cyrilzakka/clinical-trials huggingface dataset:
Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)

The Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies questionnaire, which can be used in patients with Chronic Obstructive Pulmonary Disease (COPD) and their relatives, will be adapted into Turkish and its psychometric properties will be examined, and the knowledge level of patients and their relatives about the disease and general health will be investigated.

The socio-demographic characteristics of the patients and their relatives will be obtained by asking to them by mutual interview method.

A disease-specific test, the COPD Assessment Test (CAT), will be used to assess patients' own health, and the St George Respiratory Questionnaire (SGRQ) will be used to assess patients' quality of life.

Comorbidities reported by the patient and their relatives will be filled in the Charlson Comorbidity Index. The dyspnea that patients encounter in their daily lives will be questioned with the Modified Medical Research Council (mMRC) Dyspnea Scale.

The "Individual Knowledge Statements of Patients and Resident Proxies" will be used for the individual information of the patient and their relatives about the disease and general health.

There is no control group in the study. SGRQ, CAT and numerical rating scale will be used for the validity of the Turkish version of Individual Knowledge Statements of Patients and Resident Proxies. For the test-retest, the evaluation will be done again after 15 days.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Being diagnosed with COPD by a specialist physician (for patients)
* Being clinically stable (For patients, no history of hospital admission/hospitalization due to exacerbation in the last 4 weeks)
* Having information about the diagnosis (For patients)
* To read, write and understand Turkish
* Volunteering to participate in the study
* Being a proxy of the patient (living with the patient regardless of whether they are providing care or not)

Exclusion Criteria:

* Having musculoskeletal, neurological, cardiac, and/or cognitive problems other than COPD, which may create a caregiver burden for the patient's relative
Comorbidity Management in Rheumatic Disease.

Rheumatoid arthritis is a disease where the immune system attacks the body by mistake, causing inflammation of the joints and other body parts. People with rheumatoid arthritis are at higher risk of infections, heart problems, and bone issues compared to others. They regularly see rheumatologists, arthritis care physicians, to manage their disease. However, managing these other health problems alongside their main treatment is difficult for rheumatologists due to limited resources. This clinical study is being conducted to see if adding a family doctor to a team of rheumatologists can help. Rheumatologists will complete a case report form about the patient's health and send them to a special family physician clinic. This clinic will focus on improving vaccination against diseases, heart health, and bone strength. They will check if patients need special vaccines to protect them from infections. They will screen for heart disease using blood pressure measurements, and order blood work for high cholesterol and diabetes if needed. They will also review bone health and send people for tests to check their bone density if needed. A change in routines and medications may be recommended after their checkup. Rheumatologists will complete another case report about the patient's health 6 months after their family doctor appointment. The study will assess how these markers of health management improve after this family doctor joins the team. It hopes to prove that this new way of working in the community will give people with rheumatoid arthritis better protection against certain infections, heart problems and weak bones.


Eligibility Criteria:
Inclusion Criteria: Participants will be patients of the Waterloo Rheumatology Community Clinic, aged 18 to 80 years of age, with a diagnosis of rheumatoid arthritis. Participants will have a minimum of limited working proficiency in English and no significant cognitive impairment that can inhibit their ability to engage in the study.

Exclusion Criteria: Age less than 18 years or greater than 80 years, significant cognitive impairment that impedes ability to engage in the study or unwilling to participate in the study. Patients that are currently pregnant will be excluded from the study as well. Whether or not a participant is enrolled with a primary care physician or nurse practitioner will not impact the intervention.
Causes of Disqualification of Egyptian Potential Living Liver Donors

Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has emerged as an option to the traditional deceased-donor transplantation procedure. But there is an essential risk related to liver resection for healthy donors.

The aim of this work is to identify and analyze the causes of disqualification of potential Egyptian living liver-donors in a University based liver transplant program

Eligibility Criteria:
Inclusion Criteria:

* All potential living liver donors in the period from June 2010 to June 2012

  1. Age between 18 and 50 years
  2. Relationship within 3rd degree of consanguinity with recipient or spouse.
  3. The donor-recipient pair must be blood group compatible.
  4. An informed consent should be obtained.

Exclusion Criteria:

* Patients with nknown mrsdical or surgical history that interfere with donation

  * Underlying medical condition (diabetes, cardiopulmonary disease, etc.).
  * ABO incompatibility
REBECCA - Research in Rehabilitation After Breast Cancer

The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.

