cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, 18 years of age or older.
2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
4. Willing and able to complete all procedures and evaluations related to the study.
5. Willing to provide informed consent.

Exclusion Criteria:

1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
4. Pregnant or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study or another clinical research study in the past 30 days.
Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.

This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.

Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2\*2 crossover and cluster randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Exercise With Dual Task in Knee Osteoarthritis

The purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task.


Eligibility Criteria:
Inclusion Criteria:

* men and women above 55 years old.
* diagnosed with severe knee osteoarthritis.
* scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion Criteria:

* pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
* another hip or knee joint replacement in the previous year.
* any medical condition in which exercise was contraindicated.
* participated in exercise programs (\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors

The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use.


Eligibility Criteria:
Inclusion Criteria:

* Donors must satisfy standards including those set forth by FACT (Foundation for the Accreditation of Cellular Therapy) and the criteria specified in FDA 21 Code of Federal Regulations (CFR) 1271. Specifically, screening for risk factors for communicable disease as well as infectious disease screening by serologic and PCR testing as outlined below. Including testing for IV, Hepatitis B, Hepatitis C, HTLV I and II, CMV, EBV, and toxoplasmosis, westnile virus, syphilis, varicella zoster, and Chagas disease.
* Donors must be typed for HLA-A, B, C, DR and DQ at high resolution.
* Donors accrued at MSKCC must have a hemoglobin value \> 10g/dl
* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
* Donors must weight \>/= 25 kg

Exclusion Criteria:

* HTLV/HIV (+) or Hepatitis B or C positive donors
* Donors who are pregnant
Influence of Single Session of Aerobic Exercise on Acute Pain and Function in Patients After Total Knee Replacement

The purpose of this study is to examine the immediate effect of aerobic exercise effort on clinical and experimental pain, knee active range of motion and function in people after total knee replacement.

Total knee replacement is a prevalent orthopedic elective surgery in the Western world. After surgery, especially in the first two weeks, patients suffer from high degrees of pain that may lead to delayed recovery, increased risk to chronic pain and pain comorbidities, and may harm the knee function. In purpose to alleviate the pain, most patients tend to passive coping strategies which include the use of high levels of analgesics, including steroids, which may have accompanying side effects.

Aerobic activity is found to have a beneficial effect on pain threshold and pain tolerance in healthy subjects and in chronic pain syndromes. Researches indicate that single bout of aerobic effort increase pain threshold and pain tolerance and decrease pain severity for 15-30 minutes. Until now, the effect of a one-time aerobic effort has not been tested on subjects suffering from acute pain following surgical intervention.

This trail will examine the immediate effect of single aerobic effort on clinical and experimental pain, active knee range of motion and function among people with acute pain after total knee replacement.

40 subjects undergoing total knee replacement at the medical Center for Galilee as a result of Osteoarthritis in one of they knee, will be recruited to the study. The study will take place during the hospitalization in the 5th and 6th days after surgery. In those 2 days the subjects will participate in two meetings: in one session, the participants will be asked to perform active pedaling for 20 minutes in their upper limbs of a pulse that will be calculated approximately 60% of their maximum predictive pulse. in the second meeting the participants will perform passive training with their upper limbs for the same duration. The order of interventions will be randomly determined. Before and after the intervention, it will be examined by pain measures (pressure pain threshold, spontaneous pain perception and arousal pain by the Visual Analogue Scale (VAS) scale), at rest, in a sitting-standing-sitting transfers, while carrying an equal weight on both feet and while walking. the active range of motion of the operated knee, and functional measures - 10 Meters walk Test and Timed Up and Go test.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for unilateral total knee replacement surgery in the Department of Orthopedics 'A", at f the Galilee Medical Center.
* 18 years and older.
* Diagnosed with osteoarthritis.
* Consent to participate in the trial.
* Understand simple instructions.
* Capable of walking with walking aid independently or supervised.
* Allowed to perform medium-intensity aerobic exercise to-60% of their predicted maximum pulse.

Exclusion Criteria:

\* Individuals who have a physical limitation preventing them from performing active pedaling in upper limbs for 20 minutes.
Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation.

Postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain. Although intensities of them can be various, all of them affects the total pain together. Unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its effect on postoperative pain is not studied with detail in literature.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Presumptive diagnosis of benign gallbladder disease

Exclusion Criteria:

* The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease
High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia

Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. The aim of this study is to detect the presence and patterns of specific electrograms representing slow pathway (SP) potentials and to explore Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an attempt to clarify a fast and safety catheter ablation strategy. We hypothesized that, in patients with dual atrioventricular nodal physiology, during sinus rhythm (SR), high-density mapping (HDM) catheters could identify the SP signals, making possible to delineate small areas of slow conduction associated to abnormal electrograms on Koch's triangle. On a second step, radiofrequency (RF) applications safety guided by the HDM obtained with this method, should interrupt the circuit far from the His region. Finally, SP signals should disappear after the RF procedure when performing a new 3D HDM. A control group of patients without AVN dual physiology should show absence of fragmented/slow conduction zones.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 yo with AVNRT observed after electrophysiological study

Exclusion Criteria:

* Patients \< 18 yo
The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study

Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* ages \> 19 years and \< 85 years
* the patients undergoing a general anesthesia for robot assisted prostatectomy

Exclusion Criteria:

* incomplete record
* history of opioid or steroid using
* solitary kidney
* history of kidney transplantation
Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.

