cyrilzakka/clinical-trials huggingface dataset:
Informal Caregivers at Work - Phase 2

Mental health problems are rising among children and adolescents. This may not only impact the child's level of daily functioning but also close family members. Informal caregiving is defined as unpaid care for a sick, disabled, or other closely related person. Providing long-term informal care has been associated with detrimental stress-related outcomes, and being simultaneously active in the labor market has been highlighted as an increased burden for the caregiver. Workplaces are poorly suited for dealing with private stressors despite their potential negative consequences for the caregiver's job status and health. There is a need for improving understanding of how long-term informal caregiving impacts job and health outcomes, as well as for measures minimizing potential negative consequences among at-risk occupational groups.

This Danish nationwide observational cohort study examines the associations between employees being a primary informal caregiver for a child or adolescent with mental health problems and the employees' occupational and health outcomes. In addition, we seek to identify modifying psychosocial risk factors at work as well as at-risk occupational groups. The study relies on pre-existing longitudinal data extracted from Danish national registers, including highly reliable information on occupational status, birth information, residence, public transfer payments, income, psychiatric treatment and services, treatment for substance abuse, psychotropic prescription drugs redeemed, as well as background information. In Denmark, all citizens are assigned with a unique identification number enabling merging of national register data included. Caregiver-child relationships are established based on merging of data from birth and household registers. In this study, register data are further merged with information on psychosocial work environment based on national survey data. All data are located at Statistics Denmark, and accessed and analyzed via a logged, secured platform, The Danish Occupational Cohort (DOC\*X) (www.DOC-X.dk). Exposed employees are compared to a reference group of employees without mental health problems at the familiy level matched according to age group, gender (female/male), and socio-occupational status.

Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents: Citizens aged 0-25 years in the period between 2000 and 2018. Mental disorder is indicated by redeeming of psychotropic medication, treatment for substance abuse, and psychiatric services. Children of reference adult caregivers is defined by having no personal history of a mental disorder. We exclude children born outside of Denmark.
* Adults: Citizens aged 18-67 years residing in Denmark, partaking in the work force in the period between 2000-2008, and living with a child in the household at any time until the child's 18th year or being a parent to a child at its birth.

Exclusion Criteria:

* We exclude all citizens born in the Faroe Islands and in Greenland. We exclude all citizens residing in the Faroe Islands and in Greenland in the period between 2000 and 2018.
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.


Eligibility Criteria:
Inclusion Criteria:

* Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta
* Endoscopists: Gastroenterologists with practices at the Forzani \& MacPhail Colon Cancer Screening Centre, Calgary, Alberta

Exclusion Criteria:

* Patients: patients who are not categorized as normal risk
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is \>6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of \<6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* age 1-18 years
* tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
* ASA I, II
* informed consent and assent obtained

Exclusion Criteria:

* allergic to local anesthestic
* taking chronic aspirin or Ibuprofen therapy
* ASA IV
* history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
* Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
* Informed consent not obtained
* Patients expected to receive dexamethasone or ondansetron intra-operative
Acute Coronary Syndrome and Nurse Counselling

The goal of this clinical trial is to examine in patients with acute coronary syndrome. The main questions it aims to answer are:

* Does nurse counseling affect quality of life?
* Does nurse counseling affect functional capacity?
* Does nurse counseling affect knowledge, attitudes and beliefs about syndromes?

Participants will be trained using the training booklet, and nursing counseling will then be provided for six months.

If there is a comparison group: Researchers will compare with the control group to see if the nurse counseling has had an effect.

