cyrilzakka/clinical-trials huggingface dataset:
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability

The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.

Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.

Eligibility Criteria:
Inclusion Criteria:

* patients currently taking divalproex direct release for any seizure and/or behavior disorder
* patients with intellectual disability
* other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected

Exclusion Criteria:

* patients with a recent history of status epilepticus in the past 6 months
* seizures in the past 3 months
* patients with acute illness requiring changes in concurrent drugs
* patients unwilling to change from their present direct release divalproex to divalproex extended release
* patients that do not have a reliable caregiver
* patients with lack of verbal expressive speech
Prophylactic Negative Wound Pressure Therapy (PICO-7) Following Groin Incisions in Vascular Surgery (PICO-Vasc Study)

Comparison between waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK and PICO-7, Smith \& Nephew, UK in terms of inguinal surgical wound infection and complications after lower limb revascularization.

Patients will follow a preoperative preparation:

* Routine pre-surgical skin hygiene with soap or antiseptic agent
* Groin shaving with a machine
* Preoperative antibiotic prophylaxis with cefazolin 2 gr ev. single dose or clindamycin 900 mg ev. in case of allergy to beta-lactams 30 min before the start of the intervention. In case of prolongation of the intervention (\> 4h), a second antibiotic dose will be administered
* Surgical field antisepsis using a sterile swab soaked in 2% chlorhexidine solution in 70% isopropyl alcohol, except for contraindications (such as potential contact with mucosa or open wounds, in which case 10% povidone-iodine solution will be used); usual sizing.

At the end of the revascularization surgical procedure, the inguinal wound will be closed using 2-0 or 3-0 Vicryl subcutaneous absorbable suture (Ethicon Inc, Somerville, NJ, USA) in two independent planes and skin closure with metal staples (B / Braun Manipler® AZ). The opaque randomization result allocation envelope will then be opened and the surgical area nurse will cover the wound with one of the two assigned dressings:

* Group 1 (intervention group): The surgical wound will be covered in a sterile manner with prophylactic TPN (PICO-7, Smith \& Nephew, UK).
* Group 2 (control group): The surgical wound will be covered in a sterile way with the usual dressing (waterproof sterile dressing OPSITE Post-Op Visible, Smith \& Nephew, UK).

During admission, regular follow-up will be carried out. On the 7th day, the dressings of both groups will be lifted. From this moment, if the wound allows it, air healing will be carried out without new dressings. After discharge from the hospital, the surgical wound evaluation will be carried out by the nurse responsible for Outpatient Consultations at 14 and 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-90
* Undergoing elective revascularization surgery (Rutherford clinical categories 4-6 / Fontaine III and IV) requiring a longitudinal inguinal approach (a longitudinal inguinal incision is defined as the one that runs from the inguinal ligament to the femoral bifurcation, performed with the intention of approaching the vascular bundle).
* Surgery performed by investigator and co-investigators: Vascular Surgeons of the Vascular Surgery Department at the Parc Taulí Hospital.
* Patients must be able to understand the study and sign the specific informed consent before surgery.

Exclusion Criteria:

* Urgent surgery
* Interventions in which transverse groin wounds.
* Presence of active groin infection that prevents primary closure
* Pediatric patients, pregnant women or patients with impaired higher functions who cannot understand the study or collaborate with its protocolized follow-up.
Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction

The goal of this trial is that using tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) is more effective than using tadalafil alone in improving erection rigidity and sexual function. The efficacy of the combination of li-ESWT and tadalafil has been confirmed by a number of studies, including in patients after radical prostatectomy. However, this method is still not a "first-line" method in young primary patients and its benefits in combination with drugs for these patients are not obvious.

The investigators assume that the combination of tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) will improve the subjective state of patients assessed by points of validated questionnaires and Number of successful intercourse per week.

The aim of the study is to test the hypothesis that using tadalafil plus shockwave in primary patient with ED treatment in more effective in improving erection rigidity and sexual function, then using tadalafil alone.

Eligibility Criteria:
Inclusion Criteria:• Age 20 to 45;

* Married or have had a permanent sex partner for at least 3 months;
* IIEF-5 questionnaire scores below 20

Exclusion Criteria:

* History of previous use of PDE-5 inhibitors or fSWT;
* Patients with diabetes mellitus;
* Patients after the radical prostatectomy or major pelvic surgery;
* Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury);
* Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;
Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

Present an advanced flexible, and wearable sensor intimately coupled to the skin that can measure the full spectrum of relevant physiological parameters associated with atopic dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart rate variability and respiratory rate.

