cyrilzakka/clinical-trials huggingface dataset:
Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression

Currently, very little research exists on whether patient portals could be used to integrate patient-reported outcome (PRO) measurement into the electronic health record (EHR) and clinical practice, even though 87% of ambulatory care practices have EHRs and 88% of U.S. adults have access to the internet. To date, no randomized controlled trial has examined whether patient portals can be used to collect PRO measures. The goal of this study is to implement the integration of a computerized adaptive test (CAT) for patient-reported outcome (PRO) measurement of depression symptoms into an electronic health record (EHR) and evaluate the effectiveness of collecting CAT PROs via an EHR patient portal in two randomized controlled trials. This study will advance the science of implementation of patient-centered outcomes research into clinical practice, as well as the evidence for high quality, accessible care.

The overall goal of this proposal is to implement the integration of the Computerized Adaptive Test for Mental Health (CAT-MH) into an EHR for a healthcare system and evaluate the effectiveness of collecting CAT-MH PROs via an EHR-tethered patient portal (MyChart) vs. usual care in two randomized controlled trials. The first aim of this study will consist of a randomized controlled trial comparing screening rates among adult primary care patients with an active patient portal account (MyChart) and due for depression screening who receive usual care (CAT-MH screenings during routine clinic visits) vs. MyChart population-based CAT-MH screenings. The second aim of this study involves a randomized controlled trial comparing depression remission rates among patients with active moderate-to-severe MDD who receive usual care vs. MyChart CAT-MH measurement-based care. In addition, we will examine the resources needed to integrate the CAT-MH into the EHR and design the health IT strategy for collecting PROs via the patient portal.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* considered an active clinic patient at the start date of the intervention
* have an active MyChart account that is not managed by a proxy
* receive care from a participating PCP
* due for depression screening (screening arms) or active depression (monitoring arms)

Exclusion Criteria:

* under 18 years of age
* bipolar disorder
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.

OBJECTIVES:

* Compare the recurrence-free interval and survival in patients with stage I, II, III, or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin.
* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.
* Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both

  * At least 1 positive inguinal and/or femoral lymph node
  * No inoperable (fixed or ulcerating) groin nodes
  * Must not require resection of urethra or anal sphincter to achieve negative margins
* Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization
* No metastatic disease

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Granulocyte count at least 1,500/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy

Surgery:

* See Disease Characteristics
* No more than 8 weeks since prior surgery

Other:

* No prior therapy for another malignancy that would preclude study
Analysis of Urogenital Injuries in Polytraumatized Patients

Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.

The goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.


Eligibility Criteria:
Inclusion Criteria:

* ISS (Injury severity score) \> 15 points
* Patient Age \> 16
* Fracture of the thoracic and/ or lumbar spine
* Fracture of the pelvic girdle
* at least one AIS (abbreviated injury scale) \> 2

Exclusion Criteria:

* ISS \< 16 points
* no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle
* no AIS \> 2
* patient age under 16 years of age
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.

Eligibility Criteria:
Inclusion Criteria:

* Implanted with Altis Single Incision Sling System

Exclusion Criteria:

* Refuses to be included in the survey or that their medical data will be used for research purposes
* Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.
Circulating-water Garment With Forced-air Warming and Circulating-water Mattress During Abdominal Surgery

The purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal surgery. Patients will be randomly assigned to one of these two groups.

Group A: This group will receive the circulating water garment Group B: This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body

Once the patient is moved to the operating room table, the surface of the back will begin to be warmed using either the circulating-water garment for those in Group A or the circulating-water mattress for those in Group B. Following the start of anesthesia, additional warming will be done by covering the large parts of the legs and the upper and side of the chest using either the circulating-water garment for those in Group A or upper- and lower-body forced-air warmers for those in Group B.

Patient involvement will last until the warming devices are removed prior to departure from the operating room. There is no follow-up to this study.

Eligibility Criteria:
Inclusion Criteria:

* MaJor abdominal surgery
* Age between 18 and 85 years.

Exclusion Criteria:

* Fever (core temperature \>38°C)
* Combined procedures (e.g.: simultaneous liver and kidney transplantation)
* Contraindication to forced-air or circulating-water warming which would be impacted by use of warming blanket
* Anticipated veno-venous bypass
* Current Pregnancy
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies

Brain somatic mutations in genes belonging to the mTOR signaling pathway are a frequent cause of cortical malformations, including focal cortical dysplasia or hemimegalencephaly.

The present study aims to search for brain somatic mutations in paired blood-brain samples and perform functional validation in children with drug-resistant focal epilepsy


Eligibility Criteria:
Inclusion Criteria:

* Children with focal drug-resistant epilepsy including Focal Cortical Dysplasia, Hemimegalencephaly, Tuberous Sclerosis, Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE), Hypothalamic Hamartomas, Sturge-Weber syndrome, Rasmussen encephalitis, gliomas)
* Their parents who have signed informed consent 1) for their child's participation (for parents) and 2) for themselves
* Social security coverage or foreign regime recognized in France

Exclusion Criteria:

* refusal to participate in the study
* contraindication to anaesthesia, to MRI or to surgery
* no medical insurance coverage
Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women between 45 and 79 years of age
* Must be osteopenic/osteoporotic
* Treatment with oral bisphosphonate for at least 1 year

Exclusion Criteria:

* Any woman of child bearing potential
* Treatment with other bone active agents

Other protocol-defined inclusion/exclusion criteria may apply.
Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery

Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.