After obtaining verbal and written consent from the participants, they are required to answer the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor walking test will be applied. While the control group will be followed up routinely, the training booklet prepared for the intervention group will be explained orally. Participants will then be informed that they will be called monthly. They will be told that they can reach these monthly calls and consult the nurse when they need it. After this stage, interviews with patients will begin. The standard way of communication with the participants by the researchers is by telephone, and a total of 6 interviews will be provided, the first of which is in the 1st month after the application of the tests. In each call, all the information in the training booklet will be repeated, additional information will be given in line with the needs and demands of the person, their questions will be answered and the interview will be ended. Although it varies according to the individual interviewed, it is predicted that these telephone interviews will last for 30 minutes on average. Apart from these standard calls, individuals in need will be able to reach the researcher face-to-face during phone calls, text messages, instant messaging methods or hospital visits, and in this way, the counseling process will continue actively for 6 months. After six months, the final tests will be done.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent,
* Treatment preventing communication is not a problem, literate,
* There is no obstacle to performing the 6-minute walk test.
* who did not accept to participate, were included in the study.

Exclusion Criteria:

* \<18 years of age,
* Mental or cognitive impairment,
* Diagnosed with SpO2 \<80,
* Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of individuals who are contraindicated in making are not included.
Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs，including monofocal IOL group,monovision designed group ，bifocal IOL group, mix bifocal IOL group，trifocal IOL group，Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral cataract
* Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter

Exclusion Criteria:

* Pregnant or nursing women
* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* postoperative visual acuity of worse than 0.2 logMAR in any eye
* Patients using systemic or ocular medication that affect visual acuity.
* Patients participating in other clinical trials during the study.
Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse

urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable.

This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.

60 patients, fulfilled the selection criteria were counseled and informed about the trial protocol and a written consent according to declaration of Helsinki was signed. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to group (1) or group (2). Each group consisted of 30 patients. All participants had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging. Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. Only patients allocated for group 1 were subjected to urodynamic studies before surgical intervention and then corrective procedures for POP had been done .The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimeter method, where maximum flow rate, average flow rate, voided volume and residual urine was measured. Maximum flow rate ≤15 ml/sec, and/or residual urine of more than 50 ml or 10% of voided volume in a bladder filled with a minimum of 150 ml was taken as cut off to detect abnormal voiding. Cystometric parameters which indicated normal bladder function were first desire to void between 150 and 200 ml, capacity (taken as strong desire to void) of greater than 400 ml, detrusor pressure rise on filling of less than 15 mm H2O per 500 ml infused, absence of detrusor contractions, no leakage on coughing, no significant pain on filling and finally a detrusor pressure rises on voiding (maximum voiding pressure) of less than 50 cm H2O, with a peak flow rate of more than 15 ml/s for a voided volume over 150 ml. Urodynamic stress incontinence was diagnosed when urethral leakage was seen with increased abdominal pressure, in the absence of detrusor contractions. Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post operatively.

Eligibility Criteria:
Inclusion Criteria:

- pelvic organ prolapse associated with lower urinary tract dysfunction.

Exclusion Criteria:

* are those who had previous surgery for urinary incontinence, or experienced neurological disorder such as multiple sclerosis or spinal cord injuries were not included. Or had complicated medical disease that made the patient unfit for anesthesia.
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Gender is not limited, age 18-75 years old;
2. Estimated survival is greater than 3 months;
3. Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;
4. Patients with head and neck cancer whose tumor tissue can be surgically harvested;
5. Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

1. Infected or had been infected with COVID-19;
2. Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
3. Patients with head and neck cancer who had received the following treatments:

   The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;
4. Other situations that are not appropriate to be included in the clinical trial.
A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

This study will validate the real world results of polygene methylation detection in colorectal cancer in a large prospective community cohort. In this study, questionnaire survey and polygene methylation detection technology of colorectal cancer were used as preliminary screening methods, and colonoscopy was used as further validation examination method to screen colorectal cancer and precancerous lesions. The diagnosis and outcome of all lesions were based on colonoscopy and pathological examination.

