cyrilzakka/clinical-trials huggingface dataset:
The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience

Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and their families' health-related quality of life and psychological well-being.

For this cohort study, adult survivors (≧20 years) of sudden cardiac arrest for more than 5 minutes after cardiopulmonary resuscitation will be enrolled. Basic demographic information, clinical events throughout hospitalization, and laboratory examination results will be recorded. Patients will be assessed for their neurological outcome using Glasgow coma score (GCS) and cerebral performance categories (CPC) upon hospital discharge, 1, 3, 6, and 12 months after discharge.

Post-cardiac arrest care is clinically challenging and this study aims to evaluate not just the physical well-being but also the psychological well-being of these patients on the short-term and long-term survival. Patients and their families will be assessed on their health-related quality of life and psychological well-being upon hospital discharge using the following scales: Mayo-Portland Adaptability Inventory (MPAI-4), World Health Organization Quality of Life Scale (WHOQOL-BREF), Impact of Event Scale - Revised (IES-R), and Family Resilience Framework. They will also be followed for one year after discharge at 1, 3, 6, and 12 months.

Data will be analyzed using the SPSS and SAS package. Odds ratios and hazards ratios will be determined for the factors that affect survival after cardiac arrest. The findings will help clinicians provide timely support to the patients and their families to promote physical and psychological well-being, and integrate them back to society as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.

Exclusion Criteria:

1. Under 20 years of age
2. Pregnant
3. Terminally ill cancer patients or cancer patients who are unwilling to receive treatment
4. When the ICU is over capacity and unable to provide intensive care.
5. The patient or family members refused to participate in this study.
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System

The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.


Eligibility Criteria:
Inclusion Criteria :

* Adult male and female patients
* Treatment of vertebral compression fracture (type A.1, some A.2 and rarely A.3 Magerl classification)
* Due to osteoporosis or tumorous lesions,
* Located in the thoracic and/or lumbar spine from T9 to L5.
* One unique vertebral fracture to be treated with the device
* Pain \> 4
* ASA \> 5
* For osteoporotic patient, fail in conservative treatment (8 days of antalgic medication Level III) and recent fracture (less than 6 weeks).

Exclusion Criteria:

* Unstable fractures or neoplasms with posterior involvement
* Nonmobile fractures
* Damages of the pedicles or posterior wall
* Less than one third of the original vertebral body height remaining
* Spinal canal stenosis (\>20%)
* Neurologic signs or symptoms related to the compression fracture or impeding pathological fracture
* Patient clearly improving on conservative treatment
* Pregnancy, breastfeeding
* Any contra-indication / allergy to implant material or cement
* Any previous surgical treatment (material or cement) in the targeted vertebra
* Systemic infection or infection located in the spine
* Any medical condition including but not limited to anaemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
* Patient under the age of majority
High Versus Free Humidity Incubators; A Randomized Clinical Trial

To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators

When the IVF started the majority of incubators designed to support high humidity because the designers and IVF specialists believed that the humidity will maintain stable ph and Temp.

Recent reports suggest that humidity is recommended and the others suggest no difference So we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76% to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth Edition). Some embryologists claim that the humidity free incubators may increase the chance of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt. unpublished data). This observations are never tested in a well designed randomized clinical trial (RCT) to eliminate the probability of chance and to reach a solid evidence.

The question that should be asked : is high humidity culture should be applied or there is no difference between dry and high humidity culture conditions?

Eligibility Criteria:
Inclusion Criteria:

* \< 33 years, BMI\<30,
* Normo Responder(\>8 MII)
* Fresh Cycle
* Ist attempt
* Normal or mild oligoasthenoteratozoospermia.

Exclusion Criteria:

* Testicular sperm
* \< 8 MII collected
* difficult transfer cycle
* Endometriotic patients
* Poor Endometrium \< 8mm diameter at Ovum Pickup
* any other medical diseases
Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis

Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.

The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease

The study protocol Fifty patients with SSc according to the current international classification will be included in the study. The patients, followed-up regularly in an out-patient clinic, will be tested for their thyroid function tests as well as the presence of thyroid auto antibodies. Clinical data will be collected from their medical records. Ultrasonographic examination of the thyroid gland will be performed by a single examiner. The gland will be characterized in detail with regards to its size and echotexture and cervical lymph nodes will be detected. The number and size of its nodules will be described as well as their echoic pattern (iso, hyperechoic or hypoechoic) calcifications (micro and macro), and borders status. Large nodules (≥ 1 cm in diameter) or with malignancy- associated characteristics will be aspirated according to current clinical practice. Treatment will be given according to the cytology diagnosis. Thyroid hormone supplementation will be recommended when thyrotropin level \>8 mIU/L or according to clinical judgment of the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

* non
Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies

This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.

The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.

Eligibility Criteria:
Inclusion Criteria:

1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
2. Patients must be willing to sign an informed consent.
3. age: 4 to 70 years
4. Estimated survival of ≥ 12 weeks, but ≤ 2 years
5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A\*0201 is required at the same time .
6. Subjects with solid tumor must have measureable disease
7. Routine blood test：hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
8. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
11. ECOG score ≤2
12. Adequate venous access for apheresis, and no other contraindications for leukapheresis
13. Women of child-bearing age must have evidence of negative pregnancy test.
14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.

