cyrilzakka/clinical-trials huggingface dataset:
Project Relate: Romantic Relationship Competence SSI

The COVID-19 pandemic has increased social isolation and depressive symptoms in youth, adding strain to an already overwhelmed mental healthcare system. Online single-session interventions are digital programs that can help expand access to care and teach evidence-based skills. To help youth build healthy relationships, we developed 3 online single-session interventions (SSI) to teach romantic competence skills to adolescents and emerging adults. Youth, ages 16-20, will be recruited to social media and randomly assigned to one of two conditions: the intervention condition, offering them three SSIs to select from, or an information-only control group. Within the intervention condition, youth will complete one of three romantic competence SSIs: (1) Insight, targeting awareness of one's needs in relationships, (2) Communication, teaching listening and communication skills, and (3) Stay vs. Go, helping youth make difficult decisions. Investigators will assess each SSI's relative benefits on relationship knowledge and depressive symptoms up to three months later compared to the information-only control group. Results will reveal if online SSIs can teach romantic competence skills and if engaging in these interventions has psychosocial benefits for youth with elevated depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* are fluent in English
* have consistent internet and computer/laptop/smartphone access
* report elevated depressive symptoms (a score of \>2 on the Patient Health Questionnaire-2 item version \[PHQ-2\])

Exclusion Criteria:

* fail to meet the above-listed inclusion criteria
* exit the study prior to condition randomization
* respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
* obvious lack of English fluency in open response questions
* responding with random text in open response questions
* duplicate responses from the same individual in baseline or follow-up surveys
Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency

Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study.

Iron deficiency is highly prevalent in patients with HFREF and intravenous high-dose (HD) iron application has significantly improved clinically meaningful endpoints in such patients. The best evidence is existent for ferric carboxymaltose. Intravenous HD iron may influence phosphate metabolism via increases in levels of intact FGF23 and hence induce prolonged hypophosphatemia. Such increases in FGF23 may particularly occur depending on the type of iron carrier.

FGF23 is a significant risk factor for mortality and morbidity in patients with HFREF and other cardiac populations at risk and may directly cause left ventricular hypertrophy and dysfunction. Hence, the application of i.v. HD iron may have potentially beneficial effects on cardiac function but harmful effects via FGF23-induction and hypophosphatemia at the same time. However, FGF23 metabolism has not yet been evaluated in HFREF patients following i.v. HD iron.

FGF23 is elevated in patients with chronic kidney disease. Patients with HFREF + CKD = chronic cardio-renal syndrome are at particular risk regarding elevated morbidity and mortality. The effects of intravenous HD iron upon phosphate and FGF23 metabolism in patients with HFREF + CKD is unknown and effects in this setting may be different compared to effects in patients without pre-existing FGF23 stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age \> 18 yrs
* Symptomatic HFREF (LV ejection fraction \< 45%) with optimal medical therapy (OMT) for at least 2 months
* Iron deficiency as indicated by by ferritin \<100 ng/mL or ferritin 100-299 ng/ml when transferrin saturation (TSAT) \<20% and Hb value \< 13mg/dl (women) and \<14 mg/dl (men)
* Group A: Stable CKD for at least 2 months, defined by estimated glomerular filtration rate (eGFR) (CKD-EPI formula) as 15-60 ml/min/1,73 m3 (CKD III, IV, V-non D)
* Group B: patients with stable eGFR \> 60 ml/min/1,73 m3

Exclusion Criteria:

* Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation,
* Plasma Phosphate \< 2.5 mg/dL at screening,
* Renal replacement therapy/transplantation,
* Pregnancy or lactation
* iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before
* participation in another clinical trial with an experimental drug
* expectation of missing compliance
* alcohol or drug abuse
* The subject is mentally or legally incapacitated
* patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline

Exclusion Criteria:

* Secondary or primary progressive multiple sclerosis
A Retrospective Study for Multiple Endocrine Neoplasia

Retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type I in National Taiwan University Hospital.

