cyrilzakka/clinical-trials huggingface dataset:
Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

For the esophageal carcinoma in II\~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be confirmed Esophageal Carcinoma pathologically
2. (EUS)I～IVa, without contraindication for radical radiotherapy
3. Subjects haven't been given neither radiotherapy nor chemotherapy before
4. Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
5. In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
6. Subjects should sign for the informed consent
7. Subjects should perform good compliance
8. Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
4. Patients who multiple foci esophagus
5. Patients who are/were given any other medicine tests currently/in last 4 weeks
6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
7. Women in status of pregnancy
8. Patients who have complications exist as following:

(1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
Microvascular Reactivity.

This study attempts to test capillary responses to various challenges without the need for iontophoresis (electrical current).

Studies of microvascular responsiveness often employ iontophoresis to fascilitate drug absorption. Iontophoresis is a confounding stimulus in such studies, and we are attempting to create tests of the microvasculature that do not require iontophoretic drug delivery.

Eligibility Criteria:
Inclusion Criteria: diabetic. -

Exclusion Criteria: not on nitrates or mydriatic eye drops within 48 hours.

-
A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression

The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.

The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy males or females aged 18-65 (inclusive).
* Patients must have a primary current diagnosis of MDD without psychotic features.
* Patients must be receiving ongoing antidepressant therapy at the time of screening. Duration of the current episode of MDD must be at least 8 weeks prior to enrollment without adequate response to treatment.

Exclusion Criteria:

* Patients with other psychiatric disorders.
* Patients who use tobacco products.
* Alcohol or substance abuse or dependence.
* Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.
* Pregnancy or breastfeeding.
* Clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.
Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study

Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.

The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can.

Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study.

Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes.

Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure.

Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes

Eligibility Criteria:
Recipient Inclusion Criteria:

1. Adult patients \> or = 18 years of age
2. Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK)
3. Current HCV NAT- status
4. Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers

Recipient Exclusion Criteria:

1. Unwilling to consent to post transplant DAA therapy
2. Hepatitis B Virus (HBV) viremia

Donor Inclusion Criteria:

1. HCV NAT+
2. Deceased Donor organs
3. HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis

Donor Exclusion Criteria:

1. Bilirubin \>3
2. Positive nucleotide testing for HBV
3. Radiographic, laboratory or other clinical evidence of portal hypertension
4. Fibrosis on pre-procurement liver biopsy fibrosis \> F1 or fibroscan \>7 (if both are done and discordant, use biopsy to determine eligibility
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines
* Disease duration of 3 years or less
* Age 18 years or above
* Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician

Exclusion Criteria:

* Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection
* Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment
* immunoglobulin A deficiency
* Other contraindications against immunoadsorption or intravenous immunoglobulins
Effect of Periodontal Treatment on the Biomechanical Properties of the Periodontium.

Investigation of the biomechanical properties of the periodontal tissues in patients with periodontal disease. Non-surgical periodontal therapy will be assessed between baseline and 30 post-op by general clinical measurements (KT, PPD, CAL, BOP) as well as by biomechanical analysis and compared.

The study is designed as a prospective single center comparative clinical trial to investigate the biomechanical properties of the periodontal tissues in 30 patients with periodontal disease.

Success of non-surgical periodontal therapy between baseline and 30 post-op will be assessed by general clinical measurements (KT, PD, CAL, BOP) as well as by biomechanical analysis. Besides assessment for regular treatment effectiveness, safety parameter such as wound healing and adverse events will be assessed.

Additionally 10 periodontally healthy persons without local inflammation and bone loss shall be monitored and used a control group for reference to the test teeth.

Eligibility Criteria:
Inclusion Criteria:

* Moderate/advanced/severe periodontitis
* Intact anterior dentition upper yaw.
* Expected performance of adequate oral hygiene
* Subjects must have voluntarily signed the informed consent form before any study related procedures
* Males and females with at least 18 years of age
* Subjects must be committed to the study and the required follow-up visits
* Subject must be judged in good general health as assessed by the investigator at time of non-surgical therapy

Exclusion Criteria:

* Any contraindications for subgingival instrumentation
* Uncontrolled diabetes or other uncontrolled systemic diseases
* Disorders or treatments that compromise wound healing
* Medical conditions requiring chronic high dose steroid therapy
* Bone metabolic diseases
* Radiation or other immuno-oppressive therapy
* Chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to treatment
* Presence of oral lesions (such as ulceration, malignancy)
* Mucosal diseases (e.g., lichen planus, mouth ulcer)
* History of malignant disease in the oral cavity or previous radiotherapy to the head or neck
* Treatment with an investigational drug or device within the 30 day period immediately prior to therapy on study day 0
* Female subjects who are nursing, pregnant, or plan to become pregnant
* Antibiotic treatment
PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

The aim of this randomized controlled trial is to evaluate the combined effects of pain neuroscience education plus exercise to exercise alone in the management of patients with chronic rotator cuff tendinopathy regarding pain, function, strength, kinesiophobia, and pain catastrophizing.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain due to rotator cuff tendinopathy lasting more than 6 months.
* Internal Rotation Resisted Strength Test positive.
* Test Item Cluster (Hawkins-Kennedy, painful arc, and infraspinatus test) positive.

