cyrilzakka/clinical-trials huggingface dataset:
Vascular Abnormalities and Bleeding Diathesis

Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four patients suffering from unexplained excessive bleeding has been followed clinically in France for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. The aim of the study was to better characterize the phenotype by studying VWF and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

As explained in the brief summary, whole exome sequencing (WES) of DNA was performed in a family of four patients suffering from unexplained excessive bleeding. It allowed the identification of a variant which segregated to family members with bleeding diathesis. Firstly, in vitro, functional analyses were performed in primary human endothelial cells. Then, in-vivo analysis have to be performed on affected patients.

The four related patients suffering from excessive bleeding have been followed clinically in France for many years. During the follow-up of three of these affected patients, biological studies are planned.

Biological assays include:

* Conventional assessment of primary haemostasis: platelet count, platelet aggregation, functional and antigen measurement of von Willebrand factor.
* Specific testing: Von Willebrand factor multimeric profile, immunolabeling of platelets.

Conventional assessment is part of the conventional follow-up of patients with inherited bleeding disorder. It will not require any additional blood sample. For specific testing and after informed consent, fresh blood samples of patients will be collected in 1/10 volume of acid-citrate-dextrose and centrifuged for 10 min at 200 g to obtain Platelet-rich plasma (PRP) for functional analysis of platelets and Platelet-poor plasma for the multimerization state of von Willebrand factor. Then, the results will be compared to the in-vitro findings.

Eligibility Criteria:
Inclusion criteria:

- members of the family

Exclusion criteria:

- patient who refused to participate
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults

This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated diabetes mellitus. Previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in HIV-infected adults. The Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated adults.

No further information. This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. The primary endpoint assessed whether the intervention reduced inflammation. There was no control arm.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body mass index ≥ 25 kg/m2
* Glycosylated hemoglobin (A1C) value ≥ 6.5% OR having a fasting blood glucose ≥ 126 mg/dL
* On stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma HIV-1 RNA level)
* Negative serum pregnancy test (females only)

Exclusion Criteria:

* History of pancreatitis
* Screening serum lipase value greater than or equal to 2 times the upper limit of normal (≥ 420 U/L)
* History of pancreatic cancer or thyroid cancer in patient, a first-degree relative, or a grandparent
* History of Multiple Endocrine Neoplasia (MEN) 2 syndrome
* History of gastroparesis, inflammatory bowel disease, and/or other severe gastrointestinal disease
* Estimated glomerular filtration rate (eGFR) ≤ 50 mls/minute
* Documented history of hypoglycemia (blood glucose \<40 mg/dl)
* Active moderate-heavy alcohol use (more than 2 drinks/day) or \>4 drinks in a single 24 hour period
* On an anti-diabetic medication within 3 months of enrollment
* On an HMG-CoA reductase inhibitor (statin) within 3 months of enrollment
* Persons on a didanosine (ddI) and/or stavudine (d4T)-containing cART (due to the heightened risk of pancreatitis)
Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)

The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .

The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years old, both gender;
2. ECOG: 0-1;
3. Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
4. No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel;
5. At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes);
6. Life expectancy of at least 12 weeks;
7. Before treatment, blood tests or biochemical measurements must meet the following criteria:

   * White blood cell count (WBC)≥ 4.0\*10\^9/L;
   * Neutrophil count (ANC)≥ 2.0\*10\^9/L;
   * Platelet count (PLT)≥ 100\*10\^9/L;
   * Hemoglobin (Hb)≥ 100g/L;
   * Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit;
   * Renal function: creatinine ≤ 1.5 times the upper normal limit;
8. Signed informed consent.

Exclusion Criteria:

1. Hypersensitivity reaction to the interventional drugs;
2. Pregnant or breastfeeding;
3. Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
4. Brain metastase ;
5. Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
Percussion Device (PD) for Detection of Pneumothorax

This study aims to examine the safety and efficacy of the Percussion Device in detecting a pneumothorax in patients that have undergone thoracic surgery.

A prospective, non-randomized clinical feasibility cohort study. The purpose of this feasibility study is to collect preliminary performance and safety information for the Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for study enrolment before their surgery in clinic. Following surgery and after the patient's chest tube has been removed, evaluation of the chest using the PD and ultrasound will be performed by two independent assessors (a nurse practitioner or resident on the Thoracic Surgery Team) prior to the post-removal CXR. Details of study procedure are details in section 2.8. The PD's performance metric will be compared against CXR results, which is considered the gold standard in diagnosing a pneumothorax.

