cyrilzakka/clinical-trials huggingface dataset:
Esophageal Squamous Cell Cancer Surveillance With Cytosponge

Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.

The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.

Eligibility Criteria:
Inclusion Criteria:

Patients with esophageal squamous cell cancer (ESCC):

* Patients ≥18 years of with adequate performance status for endoscopy
* Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
* Patients currently undergoing oncological treatment (Rth/Chth)
* Consent to provide tissue samples for the study
* Dysphagia grade ≤2 (able to swallow mixed foods and tablets)

Patients at high risk for ESCC:

* Patients ≥18 years of age with adequate performance status for endoscopy
* Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)
* Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)
* Consent to provide tissue samples for the study
* Dysphagia grade ≤2

Exclusion Criteria (for both groups of patients):

* Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
* Dysphagia grade ≥3 (able to swallow only liquid foods)
* History of myocardial infarction or other cardiovascular event within 6 months of enrolment
* Neurological diseases associated with impaired swallowing
* Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).
Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining white blood cells, which have been activated by a vaccine, with interleukin-2 may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus activated white blood cells in treating patients with cancer that has not responded to chemotherapy or radiation therapy.

OBJECTIVES: I. Determine the feasibility of expansion and the reinfusion of specific T-cell lines (peptide-specific activated lymphocytes), in combination with interleukin-2, in patients who were vaccinated with ras peptides. II. Assess immunologic status or antitumor response that may occur with this treatment in these patients.

OUTLINE: Autologous peptide-specific activated lymphocytes (PAL), previously harvested from the patient following vaccination on a different protocol, are expanded and reinfused intravenously; this is followed by a 4 hour observation period. Patients then receive interleukin-2 (IL-2) administered subcutaneously 5 days a week for 2 weeks; the first dose of IL-2 is administered at least 4 hours after PAL infusion. Patients are followed once a month for 2 months after treatment.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Patients must be enrolled to be treated with mutated ras peptides vaccine on another protocol Malignant disease for which no further chemotherapy or radiation options to increase survival are available No history of CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL SGOT or SGPT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemic heart disease (i.e., NYHA class III or IV cardiac disease) No myocardial infarction within past 6 months No history of congestive heart failure No ventricular arrhythmias or other arrhythmias requiring therapy Other: HIV negative No hepatitis B or C infection No active infection requiring antibiotics No history of autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease) No active second malignancy other than curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior steroids and recovered No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

Stage I Primary Objectives:

1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.

Stage II Primary Objectives:

1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Eligibility Criteria:
Inclusion Criteria :

* Healthy infants 2 months of age.
* Infants with at least 37 weeks of gestation at delivery.
* Signed informed consent from parent or guardian.
* Able to attend the scheduled visits and to comply with the study procedure.
* Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion Criteria :

* Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
* Known or suspected hypersensitivity to any component of the study vaccine to be administered.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Known HIV-positive mother.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay or neurologic disorders.
* Chronic medical, congenital, developmental or surgical disease.
* Participation in any other experimental vaccine trial.
* Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
* Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies

A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in relapsed/refractory Epstein-Barr Virus Associated Lymphoma (EBV+ lymphomas).

The purpose of this study is to determine whether VRx-3996 in combination with valganciclovir is safe, determine the side effect profile, and to determine whether this therapy may help patients with EBV-related lymphomas. The study has two phases. Goals of the first phase include determining a safe and tolerable dose that can be administered in phase 2. Goals of the second phase include further evaluating the safety and tolerability of VRx-3996 in combination with valganciclovir, evaluating how the drugs are metabolized in the body, evaluating response rates and other exploratory objectives that will help the researchers evaluate how these drugs work in the body. Participants will receive daily oral doses of the two study drugs and will have multiple study visits where they will have blood collected, physical examinations, and other medical monitoring. Following completion of the Ph2, the study will enroll additional patients into a Tablet Pharmacokinetic (PK) cohort to investigate the PK parameters of the tablet formulation.

