cyrilzakka/clinical-trials huggingface dataset:
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects

This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of LC350189 on the QTcF in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 to 55 years of age, inclusive, with a body mass index (BMI) 18 to 33 kg/m2, inclusive, at screening.
* The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
* The subject is able to provide written informed consent and agrees to comply with all protocol requirements.

Exclusion Criteria:

* The subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, or angina.
* The subject has a family history of long QT syndrome, Brugada syndrome, or sudden death.
* The subject has a resting HR of \<40 bpm or \>100 bpm when vital signs are measured at screening or check-in.
* The subject has history or presence of unstable cardiovascular disease, including myocardial infarction, cardiac arrhythmia, or cerebrovascular disease (eg, cerebrovascular accident/stroke or transient ischemic attack).
* The subject has a history of other acute or chronic cardiovascular disease or coronary revascularization surgery (eg, coronary artery bypass graft, percutaneous transluminal coronary angioplasty).
* The subject uses a cardiac pacemaker.
* The subject has a history of any other medical, psychological, or social condition that, in the opinion of the investigator or the medical monitor, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.
Surgical Therapy and Survival in HCC/ C.F. Zhang et al.

This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of surgery. The SEER database, which is one of the most comprehensive and authoritative databases concerning cancer, was used to estimate the survival benefit of patients who underwent local tumor destruction (LTD), wedge or segmental resection (WSR), lobectomy resection (LR), liver transplantation (LT), or non-surgery. This study discovered surgery offered a survival benefit compared with non-surgery for young patients with stage I-II HCC. Furtherly, LT is associated with superior survival than WSR, LR and LTD in those patients. Our results facilitate the selection of surgical strategies.

The SEER data contain no identifiers and are publicly available for studies of cancer-based epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from Institutional Review Board approval and the need for informed consent was waived. The submitted magazine requires registration on the website, so this operation is needed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were diagnosed with colorectal cancer only;
2. Patients with simultaneous metastasis of liver and lung cancer cells;
3. Patients without metastasis resection;
4. whether they underwent palliative primary tumor resection was known;
5. Their cause of death was known;
6. Their survival time were known and greater than 0 month;
7. Patients were diagnosed with microscopic confirmation.

Exclusion Criteria:

* No
Impact of Non-invasive Brain Stimulation on Motor Recuperation

tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.

tDCS will be used in chronic stroke patients to improve a variety of functions such as motor functions with superior or inferior limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after tDCS, as well as brain functional imaging data.

Eligibility Criteria:
Inclusion Criteria:

* stroke with at least slight deficit in superior or inferior limb

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand/complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition
* presence of pacemaker
* pregnancy
Isometric Resistance Exercise for Hypertension

Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control. However, the effectiveness of IREs in reducing HT is still unknown because their hypotensive effects have not been detected using ambulatory BP measurements (ABPM), which are the current standard for BP measurement.

Methods: This first adequately-powered RCT will involve 390 patients with HT who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. Adherence to the program will be monitored using smartwatches, and regular contact with patients through social media will help ensure adherence. All patients will be followed up for 1 year to investigate the long-term effects of IREs on BP. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be systolic daytime ABPM BP at 24 weeks. Secondary outcome measures will include other BP and ABPM parameters at 12 weeks, 24weeks and 1year, cfPWV at baseline, 24 weeks and 1year, and FMD at baseline and 24weeks. Safety data will be collected and reported.


Eligibility Criteria:
Inclusion Criteria:

* a suboptimal daytime SBP of \>135-160 mmHg on a 24-h ABPM
* reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week)
* on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments;
* agree for no drug changes during the intervention period (24 weeks);

Exclusion Criteria:

* cannot provide informed consent
* unwillingness to repeat ABPM
* relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
* severe osteoarthritis pending knee replacement surgery
* known secondary HT
* use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
* SBP or DBP are \>160 mmHg or \>100 mmHg, respectively, on ABPM at baseline or at 12 weeks follow-up to ensure safety
* pregnancy/breastfeeding
* active malignancy
Total/Subtotal Colectomy in Ovarian Cancer

The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).

This trial is to assess the perioperative complications, hospitalization expenses and days, and one year disease-free survival of patients who underwent total or subtotal colectomy as part of the surgical procedures for ovarian cancer, versus partial intestinal resection in the therapy for ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤ 75 years.
* Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
* Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
* Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* American Society of Anesthesiologists (ASA) performance 1-2.
* Follow-up available.
* Written informed consent.

Exclusion Criteria:

* Low-malignant potential ovarian tumor.
* Patient who underwent enterostomy in the surgery procedure.
* Tumor involving small intestine alone.
* More than 2 anastomoses.
* Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
* Prior invasive malignancies within the last 5 years showing activity of disease.
Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device

Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.

112 women operated by two surgeons at one center (2 years follow up) are to be compared to 207 women operated by twenty six surgeons at twenty four centers (1 year follow-up).

Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system.

Surgical data including operation data, complications and hospital stay are to be compared.

Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function to be estimated by PISQ-12.