1. The informed consent signed by shougang Community will be completed in the baseline period: Colorectal cancer risk factors assessment questionnaire, medical history collection, fecal immunochemical (FIT), carcinoembryonic antigen (CEA) blood test and blood bowel cancer gene methylation detection, for colorectal cancer gene methylation detection results more positive subjects and the result of the negative part of the subjects (n = 500), within 3 months after receiving the results complete colonoscopy.
2. Follow-up at 1, 2, 3, 4, and 5 years after baseline included: ① Central follow-up at 1, 3, and 5 years: history collection, colonoscopy, FIT test, and CEA examination; ② Telephone follow-up at the 2nd and 4th years: medical history was collected; (3) Survival outcome registration was performed in the fifth year; Follow-up history was collected at 1, 2, 3, 4, and 5 years after completion of baseline, and survival outcomes were registered at 5 years.
3. During the follow-up, the subjects were confirmed to be diagnosed with colorectal cancer by evaluation (colorectal cancer was diagnosed by colonoscopy), and the subjects who were treated after polyps or adenomas were found during colonoscopy also reached the study endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Chronological age ≥40 years;
2. Full capacity for action;
3. After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
4. In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;

Exclusion Criteria:

1. History of colorectal cancer and other malignant tumors;
2. Previous colorectal resection;
3. undergoing any cancer-related treatment;
4. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
5. Participate in other interventional clinical investigators within 3 months;
6. Pregnant or lactating women;
7. Have autoimmune disease, hereditary disease, mental illness/disability, etc
8. Poor compliance, unable to complete the study.
Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients

18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.

We propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.

In order to improve locoregional control and to eradicate micrometastases for patients with locally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy followed by concurrent chemoradiotherapy has been the preferred therapeutic approach.Although it would be of great advantage to identify non-responder during or immediately after therapy to formulate an alternative treatment strategy, non-invasive methods for early evaluation of therapeutic response for advanced NPC patients have not been fully evaluated. Decrease of tumor volume in anatomical images and relief of symptoms in clinical follow-up have been used in many conventional approaches to evaluate the effectiveness of therapy. However, an effective therapy could very well have resulted in early subclinical alterations in tumor physiology and biochemistry. These alterations may have occurred long before changes in the tumor mass become apparent. Thus therapeutic effect may not be assessed accurately using the conventional anatomical imaging studies, such as CT and MRI.Recent studies have shown that 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.We therefore propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed locally advanced NPC patients who are receiving induction chemotherapy for treatment

Exclusion Criteria:

* age below 18 year old
* pregnancy women
Evaluation of Von Willebrand Factor as a Marker For Early Diagnosis of Acute Respiratory Distress Syndrome (A.R.D.S) in Comparison to Interleukin 6 [IL-6]

In this prospective study of 60patients, we tested the hypothesis That markedly elevated levels of plasma von Willebrand factor (VWF) a marker of endothelial cell injury might predict the development of acute respiratory distress syndrome (A.R.D.S) in risky patients. We compared our result to IL.6 as control biomarker for A.R.D.S development.

Acute lung injury was quantified on two -point scoring system (Berlin definition of ARDS and Murray score of acute lung injury).

Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years old of both sexes.
* risk factor for development of acute respiratory distress syndrome or acute lung injury either by:
* Direct lung injury includes: Severe pneumonia (infection), Breathing a vomited stomach contents (aspiration), Breathing harmful fumes or smoke, severe trauma to the chest or other accident that bruises the lungs.
* Indirect lung injury includes: sepsis, Severe injury or trauma with shock, blood transfusions , drug overdose acute pancreatitis, fracture of the long bones, near drowning ,anaphylaxis, uremia, fat embolus , and intracranial insult.

Exclusion Criteria:

* (1) pregnancy;
* (2) a preexisting medical condition with a life expectancy less than 3 months
* (3) evidence of cardiogenic pulmonary edema
* (4) age under 18 years old or above 80 years old
* (5) late stages of liver cell failure, renal failure
* (6) severe myocardial infarction
* (7) deep coma.
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients

This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT
* HbA1c between 6.0% and 10.0%
* On stable statin therapy or statin intolerant
* Patients who are eligible and able to participate in the study

Exclusion Criteria:

* Contraindications to MRI
* NYHA class IV Heart Failure
* NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening
* Patients with type 1 diabetes
* Acute infections
* HsCRP \> 30 mg/dL
* Aortic aneurysm ≥5cm

Other protocol-defined inclusion/exclusion criteria may apply