Eligibility Criteria:
Inclusion Criteria:

* Participants with mild to moderate atopic dermatitis ages 2 years or older. This will be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria with a baseline Investigators Global Assessment score of mild (2) or moderate (3)
* Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment
* Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment
* Willingness and ability to set up an infrared video camera nightly
* Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body

Exclusion Criteria:

* Active skin or systemic infection
* Inability to operate a smartphone or video camera
* Active atopic dermatitis on he dorsum of the hand or suprasternal notch
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain diagnosis
* Opioid tolerant
* Has on average 1-4 breakthrough pain episodes per day

Exclusion Criteria:

* Drug abuse history
* Cardiopulmonary disease
* Monoamine oxidase inhibitors (MAOIs)
* Expected to have surgery to relieve the pain
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed head and neck cancer surgery and got a feeding tube perioperatively
* Patients of legal age
* Patients who can understand and read Scandinavian languages

Exclusion Criteria:

* Patients with allergy to components in parenteral nutrition
* Patients where it is impossible to give parenteral nutrition
Exploring Use of Companion Robot Pets for Older Adults in Care Homes

This study will assess the use and impact of the affordable 'Joy for All' robot pets for older people with and without dementia living in the care homes in South West England.

Robot pets such as Paro have shown potential in improving wellbeing (including reduced agitation, loneliness, medication use, anxiety and depression), however previous work conducted by the investigators suggests Paro is less acceptable to older adults than alternative devices; the Joy for All cat and dog. Paro is also much more expensive (£5000 compared to £100) limiting its use within the real world, and limiting the number of people able to benefit.

The investigators therefore wish to explore the potential of these more affordable robots in achieving wellbeing benefits.

This study will be an eight month stepped-wedge, cluster randomised control trial exploring the use and impact of 'Joy for All' robot pets with older people living in care homes in South West England. Participants will include individuals with and without dementia.

The study aims to:

* See if affordable robot pets lead to improved wellbeing and are robust and engaging over 4-8 months in care homes and nursing homes.
* Identify under what circumstances, for which care home residents, and with what impact the robot pets are used.

The wellbeing outcomes to be explored include; neuropsychiatric symptoms, challenging behaviour, communication and loneliness.

Additional outcomes include monitoring of medication use, 1:1 care applications, and maintenance of a usage chart.

Qualitative data will also be collected through reflective diaries maintained by care staff, and interviews following completion of the study.

The study will include residents of eight care homes, which will be stratified into two clusters based on size and dementia service. The two clusters will then be randomised to immediate start (and receive robot animals immediately), or delayed start (and receive robot animals after four months). This provides a period of control. The sample size is primarily informed by feasibility, and the number of residents in each home likely to participate. In total there are approximately 190 residents of which the investigators estimate 100 across the 8 homes will give consent and interact with the robots. If 70% residents (across both arms and over the whole study) benefit from interacting with the robots the 95% confidence interval is 61-79%. This is of sufficient precision.

Measures will be completed at baseline, 4 months and 8 months. Interviews will be conducted at 8 months, and analysed alongside reflective diary entries.

This study should provide understanding of the potential for these more affordable robot pets in improving wellbeing for older people, and insight into their use and implementation.

Eligibility Criteria:
Inclusion Criteria:

* Any resident at a collaborating care home or nursing home that has consent to participate.

Exclusion Criteria:

* Any resident at a collaborating home without consent to participate.
Fimasartan in the Senior Subjects

The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
2. Elderly aged 70 years or older
3. At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.

   * For treatment-naïve patients who have not taken drugs for hypertension within the last 3 months from the screening visit: Mean siSBP ≥ 140mmHg
   * For patients with essential hypertension who are taking drugs for hypertension: Mean siSBP ≥ 130mmHg
4. At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period
5. Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Exclusion Criteria:

1. Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at screening, it is based on the blood pressures measured from both arms, and the patient is excluded if the result from any of the arms falls within the criteria.)
2. Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood pressures in the selected arm at the screening visit (Visit 1)
3. Patients with a history of secondary hypertension and any history suspected of secondary hypertension (but not limited to the following: coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
4. Orthostatic hypotension with symptoms
5. Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c \> 9.0% at the screening visit (Visit 1))
6. Patients with a history of malignant tumor, including leukemia and lymphoma, within the past 5 years (however, participation is allowed if it has not recurred for at least 5 years after a tumor surgery)
7. Patients with any chronic inflammatory disease requiring chronic anti-inflammatory treatment, consumption disease, autoimmune disease like rheumatoid arthritis and systemic lupus erythematosus, etc., or connective tissue disease at present or in the past
8. Patients with a history of hypersensitivity reaction to any component of the investigational product and its similar compound Renin-angiotensin system inhibitors, ACE inhibitors, thiazide diuretics and sulfonamides, Yellow 5 (Sunset Yellow FCF), etc.
9. Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)
Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.

