cyrilzakka/clinical-trials huggingface dataset:
Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment

Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy

The study will be conducted in four stages:

Stage I - Item generation Approximately 20 interviews will be conducted with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on national social distancing guidance at the time. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.

Stage II - Cognitive interviewing Following the initial interviews, approximately 7 participants will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.

Stage III - Item reduction and refinement of the draft PROM A draft PROM and the EORTC QLQ-C30 (a validated measure of health related quality of life for cancer patients in clinical trials) will be administered to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability. Hierarchical item reduction and Rasch analysis will be used to determine which items should be included in the final PROM.

Stage IV- Pilot testing The final PROM will be pilot tested with approximately 10 patients at The Christie site to assess its acceptability

Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving combined surgery and chemotherapy for advanced ovarian cancer
* Aged over 18 (no upper age limit)
* Ability to understand and communicate in the English language
* Able to provide written informed consent

Exclusion Criteria:

* Patients who are not receiving combined surgery and chemotherapy for advanced ovarian cancer
* Unable to understand and communicate in the English language
* Aged under 18
* Unable to provide written informed consent
* Patients who are not able to complete informed consent or the study questionnaires
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients

This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid

Eligibility Criteria:
Inclusion Criteria:

1. Over 19 years old(male or female)
2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
3. Agreement with written informed consent

Exclusion Criteria:

1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
2. Patients with high sensitization who need desensitization therapy
3. Multi organ recipients or previous transplant with any organs
4. Diagnosed with cancer within five years
5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
6. Patients who have positive HIV, HBsAg or Anti-HCV test result
7. At screening

   * Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
   * WBC\<2,500/mm3, PLT \<50,000/mm3, ANC\<1,500/mm3
8. Pregnant or lactating women
9. In investigator's judgment
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women

This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.

Aim: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.

Methods: Sixty pregnant women between 24 and 36 weeks of pregnancy were included in the study. Pregnant women were randomly divided into two groups: The percussion massage treatment (PMT) group and the control group. Pregnant women included in the PMT group received a total of 10 sessions of percussion massage therapy, applied to their bilateral medial gastrocnemius, lateral gastrocnemius, peronus longus and tibialis anterior muscles three times a week. No massage therapy was applied to the lower extremities of the pregnant women in the control group. Pain assessment with Visual analog scale (VAS), ankle, knee, and thigh circumference measurements with tape measure, fatigue level with Fatigue Severity Scale (FSS), and quality of life assessment with Short Form- 36 (SF-36) were conducted.

Eligibility Criteria:
Inclusion Criteria:

* being pregnant between the ages of 18-40,
* being in the 24-36 weeks of pregnancy,
* not being at risk of pregnancy,
* being pregnant with a single baby,
* having complaints of pain or edema in the lower extremities,
* volunteering to participate in the study 3 days a week

Exclusion Criteria:

* multiple pregnancies,
* pregnant women with anemia,
* presence of circulatory problems,
* cardiovascular disease,
* chronic orthopedic disease,
* foot-related orthopedic and vascular disease.
Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib

The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with Iruplinalkib or planned to receive Iruplinalkib treatment in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed patients with locally-advanced or metastatic ALK-positive non-small cell lung cancer.
* Currently receiving, or planned to receive treatment with Iruplinalkib.
* Subjects had imaging reports of chest and abdominal enhanced CT and brain MRI within 42 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.
* Subjects had routine and biochemical reports within 30 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.

Exclusion Criteria:

* Patients who had previously been treated with ALK-TKI, but who had previously only been treated with ALK-TKI as neoadjuvant and/or adjunctive treatment could be enrolled.
* Mental disorder or inability to cooperate with examination or follow-up.
* Women known to be pregnant or lactating.
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months

To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months to see if these improvements are correlated with specific changes in the enteric microbiome.


Eligibility Criteria:
Inclusion Criteria:

children residing in catchment area of Limela, Machinga District and Ntenda (Chikwawa District), Malawi aged 6-11 months youngest eligible child in each household

-

Exclusion Criteria:

Unable to drink 20 mL of sugar water Demonstrating evidence of severe acute malnutrition Apparent need for acute medical treatment for an illness or injury Caregiver refusal to participate and return for 3 and 6 month follow-ups -

-
Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)

Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. The goal of this randomized clinical trial (RCT) is to evaluate an intervention which will provide 1) additional teaching on management of HF to the patient and CP following hospital discharge, 2) improved communication with the family physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital talking scale. The investigators believe this intervention will improve outcomes and be cost saving.

The investigators hypothesize that enhanced education and support for the CPs to assist older HF patients following hospital discharge, combined with improved communication with family physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and cost-effective approaches to manage HF patients following hospital discharge are urgently needed in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria \>= 5 points
* 60 years of age or older

Exclusion Criteria:

* Residence in, or planned discharge to a long-term care facility (LTC)
* Life expectancy less than 3 months
* Patient transferred to Geriatric Rehabilitation unit
* No caregiver
* Residence is more than a 30 minute rive from hospital of discharge
* Patient refused to participate
* Caregiver refused to participate
* Patient referred for CV surgery prior to hospital discharge
* Patient on IV Lasix at or bumetamide at hospital discharge
* Not on PO Lasix at hospital discharge
* Patient currently on dialysis
* Caregiver unavailable during daytime hours
* Caregiver has disability, serious mental illness or cognitive dysfunction
* Patient discharged early
* Patient enrolled in another randomized controlled trial
* Patient expired
* Patient and caregiver unable to speak and read English (Patient may be enrolled if nurse can converse minimally with patient and caregiver. S-TOFHLA will not be done for reading comprehension and questionnaires will be administered orally.)
* Severe aortic stenosis or severe mitral stenosis
The Effect of Tactile Deficit on Motor Function in Unilateral Cerebral Palsy

Cerebral palsy(CP) is the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Besides classical appearance of symptomatology, tactile impairment takes an important place to be evaluated. Assessment of the integrity of tactile function composes of two main steps: tactile registration and tactile perception. Our main goal is the define the effect of tactile impairment on hand motor function with the usage of identical assessment tools in patients with unilateral cerebral palsy (UCP) and typically developed children (TDC).


