cyrilzakka/clinical-trials huggingface dataset:
Quality Register for Geriatric Psychiatry

QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. The data in the register will be used for quality assurance and for research.

Aims:

* Quality assurance
* Further development of our diagnostic and screening tools
* Contributing to improving the treatment, with and without drugs
* Contributing to improving the dialogue and collaboration between primary healthcare and hospitals

Data collected:

* Demographic data
* Previous and present disorders and use of drugs
* Data from relatives regarding:

  * the patient's cognition
  * psychiatric health
  * behaviour
  * activities of daily living
  * the stress and care burden of relatives
* Tests of cognitive functions
* Methods and duration for treatment
* Transfer to primary healthcare
* Possible readmissions

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to geriatric psychiatry units and their relatives who sign the consent form

Exclusion Criteria:

* Patients and relatives who refuse to sign the consent form
Investigation of Biomarkers in Susac Syndrome

Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult. The aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of Susac syndrome

Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. Because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed.

The aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and healthy subjects as controls are investigated.

Furthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of Susac syndrome.

Eligibility Criteria:
Inclusion Criteria:

* adult male and female patients with definite Susac syndrome or matching healthy control subjects
* ability to provide informed consent

Exclusion Criteria:

* pregnancy
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema

This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with secondary lymphedema
* Presence of a venous ulcer that has not healed in more than 6 months
* Localized wound pain greater than 3 with VAS
* Ulcer must be on lower leg (below knee)
* Ulcer must be of venous etiology
* CVI proven by duplex studies
* Subject must have adequate arterial blood flow (ABI \> 0.70)
* Subject must be able to tolerate compression bandages
* Subject must be ambulatory
* Capable of understanding consent process

Exclusion Criteria:

* Wound infection
* Ulcer of non-venous etiology
* Ulcer on toes or plantar surface of the foot
* Subject taking any medication that in the opinion of the investigator affects wound healing
* Alcohol or drug abuse
* Active deep venous thrombosis (DVT)
* Subject has a cancer diagnosis
* Diabetic with hemoglobin A1C\>12
* Arterial insufficiency ABI\<0.70
* Subject is not capable of walking (wheelchair-bound or bed-bound)
* Subject currently enrolled in another clinical trial
* Moderate to severe congestive heart failure
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
* Age: less than 80 years
* WHO Performance \> 2
* Adequate bone marrow reserve, renal and hepatic functions
* Informed consent

Exclusion Criteria:

* Rectal cancer
* R1or R2 resection; carcinosis peritonei
* Start of treatment \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma
China Resolute Integrity 34/38 mm Study

To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.


Eligibility Criteria:
Key Inclusion Criteria:

* The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent
* The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length \>27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent

Key Exclusion Criteria:

* STEMI within 24 hours
* Left main disease
* Bifurcation disease
Lafiya HIV-status Neutral Study - Protocol

The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma \& discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake.


Eligibility Criteria:
Inclusion Criteria:

* YGBMSM FGD and IDI: To be eligible for FGD, the person must be between 18 to 25 years old, currently identify as a cis-gender man, have had sex with another man within 8 months before engaging with the recruitment team, and must reside within a slum community in the Accra metropolitan areas. To be eligible for IDIs, participants must self-disclose living with HIV.
* GBMSM civil society organizations FGD: The person must have experience providing GBMSM with HIV prevention and care services for at least one year. Must reside in the Accra metropolitan area.
* HCF staff FGDs: HCF staff are eligible to participate in the FGDs if employed at a study-participating facility.
* Anti-ISD Trained Nurses IDIs HCF staff are eligible to participate if they are trained in our previous interventions and have previously delivered them in a Ghanaian HCF.