The investigators will retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type I in National Taiwan University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple endocrine neoplasia

Exclusion Criteria:

* Patients younger than 18 years old
Negative Pressure Wound Therapy Registry

The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the effectiveness and safety of various NPWT devices and methods among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.

The purpose of the Negative Pressure Wound Therapy Registry (NPWTR)) for Wounds and Ulcers is to provide comparative effectiveness data on NPWT including different NPWT devices, and safety data on NPWT (e.g. the frequency of adverse events experienced by typical NPWT patients).

NPWT promotes wound healing by applying a vacuum through a special sealed dressing. The mechanical micro-deformation of the wound bed in response to suction has been shown to stimulate and accelerate the formation of new blood vessels (angiogenesis). The continuous vacuum removes fluid and reduces edema, thereby increasing tissue oxygen levels. The vacuum may be applied continuously or intermittently, depending on the type of wound being treated and the clinical objectives. Depending on the NPWT device, a variety of dressings are placed into the wound bed in conjunction with NPWT, and a variety of suction pressures may be applied.

The diversity of NPWT devices and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of NPWT in wound healing.

Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives including participation in PQRS, and to meet their Stage 2 Meaningful use criteria. The NPWTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating outpatient clinics are transmitted to the USWR where data are available for benchmarking, PQRS and other initiatives. Data used for comparative effectiveness research is HIPAA de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Provision of NPWT

Exclusion Criteria:

* patients not undergoing NPWT
Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)

Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools

Multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with unexplained dyspnea NYHA II-III in order to identify patients with a heart failure with preserved ejection fraction (HFpEF). The results will be compared to previously reported diagnostic scores such as the H2FPEF and the HFA-PEFF score.

Eligibility Criteria:
Inclusion Criteria:

* dyspnea NYHA II-III
* age 18-90 years
* left ventricular ejection fraction ≥ 50%
* ability to give informed consent

Exclusion Criteria:

* unstable cardiac disease with acute decompensation
* documented former LVEF ≤ 40%
* heart valve disease with medium or high grade insufficiency or stenosis
* coronary heart disease with hemodynamically relevant coronary stenosis
* specific cardiomyopathia
* acute or chronic cardiac inflammation (myocarditis, pericarditis)
* former heart transplantation
* relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea
* FEV1/VC \< 70%
* hemoglobin \< 5 mmol/l
* pregnant or nursing women
* contraindication for one of the diagnostic tests
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.

The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later.

Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study:

* HR+/HER2- MBC
* First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.


Eligibility Criteria:
Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.
Study of Cytokines Serum Levels in Chronic Low Back Pain

The purpose of this study is to:

* evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease
* measured cytokines levels in chronic low back pain and in healthy subjects.

23 patients with at least three months of back pain due to herniated disk disease were selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³ 5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst imaginable pain).

The exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 23 patients

  * least three months of back pain due to herniated disk disease
  * pain severity had to be 5 points on the Numerical Rating Scale (NRS)
* 10 healthy volunteers:

  * without previous history of back pain

Exclusion Criteria:

* One or more of the following:

  * psychiatric disorders
  * systemic or inflammatory disease
  * history of allergy
  * presence of motor deficits
  * history of blood dyscrasia
  * pregnancy
  * active infection, tumor
  * use of analgesic drugs in the week before
  * inability to come to the hospital for evaluation.
Spatial Skill Training for Robot-assisted Surgery

Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. After training/watching the presentation, they repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon performance, especially regarding tissue damage was documented.

Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient training techniques are essential for enhanced performance. Optimal performance during a surgical task is key to successful surgery and minimal adverse events.

Objective: To introduce and examine a single session of spatial skill training as an efficient means of improving surgical suturing performance in robot-assisted surgery.

