cyrilzakka/clinical-trials huggingface dataset:
Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas

The purpose of this study is to preliminarily evaluate the safety and efficacy of cabergoline combined hydroxychloroquine/chloroquine(HCQ/CQ) therapy for cabergoline-Resistant Prolactinomas

The dopamine agonist cabergoline (CAB) has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients with prolactinoma. Chloroquine (CQ) is an old drug widely used to treat malaria. Recent studies, including our own (J Clin Endocrinol Metab, 2017; Autophagy, 2017; Oncotarget, 2015), have revealed that CAB and CQ are involved in induction of autophagy and activation of autophagic cell death. Furthermore, CQ enhanced suppression of cell proliferation by CAB. We established a low-CAB-dose condition in which CAB was able to induce autophagy but failed to suppress cell growth. Addition of CQ to low-dose CAB blocked normal autophagic cycles and induced apoptosis, evidenced by the further accumulation of p62/caspase-8/LC3-II. The data suggest that combined use of CAB and CQ may increase clinical effectiveness in treatment of intolerance and/or resistant prolactinomas.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 70 years old, either sex;
2. Karnofsky performance status ≥ 70;
3. Patients who were suffered drug-resistant,which has taken cabergoline ≥2.0mg/week no less than 3 months, referring to failure to normalize PRL levels and failure to decrease macroprolactinoma size by \>or=50%;
4. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Patients who use any dopamine receptor agonists other than cabergoline;
5. pregnant or lactating women, or women preparing pregnant;
6. Patients with poor compliance, who cannot implement the program strictly.
7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
8. Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency.
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate

The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by measuring blood levels of urea at the beginning and end of dialysis at two different dialysate flow rates.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (ESRD) three times a week for at least three months with a stable treatment prescription
* Subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
* Subject with an AV fistula or graft capable of routinely delivering a blood flow rate of 400 mL/min

Exclusion Criteria:

* Subject who is non-compliant with dialysis prescription
* Subject whose hemodialysis schedule is not three times a week
* Subject using a catheter for blood access
* Subject who is not anticoagulated with heparin during hemodialysis
* Subject with a current malignancy involving sites other than skin
* Subject with a history of drug or alcohol abuse within the last six months
* Subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
* Subject who is pregnant
* Subject who is considered incompetent to give an informed consent
* Subject with a positive test for hepatitis B surface antigen within the past 30 days (testing for hepatitis B surface antigen is not required for subjects who have tested positive for hepatitis B antibody within the past year and any such patients will not be subject to this exclusion criterion)
* Subject with known HIV infection (if this is not known, no HIV testing will be performed
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position

Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta.

The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.

Eligibility Criteria:
Inclusion Criteria:

Patient aged 18-85 years

Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft

Exclusion Criteria:

Patient treated as an emergency

Patient included in another investigation

Patient pregnant or lactating or woman of childbearing potential

Patient with a known allergy to the material device used (collagen, triclosan, silver)

Patient with previous aorto-iliac bypass or replacement
Effect of Exercise on Renal Function in Predialysis

The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;

1. Preserves renal function.
2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min)
* Male or female
* Aged \>18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy

  * Requiring support for ambulation less than 20m
  * Vasculitis,
  * Proliferative diabetic retinopathy,
  * Severe osteodystrophy,
  * Uncontrolled diabetes,
  * Psychiatric illness, including anxiety, mood and untreated eating disorders
  * Infection or course of antibiotics within the last month
Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection.

This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.

A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry.

Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups:

QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative.

After finishing the block \& assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room.

Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours.

If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at \<3 with maximum total 24-hours morphine 10 mg.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

Exclusion Criteria:

* Coagulopathy, infection at the injection site,.
* Allergy to local anesthetics.
* Severe cardiopulmonary disease (≥ASA IV),.
* Diabetic or other neuropathies.
* Patients receiving opioids for chronic analgesic therapy.
* Contraindication to spinal anesthesia.
* Inability to comprehend visual analogue scale (VAS).
Multicultural Healthy Diet in Chronic Kidney Disease

This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.

This is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. The study will recruit 20 adult participants with chronic kidney disease (CKD) from nephrology clinics in the Bronx. The diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with CKD. The investigative team will assess whether the diet is feasible, acceptable, and safe in patients with CKD through dietary intake assessments, questionnaires and serum biomarkers. Information from study will help inform the study design and intervention of a future large-scale, study aimed at improving CKD outcomes. The clinical site for the proposed study is at the Albert Einstein College of Medicine and Montefiore Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* CKD stage 3 (estimated glomerular filtration rate (GFR) \< 60 - \>30 ml/min/1.73m2)
* Residency in the Bronx
* English or Spanish speaking
* Provide written informed consent

Exclusion Criteria:

* History of hyperkalemia, or baseline serum potassium (K) \> 4.8
* CKD stage 4 or higher (eGFR \<30 ml/min/1.73 m\^2)
* Unwillingness to make dietary changes
* History of kidney transplant
* Poorly controlled diabetes (HbA1c \>9%) or insulin use
* Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities
A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)

This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. Upon successful completion of the screening period (\~2 weeks), each subject entered the 24 week study.


Eligibility Criteria:
Inclusion Criteria:

* Documented physician diagnosis of moderate to severe, persistent asthma, defined in the National Heart, Lung, and Blood Institute (NHLBI) guidelines as FEV1 \< 80% predicted for height, age, and sex or a history of FEV1 \< 80%
* Between 6 and 75 years old at the time of screening (Visit 1 \[Week -2\])
* Current treatment with the following medications: Moderate doses of any inhaled steroid preparation on a daily basis for at least 30 days prior to screening; and/or oral steroids at a stable dose on a daily basis for at least 30 days prior to screening; and currently treated with at least one of the following drugs on a daily basis at a stable dose for at least 30 days prior to screening: long-acting β-adrenergic (salmeterol), leukotriene receptor antagonist (LTRA), xanthine derivatives, or sodium cromoglycate
* Signed informed consent (in the case of a minor, consent must have been given by the child's parent or legal guardian)
* Serum IgE level of ≥ 30 IU/mL and ≤ 1300 IU/mL and a body weight ≥ 20 kg and ≤ 150 kg and fell within the protocol-defined dosing table ranges
* For females of childbearing potential, in the opinion of the investigator, use of an effective method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study
* Willingness to participate fully for the duration of the study

Exclusion Criteria:

* Current active AEE defined as requiring initiation or increase in oral steroid dose or treatment with at least a doubling of inhaled steroid dose
* Thrombocytopenia as evidenced by platelets \< 100,000/uL
* Pregnancy or lactation
* Previous randomization in this study
* Use of any experimental drug within 30 days prior to study screening
* Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
* Diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
* Active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease)
* History of smoking within 2 years of the study screening visit or history of smoking ≥ 10 pack years
* Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrinologic or gastrointestinal disease) within the previous 3 months
* History of neoplasia
* History of noncompliance to medical regimens
* Any systemic condition requiring regular administration of immunoglobulin
Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.

At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Show evidence of reversible airflow obstruction documented within the previous 12 months or prior to Randomisation.
* Meet the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria for severe asthma at Screening.
* Have documented evidence of eosinophilic airway inflammation during the 12 months prior to Screening.
* Have evidence of eosinophilic airway inflammation at Screening as reflected by an induced sputum eosinophil count of ≥3%.
* Subjects who are taking oral corticosteroids (OCS) must be receiving a 20 mg prednisolone equivalent dose, or less, daily for at least four weeks before the first dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to the Baseline visit.

Exclusion Criteria:

* Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.
* Subjects with clinically significant abnormal serum biochemistry, haematology and urine examination values
* Subjects who have been hospitalised in the last 3 months.
* History of more than 2 episodes of confirmed bacterial lower respiratory tract infection or current lower respiratory tract infection.
* Subjects are current smokers or have a smoking history of \>15 pack years.
* Significant comorbidity that in the Investigator's opinion is likely to impact the subject's participation in a 26 week study.
* Presence of a clinically important lung condition other than asthma, malignancy or previous history of cancer in remission for less than 12 months, clinically important liver or kidney disease, uncontrolled clinically significant cardiovascular disease, hypereosinophilic syndromes such as Churg-Strauss Syndrome or eosinophilic oesophagitis.
TAilored Post-Surgical Therapy in Early Stage NSCLC

Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)
* Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
* Performance status (PS) = 0 or 1
* 18 years \<= age \< 70 years
* Signed inform consent

Exclusion Criteria:

* Squamous cell carcinoma
* Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
* Inadequate renal or cardiac functions
* Pregnant women
* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis
Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.


Eligibility Criteria:
Inclusion Criteria:

* ≥14 natural teeth, excluding third molars
* ≥10 posterior teeth
* ≥35 years old
* ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm
* Bleeding on probing ≥20% of sites
* Extensive bone loss determined radiographically

Exclusion Criteria:

* Periodontal treatment before the time of examination
* Systemic illness
* Pregnancy
* Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients

the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes mellituspatients.

All patients were subjected to thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude calcular cholecystitis and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity comorbidities and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.

Eligibility Criteria:
Inclusion Criteria:Type 2 diabetic obese pateints -

Exclusion Criteria:patients age above 65 or below 18 years old, history of upper laparotomy, unfit for anesthesia or laparoscopy, major psychological instability and drug abuse.

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Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection

Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
2. American society of anesthesiologist physical status 1\~3

Exclusion Criteria:

1. Patient refusal
2. Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
3. History of gastrectomy or previous endoscopic submucosal dissection at same site
4. Allergies to propofol or its ingredients, soybeans or peanuts
5. Pregnant or breastfeeding patients
6. Patients with severe debilitating underlying medical conditions
7. Patients with altered mental status
8. Illiterate patients or foreigners