Eligibility Criteria:
Key Inclusion Criteria:

* Relapsed/refractory, pathologically confirmed Epstein-Barr Virus positive (EBV+) lymphoid malignancy or lymphoproliferative disease
* Absence of available therapy with reasonable likelihood of cure or significant clinical benefit
* Adequate hematologic, hepatic and renal function as defined by laboratory assessment

Key Exclusion Criteria:

* Known primary central nervous system (CNS) lymphoma
* Known CNS metastases or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Refractory graft versus host disease (GvHD) not responding to treatment
* Known active hepatitis B virus infection
* Circulating hepatitis C virus on quantitative polymerase chain reaction (qPCR)
* Known history of human herpes virus (HHV)-6 chromosomal integration
* Known history of HIV infection
Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest

The purpose of this study is to determine whether there is potential benefits of prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated in intensive care unit with therapeutic hypothermia.

Postresuscitation management of comatose survivors of out-of-hospital cardiac arrest (OHCA) significantly improved and "bundle of care" including therapeutic hypothermia, immediate coronary angiography, percutaneous coronary intervention (PCI) and contemporary intensive care nowadays leads to survival with good neurological recovery. Benefit of prophylactic antibiotics, which may suppress development of postresuscitation infection and especially early onset pneumonia and thereby decrease the severity of postresuscitation systemic inflammatory response, is controversial. Because of these uncertainties, the investigators performed a single-center randomized clinical trial comparing prophylactic versus clinically-driven administration of antibiotics in comatose survivors of OHCA. The investigators hypothesized that prophylactic antibiotics may decrease the severity of postresuscitation systemic inflammatory response by reducing the incidence of postresuscitation infection and especially pneumonia which was further addressed by repeat microbiological sampling.

Eligibility Criteria:
Inclusion Criteria:

* Female and male over 18 years old
* Comatose survivors of out-of-hospital cardiac arrest treated in intensive care unit with therapeutic hypothermia

Exclusion Criteria:

* Suspected or confirmed pregnancy
* Allergy to amoxicillin-clavulanic acid
* Tracheobronchial aspiration
* Antibiotic therapy before cardiac arrest
* Need of antibiotics due to other causes
* Candidates for immediate veno-arterial extracorporeal membrane oxygenation (VA ECMO)
* Patients in whom no active treatment was decided on admission
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
* Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
* Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
* Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
* Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

Exclusion Criteria:

* Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
* Known medical history or presence of diabetic complications
* Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
* Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
* Have impaired renal function (estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2)
Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness

This is a prospective longitudinal study that will evaluate the unmet needs of older adults (65 and older) who return home (either directly or after short-term rehab) after an ICU hospitalization, evaluate the association of these unmet needs with clinically relevant outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed research will inform the development and evaluation of a subsequent intervention to improve functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce disability.

To identify unmet needs in multiple domains after return home from an ICU hospitalization, evaluate whether these unmet needs are associated with disability burden in the subsequent 6 months, and ascertain whether these associations are moderated by initial discharge destination (home or STR).

Eligibility Criteria:
Inclusion Criteria:

PARTICIPANTS

* Age ≥ 65 years
* Survived an ICU admission of ≥2 days

CAREGIVERS

* Age ≥ 18 years
* Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.

Exclusion Criteria:

PARTICIPANTS

* Advance directive of comfort measures only (CMO) or a transition to hospice
* Planned discharge to a location other than home or Short-Term Rehab
* Tracheostomy with ventilator dependence
* Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive stroke)
* Advanced dementia
* ICU admission for monitoring only (e.g., antibiotic desensitization)
* Primary language other than English.
* Homelessness
* Active drug or alcohol use disorder.

CAREGIVERS

* Primary language other than English
* Is a paid caregiver
* Unwilling to complete a qualitative interview
CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap

Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in surgery for microvascular decompression is reported up to 3%.