Exclusion Criteria:

* YGBMSM FGD and IDI: Persons outside the age range of 18 to 25 years old, persons who do not identify as cis-gender men, persons who have not had sex with another man within 8 months before engaging with the recruitment team.
* GBMSM civil society organizations FGD: persons who do not have experience providing GBMSM with HIV prevention and care services for at least one year. Persons who do not reside within a slum community in the Accra metropolitan area (residence outside this area would be excluded).
* HCF staff FGDs: HCF staff are not eligible to participate in the FGDs if they are not employed at a study-participating facility.
* Anti-ISD Trained Nurses IDIs: HCF staff are not eligible to participate if they are not trained in our previous interventions and have not previously delivered them in a Ghanaian HCF.
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects

This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
* Able to complete the study in compliance with the protocol;
* Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug;
* Male and female subjects between the ages of 18 and 45 years, inclusive;
* At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index between 19.0-26.0 kg/m2, inclusive;

Exclusion Criteria:

* More than 5 cigarettes per day on average within 3 months prior to screening;
* with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any excipients;
* History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;
* Donation or loss of a significant volume of blood (\>400 mL) within 3 months prior to screening;
Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).


Eligibility Criteria:
Inclusion Criteria

Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab

Exclusion Criteria:

Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
Prader-Willi Syndrome Macronutrient Study

The overall objective is to explore the mechanisms by which macronutrients regulate food intake and weight gain in Prader Willi Syndrome (PWS).

Previous studies from the investigators' labs suggest that the increased appetite of PWS may be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating hormone produced primarily by the stomach. This study will compare the effects of low carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and markers of insulin sensitivity in patients with PWS.

The investigators hypothesize that the low carbohydrate diet will suppress plasma active ghrelin and increase appetite-suppressing hormones to a greater degree and for longer duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The investigators also hypothesize that the low carb diet will improve hormonal and metabolic markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory cytokine profiles of children with PWS.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Prader Willi syndrome confirmed by chromosome analysis (ie. interstitial deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other chromosome 15 abnormalities)
* age 5 years to 17 years
* written informed consent and assent obtained and willingness to comply with the study schedule and procedures
* free T4, TSH values in the normal range (either endogenous or with thyroxine replacement)
* weight stable (BMI percentile fluctuation of \<5 percentiles) over the preceding 2 months prior to the study

Exclusion Criteria:

* presence of other clinically significant disease that would impact body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
* concomitant use of medications known to affect body weight or investigational drug in the past year
NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial

To demonstrate the clinical efficacy and safety of vascular endothelial growth factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of life and exercise capacity

A multicentre, double blind, placebo controlled trial to assess efficacy of VEGF and promote myocardial angiogenesis in patients with CCS III-IV angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
* LVEF\>20%
* Ischemic defects on myocardial stress SPECT imaging

Exclusion Criteria:

* NYHA\>2
* History of or diagnosis of age related macular degeneration, retinopathy
* Atrial fibrillation
* Primary valvular heart disease
* Evidence of or known history of cancer with in past 10 yea
* Uncontrolled hypertension
* Liability to receive dipyridamole
* History or diagnosis of rheumatoid arthritis
* Recent MI(within 4 weeks)
* Important ilio-femoral peripheral vascular disease, limiting catheter access
* History of unexplained gastrointestinal hemorrhage with the past 5 years
* LV thrombus visualized by either echocardiography or contrast LV angiogram
* Other severe concurrent illnesses
Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* English speaking veterans
* has home internet access
* has access to and familiarity in using a computer or tablet at least weekly
* Asymptomatic patients with chronic conditions
* has access to a mobile device with Short Message Service (SMS) text and picture capability
* has an active clinical diagnosis of major depressive disorder based on the International Classification of Diseases, 10th version (ICD-10)
* has an ICD-10 diagnosis of epilepsy with at least one seizure documented within the last five years

Exclusion Criteria:

* pregnancy
* Veterans that have current suicidal ideation
* have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
Duration of Effect of Biotene Spray in Patients With Dry Mouth

To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).


