cyrilzakka/clinical-trials huggingface dataset:
Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma

PART 1:

1. To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.
2. To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.

PART 2:

To evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF；
* Age ≥18 at ICF signing, regardless of gender；
* Histologically confirmed relapsed or refractory lymphoma.

Exclusion Criteria:

* Lymphoma with known CNS involvement；
* Severe cardiovascular/cerebrovascular diseases.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Clip Ascent and Sleeve Gastrectomy

This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with chronic gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. Those symptoms appeared at least 6 months after the surgery. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss.

There is a strong association between gastric reflux and obesity. A severe reflux is a contraindication for a sleeve gastrectomy for some surgeons. However the impact of sleeve gastrectomy on reflux is not clear. A de novo reflux is described for 2 to 18% of patients and many patients have unclear epigastric symptoms. One of the cause could be clip ascent which could justify a second surgery. This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection, confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss. A medical information note is given to every patient at the first consultation.

Eligibility Criteria:
Inclusion Criteria:

* sleeve gastrectomy operated for at least 1 year

Exclusion Criteria:

* acute abdominal pain,
* epigastric pain occuring after the surgery (no 6 months delay),
* pregnant women
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application.

Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).


Eligibility Criteria:
Inclusion Criteria:

* patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist

Exclusion Criteria:

* No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients

In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.


Eligibility Criteria:
Inclusion Criteria:Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.

* Subjects who have required IV iron at any time in the 2 months preceding enrollment.

Exclusion Criteria:

* Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"
* Subjects with a current malignancy involving sites other than skin.
* Subjects with a history of drug or alcohol abuse within the last 6 months
Restrictive Versus Liberal Red Cell Transfusion Strategy in Orthopedic-Oncology Patients Undergoing Surgery - a Randomized Controlled Study

The rationale for perioperative red blood cell (RBC) transfusion is based on the observation that anemia is an independent risk factor for morbidity and mortality after cardiac operations. However, transfusions have been associated with high rates of morbidity and mortality in critically ill patients, and some recent studies have shown worse outcomes, including increased occurrence of renal failure and infection, as well as respiratory, cardiac, and neurological complications, in transfused compared with non transfused patients after cardiac surgery. On the basis of past clinical observations, some authors have suggested that hematocrit should be maintained at around 30% and hemoglobin concentration at 10 g/dL. Recently, however, this hemoglobin threshold has been reconsidered because of recognized risks associated with transfusion and greater appreciation of the importance of individual physiological responses to anemia. In a comparative trial of 428 patients undergoing elective coronary artery bypass graft(CABG) surgery, Bracey et al reported that reducing the hemoglobin trigger to 8 g/dL did not adversely affect patient outcomes and resulted in lower costs. An important multicenter Canadian Study by Hebert et al that included a large number of critically ill patients revealed that A restrictive strategy of red-cell transfusion (hemoglobin concentration maintained between 7.0and 9.0g/dL) is at least as effective as and possibly superior to a liberal transfusion (hemoglobin concentration between 10 and 12 g/dL) strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction and unstable angina, in terms of reducing organ dysfunction and mortality.

The investigators would like to determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produce equivalent results in orthopedic-oncology patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive ASA I-III patients, with preoperative hemoglobin 12 gr% or less scheduled for major orthopedic-oncology surgery (one that is expected to carry moderate to severe blood loss) at Tel Aviv Sourasky Medical Center will be included in the study.

Exclusion Criteria:

* Patients will be excluded for any of the following reasons:
* an age of less than 18 years;
* inability to receive blood products;
* pregnancy;
* emergency procedures;
* hepatic dysfunction (total bilirubin value higher than 1.5 mg/d);
* end-stage renal disease (receiving chronic dialysis therapy);
* acute coronary syndrome, active heart or lung disease and refusal to consent.
Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury

The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.

Transcutaneous spinal stimulation (TSS) is a noninvasive electrical stimulation that is applied over the skin of the low back and stomach. In prior research studies, TSS has reduced spasticity without the negative side effects of drug therapies. Although research in TSS is growing, the best dosage of TSS remains unknown. The investigators want to further advance the effects of TSS by comparing three different frequencies. Frequency is the number of electrical pulses that are delivered over a period of time. Frequency can affect the activation of nerves and therefore affect the outcome of TSS. Participation in this study includes testing of the participants' spasticity, strength, and pain before and after 30 minutes of TSS.

Eligibility Criteria:
Inclusion Criteria:

* Participants must agree to allow use of health information.
* Participants should be 16 years old or older.
* Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.
* Participants should have at least a small amount of spasticity in the legs.
* Participants must inform the investigators if there is a change in medications during the study.
* Participants must be able to follow instructions.
* Participants must be able to communicate if pain or discomfort is experienced.

Exclusion Criteria:

* People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
* People neurological problems other than SCI.
* People with an injury level is below T12.
* People with heart issues, such as atrial fibrillation.
* People with bone or joint problems that would make it hard to follow the study plan.
* Women who are pregnant.
* People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
* People with infection.
* People with skin that is broken.
* People who have or had certain types of cancer.
* People who have had long-lasting spasticity treatment (like botox or selective dorsal rhizotomy).
Role of Hyaluronic Acid in the Prevention of Post-operative Adhesions: a RCT

The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.


Eligibility Criteria:
Inclusion Criteria:

- All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation

Exclusion Criteria:

Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed

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Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly

In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

- aged 40-90 years old

Exclusion Criteria:

- previous diagnosis of dementia (including Alzheimer's disease, Lewy body dementia, Parkinson's disease, or other dementias) were excluded.
Correlation Between Popliteal Vein Compliance and Venous Clinical Severity Score

When the liquid flow increases, the luminal caliber's stretching amplitude decreases, leading to a higher hydraulic pressure according to Poiseuille's law. In this study, investigators measured the caliber change of the popliteal vein under a rated pressure gradient and evaluated the relationship between popliteal vein compliance and venous clinical severity score (VCSS).