The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.

The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:

  1. LCNEC
  2. combined type LCNEC
* Patients with LCNEC, combined LCNEC without prior treatment independently from the clinical stage according to the 8th edition of TNM 2017
* Patients with generalized, unresectable of LCNEC, combined LCNEC before, during and after palliative treatment
* Patients with generalized, unresectable LCNEC, combined LCNEC treated only symptomatically
* Patients with locally advanced, unresectable LCNEC,combined LCNEC before, during and after radical treatment
* Patients with locally advanced, resectable LCNEC, combined LCNEC before, during and after treatment

Exclusion Criteria:

* NA
Merkel Positron Emission Tomography (PET) Protocol

A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.


Eligibility Criteria:
Inclusion Criteria for Trial Registration:

Patients may be registered on the trial only if they meet all of the following criteria:

* Age 18 years or older
* Written informed consent to participate in the study
* Able to undergo 18-FDG PET scan (no uncontrolled diabetes mellitus or severe claustrophobia).
* Available for follow-up.
* Using adequate contraception if capable of child bearing
* Any Merkel Cell carcinoma confined to the primary and/or nodal sites
* ECOG 0-2.
* Full Blood Count (FBC) should be satisfactory ( Haemoglobin \> or equal to 10g/dl, neutrophils \> or equal to 2.0 x 109 /l and platelets \> or equal to 100 x 109 /l) and renal function (GFR \> or equal to 50 ml/min) and hepatic function ( ALT \< 5 X upper limit normal, bilirubin \< 1.5 X upper limit normal)
* Patients must be able to tolerate protocol treatment

Exclusion Criteria for Registration:

* Previous chemotherapy in the past 5 years or prior radiotherapy to the area of concern
* Unable to comply with treatment protocol eg dementia
* Other malignancy in the past 5 years other than non-melanoma skin cancer.
* Women who are pregnant or lactating.
* Clinical evidence of metastatic disease.
* Immunosuppression from long term steroid use or immunosuppressive drugs.
* Any serious illness or medical condition that precludes the safe administration of the chemotherapy including:

  1. Active infection
  2. Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias

Inclusion Criteria for Treatment Registration:

Patients may proceed to protocol treatment if they meet the following criteria:

* High risk disease with no evidence of distant spread: Biopsy proven MCC with a primary that is \> 2cm (T2N0M0= Stage II) and/or regional nodes (any T, N1M0= Stage III); OR Recurrent MCC not previously treated with radiation treatment; Dermal or in-transit metastasis with or without nodes; Occult primary with involved nodes
* Patients who have no metastases on CT or PET scan OR If CT is suggestive of metastases, they must be PET negative
Stroke Team Remote Evaluation Using a Digital Observation Camera

The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.

The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) system is a digital video camera system that can transfer video and audio images from the clinic or emergency room to a distant (remote) place where a stroke specialist can review the images in real time (as they happen). This system uses site independent software to access the camera system from multiple locations. The study will determine if video consultation is superior to telephone consultation for remote evaluation or treatment of stroke patients, and the usefulness of this system in evaluating patients with suspected stroke symptoms. However, this method is being used in other fields of medicine for assistance in medical evaluations.

Participants will be randomly assigned to receive evaluation by either the video camera system or by telephone alone. For those assigned to the video camera system, the system will be activated and will record and transmit video and audio images to a stroke specialist located at a remote location. He/she may ask the participants questions relating to medical illnesses and current symptoms, and may also review laboratory tests and x-ray images using a computer, if available. The stroke specialist will also perform general physical and neurological examinations, which will take place by video camera with the assistance of a bedside physician who will perform the actual examinations.

For those participants assigned to the telephone-only consultation, the video system will not be activated, but the same procedure as above will be followed except the stroke specialist will not be able to see the participants or examine them using the video camera system. Participation in the study will last for the entire time the participants are in the hospital. Participants will be contacted by telephone by a study nurse 3 months post-stroke for a 10-minute interview regarding their current health. The total duration for individual participation is 3 months.

The study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Symptoms consistent with acute stroke (ischemic or hemorrhagic)
* Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

Exclusion Criteria:

* Unlikely to complete study through 90-day follow-up
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.


Eligibility Criteria:
Inclusion criteria:

Inclusion Criteria:

* Female patients age 18 years or older
* Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
* HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
* At least one measurable tumour lesion (RECIST);
* Availability of tumour samples
* Written informed consent that is consistent with ICH-GCP guidelines and local law
* Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.

Exclusion criteria:

Exclusion Criteria:

* Active infectious disease
* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
* Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
* Active/symptomatic brain metastases
* Cardiac left ventricular function with resting ejection fraction \< 50% (below upper limit of normal)
* ANC less than 1500/mm3 platelet count less than 100 000/mm3
* Bilirubin greater than 1.5 mg /dl (\>26 and#61549 mol /L, SI unit equivalent)
* AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
* Serum creatinine greater than 1.5 mg/dl (\>132 and#61549 mol/L, SI unit equivalent)
* Patients who are sexually active and unwilling to use a medically acceptable method of contraception
* Pregnancy or breast-feeding
* Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
* Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
* Active alcohol or drug abuse
* Other malignancy within the past 5 years