Exclusion Criteria:

* History of: tumors, metastasis, osteoporosis, shoulder fractures, shoulder luxation and/or instability, previous shoulder surgery, cervical radiculopathy, full-thickness rotator cuff tears, glenohumeral joint degeneration, inflammatory arthropathy, acromioclavicular joint arthrosis, and rotator cuff calcifications.
* Being treated by other physical therapy or medical treatment for their shoulder pain at the time of recruitment.
Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening

Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal occult blood testing (FOBT) has an established positive balance of benefit and risk, is the least expensive, and is the preferred method for nearly half of patients. A newer fecal screening test, the fecal immunochemical test (FIT), offers significant improvements over the FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly sensitive and specific and it is the only FIT test approved in the US that can be processed in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer from several limitations: they were conducted in populations not optimal for assessing screening performance in average risk patients in the U.S. and the studies did not clearly establish optimal number of samples required and cut-points for test positivity. Therefore, the overall goal of MY-FIT is to capitalize on the highly integrated and extensive electronic medical record system of the study site to collect two separate sets of data that, when synthesized, will provide a thorough picture of the comparative patient adherence to, sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT. Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:

1. Compare the sensitivity, specificity, positive predictive value, and negative predictive value for colorectal cancer and advanced adenoma (advanced neoplasia) between a single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut points for a positive test (n=2100).
2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).
3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points for a positive test) (n=78,000).

Answering the above questions will provide a much-needed strong evidence base for a best-practice, cost-effective method of using the OC-Micro FIT to screen for CRC in a general U.S. population.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for standard KPNW automated telephonic colorectal cancer screening reminder and have indicated on the call that they wish to screen with FIT.

Exclusion Criteria:

* Kaiser Permanente members less than 1 year.
* Currently on the Kaiser Permanente Center for Health Research Do Not Call list.
Virtual Reality in Orthopedic Rehabilitation

The study's objective is to evaluate the efficacy of implemented Virtual Reality therapy for patients who have undergone lower limb arthroplasty and are in inpatient rehabilitation. The study aim to examine its influence on reducing anxiety levels, mitigating depressive symptoms, enhancing motivation for elderly patients to participate in physiotherapy, and improving their overall functional state and fall risk.

The study will include elderly patients (60+) who present sequentially at the General Systemic Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica, within 3 months of having undergone hip or knee joint arthroplasty surgery. Patients will be randomly assigned to one of two groups: A. Virtual Reality Group: 8 therapy sessions, two sessions per week; B. Control group, undergoing conventional rehabilitation. Participation in the study is entirely voluntary, and written consent is required.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.

Exclusion Criteria:

* cognitive impairments that prevent independent completion of research questionnaires
* reported consciousness disorders
* bipolar affective disorder and other serious mental disorders in the patient's medical history
* use of psychoactive drugs
* ongoing psychiatric treatment or individual psychological therapy
* contraindications to Virtual Reality such as epilepsy, vertigo, serious vision disorders
* functional status preventing independent movement (orthopedic aids are allowed, e.g., crutches, walker)
* refusal to participate in the study at any stage
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.

Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. After written consent and an extended anamnesis of existing coagulopathy, we take three blood samples in these patients: before surgery, on the day after surgery and 4 weeks after surgery. We determine von Willebrand factor in lab and by a point-of-care platelet function analyzer (Multiplate TM). We measure amount of mediastinal drainage after 24 hours and blood product consumption in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis (Orifice area \< 1 cm2)

Exclusion Criteria:

* missing consent
* severe hepatic or renal disfunction
Assessment of Pubertal Growth Spurt in Growing Girls Using Middle Phalynx Finger and Correlate With Mandibular Second Molar

Assessment of Pubertal Growth Spurt in Growing Egyptian Females Using Modified Middle Phalanx of The Middle Finger Stages and Its Correlation With Development Stage of Mandibular Second Molar

The sample will be selected randomly from different schools in the government.

* Digital periapical radiograph for the middle finger for each participants will be taken using Digital x-ray portable machine.
* Radiographical images will be stored in a digital sensor to be transferred to computer then we asses growth spurt in girls and correlate it with devlopemt stage of mandibular second molar

Eligibility Criteria:
Inclusion Criteria:

* Egyptian citizen

Exclusion Criteria:

* Systemic disease and syndromes
* Severe crowding
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent (deferred consent when possible according to national legislation)
* AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
* DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
* Either

  * Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
  * MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).

Exclusion Criteria:

* Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
* Intended reversal by specific or unspecific reversal agents
* Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria

  * Age \> 55 years OR
  * Age \< 55 years and at least 12 months since last menstrual period OR
  * Have had a documented surgical sterilization
* Patient \< 18 years of age (since the benefit of IVT is unproven in this population)

Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:

* Intended treatment with endovascular reperfusion strategies
NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation

The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.


Eligibility Criteria:
Inclusion Criteria:

* Derivatives from the outpatient clinic of the center itself, as well as patients referred from other centers that have ours as a reference for a first AF ablation procedure.
* Have signed the informed consent.

Exclusion Criteria:

* Patients with cognitive impairment or disorientation.
* Patients with problems of comprehension or expression of Spanish or Catalan.
* Patients who are part of the medical or nursing group.
* Patient with defined heart failure with a left ventricular ejection fraction (LVEF) less than 40% and a NYHA III or IV.