Eligibility Criteria:
Inclusion Criteria:

* Adults who are in good general health and reply initially affirmatively to the question, "Do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep?" This question is an adaptation of the question used successfully by Jose and others (2016) to recruit study subjects.
* Adults who are able to communicate easily in English and who are able to demonstrate understanding of the study instructions.
* Adults who are physically able to perform an unstimulated whole saliva flow rate (UWSFR) test and who produce 0.2 mL/min or less of saliva.

Exclusion Criteria:

* Adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications.
* Adults who regularly "self-medicate" their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits.
* Adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction)
* Adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver.
* Adults with a known allergy to any of the ingredients in Biotène Spray (eg. dairy allergy)
Outcomes of Concomitant Bypass Surgery in Septal Myectomy

To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy.

Surgical septal myectomy (SM) is an effective approach for treating patients with drug-refractory obstructive hypertrophic cardiomyopathy (HCM).However, numerous patients with HCM exhibit concurrent ischemic heart disease, including atherosclerotic coronary artery disease (CAD) and myocardial bridging (MB). Although patients with HCM have been known to possess diminished coronary flow reserve,additional CAD can worsen myocardial ischemia, contributing to an unfavorable prognosis.MB, although infrequent, may affect diastolic heart perfusion, leading to angina and even sudden death.Current guidelines recommend revascularization for ischemic heart disease caused by CAD and MB.However, the impact of concomitant coronary revascularization during HCM management remains unclear. In this study, we analyzed the clinical characteristics and surgical scenarios of patients who underwent concomitant coronary artery bypass grafting (CABG) during ventricular SM and investigated their prognosis.

Patient clinical and survival data from 2009-2020 were retrospectively reviewed. The median follow-up period was 5.1 years. All-cause mortality was the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of obstructive hypertrophic cardiomyopathy.
2. Undergo ventricular septal resection and cardiac bypass surgery at the same time.

Exclusion Criteria:

Incomplete surgical and follow-up data
The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity

This study was conducted to determine the effect of progressive relaxation exercises with music therapy on sleep quality and pain severity of patients hospitalized in the surgical departments of a university hospital.This single-blind, pre-test-post-test with control group design quasi-experimental study was carried out between March-July 2019. 31 patients who were hospitalized in surgical departments for at least one week and regularly performed relaxation exercises consisted of experimental group, and 31 patients who were hospitalized for at least one week but did not do relaxation exercises consisted of control group. The study data were collected by using "Descriptive Characteristics Form", pain severity of patients was measured using "Visual Analogue Scale", and sleep quality of patients was measured using "Visual Analogue Sleep Scale". The patients were asked to perform the exercises with music an average of 30 min before sleeping every day for a week. The observation of the nurse working in department and the patient's statement were used for control. The ethical permission and the approval of hospital management were obtained for the study. In the statistical analysis of the data, independent sample t test, one-way anova and paired sample t test were used. Statistical significance level was taken as p\<.05.

Inclusion criteria in the study:

* Agree to participate in research
* Staying in surgical wards for at least one week between the dates of the study
* Being 18 years or older
* Not regularly practicing relaxation exercises before

Exclusion criteria from the study:

* Refusing to participate in research
* Being discharged before one week after admission to surgical services within the range of the study date
* Those who are hospitalized for more than a week due to the possibility of serious illness diagnoses that prevent patients from performing relaxation exercises
* Being 18 years or younger
* Communication problem
* Regularly practicing previous relaxation exercises

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in research
* Lying in surgical wards for at least a week in the range of the date of the study
* Being 18 or older
* Don't practice relaxation exercises regularly before

Exclusion Criteria:

* Not agreeing to participate in research
* Discharge before a week after admission to surgical wards within the range of the date of the study
* Those with more than a week's sleep due to the likelihood that patients may have received serious disease diagnoses that would put them off doing relaxation exercises
* Being 18 and under
* Don't be a communication problem
* Practice relaxation exercises regularly before