Eligibility Criteria:
Inclusion Criteria:

* All patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at London Health Sciences Centre (LHSC), London, Ontario.

Exclusion Criteria:

* Patients less than 18 years old Patients unable to consent Patients with known persistent pneumothorax prior to chest tube removal Patients who are pregnant Patients with severe chest wall deformity.
The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study

The Intelligent Cardiopulmonary Rehabilitation System (ICRS) was developed to automatically control the resistance of pedaling in combination with the conventional stationary bike by monitoring the user's heart rate for clinical use. To test its feasibility, 8 healthy participants were recruited to complete 12 sessions (3 times per week for 4 weeks) of indoor cycling on the stationary bicycle with ICRS. Subjects were received cardiopulmonary exercise testing (CPET) before and after the biking sessions.The 60-80% of heart rate reserve (HRR) of each participant was determined according to their first CPET results. The algorithm of ICRS was designed to enable the bicycle to adjust its training intensity in accordance with the subject's 60-80% HRR which was detected by wearing a wristband heart rate monitor during cycling. With ICRS, the participants' heart rates during training were expected to fall in the 60-80% HRR, increasing their cardiopulmonary fitness after 12 sessions of indoor cycling.


Eligibility Criteria:
Inclusion Criteria:

* age of 20-50
* no regular exercise habits
* no documented cardiopulmonary disease

Exclusion Criteria:

* abnormal lung function
* medications affecting exercise capacity
* hypertension
* diabetes mellitus
* recent illness including upper respiratory tract infection
* the presence of any factor that may limit ability to participate in the CPET
Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia

Aerosol antibiotic administration offers the theoretical advantages of achieving high drug concentration at the infection site and low systemic absorption, thereby avoiding toxicity. Antibiotic aerosolization has good results in patients with cystic fibrosis, but data are scarce for patients under mechanical ventilation.

Prospective, randomized 1:1, open-label study to assess the microbiological cure and pharmacokinetics (PK), safety and efficacy of nebulized Aztreonam lysine (75 mg dose) each 8 hr during 5 days in ventilated patients heavily colonized by Gram-negative bacteria. It is planned to include a total of 20 ventilated patients heavily colonized. Only ten of them (active group) will receive 5 days of treatment with nebulized AZLI.The control group will not receive treatment.

The main objectives of this study is:

To compare the microbiological cure at day 5 of treatment and the incidence of Gram-negative IVAC between 7th and 10th days after last dose in patients heavily colonized by Gram-negative bacteria treated with nebulized AZLI vs. no treatment.

The secundary objective of this study are:

1. Safety and tolerability of AZLI administered during 5 days in adults patients under mechanical ventilation heavily colonized by Gram-negative bacteria
2. The pharmacokinetic profile in endotracheal aspirate (EA) or bronchoalveolar lavage (BAL).
3. The plasma levels of nebulized AZLI in patients under mechanical ventilation heavily colonized by Gram-negative bacteria.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients under mechanical ventilation for more than 5 day.
3. Patient with heavy colonization by Gram-negative microorganisms.
4. No clinical suspicion of infections-related ventilator-associated complications (IVAC) according CDC criteria (Figure 1).
5. Patients or his/her legal representative with ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
6. Informed consent signed

Exclusion Criteria:

1. Suspected of IVAC.
2. Patients with known hypersensitivity to Aztreonam.
3. Patients who received more than 48 hours of broad spectrum antibiotics.
4. Evidence of active mycobacterium infections, chronic pulmonary infection or bronchial obstruction.
5. Granulomatous disease, lung cancer or lung transplant.
6. Acute respiratory distress syndrome (ARDS)
7. Woman who is pregnant or breast-feeding while enrolled in this study.
8. Any medical condition which, in the opinion of the Investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study
YH4808 Postprandial PK/PD Study in Healthy Subjects

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
3. Subject who shows negative reaction of UBT(Urea Breath Test)
4. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
6. Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
3. Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
4. Other exclusions apply
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved CD20+ DLBCL;
* previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
* at least one evaluable lesion；
* ECOG PS 0-1;
* 18-65 years;
* proper functioning of the major organs.