Prevention of leakage is important since meningitis may follow. Also, leakage usually means longer hospital stay and increased cost.

In case of detected leakage extra sutures may be applied, placement of a lumbar drain may be considered or a revision and improved closure may be attempted. With leakage in the subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms may also occur. In addition to being burdensome and being associated with longer hospital stays with possible revision surgery, such complications are also very costly. The best way to reduce cost and burden, and to improve patient care, is to prevent CSF leakage.

The aim of this study is to determine if prophylactic lumbar tap is beneficial for prevention of cerebrospinal fluid leakage following microvascular decompression, by comparison of surgical approaches in 3 geographical areas in the Scandinavian health system.

Hypothesis: There is no difference in cerebrospinal fluid leakage between the group subject to prophylactic spinal tap versus the group without prophylactic spinal tap.


Eligibility Criteria:
Inclusion Criteria:

* microvascular decompression surgery for neurovascular conflict (hemifacial spasm, trigeminal neuralgia)
* surgery between 1990 and 2013
* Follow-up visit registered in medical charts \> 30 days postoperatively (at either local hospital, treating neurologist or at neurosurgical clinic)

Exclusion Criteria:

-
Multicell Air Cushions: Sitting Posture and Limits of Stability

The study's aim is to assess the sitting and dynamic postural control of stability of wheelchair users who have compromised postural control and risk of ulcers while using individually adjusted multi-cell air cushions with and without individual cell-locking function and variable depths.


Eligibility Criteria:
Inclusion Criteria:

* individuals who use a wheelchair
* have used a wheelchair for no less than 2 years
* score from 3-6 on the Functional Independence Measure
* not currently inpatients or those currently accessing acute care for concomitant health-related issues
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity

Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride Varnish (Biflourid 10) affects the degree of pain in patients complaining from hypersensitivity due to non-carious lesions?

* Population: Patients complaining from Dentin Hypersensitivity due to non-carious lesions.
* Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.)
* Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany)
* Outcome measures: Dentin Hypersensitivity

Outcome name Measuring device Measuring unit Dentin Hypersensitivity

* Thermal
* Tactile
* Evaporative

Eligibility Criteria:
Inclusion Criteria:

* Males or females.
* Age: 18-70 years old.
* Patients with good oral hygiene.
* Co-operative patients who show interest to participate in the study.

Exclusion Criteria:

* Patients with bad oral hygiene.
* Patients with orthodontic appliances, or bridge work that might interfere with evaluation.
* Patients who did any periodontal surgeries within the previous 6 months.
* Patients who are allergic to any ingredients will be used in the study.
* Pregnant and lactating women.
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* histologically documented, locally advanced or recurrent or metastatic NSCLC;
* measurable disease;
* disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

* any other malignancies within the last 5 years;
* unstable systemic disease.
Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach

The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnose of a primary groin hernia that requires surgical intervention.
* Eligible for procedure performed under general anesthesia.
* Eligible for both laparoscopic and Onstep procedure.

Exclusion Criteria:

* Not able to understand Danish/Swedish, written and spoken.
* Emergency procedures.
* Previous inguinal hernia on ipsilateral side.
* ASA score more than 3.
* Irreducible inguinoscrotal hernia.
* Local or systemic infection.
* Contralateral hernia being operated at the same time or planned operated during follow-up.
* Other abdominal hernias being operated at the same time or planned operated during follow-up.
* Previous surgery that has impaired the sensation in the groin area.
* BMI \> 40 or \< 20.
* Daily intake of alcohol \>5 units, 1 unit = 12g pure alcohol.
* Known disease which impairs central or peripheral nerve function.
* Concurrent malignant disease.
* Impairment of cognitive function (e.g. dementia).
* Chronic pain that requires medication.
* Mental disorder that requires medication.
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.

To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.

Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.

Eligibility Criteria:
Inclusion Criteria:

18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.

Exclusion Criteria:

Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.