In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark
* lives in Copenhagen municipality
* score ≥7 on distress thermometer
* able to read and understand Danish
* not pregnant
* expected survival more than 6 months
* physically able to participate in rehabilitation
* no severe psychiatric disease demanding treatment
* no severe cognitive problems (e.g. dementia or confusion)
Genetic Study of the Dilatations of the Idiopathic Bronchi in French Polynesia

Bronchiectasis, defined by an increase in bronchial caliber and thickening of the bronchial wall, is associated with recurrent respiratory infections, chronic cough and bronchorrhea, and a frequent progression to chronic respiratory failure. Investigator distinguish focal bronchiectasis usually resulting from a localized cause and diffuse bronchiectasis which the possible causes are multiple (immune deficiencies, genetic diseases, auto immune pathologies, aspergillosis broncho -allergic lung, sequelae of pulmonary infections).The etiological assessment is negative in 26 to 53% of cases, defining the idiopathic bronchiectasis. However, the discovery of an underlying cause can change the patient's management (up to 37% of cases).

Despite the lack of epidemiological data in French Polynesia, Australian and New Zealand studies found a high prevalence of bronchiectasis in Polynesians. Few clinical studies published in the early 1980s suggested a ciliary origin.

Due to its geographic characteristics, the Polynesian population constitutes an interesting ethnic group. Indeed, there is a low genetic mixing and the prevalence of certain genetic diseases like the syndrome of Alport or some hereditary retinal dystrophies are high. This type of population is very suitable for discovering new genes in human pathology.

Investigator decided to conduct an observational study to find an underlying genetic cause of bronchiectasis in Polynesians by performing a whole exome sequencing. Investigator chose to study index cases defined by an upset of symptoms during the childhood, a family history of idiopathic bronchiectasis, and/or a consanguinity. Investigator also want to study healthy first degree relatives, in order to be able to better identify the clinical significant of DNA variants and focus the analysis on those that may be pathogenic


Eligibility Criteria:
\*Patients

Inclusion Criteria:

* Polynesian adult more than18 years
* dilatation of idiopathic bronchi confirmed to thoracic CTscan
* Negative etiological balance (including sweat test, research of Dyskinesia Ciliary Primitive and immunological check-up)
* Appearance of symptoms in childhood, or family history of chronic bronchial disease, or notion of inbreeding
* Signed consent
* Affiliated with a social security system

Exclusion Criteria:

* Refusal to participate in the study

  \*Relatives
* First-degree healthy relatives
* Polynesian adult more than 18 years
* Signed consent
* Affiliated with a social security system

Exclusion Criteria:

* Refusal to participate in the study
Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia

The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.

Sarcopenia is a common condition in patients with cirrhosis, with a prevalence of around 50%. It is unknown if the presence of sarcopenia may influence the prevalence of abdominal hernias in this group of patients. Clinical, nutritional and radiological evaluation will be performed in two groups of cirrhotic patients to evaluate this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Previous diagnosis of cirrhosis

Exclusion Criteria:

* Acutely decompensated cirrhosis
* Other chronic diseases in advanced stage (e.g. cardiac failure, chronic obstructive pulmonary disease, cancer)
* Cognitive impairment, delirium, non-controlled psychosis
Predictors of Cognitive Decline in Normal Aging

The goal of this project is to develop an early diagnostic test for Alzheimer's disease (AD) by monitoring loss of neurons and brain size reductions over a period of five years.

Studies of normal aging and mild cognitive impairment (MCI) show that loss of neurons and reduction in size of the hippocampal part of the brain predict a person's conversion from MCI to Alzheimer's disease (AD). Increases in tangle-related abnormal tau proteins, specifically P-tau231, also appear to be related.

This study will collect neuropsychological data, magnetic resonance imaging (MRI), and cerebrospinal fluid (CSF) from volunteer participants to measure the relationship between changes in brain volume, CSF levels, and memory performance.

From the data researchers hope to develop an early diagnostic test for AD.

The study will include 170 participants between the ages of 60 and 80 years, some normal, some with MCI, some with mild AD, and some with frontotemporal dementia. After initial screening of volunteers, the researchers will give participants a complete baseline exam and 24-month follow-up exams over a period of five years.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, from all racial and ethnic categories between the ages of 60-80 years of age, with English as their first language.
* Residents of the New York City metropolitan area.
* Minimum of 12 years of education.
* Participants will be grouped according to the following classifications: normal aging, mild cognitive impairment (MCI), Alzheimer's disease (AD), or frontotemporal dementia (FTD).
* Participants will agree to ApoE genotyping and DNA banking.