The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* biopsy proven rectal cancer (anal verge ≤ 10cm)
* neoadjuvant radiotherapy or chemoradiotherapy
* no radical surgery after neoadjuvant therapy

Exclusion Criteria:

* other malignant disease
* other fatel disease
* incompletion of half of radiotherapy course
* metastasis on initial presentation
Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.

BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22% germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype, including those women who have no family history of breast or ovarian cancer. With the rapid advancement of therapeutics targeted this population, this protocol seeks to provide genetic BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may help in selection of future treatment options and genetic testing for BRCA1/2 may be used to potentially prevent a proportion of cancer for the family members.

This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population.

Primary Objectives

· To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.

Secondary Objectives

* To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA1/2
* To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA1/2-positive
* To correlate impact of BRCA1/2 mutational status on clinical outcome
* To track utilization of genetic counseling services at Princess Margaret Cancer Centre

Eligibility Criteria:
Inclusion Criteria:

* Patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort
* Patient must be ≥18 years old
* All patients must have sufficient archival tumor tissue for molecular analysis
* All patients must consent to have a genetic testing
* All patients must have signed and dated an informed consent form

Exclusion Criteria:

· Other histology subtype
Newborns From Patients Treated With ART (Assisted Reproductive Technology)

The Prospective Cohort Study for Newborns from patients treated with ART was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Since the last twenty years, thousands of babies were born from infertile couples treated in our center. However, the short, and especially the long term prognosis of these children were barely known.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. In addition, information of each newborn from our center has also been kept in CCRM/EMRCD. The current project plans to recruit these newborn babies in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for Newborns from patients treated with ART prognosis.

Eligibility Criteria:
Inclusion Criteria:

* All newborns from patients treated with ART in our center.

Exclusion Criteria:

-
High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

In this study, the investigators will determine the impact of a high calorie and high protein nutrition supplementation strategy on quality of life in participants with advanced heart failure. The investigators hypothesize that participants with advanced heart failure who receive the high calorie high protein nutrition supplementation strategy will experience an improvement in quality of life compared to those patients that receive usual care.

This is a single center, prospective randomized open with blinded endpoint (PROBE) trial with an individual follow-up time of 30 days duration designed to determine the impact of a high calorie high protein nutritional supplementation strategy on quality of life and functional outcomes in adults with malnutrition advanced systolic heart failure. 48 participants will be randomized in a stratified fashion by gender and Subjective Global Assessment (SGA) class (B versus C). Study subjects will receive a calorie and protein nutritional supplement, Ensure Original, manufactured by Abbott laboratories for 30 days after hospital discharge. The study site will be Columbia University Irving Medical Center. Investigators will be blinded to group assignment and dietary recalls until the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Hospitalized at Columbia University Irving Medical Center/New York Presbyterian Hospital
* Left ventricular ejection fraction \<=40%
* At least mild malnutrition as determined by the Subjective Global Assessment (SGA)

Exclusion Criteria:

* Inability to eat orally
* Inability to eat independently
* History of dysphagia
* Allergy to nutritional supplement
* Need for inotrope and/or mechanical support at hospital discharge
* Listed for heart transplant
* Insulin dependent diabetes and/or most recent A1c \>7%
* Having two or more results of a serum potassium \>5.0 mmol/L during hospitalization or history of serum potassium \>6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
* Severe renal insufficiency (estimated glomerular filtration rate \<30 ml/min/1.73m\^2 at discharge)
* Cirrhosis
* History of bariatric surgery
* Nursing home residence
* History of persistent noncompliance with treatment recommendations as judged by the investigators
Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis

The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
2. Age 14 - 18 years
3. History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
4. Clinically stable at the time of enrollment, without increased respiratory and/or GI symptoms or treatment with IV and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. Participants receiving inhaled antibiotics every other month are eligible to enroll. Participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate
5. Access to an iOS device (iPhone or iPad) and internet/data plan
6. Parent/participant enrolled in MyChart
7. Willing to participate in study after informed consent and assent has been obtained
8. English speaking

Exclusion Criteria:

1. Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
2. Developmental or cognitive delay preventing participant from interacting with voice journaling app
3. Unable to speak and write proficiently in English
4. Enrollment in another behavioral health study
5. Actively in treatment with a mental health provider