Eligibility Criteria:
Inclusion criteria:

1. Patients undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure.
2. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible).
3. Patients have an American Society of Anesthesiology physical status I-III.

Exclusion criteria:

1. Females who are pregnant.
2. Patients who are taking chronic daily opiates for one month prior to surgery except tramadol.
3. Diabetic patients.
4. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
5. Patients with contralateral pneumothorax or diaphragmatic paralysis.
6. Patients with coagulopathy.
7. Patients with clinically significant previous nerve injury in surgical extremity.
8. Patients with an allergy to NSAIDs.
9. Patients who are refusing a block.
10. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (COPD).
Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

Observational study of functional recovery of stroke patients after discharge from rehabilitation

Cerebrovascular diseases, such as stroke, are among the greatest challenges in healthcare. This proves the importance of neuro-rehabilitative research. Stroke research is often focused on the acute treatment phase as well as the inpatient rehabilitation. A remaining question is how do stroke patients clinically develop after being discharged from the hospital? How stable are the achieved rehabilitation effects and how much more clinical improvement is seen in the following time period, especially with regard to ICF functionality? In this observational longitudinal study, the current practice of neurorehabilitation will be investigated and the influence of motor skills, cognition, care situation, depression, information and fatigue on functional recovery as well as participation, autonomy and quality of life will be evaluated. Stroke patients will be examined at the end of rehabilitation, after three, six and 12 months. In addition, a group of chronic patients undergoes the same examinations and thereby represents a comparison group.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or haemorrhagic stroke according to ICD 10 I61-I69
* Patients in or after completion of rehabilitation phases C and D according to BAR criteria
* Age \>= 18
* Sufficient knowledge of German
* Existing declaration of consent
* Deficit still existing (Rankin score of at least 1 at inclusion)

Exclusion Criteria:

* need for care prior stroke
* SAB, craniocerebral trauma, TIA as primary diagnosis
* Severe pre-existing psychiatric disease
* Participation in follow-up examination not possible
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.


Eligibility Criteria:
Inclusion Criteria:

* Willing to undergo cataract surgery.
* Able to lie flat in a supine position.
* Able to understand and willing to sign the Informed Consent Form (ICF).
* Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or lactating mothers.
* Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
* Corneal opacity that would interfere with the laser beam.
* Presence of blood or other material in the anterior chamber.
* Hypotony or presence of corneal implant.
* Poorly dilating pupils.
* Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
* Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
* Any contraindication to cataract surgery.
* Other protocol-specified exclusion criteria may apply.
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

Eligibility Criteria:
Inclusion Criteria:

* between 19 years and 85 years old(male or female)
* Type 2 diabetes mellitus
* BMI between 18.5kg/m2 and 40kg/m2
* Agreement with written informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus or secondary diabetes mellitus
* Patients with complications of severe diabetes such as proliferative diabetic retinopathy
* Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Patients with abnormal laboratory test results according to the protocol
* Continuous or non continuous treatment insulin within 12 weeks prior to screening
* Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening
No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.

This is a phase II clinical trial investigating the postoperative surgical site infection (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy. Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the previous reports and our data. If SSI rates are within the target range, the investigators will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial use for laparoscopic gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric adenocarcinoma clinical stage T1-2N0M0 patients who underwent laparoscopic distal gastrectomy
* Age between 18 and 65 years
* American Society of Anaesthesiologists (ASA) status \>2
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Normal blood, liver, pulmonary, cardiac, and renal function
* Informed consent

Exclusion Criteria:

* Administration of antibiotics within 1 month before surgery
* Active infection at the time of surgery
* Combined resection during operation (i.e., spleen, liver, colon, etc.)
* History of upper abdominal surgery
* Previous chemotherapy or radiotherapy within 6 months before surgery
* Uncontrolled underlying comorbidities
* Malnutrition with BMI less than 18.5 kg/m2
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis

The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis : Adhesive Capsulitis of the Shoulder
* defining of adhesive capsulitis

  * the presence of shoulder pain
  * limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder
* duration : symptomatic for \< 1 year

Exclusion Criteria:

* bilateral symptoms
* uncontrolled diabetes mellitus
* overt hypothyroidism or hyperthyroidism
* previous shoulder surgery
* previous glenohumeral joint injection within recent 6months
* trauma to the shoulder the last six months that required hospital care
* neurological symptoms
* allergy to injection material
* secondary adhesive capsulitis
* systemic inflammatory ds including rheumatoid arthritis
* degenerative arthritis of shoulder joint
* infectious arthritis of shoulder joint
* dislocation of shoulder joint
* blood coagulation disease
* rotator cuff tear
* serious mental illness
* pregnancy
* fracture in shoulder lesion
* CVA
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery

Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

The 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6 weeks, so all patients will receive treatment for 12 weeks in total. Induction of hypoglycaemia will take place at 0 weeks, 6 weeks and 12 weeks to determine the glucagon response.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus 5-20 years duration
* C-peptide negative
* Willing and able to give written informed consent

Exclusion Criteria:

* Impaired awareness of hypoglycaemia
* BMI \> 27 kg/m2
* Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy)
* Acute illness within 3 months before the study
* Significant renal impairment (creatinine clearance \< 50ml/min)
* Use of beta-adrenoreceptor blockers
* Cardiac history (previous arrhythmia)
* History of epilepsy