cyrilzakka/clinical-trials huggingface dataset:
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination-2nd Trial

The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
* Able to participate in the entire trial.
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
* show evidence of acute disease within 28 days prior to the first IP administration.
* Have the medical history of bleeding symptom or bleeding disease
* Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
* Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Have hypersensitivity reaction histories for Clopidogrel or aspirin.
* Have abnormal laboratory result. AST or ALT \> 1.25 times of upper limit/ Total bilirubin \> 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count \<150X10\^9/L or \>350X10\^9/L
* A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Have donated whole blood within 60 days prior to the first IP administration.
* Participated in the other clinical trials within 90days prior to the first IP administration.
* Take medicine which affect to this trial within 10 days prior to the first IP administration.
* Appropriate subject for the trial judging from principal investigator.
Improving Diabetes Care for African Americans

The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.

Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c \<7.0), LDL cholesterol (\<100 mg/dL), and blood pressure (\<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
* At least 18 years old
* At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years

Exclusion Criteria:

* Any patient not categorized as either White or Black based on race identifier in the electronic medical record
Saphenous Vein Allografts for Coronary Bypass

The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.

This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.

Eligibility Criteria:
Inclusion Criteria:

* Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
* Patients \> 18 years of age at implant.

Exclusion Criteria:

• Patients \< 18 years of age.
Temporomandibular Joint Dysfunction Prevalence and Oral Habits, Food Consumption Frequency and Eating Behaviour

This study was planned to investigate the prevalence of TMD in university students and to determine possible predisposition factors by evaluating oral habits, food consumption frequency and eating behaviors thought to be related to TMD.

No study has been found examining the relationship between temporomandibular joint dysfunction (TMD) and oral habits, food consumption frequency and eating behavior. In this context, it is thought that understanding the relationships mentioned may provide different perspectives and help develop an effective treatment program.

Eligibility Criteria:
Inclusion Criteria:

1. Continuing undergraduate education at faculties/colleges affiliated with Karadeniz Technical University
2. Being able to read and write in Turkish
3. Agreeing to participate in the study

Exclusion Criteria:

1. Having a local or systemic disease that may affect oral and jaw health
2. Having had an operation / trauma to the cervical region or TMJ
Accuracy of Bladder Scanners in Post-operative Voiding Trials

The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.

The primary aim of this study is to determine if bladder scanners are accurate in determining a post-void residual volume (PVR) after Urogynecologic surgery.

The secondary aim of this study is to determine if a post-void residual volume (PVR) measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Urogynecologic surgery
* Able to consent
* Greater than 18 years old
* Non pregnant

Exclusion Criteria:

* Need for prolonged catheterization
* Unable to consent
* Prisoner
Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.

This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March 2022 and October 2022.

This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients.

All CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be included in the study.

Each patient will be followed for a maximum of 12 months from the first COVID-19 prophylaxis dose.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab as per label indication between March 2022 and October 2022.
3. Signed informed consent, if applicable

Exclusion Criteria:

None
Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)

Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.

The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states

Eligibility Criteria:
Inclusion Criteria:

1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure.

Exclusion Criteria:

1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. No diagnose of middle ear infection and no plan for surgery procedure.
4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 7 and 15 years
* Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
* Patients with a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion Criteria:

* Patients with vasomotor rhinitis or eosinophilic rhinitis
* Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
* Patients with a history of any of the nasal surgical procedures
* Patients with current or previous history of drug allergy
* Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Single and Two-visit Pulpectomy in Primary Molars

A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.

Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.

Clinical and radiographic evaluation for 3 , 6, 12 months

All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.

Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.

In case of single visit pulpectomy (21):

Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.

In case of two visit pulpectomy (13):

First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days.

In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review.

Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.

Exclusion Criteria:

* Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food

Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60 years with major consequences especially on the cardiovascular system.

This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet, logically leading to atrophy of the muscles aerodigestive crossroads.

Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the individual to a higher risk of apnea and hypopnea during sleep.

The objective of this study is to determine if there is a significant increase in the prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term care units, receiving a mixed food compared to residents in supply to normal texture.


Eligibility Criteria:
Inclusion Criteria:

* Resident of a unit of long-term care
* Recipient or affiliated with Social Security
* Signature of consent by the patient, guardian or person of trust

and mixed food or normal texture food

Exclusion Criteria:

* OSA diagnosed and treated earlier
* Patients with an abnormal upper airway out edentation
* Patients unable to give informed consent and having no confidence in individual capacity to do so.
* Patients with a gastrostomy or jejunostomy
Mindful Compassion for Perfectionism

The aim of this study is to confirm the feasibility of an integrative form of group psychotherapy in treating perfectionism. In a previous pilot study we suggested that this new treatment is safe and feasible, also reporting a significant reduction of perfectionism at final assessment. The intervention integrates the Paul Hewitt relational model of perfectionism and the Paul Gilbert Compassion Focused Therapy. We will explore the feasibility of the proposed group therapy through a three-arm waiting-list randomized controlled trial. Our hypothesis is that those in the treatment groups (either online or in presence format) will show at the end of the intervention a lower level of perfectionsm than those in the control group.

After being informed about the study and potential risks, all partecipants giving written informed consent will undergo a psychological assessment so as to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to (i) new integrative group psychotherapy through an in presence format, (ii) the same integrative group psychotherapy through an online format, (iii) a waiting-list control group. At the end of active experimental groups treatment (2 months), all the partecipants will have access to the final follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 18 and 30
* Reporting at least a clinically significant value at Multidimensional Perfectionsm Scale (at least one of the dimensions must have scores equal to or greater than the clinical population mean of the questionnaire manual)

Exclusion Criteria:

* Being diagnosed with neurodevelopmental or schizophrenia/psychosis spetrum disoders;
* Being under either psychiatric or psychological treatment
Contraception Perspectives in Adolescents in Haiti

The overall goal of this study is to assess facilitators and barriers to contraception with a focus on long-acting reversible contraception (LARC) among adolescents and health care providers (HCPs) in rural Haiti. The investigator plans to accomplish the following objectives:

Objective 1: Develop locally-informed surveys and in-depth interview guides, based on the ecologically-expanded Theory of Planned Behavior, to assess attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among adolescents and HCPs in rural Haiti.

Objective 2: Conduct a formative mixed methods study of attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among female adolescents (N=150 survey, 25-50 in-depth interviews) and HCPs (N=15; survey and in-depth interviews) in rural Haiti.

Eligibility Criteria:
Inclusion Criteria:•

* Adolescents who are biologically female and have reproductive potential (14-24 years old)
* Adolescents who reside in the birthing clinic catchment area
* Health care providers, including nurse midwives, who work at the local birthing clinic and providers at the local hospital

Exclusion Criteria:

-Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria

* Age 18 years or older at the time of informed consent.
* Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
* ECOG Performance Status \</= 2.

Exclusion Criteria

* History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction within 6 months prior to Day 1.
* Presence of \>/= Grade 2 peripheral neuropathy.
* Known presence of central nervous system or brain metastases.
* Prior therapy with a conjugated or unconjugated maytansine derivative.
Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);


Eligibility Criteria:
Inclusion Criteria:

- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Exclusion Criteria:

* rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre