cyrilzakka/clinical-trials huggingface dataset:
The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R

The aim of the study is to investigate the validity, reliability and clinical features of a Danish version of the Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R). A self-reporting scale devise used as a supplementary questionnaire in diagnosing autism spectrum disorder (ASD) in adults. Furthermore the validity of novel screening questionnaire: SchiZotypal Autism Questionnaire (ZAQ), will be investigated. ZAQ is developed to discriminate Schizotypal Disorder from ASD.

The study has 2 parts.

Part 1:

The objective is to develop and validate a self-report screening questionnaire to efficiently discriminate between Schizotypal Disorder (SD) and Autism Spectrum Disorder (ASD) within the adult population. Discriminating ASD from SD in a clinical setting is a complex and time-consuming task, as they share considerable features both at the symptomatic and the diagnostic criteria. A pilot version of this questionnaire have been developed with 139 questions and named schiZotypy Autism Questionnaire (ZAQ), to discriminate between these conditions.

Part 2:

RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders The scale is a self-administered questionnaire completed by the patient himself assisted by a clinician (psychiatrist, psychologist) which ensures the understanding of issues and the choice of answers. The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions to describe non-symptomatic behaviors.

The objective of this study is to perform a complete validation of this scale in a Danish translation.

For both parts of the study 600 adults will be included, 200 adults referred for assessment of autism, 200 adults with another psychiatric disorder, and 200 adults without psychiatric disease.

Eligibility Criteria:
Inclusion Criteria:

1. Al patient referred to the outpatient clinic for ADHD and Autism at PCG, in the research period, for diagnostic assessment of Autism Spectrum Disorder (Pervasive Developmental Disorder, infantile autism, atypical autism and Asperger Syndrome)
2. WAIS \> 85, or Raven or no-clinical suspicion and education level of 11 years or above
3. Completion of

   1. Clinical assessment
   2. Adult Asperger Assessment (AAA)
   3. Psychopathology evaluation using DSM-V
   4. A conclusion based on interdisciplinary consensus

Exclusion Criteria:

1. Insufficient Danish language skills
2. Acute psychiatric illness prompting departure/dismissal from the diagnostic assessment
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.


Eligibility Criteria:
Inclusion criteria:

* Male or female patient age \>= 18 years at screening. For Japan only: Age \>= 20 years at screening
* Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) \<=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

  * If EF \>= 36% to \<= 40%: NT-proBNP \>= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP \>= 5000 pg/ml for patients with AF
  * If EF \>= 31% to \<= 35%: NT-proBNP \>= 1000 pg/ml for patients without AF and NT-proBNP \>=2000 pg/ml for patients with AF
  * If EF\<= 30%: NT-proBNP \>= 600 pg/ml for patients without AF and NT-proBNP \>=1200 pg/ml for patients with AF
  * EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP \>= 1200 pg/ml for patients with AF
* Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
* Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
* Signed and dated written ICF (Informed Consent Form)
* Further inclusion criteria apply

Exclusion criteria:

* Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
* Heart transplant recipient, or listed for heart transplant
* Acute decompensated HF
* Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.
* Symptomatic hypotension and/or a SBP \< 100 mmHg
* Indication of liver disease
* Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
* History of ketoacidosis
* Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
* Currently enrolled in another investigational device or drug study
* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Further exclusion criteria apply
Dietary Soy Isoflavones for the Prevention of Cancer

RATIONALE: Eating a diet rich in soy foods appears to reduce the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent the development of cancer.

PURPOSE: Clinical trial to determine the most effective amount and type of soy isoflavones needed in the diets of healthy men and women to prevent cancer.

OBJECTIVES: I. Determine the effect of varying the dietary intake of soy nuts on plasma levels and urinary excretion of isoflavones. II. Determine the effects of different food composition, along with age and gender of subjects, on plasma levels and urinary excretion of isoflavones.

OUTLINE: This is a two part study. In part I; participants are stratified according to menopausal status. In part II; participants are stratified according to gender and age (under 50 vs. over 50). Part I - Study participants are given 3 different amounts of toasted soy nuts separated by one month intervals. The sequence in which each amount is given is randomized. Blood and urine samples are taken to measure isoflavone levels. Part II - Study participants are given toasted soy nuts, soy milk, and tempeh on separate occasions separated by one month intervals. The sequence of each food is randomized. Blood and urine samples are taken to measure isoflavone levels.

PROJECTED ACCRUAL: 10 women, 5 premenopausal and 5 postmenopausal, will be accrued for part I of the study. 80 subjects, 40 women and 40 men, will be accrued for part II.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Healthy women and men

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic liver disease Renal: No chronic renal disease Cardiovascular: No chronic cardiovascular disease Pulmonary: No chronic pulmonary disease Other: No known allergy to soy proteins No consumption of soy protein within past week

PRIOR CONCURRENT THERAPY: Biologic therapy: No antibiotics within past 3 months Chemotherapy: Not specified Endocrine therapy: No oral contraceptive or hormone replacement therapy Radiotherapy: Not specified Surgery: Not specified Other: No medication likely to affect gastrointestinal, liver, or kidney function
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. A disease assessment will be performed at study week 9 (+/- 3 days). The assessment will be based on clinical signs and symptoms, changes in radiographic images, and changes in CA-125 levels. Subjects without evidence of disease progression may continue to receive AGS-8M4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression intolerability of AGS-8M4 or consent withdrawal. For subjects that continue dosing, disease assessments will be performed every 8 weeks during the extended treatment period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-8M4.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
* Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime

Exclusion Criteria:

* No epithelial ovarian tumors of low malignant potential
* Active infection requiring treatment with systemic anti-infectives within 72 hours of screening
* Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
* Prior monoclonal antibody therapy
Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress

Cortisol deficiency is diagnosed by the adrenocorticotrophin (ACTH) stimulation test. This test measures cortisol levels in the blood before and after giving an injection of ACTH. Currently, the results of this test can only be reliably interpreted when it is carried out on people in non-stressful situations. Frequently the test is carried out in hospitalized patients in stressful situations, giving results that are hard to interpret.

Our study is to first do this test in a non-stressful situation, followed by a repeat test in a stressful situation, to compare the results and create a set of guidelines for interpreting the test when it is carried out in stressful situations.

This study proposes to provide the reference range of cortisol results when the ACTH stimulation test is done under stressful conditions. This important information is currently not available in the literature. To achieve this, we will perform the ACTH stimulation test in a cohort of patients who are booked for elective surgery. By choosing elective surgery patients, we afford ourselves the opportunity of performing the test once before surgery. The test is then repeated within 12 hours of surgery. The first test will be done on an out-patient basis under usual conditions (minimal stress) while the second will be done under intense physical stress. The 2 sets of results will be compared and the effect of stress on test results will be determined. For the sake of uniformity, we have chosen patients who are booked to undergo repair of an abdominal aortic aneurysm (AAA) as our study cohort.

The ACTH stimulation is an important test that suffers from limitations resulting from lack of clear guidelines for the interpretation of results done under stressful conditions. This study will thus improve the usefulness of an important tool in the evaluation of the hypothalamic-pituitary-adrenal axis in stressed patients.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 40 to 80 years, who are booked for elective open repair of abdominal aortic aneurysm at The Ottawa Hospital Civic campus

Exclusion Criteria:

* Inability to provide informed consent
* Pre-operative signs and symptoms of hypofunction of the HPA axis
* Pre-operative AST results that indicate HPA failure, necessitating perioperative hydrocortisone coverage (Cortisol level post-ACTH \< 500 nmol/L)
* Presence of multiple co-morbidities such as poorly controlled diabetes, dialysis-dependant renal failure, hepatic failure
* Presence of hypoalbuminaemia \< 35 g/L
* Untreated endocrine disorders such as hypothyroidism, hypopituitarism, hypogonadism detected by pre-operative measurement of TSH, FT4, LH, FSH and free testosterone. Such patients will receive any appropriate treatment prior to surgery. Once treated, participation in the study will be offered again and results analysed separately
* Being on drugs (a) that affect cortisol synthesis (eg. Ketoconazole, etomidate) or protein binding (eg. Estrogens), (b) any form of glucocorticoid which would inhibit CRH and ACTH secretion.
* Use of herbal or anabolic supplements
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule.

OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non hematologic malignancy refractory to standard therapy, or for which no known effective therapies exist

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 2,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminase no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No myocardial infarction within 6 months No current, uncontrolled cardiac arrhythmias Other: No history of anaphylactic reactions Not pregnant Fertile patients must use effective contraception No serious uncontrolled, concurrent medical disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior paclitaxel allowed No prior irinotecan At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management

Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as \> 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic malignant pleural effusion requiring intervention

Exclusion Criteria:

* \<18 years of age
* pregnant or lactating patients
* expected survival \<3 months
* chylothorax
* previous attempted pleurodesis
* pleural infection
* leukocytopaenia (\<1.0 x 10\^9/L)
* uncorrectable bleeding diathesis
* inability to give informed consent or comply with the protocol
"Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers

The objective of this study is to develop and test the effectiveness of a resilience-based intervention for distressed partner caregivers of cancer patients in reducing symptoms of anxiety, depression and distress, while improving quality of life and resilience (meta-reflective skill, values clarification and coping strategies).

Informal caregivers of cancer patients often experience significant psychological distress, which may even exceed that of the patient's. Partners or spouses are typically the most important caregiver and emotional support person for the cancer patient, but there is a lack of psychological interventions that specifically target caregiving partners. "Resilient Caregivers" is a novel 7-session group-based program aimed specifically at improving the participant's ability to cope with the stresses of being a partner to a cancer patient. In this randomized trial, the investigators aim to assess the potential efficacy of this program in improving the caregiver's resilience and quality of life, as well as reducing symptoms of anxiety, depression and distress. Outcomes will be assessed at baseline and at 3, 6 and 12-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Partner/Spouse to a patient diagnosed with Stage I-III cancer and receiving cancer treatment at Herlev Hospital
* Patient performance status 1 or 2
* Distress Thermometer score \> 4
* Able to speak and understand Danish
* Has given written informed consent to participate in the study

Exclusion Criteria:

* Being a cancer patient
* Has untreated psychopathology or physical impairment that may prevent attendance and participation in the study
* Active substance abuse
Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position

The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.

The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20 subjects with both the investigational instrument followed by a commercially available instrument.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation for the study.
2. Have:

   1. Read the Informed Consent
   2. been given an explanation of the Informed Consent
   3. indicated understanding of the Informed Consent
   4. signed the Informed Consent document.
3. Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
4. Be in good general health, based on his/her knowledge.
5. Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
6. Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -

Exclusion Criteria:

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

1. Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
2. Poor personal hygiene as observed by the investigational site personnel.
3. Strabismus
4. Currently pregnant (to the best of the subject's knowledge) or is lactating.
5. Previous refractive surgery or current or previous orthokeratology treatment.
6. Aphakic or pseudophakic or has cataracts that interfere with visual acuity.
7. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
8. The need for topical ocular medications or any medication which might interfere with the study evaluations.
9. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
10. Slit lamp findings, including but not limited to:

Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels \> 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of \> Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis

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