cyrilzakka/clinical-trials huggingface dataset:
Intravital Microscopy in Human Solid Tumors

This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.

PRIMARY OBJECTIVE: To determine the feasibility and clinical utility of performing HIVM in patients with solid tumors during standard course of treatment (surgical resection).

SECONDARY OBJECTIVES:

1. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.
2. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
3. To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.

OUTLINE:

Patients receive fluorescein intravenously (IV) and undergo HIVM over 1-2 minutes per field.

After completion of study, patients are followed up at 2-3 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age.
2. ECOG Performance Status of ≤ 2.
3. Measurable tumor by direct visualization requiring surgical resection in the OR.
4. Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal organs.
5. Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent.
6. Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
2. Renal dysfunction as defined as a GFR \< 45.
3. Liver dysfunction as defined by Child-Pugh score \> 5, or LFT's 1.5x above normal range.
4. Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein.
5. Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test.
6. Unwilling or unable to follow protocol requirements.
7. Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal EKG, including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test).
8. Any condition that excludes surgery as the standard of care (e.g. high disease burden where alternative treatments like systemic chemotherapy would be preferred).
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer

This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. bladder urothelium carcinoma
2. cT2-4aN0M0
3. life expectancy≥1 year
4. ECOG PS 0-1
5. have no previously received radiotherapy or chemotherapy
6. have no major organ dysfunction
7. have been provided informed written consent

Exclusion Criteria:

1. extensive carcinoma in situ or ureter invaded
2. distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis
3. have severe major organ dysfunction
4. cannot finish treatments because of other severe diseases or life expectance≤6 months
5. exist other malignant tumors
6. have severe coagulation disorders
7. no other trails participated in 4 weeks
Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy

OBJECTIVES:

I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in immunosuppressive dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures
Time Course and Nature of Nutrient Sensing During Fasting in Humans

Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. A better understanding of this energy sensing machinery in humans is of utmost importance to give us new insights into developing new therapies for common diseases such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases, disturbances in the energy-sensing machinery possibly play a role. To determine the time course of energy sensing events in humans, the investigators will measure the concentration of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time points during starvation in humans. The investigators choose to study the molecular machinery in muscle, since muscle is very sensitive to fuel deprivation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age 19-29 years old
* Body mass index (BMI) 19-25 kg/m2
* Stable weight for the last 3 months
* Caucasian
* Fasting plasma glucose (FPG) \< 6 mmol/L
* Well-controlled blood pressure (\< 150/95 mmHg)
* Creatinine \<100 umol/l
* Hb \> 7.5 mmol/l
* Negative family history (first degree) of type 2 diabetes mellitus (DM2)

Exclusion Criteria:

* Use of medication known to affect glucose metabolism (for example prednisone) or lipid metabolism
* Significant (chronic) disease
* Smoking (current)
* Alcohol consumption of more than 14 units per week at present or in the past
* Difficult accessible veins for insertion of an intravenous catheter
* Recent blood donation (within the last 3 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Rigorous exercise/sports 5 or more days a week
Disturbances of Kynurenine Pathway of Trytophan Metabolism in Schizophrenia: A Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) Study

In this pilot study, the investigators propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, the investigators will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.

In this pilot study, we propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, we will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.

Primary hypotheses: We hypothesize that patients with schizophrenia will differ in their expression of macrophage IDO mRNA, reflecting activation of this pathway compared to normals. We further hypothesize that patients with deficit syndrome will have higher degrees of enzyme activation.

Secondary hypotheses: Serum tryptophan levels will be lower in patients with schizophrenia compared to controls, and they will correlate with measures of dysphoria. Serum kynurenine levels will be elevated in patients with schizophrenia, particularly in deficit syndrome patients. mRNA expression levels of enzymes downstream from IDO will differ between patients and controls. Measures of immune activation will be influenced by medical disease burden (medical comorbidities).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
2. Ages 18-65 years
3. Males or females
4. English speaking with ability to complete symptom ratings
5. Ability to provide informed consent
Survey on Itch in Outpatients of a University Clinic

This study is to investigate the pruriception (i.e. the perception of the character and intensity of itch), the impact of itch on quality of life, the response to itch and the subjective efficacy and preferences of the different treatment options among patients with different skin diseases. Better insights into these aspects might help to optimize itch treatment in clinical Settings.


Eligibility Criteria:
Inclusion Criteria:

* outpatients suffering from itch

Exclusion Criteria:

* outpatients (suffering from itch) not willing or able to participate
Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources.

The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed.

The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged \> 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.


Eligibility Criteria:
Inclusion Criteria:

* At risk of developing pressure ulcers (Braden score \< 17)
* Maximum 24hours admitted on the ward at the time of inclusion
* Expected lenght of stay: 8 days
* Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study

Exclusion Criteria:

- Patients with no active or supportive therapy
Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block

The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.

Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes.
* ASA grade I and II.
* Age between 50-70 years.
* Elective open radical cystectomy.

Exclusion Criteria:

* Any history or signs of cardiac, hepatic and renal failure.
* Patients with coagulopathy or under anticoagulation therapy.
* Infection near the site of needle insertion.
* Morbid obesity (BMI\>40 kg/m2).
* History of allergic reactions to any of the study medications.
* Previous abdominal surgery.
* Patients with any neurological or neuromuscular disorder or history of seizures.
Clopidogrel Resistance in Stroke Patients From Different Ethnicities

Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. The aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in Northern Israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. Quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (VASP) assay.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and to be compliant with protocol assessments.
2. Ages 18 and above inclusive
3. Both genders eligible for the study
4. Diagnosis of ischemic cerebrovascular event

Exclusion Criteria:

1. Pregnant patients will be excluded
2. Ages below 18
3. Patients not able to provide informed consent
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter.

Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).


Eligibility Criteria:
Inclusion Criteria:

* opiate dependent persons
* 21-50 years old
* interested in initiating outpatient buprenorphine treatment

Exclusion Criteria:

* current methadone maintenance treatment program participation
* medically necessary prescription opiate treatment (e.g., for chronic pain)
* current criteria for a DSM-V diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
* diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder
* current suicidality on the Modified Scale for Suicidal Ideation
* evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination•
* anticipated major painful event (significant surgical procedure) in the coming 4 months
* probation or parole requirements or an upcoming move that might interfere with protocol participation
* history of allergic reaction to buprenorphine or naloxone
* currently pregnant or planning to become pregnant in the next 4 months
* history of neurological disorder (e.g., epilepsy, stroke, brain injury)
* impaired uncorrected vision
* FMRI contraindications (e.g., claustrophobia, specific metallic implants and injuries)
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.

RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region.

Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
2. Patients must be ≥20 years of age
3. Patients must have received definitive radiation therapy for cancer in pelvic area.
4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion Criteria:

1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
3. Abnormal coagulation profile with PT/INR higher than normal
4. Thrombocytopenia with platelet counts \< 100,000/μL
5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \>12,000/μL)
7. Patients with known urinary tract infection within 6 months of randomization.
8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
9. Any previous hyperbaric oxygen therapy within 6 months of randomization
10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
11. Has history of thrombocytopenia, hemophilia or bladder cancer
12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
13. Has known history of drug allergy to pentosan polysulfate sodium
14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list.

All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.

The outcome will be assessed by the improvement in quality of life and functional capacity.

The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant.

Inclusion criteria:

Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment

Exclusion criteria:

Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation

Protocol Design:

Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).

Eligibility Criteria:
Inclusion Criteria:

* patients on waiting list for heart transplant

Exclusion Criteria:

* patients that won't accept to participate in the protocol