Eligibility Criteria:
Inclusion Criteria:

* C1 to C6 disease using the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification.

Exclusion Criteria:

* acute or chronic thrombosis of deep veins, previously received intravenous surgery or injection sclerotherapy, ankle brachial index\<0.90, and concomitant cardiovascular, pulmonary, renal, or metabolic diseases.
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Participant whose age ≥ 22 and ≤75 years
* Participant has single target aneurysm located in the internal carotid artery
* Participant sign and date an IRB/EC approved informed consent prior initiation of any study procedures

Exclusion Criteria:

* Participant who suffers from an intracranial hemorrhage in the last 30 days
* Participant who suffers from a subarachnoid hemorrhage in the last 60 days
* Participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region
* Participant who is pregnant or breastfeeding
* Participant has an arteriovenous malformation (AVM) in the area of the target aneurysm
Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Patients with advanced primary liver cancer will be enrolled in the trial , then the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment in the treatment of advanced primary liver cancer

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old，No limit on gender
* Patients who are confirmed Locally advanced or metastatic primary liver cancerin accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination, Patients who are unable to accept surgery,radiofrequency ablation、TACE and local therapy ，orLocal treatment progress failed
* have systematic treatment before( including systematic chemotherapy and/or molecular targeted therapy) , but the treatment was unsuccessed and the tumor progress
* According to RECIST V1.1，1at least has one measurable lesions
* ECOG Score ≤2
* Patients who have primary liver cancer with Child - Pugh liver function grade rating A or better B(score\<=7)
* Laboratory inspection basically meets the following requirements： Blood test：a. Hb\>=90g/L(without blood transfusion within 14 days), b. ANC\>=1.5×10\^9/L, c. PLT\>=60×10\^9/L. Biochemical test：a. ALB\>=29g/L(without blood transfusion within 14 days), b. ALT and AST \<=5ULN, c. TBIL\<=2ULN, d. Cr\<=1.5ULN. Blood Coagulation function:PT\<=ULN+6seconds.
* Life expectancy of at least 3 months
* Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria:

* Patients have other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer
* In the past or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted
* Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature\>=39℃ ， Pleural effusion（medium and large） combined with infection
* Women who is pregnant or during breast feeding and not willing to contraception during the test
* Coagulation dysfunction(PT\>16 seconds ， APTT\>43 seconds , TT\>21 seconds , Fib\<2g/L) , With bleeding tendency or the presence of vital organ thrombosis (lung, brain) is receiving thrombolytic or anticoagulant therapy
* With a mental illness, or has a history of drugs abuse
* Patients accepted any experimental drugs in the past 4 weeks
* Other reasons the researchers think not suitable
Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients

The studies that correlate periodontal disease (PD) and diabetes mellitus (DM) suggest that individuals with poor glycemic control are at increased risk for developing infections. Despite being controlled for other important risk factors, diabetic patients are three times more likely to develop PD, and therefore, periodontitis has been proposed as the sixth complication of DM.

Besides the effect of diabetes on DP, the reverse has also been studied over the past 15 years, through the idea that chronic and acute infections can directly affect the tissue resistance to insulin. Recent studies have provided evidence that controlling periodontal infection has an impact on improvement of glycemic control in diabetes mellitus patients. The vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory mediators, pathogenic bacteria and their products into the bloodstream. Some researchers have suggested that periodontal treatment in type 2 diabetes mellitus (DMT2) patients, results in beneficial effect on the level of glycemic control. However, there is no conclusive evidence to support this hypothesis.

This research project aims to determinate the impact of periodontal therapy on metabolic control in DMT2 individuals, and determinate the possible association between periodontal disease and DMT2. For the HbA1c outcome this clinical trial had a sample size calculation estimated at 120 patients. For the inflammatory serum markers this study had a sample size estimated at 22 individuals. Blood samples will be collected for evaluation of Hba1c and inflammatory serum markers. This data will highlight the possible role of periodontal therapy on DMT2 metabolic control.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged over 30 years old
* Subject diagnosed with T2DM
* Subject consenting to the study
* Subject with signs of severe periodontitis (at least 50 periodontal pockets, PPD \> 4mm and Bleeding on Probing)

Exclusion Criteria:

* Pregnancy - Lactation
* Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit
* Subject with known HIV or Hepatitis (B, C)
* Subjects with uncontrolled systemic diseases (cardiovascular diseases including hypertension, liver, pulmonary diseases, end stage renal failure) and/or neoplasm
* Subjects not capable to provide informed consent
* Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures
Allopurinol Outcome Study

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
* Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
* If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
* Must have had at least 2 gout flares in the past year.

Exclusion Criteria:

* Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz \[360 mL\] of beer, or 1.5 oz \[45 mL\] of hard liquor).
* History or suspicion of drug abuse.
* History of autoimmune disease requiring systemic treatment.
* Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
* History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
* Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
* Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
* Estimated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula.
* Kidney or other organ transplant.
* Active peptic ulcer disease requiring treatment.
* History of xanthinuria, active liver disease, or hepatic dysfunction.
* If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
* Known hypersensitivity or allergy to allopurinol.
Metabolic Effects of Cocaine

The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence


Eligibility Criteria:
Inclusion Criteria:

* Individuals with DSM IV diagnosis of cocaine dependence, medically healthy

Exclusion Criteria:

* Other than cocaine dependence DSM-IV axis I diagnosis