Exclusion Criteria:

* Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder.
* Significant history of alcoholism or drug abuse.
* History of psychiatric illness (e.g., schizophrenia, mania or depression).
* Any focal signs or significant neuropathology.
* A score of 4 or greater on the Modified Hachinski Ischemia Scale suggesting cerebrovascular disease.
* A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression.
* Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions.
* Physical impairment of such severity as to adversely affect the validity of psychological testing.
* Hostility or refusal to cooperate.
* Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.
* History of familial early onset dementia.
Safety and Feasibility of the Infinity Catheter for Radial Access

The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.

Patients who are undergoing endovascular intervention will be enrolled into the study. Consent will be obtained for the procedure and for the use of their prospectively collected clinical data. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr). If the artery does not meet the size criteria, only a 6Fr sheath will be used, and the data recorded during the procedure will not be utilized for analysis in this study. The preoperative and postoperative care will be the same for all the patients. No tests will be done outside of standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age group 18 years and above.
* Patients undergoing neuro-embolization using large bore catheters

Exclusion Criteria:

* Patients with Radial artery diameter less than 2.4 mm measured with Ultrasound
* Age\<18
* Patients who have previous surgeries at either approach site which precludes the use of one of the approach sites
* Patients who has poor collateral circulation, Raynaud's phenomenon, radial loop, brachial or subclavian stenosis, aberrant origin of the subclavian artery
* Pregnant patients
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age : 18 \~ 80 year old male or female
* Biopsy-proven adenocarcinoma
* Rectal cancer or Rectosigmoid junction cancer
* Primary cancer
* Non-metastatic cancer
* Planned (or elective) curative resection
* Low anterior resection with double-stapled technique

Exclusion Criteria:

* Preoperative systemic chemotherapy
* Distant metastasis at initial diagnosis
* Palliative surgery
* Emergent surgery
* Lynch syndrome or FAP-associated cancer
The Feasibility of Pertussis Immunization in a Canadian Emergency Department

Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to patients presenting to the emergency department. Rates of vaccination as well as effects on department efficiency will be measured.

This study is a prospective randomized, controlled trial of two strategies to provide patients with the pertussis vaccine. Eligible adult patients with be offered pertussis vaccination in the Emergency Department vs. a referral to Public Health for pertussis vaccination. The effect of both strategies on triage time as well as measure of emergency department efficiency including length of stay, time to physician and left without being seen rates will be compared. At a four-month follow up, rates of pertussis vaccination will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and above
* Have not received Tdap vaccine as an adult (age 18 and above) or have not received Tdap vaccine within 10 years, or unsure of vaccination status

Exclusion Criteria:

* Acute significant illness (Canadian Triage and Acuity Scale = 1)
* Deemed "in too much distress" by triage nurse
* Acute Febrile illness
* Allergy to vaccine or vaccine components
* Pts presenting for wound care (are normally given the vaccine as part of wound care)
* Pregnancy \< 26 weeks
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers

Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
* Age ≥ 18 and Age ≤ 50 years
* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections (e.g. HIV)
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than five half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or drugs which prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
* A history of additional risk factors for torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Exclusion criteria specific for this study:

* Galactose intolerance
* Lactase deficiency
* Glucose-galactose-malabsorption
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers ages 18-60
* If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
* Men \> 18 years.
* Ability and willingness of subject to provide informed consent
* Screening tests' results within 15% of normal values

Exclusion Criteria:

* Female
* Continuous use of the following medications for more than 3 days within 30 days of study entry:
* Immunosuppressives
* Immune modulators
* Systemic glucocorticoids
* Anti-neoplastic agents
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
* Subjects with a clinically significant infectious, immune mediated or malignant disease
* Subjects with anemia (Hb \<10.5 gm/dl)
* Subjects with thrombocytopenia (platelets \<100K/µl)
* Subjects with lymphopenia (absolute lymphocyte count \<0.7)
* Subjects who were previously vaccinated against flu.
* Subject who received any vaccination within the last 6 months
Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma

The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).

The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.

Eligibility Criteria:
Inclusion Criteria:

* Papillary thyroid carcinoma with central neck metastasis
* No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography

Exclusion Criteria:

* History of previous thyroid operation
* Isthmic thyroid lesion