Exclusion Criteria:

1. ECOG \>= 3
2. Patients with history of T cell tumors
3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
4. Acute or chronic GVHD after allogeneic hematopoiesis
5. steroid hormoneswere used before and after blood collection and infusion
6. HIV infection or active hepatitis B or hepatitis C infection
7. Uncontrolled active infection
8. Enrolled to other clinical study in the last 4 weeks.
9. Subjects with systemic auto-immune disease or immunodeficiency.
10. Subjects with CNS diseases.
11. Other patients that researchers considered unsuitable for inclusion
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
* Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.
* Meets Hanifin and Rajka criteria for AD.
* Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).
* Documented history (within 12 months prior to the Baseline Visit) of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable.

Exclusion Criteria:

* Prior exposure to Janus Kinase (JAK) inhibitor.
* Requirement of prohibited medications during the study.
* Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study.
Investigating Nutrition and Functional Outcome in Critically Ill Patients

This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.

The investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. At least 100 consecutive patients requiring surgery, who are admitted to any surgical ICU at the University Hospital RWTH Aachen will be recruited. Nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from ICU-admission until hospital discharge. Patient outcomes, such as ICU- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. To assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured.

This observational trial aims to assess the current standard of nutritional practice in the ICU, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. This study also aims to compare the outcome of the predefined subgroups of critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Adult patients (≥ 18 years)
* Patients admitted to a surgical ICU requiring surgical Intervention
* Patients requiring sedation and invasive ventilation for ≥ 48 hours
* Patients with an expected ICU-length of stay ≥ 72 hours

Exclusion Criteria:

* Pregnant or lactating patients
* Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission
* Patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before ICU admission
* Patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders)
* Death expected within 96 hours after admission due to severity of disease
* Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)
Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates).

To achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer.

Researchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.

Female patients with no known uterine pathologies scheduled to undergo embryo transfer will be identified through patient records and invited to participate in the study. Five days after luteinizing hormone (LH) surge, peripheral blood mononuclear cells (PBMC) will be isolated from these patients' peripheral blood by density gradient centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU/ml IFNt at 37˚C for 24 hours. This cell suspension will be carefully introduced in the uterine cavity by catheter on day 6 post LH surge. Embryo transfer will be performed the following day. A suitable age-matched control group will be recruited that will undergo embryo transfer but will not be administered immunomodulated PBMC prior to the transfer.

Reproductive outcomes in terms of rate of implantation, rate of clinical pregnancy and live birth rates will be recorded and compared between the two groups.

Data analysis will be performed by investigators blind to the patient group.

Eligibility Criteria:
Inclusion Criteria:

* Participating in Assisted Reproduction Treatment
* Having primary infertility
* Having regular menstrual cycles
* Scheduled to undergo embryo transfer of euploid embryos only

Exclusion Criteria:

* Uterine pathologies
* Endometrial bacterial infections
* Active endometrial inflammation
* Polycystic ovary syndrome
* Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
* Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
* Oncological condition
* Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease

Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.

The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.


Eligibility Criteria:
Inclusion Criteria:

* myocardial infarction, stable angina, heart surgery
* finished phase 2 cardiac rehabilitation
* clinically stable
* able to communicate in Norwegian
* able to do a maximal treadmill test

Exclusion Criteria:

* unstable angina
* serious cardiac arrhythmia
* serious heart valve insufficiency
* heart failure
* any contraindication for high intensity exercise training
* participation in other exercise study
* pregnancy
* cognitive impairment
* drug abuse
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context

The aim is to investigate potential barriers to informed decision making in a breast cancer screening context. This is a necessary step prior to developing and investigating improved information or decision aids in a Danish breast cancer screening context.

In this study, preferences and attitudes towards breast cancer screening, invitation, and decision making among Danish women will be investigated. The aim is to gain knowledge about barriers for (informed) decision making in a Danish breast cancer screening context. The study will be conducted by sending out an online questionnaire to women aged 44-49 in Denmark. The questionnaire will be sent out using the official digital mail system, e-Boks, with an invitation, link, and login information to access the online questionnaire. The questionnaire will consist of background questions about the participants, questions related to the current information material and invitation to the Danish breast cancer screening program, and questions about decision making and informed choice. Women will be randomized to one of three questionnaires: 1) Questionnaire with "Stage of Decision Making" to investigate women's decision making process regarding participation in screening, 2) Questionnaire with choice framing (presentation of a choice between participation in breast cancer screening or no screening), or 3) Questionnaire with opportunity framing (only presentation of screening, no alternative) to investigate decision making process and impact of different framing. The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing.

1000 women will be invited to each group in this study and thus 3000 in total, as this is the minimum number satisfying the requirements for both the main hypothesis and secondary aims (not described in detail here). No similar studies were found, therefore, this sample size calculation is based on proportions of 50% to have enough power in our study. With a desired standard error no larger than 2.5%, 400 women are required (SE of a binomial random variable). Assuming 40% participation, a study population of 1000 women in each group is required.

Next, questionnaire data will be linked to register data on sociodemographic factors from Statistics Denmark.

The study is registered at Aarhus University's internal records: 2016-051-000001, 2563.

Eligibility Criteria:
Inclusion Criteria:

* All women living in Denmark in this age group

Exclusion Criteria:

* None
Prognostic Value of Prothrombin Fragments 1+2 for Pulmonary Embolism Incidence

To determine the possible association of prothrombin fragments 1+2 elevation with incidents of pulmonary embolism in patients with COPD exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* COPD exacerbation
* Able to give informed consent
* Able to perform spirometry

Exclusion Criteria:

* Known malignancy
* Known hypercoagulable state
* Receiving anticoagulant treatment
* Pregnancy
* Renal failure
* Allergy to Iodine
Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease

More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of GERD
* GerdQ score of \>=8
* documented PPI use for GERD
* internet access at home or computer/mobile device
* ability to provide written or e-consent.

Exclusion Criteria:

* Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
* non-English speaking patients