Eligibility Criteria:
Inclusion Criteria:

* Ages between 5-15 years
* Being evaluated as Class I-II-III in Gross Motor Function Classification System
* Being evaluated as Class I-II-III in Manual Ability Classification System

Exclusion Criteria:

* Inability to understand and/or follow test instructions due to intellectual or behavioral difficulties
* History of upper extremity botulinum toxin type A injection in the last three months,
* Previous upper extremity orthopedic surgery
* History of major trauma, and visual impairment
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Prior diagnosis of Crohn's disease
* patients who have Crohn's fistula
* negative for serum beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* patients who have allergy to bovine-derived materials or an anesthetic
* patients with a diagnosis of auto immune disease except for Crohn's disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients who have a symptom of septicemia
* Patients with a diagnosis of active Tuberculosis
* Patient who are pregnant or breast-feeding
* Patients who are unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
* Patients who are sensitive to Fibrin glue
* Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
* Insufficient adipose tissue for manufacturing of ADIPOPLUS
* Patients who are considered not suitable for the study by investigator
* Patients with a diagnosis of active refractory Crohn's disease
* Patients who have history of surgery for malignant cancer in the past 5 years
* Patients who have \> 2 cm diameter of fistula
Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population

The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.

Over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of Copenhagen, Denmark. The study also include a follow-up of a previous population study (the Health2006). Participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.

Eligibility Criteria:
Inclusion Criteria:

* persons living in 10 municipalities of Copenhagen

Exclusion Criteria:

* pregnancy, non-Danish citizenship
Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea

Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU.

PURPOSE: Intubation in ICU strongly differs from intubation in operative rooms. The results of studies about risk factors of difficult intubation performed in operative rooms cannot therefore be extrapolated directly to ICU.

The primary purpose of this trial (cf Part "Design" of this registration) is "other" and more particularly "Prognosis" because it is is an assessment of risk factors of difficult airway in intensive care units.

DESIGN AND METHODOLOGY: This is an open prospective multicentric study of intubation in ICU in more than 50 centres. Consecutive intubations will be included in each centre, in order to reach the sample size required (at least 1000 procedures intubations). The usual risk factors of difficult intubation in operative rooms, the demographic parameters and the complications of intubation will be assessed, as well as survival status at 28 days.

Eligibility Criteria:
Inclusion Criteria:

* More or equal to 18 years old
* Men and women
* Informed patient
* Affiliated or benefit from an disease insurance
* Available for a 28 days follow-up
* Intubated patients in Intensive Care Unit

Exclusion Criteria:

* Law protected patients
* Opposed to participate to study
Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.

Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
* Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
* Failed to keep their viral load low during previous anti-HIV treatment.
* Are at least 18 years of age.
* Agree to use an effective barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have used a protease inhibitor for more than 14 days.
* Have used ddI or d4T for more than 30 days.
* Are pregnant or breast-feeding.
* Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
* Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
* Are at risk for, or have had, pancreatitis (disease of the pancreas).
* Have difficulty absorbing medications.
* Have a cancer, other than Kaposi's sarcoma, that may require systemic treatment.
* Have any medical condition or treatment that may cause a rise in viral load.
* Have any other condition or previous treatment that would interfere with the study.
* Are unable to take drugs by mouth.
* Are receiving or have received recently any of the following drugs: terfenadine, astemizole, cisapride, triazolam, midazolam, ergot alkaloids, amiodarone, bepridil, flecainide, propafenone, quinidine, pimozide, rifampin, and intravenous (IV) pentamidine.
* Are receiving vincristine, thalidomide, foscarnet, or cisplatin or other medications that may cause nerve damage.
* Have received any experimental drug within 30 days prior to treatment.
* Are receiving treatment with testosterone, anabolic steroids, growth hormone, or megestrol acetate, except for certain hormonal problems.
Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery

To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.

In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation \> 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Age ≥18 years of age
* Double valves replacement surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

* The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data
* Preoperative renal dysfunction needs renal replacement therapy
* Emergency surgery
* Preoperative intubated patient
* Unable to cooperate with the study, i.e., mental illness, et al
* Patients with hemoglobin and anemia
* Participate in other trials in the prior 3 months
* Patient refuses to participate in the study
* Patient is unfit for the study decided by reach stuff
Tumor-educated Platelets in Venous Thromboembolism

Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.


Eligibility Criteria:
Inclusion Criteria:

* First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg
* Age 40 years or older
* Written informed consent

Exclusion Criteria:

* known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed);
* trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months;
* previous unprovoked venous thromboembolism;
* known hereditary or acquired thrombophilia;
* current pregnancy or puerperium (up to 3 months postpartum);
* current estrogen therapy.
* Greater than 10 days after VTE diagnosis;
* Inability for blood withdrawal at baseline;
* Inability or refusal to provide written informed consent.