Eligibility Criteria:
Inclusion

* Posthysterectomy prolapse of the vaginal apex, with or without cystocele, where the vaginal apex descends at least 50% of the total vaginal length
* Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends at least 50% of the total vaginal length and TVL minus point C= ≤ 2 cm
* Prolapse specific pelvic symptom of pelvic heaviness and/or vaginal bulging
* Reproductive years in the past (biologically or reproductive decision)
* Being able to make an informed consent on participation
* Physically and cognitively capable of participating in the required follow-up
* No exclusion criteria fulfilled

Exclusion Criteria:

* Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele is present or not
* Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
* If cervix elongation is present corresponding to: TVL minus point C= \>2 cm.
* If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
* Previous or current pelvic organ cancer (regardless of treatment)
* Severe rheumatic disease
* Insulin treated diabetes mellitus
* Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Dahnlos, collagenosis, polymyositis eller rheumatic myalgia)
* Current systemic steroid treatment
* Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence, cervix elongation and posterior prolapse
* Decision to perform prolapse surgery using other medical devices/mesh
Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

The objective of this randomized clinical trial is to examine the efficacy of L-glutamine for the treatment of generalized anxiety disorder compared versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with generalized anxiety disorder defined by the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* Generalized anxiety disorder is the primary psychiatric disorder.
* Untreated patients or; patients treated with paroxetine, sertraline, citalopram, escitalopram, venlafaxine or duloxetine at least for 6 weeks on a stable dose; or patients treated with any benzodiazepine at least for 4 weeks on a stable dose.
* Hamilton Anxiety Rating Scale score major or equal to 20 and a score major or equal to 2 on items 1 and 2 of the same scale at both screening and baseline.
* Clinical Global Impression-Severity major or equal to 4 at both screening and baseline.

Exclusion Criteria:

* Unable to give informed consent.
* Currently participating in another clinical research.
* Any other psychiatric disorder not included in the Anxiety Disorders section of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Secondary diagnosis of other anxiety disorders are allowed provided the diagnosis is not more prominent than generalized anxiety disorder symptoms.
* Suicide risk as assessed by the researcher at screening or baseline.
* History of substance abuse in the previous six months before the screening visit.
* Suffering a medically relevant or instable disease.
* If woman, being pregnant at screening visit.
* If woman, being breastfeeding.
* A score major or equal to 20 on the Montgomery-Asberg Depression Rating Scale at screening or baseline.
* As judged by a researcher, the patient might not adhere to the intervention or complete follow-up.
* History of use of a banned drug in the past two weeks prior the baseline visit; three weeks in the case of monoamine oxidase inhibitors; one week in the case of fluvoxamine or a tricyclic antidepressant; two weeks for any antipsychotic and; six weeks por long-acting injectable antipsychotics.
* History of use of L-glutamine the most part of the days of the previous month before the baseline visit.
* History of psychotherapy treatment in the past month before the baseline visit.
Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal
* infection at the site of intervention
* local anesthetic allergy
Classification of Periodontitis Revisited: A Cluster Analysis

This study aims to identify phenotypic groups of patients with periodontitis by applying a cluster analysis.

This is a retrospective cross-sectional study based on a prospectively maintained database of consecutive patients attending the Departement of Periodontology at the Rothschild hospital. A cluster analysis will help to distinguish clinical and microbiological profils of periodontal patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with periodontitis either aggressive or chronic

Exclusion Criteria:

* Patients who had received periodontal therapies or antimicrobial therapy within the 6 months preceding the examination
Colchicine for the Treatment of Osteoarthritis of the Knee

This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.


Eligibility Criteria:
Inclusion Criteria:

* Are 40 years old or older
* Continue to experience frequent knee symptoms as defined above
* Have KL grade 2 or 3 on their last knee radiograph done for the parent study
* Have an estimated glomerular filtration rate (eGFR) \> 30 ml/min (MDRD equation) and liver transaminases \< 2x the upper limit of normal
* Have a BMI ≤ 32 at the time of enrollment
* Agree to be randomized to take colchicine or placebo daily for 3 months

Exclusion Criteria:

* Have received hyaluronic acid or corticosteroid steroid injection within the past 3 months
* Have a diagnosis of gout/pseudogout or other inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthropathy etc).
* Have a diagnosis of diabetes mellitus, chronic infectious disease, congestive heart failure, non-cutaneous cancer within the past 5 years
* Plan on undergoing total knee replacement within the next 3 months
* Be using any medication that is a strong CYP3A4 inhibitor whose metabolism may interact with colchicine (e.g., certain protease inhibitors, certain azole antifungal agents, clarithromycin).
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. II. Determine the toxicities associated with this combination regimen in this patient population. III. Evaluate the clinical response to this combination regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of advanced solid tumor No lymphomas Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AND SGOT no greater than 2.5 times ULN AND Alkaline phosphatase no greater than ULN OR SGOT no greater than ULN AND Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No pre-existing peripheral neuropathy greater than grade 2 Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No more than 2 prior treatments for metastatic disease Biologic therapy: Not specified Chemotherapy: No prior high dose (pre transplant) chemotherapy Prior paclitaxel allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: Not specified
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department

To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).


Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years old
* in good functional capacity, as determined by the ED-attending clinician
* no known infection with HPV high risk strain types 6, 11, 16 and 18.

Exclusion Criteria:

* will not receive vaccine if participants lack mental clarity and if running a fever or in some pain.
* Patients aged \<18 or \> 45 years of age.
* Female patients with abnormal HPV results (including those with the high-risk HPV strain types 6, 11, 16, and 18) as determined by a previous PAP smear test or HPV test.
* Female patients who are known to be pregnant.
* Male patients with known cases of HPV-associated infections will also be excluded from the study
ABLATOR Brazil - Ablation Observational Study (Registry)

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

The objectives of this registry are the following:

* To confirm patient safety as part of the post market surveillance study.
* To assess performance of a combination of SJM products during procedures.
* To assess the learning curve with a combination of SJM products.
* To collect operator feedback on a combination of SJM products.

All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.

In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria:

* Pregnant women