Exclusion Criteria:

* involvement of central nervous system;
* with other malignancy;
* patients receiving or received drug of other clinical trial within 30 days；
* previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
* patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
* grade 2 or more peripheral neuropathy.
Wastewater Surveillance to Boost COVID-19 Vaccine Uptake

The goal of the study is to determine the effect of a communications campaign sharing wastewater surveillance data to influence vaccine uptake in a metropolitan and non-metropolitan environment. The study will be conducted in Onondaga and Cayuga counties in New York State. Individuals of all ages within the selected counties, located in metropolitan and non-metropolitan environments will receive the intervention. The evaluation study design is a comparison-control trial. The primary outcome measure is the proportion of vaccine-eligible individuals in the county that received the COVID-19 vaccine stratified by type of vaccine dosage and age group. Vaccination data will be aggregated to the county by the State Department of Health and shared with the research team. Wastewater data will be pulled from the wastewater surveillance network. A difference in differences analysis will be used to estimate the effect of the intervention on both the outcomes between intervention and comparison groups following the intervention, while adjusting for potential confounding factors.


Eligibility Criteria:
Inclusion Criteria:

* None - county-level vaccine uptake - no direct interaction with people getting vaccines

Exclusion Criteria:

* None
Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants

The main aim of this clinical trial is to analyze the survival rate of short-length implants (\<4.5 mm) in partial edentulism subjects. 6.5 mm length implants will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors
* Bone height in the area of interest sufficient to place implants 6.5mm length dental implants
* Availability to be observed during the follow-up period
* Signature of the informed consent

Exclusion Criteria:

* Need to perform bone augmentation surgery prior to implant placement surgery
* Smokers (\> 10 cigarettes per day)
* Patients with poorly controlled diabetes
* Patients on chronic treatment with non-steroidal anti-inflammatory drugs
* Patients receiving oral or intravenous bisphosphonates
* Patients under chemotherapy or radiotherapy treatment
* Patients receiving systemic corticosteroids
Evaluation Research of a National Accreditation and Improvement Programme for General Practice

Objective: This study aims to determine the effectiveness and efficiency of a national accreditation and improvement programme for general practice, focusing on patients with established cardiovascular diseases.

Design: Cluster randomised trial with a block design. All practices start with the accreditation procedure.Intervention group practices are requested to focus their improvement plans in the first year on cardiovascular disease. Control group practices are requested to focus their improvement plans in the first year on other domains. Measurements at baseline are based on the standard audit in the accreditation procedure. Follow-up measurements are done 12 months after approval of improvement plans.

Participants: Primary care physicians in The Netherlands.

Interventions to be implemented: improvement plans concerning cardiovascular risk management, as described by recently updated national multidisciplinary evidence-based NHG / CBO guidelines, considering patients with established cardiovascular diseases.

Implementation strategy: The national programme for accreditation and improvement of general practice. This procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up.

Outcome measures: Primary outcomes are percentages of patients with CVD who have acceptable systolic blood pressure and cholesterol levels (quantified according to the indicators in the accreditation)and who use aspirin or alternatives. Secondary measures include clinical and organisational indicators of quality of cardiovascular care, such as percentages of patients with cardiovascular disease whose risk factors were assessed and who received specific medication.

Economic evaluation: Incremental cost effectiveness ratio's are determined of the implementation strategy compared to no implementation. The analysis will take a societal perspective and a time horizon of the observed period as well as a hypothetical 10 years period (using modelling). Uncertainty related to the estimations is examined with sensitivity analyses and bootstrapping. The long term economic evaluation is based on Markov modelling.


Eligibility Criteria:
Inclusion Criteria:

* Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)

Exclusion Criteria:

-
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets

This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.


Eligibility Criteria:
Main Inclusion Criteria:

1. Healthy subjects, over the age of 19 years old
2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
3. All subjects should be judged normal and healthy during a pre-study medical evaluation

   * Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
4. Subject is willing to participate and to Sign written informed consent form
5. Female subjects of childbearing age who use contraception other than hormonal contraception.
6. Subjects who has no history of psychical disorder within the last five years

Main Exclusion Criteria:

1. Subjects who have a medical history specified in protocol
2. Subjects who are expected to have the prohibited medication and activity etc. during the study period
3. Subjects who can not comply with requirements as per protocol
4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
5. Subjects who are not suitable for the clinical trial
Sunlight Exposure and Vitamin D in Children

The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren in each season throughout the year.


Eligibility Criteria:
Inclusion Criteria:

* Healthy school children aged 12-15 years
* White Caucasian
* Male or female

Exclusion Criteria:

* History of photosensitivity disorder