ≤4mm and BOP in \<30% sites)
4. Non-smokers or former smokers ≥5 years after quitting

Exclusion Criteria:

1. Pregnant or lactating women
2. Subjects taking medications known to affect the periodontium including phenytoin, cyclosporine
3. Subjects with immunosuppressive conditions or diseases including HIV infection or Hepatitis (B, C).
4. Subjects who require antibiotic prophylaxis for dental procedures.
5. Subjects who have taken antibiotics in the last 6 months
6. Subjects taking daily NSAIDS or on steroidal anti- inflammatory medications
Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.

Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.

Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.

Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.

Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
* Patients will be limited to:

  * ≥ 70 years of age, OR
  * with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
  * KPS ≤ 80, OR
  * Creatinine clearance \< 30 cc/min
* Laboratory criteria:

  * WBC \> 3500/ul
  * Granulocyte \> 1500/ul
  * Platelet count \> 100,000/ul
  * Total Bilirubin \< 1.5 X ULN
  * AST and ALT \< 2.5 X ULN
* Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

* Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
* Prior head and neck radiation or chemotherapy.
* Documented evidence of distant metastases.
* Patients with nasopharyngeal carcinoma.
* Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
* Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
* Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
* Patients residing in prison.
Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia

Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.

Before entering the operation room, patients are randomized in one group (A or C). For sedative premedication, all patients will be injected intramuscularly with midazolam 1mg. After entering the operation room, all patients will be monitored blood pressure, ECG and oxygen saturation. Before induction of spinal anesthesia, all patients will be loaded with plasma solution 5mL/kg. After induction of spinal anesthesia, block level will be checked. After fixation of block level, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes. However, just before starting dexmedetomidine,atropine .01\~0.03mg/kg up to 0.5mg would be injected in group A. Otherwise normal saline 0.5mL would be injected in group C. The syringed would be blinding not to be noticed. After loading of dexmedetomidine, the diluted solution would be injected with 0.25ug/kg/hr until the end of the surgery. Every patients undergoing sedation would be applied the oxygen by nasal prong.

The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. The number of medication treated would be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergoing spinal anesthesia with sedation over 19 years old.

Exclusion Criteria:

* Patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs.
* Patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.
Study of Mindfulness-Based Cognitive Therapy

Research aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy


Eligibility Criteria:
Inclusion Criteria:

* History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year
* Can speak, read, and understand English

Exclusion Criteria:

* Meet Criteria for Current Major Depressive Episode or are in partial remission
* BDI-II score above 19
* Abuse alcohol or drugs
* Current Dysthymic Disorder
* History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa
Open Wedge High Tibia Osteotomy

The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.

The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.

Eligibility Criteria:
Inclusion Criteria:

* Adult and active patient
* Varus malalignment of the leg
* Intact lateral joint compartment
* Physiological age-appropriate ROM in hip, knee and ankle of affected leg

Exclusion Criteria:

* BMI\>35
* Drug or alcohol abuse
* Known equine protein allergy or immunological anormalities
* Immunosuppressive treatment
* Systemic or severe local inflammation or infections
* History of active malignancy or systemic disease
* Impossible to obtain informed consent
* Legal incompetence
* Pregnant and nursing women
* Patients before, during or one year after radio- or chemotherapy
* Patients with metal or metal implants near vulnerable structures
* Patients with pacemakers or other implanted devices
Postoperative Music for Orbital Decompression

The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.