Design: Forty-one surgical residents will be randomly assigned to training and control conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to determine baseline performance. (2) the training group will undergo computer-based simulator training of spatial skills while the control group will engage in a neutral activity. (3) two dVSS tasks will be performed within 2 days of training completion to evaluate post-training performance. The experiment will be conducted until December 2018.

Participants: A convenience sample comprised of 41 surgical residents with non-robotic surgical suturing skills.

Eligibility Criteria:
Inclusion Criteria:

* Surgical Residents with no previous robotic surgery experience.

Exclusion Criteria:

* Non surgical residents.
Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biopsy-proven upper GI cancer, stage III-IV
* ECOG performance status 0-1
* Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging
* Able to read and speak English fluently
* Capable of providing informed consent

Exclusion Criteria:

* Regular engagement in RT (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
* Numeric pain rating scale of ≥ 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function
Ultrasonography in Juvenile Idiopathic Arthritis

The purpose of this study is to analyse the usability of ultrasonography together with biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The investigators hypothesize that serum and urine markers of cartilage and bone synthesis and degradation, together with ultrasound measurements of joint cartilage thickness, are useful tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring methods.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type.
* Informed consent from parents
* between 5-15 years of age

Exclusion Criteria:

* Other diagnoses that involves bones or cartilage
* Intraarticular steroid injections within 1 month of the trial investigation
Lateral Prostate Capsule Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA\<2.5ng/ml.
4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
5. Patients those who are able to cooperate and complete the follow-up.
6. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility Criteria:
Inclusion Criteria:

- progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history

-
IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine \[Xeloda\], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.


Eligibility Criteria:
Inclusion Criteria:

General

* Pathologically confirmed rectal adenocarcinoma
* T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum.
* ECOG performance status equal or less than 1
* Male and female patients, aged ≥ 18 years and ≤ 80 years
* Written informed consent
* Adequate haematological, liver, renal function

Resectability

* Patients categorized as having resectable locally advanced cancer
* Favorable general condition

Exclusion Criteria:

Resectability

* Diagnosis of metastatic disease
* Clear indication of involvement of pelvic wall(s), on imaging.
* Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes
* Histology other than adenocarcinoma
* Obstructed rectal carcinoma without defunctionalizing colostomy

Prior treatment

* Previously undergone treatment for this disease
* Prior chemotherapy for colorectal cancer
* Prior chemotherapy for other malignancies in past 12 months
* Prior radiotherapy other than skin cancer
* Concomitant use of St John's Wort
* Treatment with any other investigational agent
* Current use of full-dose of warfarin for therapeutic

Other conditions

* Confirmed or suspected brain metastases
* History or evidence of CNS disease
* Past or current history of other malignancies
* Clinically significant cardiovascular disease
* Evidence of bleeding diathesis or coagulopathy
* Known hypersensitivity to any of the study drugs
* Serious, non-healing wound, ulcer or bone fracture
* Major surgical procedure or significant traumatic injury within 28 days prior to treatment
* Disease or condition that contraindicates the use of an investigational drug
* Life expectancy less than 5 years
* Inability or unwillingness to comply with the protocol
* Neuropathy ≥ Gr.2
* History of ulcerative colitis or Crohn's disease
* Pelvic abscess or perforated pelvic carcinoma

Pregnancy / Contraception

* Pregnancy or lactation
* Positive serum pregnancy test within 7 days of starting study treatment
Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients

In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done .

correlate relationship between optical coherence tomography changes and visual acuity in patients with type 2 diabetes and hypertension

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with hypertension .

Exclusion Criteria:

* Patients with type 1 diabetes mellitus .
* Ocular disease ( such as high myopia , glaucoma ) .
* Patients with opacities in the media ( corneal opacities , dense cataract , vitreous hemorrhage ) .
* Systemic medication (Tamoxifen , Chloroquine , Canthaxanthine ) to avoid its effect on macular thickness .
* Central visual field defect that prevents fixation on OCT .
* Intraocular inflammation such as anterior or posterior uveitis .
* Refractive error greater than 6 diopter .