To investigate the effect of music to the postoperative pain and discomfort after orbital decompression under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 16-75 years old
* diagnosed as thyroid eye disease
* bone removal orbital decompression under general anesthesia

Exclusion Criteria:

* any uncontrolled clinical problems
* orbital decompression under local anesthesia
* Reluctance to participate in clinical trials
New Stereophotogrammetry System to Capture Complete-arch Impression

Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis


Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients aged ≥18 years
2. Full mouth bleeding and full mouth plaque index lower than or equal to 25%
3. Bone height for at least 10 mm long implants
4. Bone width of at least 5 mm and 6 mm for narrow (NP 3.75/3.5 mm) and regular (RP 4.3 mm) implants, respectively
5. Fresh extraction sockets with an intact buccal wall
6. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla
7. Minimal insertion torque of 45 Ncm

Exclusion Criteria:

1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
2. Pregnancy and/or breastfeeding
3. Any interfering medication such as steroid therapy or bisphosphonate therapy
4. Alcohol and/or drug abuse
5. Heavy smoking (\>10 cigarettes/day)
6. Radiation therapy to head or neck region within 5 years
7. Untreated periodontitis
8. Acute and chronic infections of the adjacent tissues or natural dentition
9. Severe maxillomandibular skeletal discrepancy
10. High and moderate parafunctional activity
11. Absence of opposite teeth
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
* To evaluate PSA (tumor marker) response rate
* To evaluate safety


Eligibility Criteria:
Inclusion Criteria:

* Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria:

* 1.Body temperature \> 38 degree centigrade.
* 2.Prior radiotherapy to \> 25% of bone marrow.
* 3.Prior isotope therapy and/or brachytherapy
* 4.Prior gene therapy.
* 5.Active double cancer.
* 6.Known brain or leptomeningeal involvement.
* 7.History of hypersensitivity reaction to drug
* 8.Other serious illness or medical condition
* 9.Subjects whom the investigators consider inappropriate from social or medical aspects.
Post-transfusion Platelet Count

The purpose of this study is to identify how the platelet count, complement system and endothelial markers are affected over time, after platelet transfusion in 4 different hematological patient groups.

Patients who are hospitalized at the Clinic for Hematology Diseases at the Skåne University Hospital (SUS) in Lund, Sweden with a central venous catheter or port-a-cath and should receive platelet transfusion due to thrombocytopenia are asked to participate in the study. Some patients who are being considered for platelet transfusions on several occasions will be able to attend more than one time in this study. After signed informed consent blood samples are drawn from the central line before, immediately after and then approximately. 1, 4, 8, 16 and 24 hours following the platelet transfusion. The platelet count (PLC) will then be taken daily following 4 days.

Sample size. Data from previous studies (Norol-98) shows that the PLC after platelet transfusion rises by 33 ± 25 x109/L (mean ± SD) 12 hours post-transfusion in patients with acute myeloid leukemia or pre-conditioning prior to bone marrow transplantation. The investigators want to show the same rise in the PLC after 12 hours with 80% power and 5% alpha risk of error for each group resulting in the sample size 13 per group and a total of 65 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden belonging to either of the groups described in paragraph 8 above and are prescribed platelet transfusion.

Exclusion Criteria:

* Patients with aplastic anemia or treatment with antithymocyte globulin (ATG)
Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL
Phase III ALTU-135 CP Safety Trial

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).


Eligibility Criteria:
Inclusion Criteria:

* Females of childbearing potential must be willing to use birth control
* Fecal elastase levels \< 100 micrograms per gram (µg/g) stool measured at screening
* Able to perform the testing and procedures required for the study, as judged by the investigator
* Diagnosis of chronic pancreatitis or status post pancreatectomy

Diagnosis of chronic pancreatitis is based upon at least one of the following:

* Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
* Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration \< 75 milliequivalents per liter (mEq/L)
* Presence of pathognomic pancreatic calcifications
* Pathology proven chronic pancreatitis on surgical specimens

Exclusion Criteria:

* Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control during the study
* History of liver transplant
* Liver transaminases \>3x Upper Limit Normal (ULN) or total bilirubin \>1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* History of pancreatic cancer
* Diagnosis of cystic fibrosis
* Active alcohol or drug abuse
* Presence of any medical condition that is likely to preclude survival for 12 months
* Demonstrated unlikely to comply with protocol requirements or complete the study
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).


Eligibility Criteria:
Inclusion Criteria:

- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.

Exclusion Criteria:

- Patients who are contraindicated based on the product label and have already received Xarelto treatment.