cyrilzakka/clinical-trials huggingface dataset:
Four Versus Six Cycles of Pemetrexed/Platinum for MPM

The prognosis of mesothelioma is generally poor. The median survival of patients with unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is poor because there is no curative treatment.

Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality treatment regimens have been reported to prolong survival. Other new therapeutic approaches include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and photodynamic therapy, but the results have not yet been completely validated. Even with the introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean survival of 12 months. The current standard of care for unresectable malignant pleural mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study including 448 patients from 19 countries which was the largest trial to date among patients suffering from malignant mesothelioma. Results showed statistically significant increase in overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for cisplatin alone. In addition, there was an improvement in lung function (forced vital capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.

Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in malignant mesothelioma and there are no approved predictive markers for response.

Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable toxicity and so we need to rationalize its use in our Egyptian patients.

Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for response.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma
2. No prior chemotherapy.
3. ECOG less than or equal to 2 .
4. Measurable disease according to the requirements of SWOG criteria.
5. Age ≥ 18 years .
6. Estimated life expectancy of at least 12 weeks .
7. Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Presence of central nervous system metastases.
2. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
3. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
4. Serious concomitant systemic disorder incompatible with the study.
5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
6. Pregnancy
Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma

Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of moderate to severe asthma patients.

This study is a randomized, placebo controlled trial in which subjects will receive either 3 months of L-arginine supplementation or a placebo. The investigators will monitor subjects' symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each monthly visit.

The primary objective of this 3 month clinical study is to determine if supplemental L-arginine can decrease the number of asthma exacerbations in patients with severe asthma. L-arginine, a natural amino acid, produces nitric oxide (NO) when it is converted to L-citrulline in the presence of the nitric oxide synthase enzymes. We and others have found that NO can protect against allergic airway inflammation, airway hyperresponsiveness and airway fibrosis in various animal models. In addition, we have found that arginase I expression correlates strongly with the lymphocyte and eosinophil influx into the lung and this enzyme may regulate the airway inflammatory response. Our central hypothesis is that L-arginine will increase NO levels in the lung and decrease the number of acute exacerbations of asthma. It may do this by either decreasing the number of Th2 lymphocytes or down-regulating arginase I expression or both.

Our specific aims are, therefore,

1. To test the hypothesis, in a randomized, double-blinded, placebo controlled trial, that 3 months of L-arginine supplementation will decrease the number of acute asthma exacerbations in severe asthmatic patients,
2. To determine whether L-arginine decreases the ratio of peripheral blood Th2 to Th1 lymphocytes and
3. To determine whether L-arginine will modulate serum arginase I/II levels and their downstream products.

Patients will be recruited primarily from the UC Davis Asthma Network (UCAN) clinics, which focus on the care of severe asthmatics, and the study will be performed at the UC Davis/VA General Clinical Research Center.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe persistent asthma
* Subject is stable on same asthma medications for at least one month
* If the subject is a woman of child-bearing age, a negative pregnancy test

Exclusion Criteria:

* Less than 18 yrs/ age
* Baseline Forced Expiratory Volume in 1 second (FEV1) \<40% predicted
* Known or suspected allergy to L-arginine
* Pregnant women, nursing women, or women actively trying to achieve pregnancy
* Current smokers
* Subjects with more than a 15 pack-year history of smoking
The Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity

The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).

Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD.

24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) during last one year with at least 1 or more episodes a week
* Age ≥ 18 years and \<65 years
* Helicobacter pylori (an infection) negative
* Have a body mass index (BMI) between 18 and 33 kg/m²
* pH\>4 gastric exposure \<25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
* Pathologic intraesophageal acidity exposure (DeMeester score \>14.75 and/or \>4% of pH\<4 (at least 21 hours measured)

Exclusion Criteria:

* Have food existence at stomach during upper GIS endoscopy, Barrett's stricture, GIS bleeding, malignite, and all type of GIS pathology to affects the study
* Have allergy to the study drug or any of the excipients of the formulation
* Must use of pain relieving medications (NSAIDs) during study, (paracetamol not excess of 2 gram/day can be used)
* Use of any concomitant therapy which are drug affects the motility of GIS and acid secretion
* Use of prostaglandin analogs and sucralfate
* Have taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study
* History of surgery of cholecystectomy
* Abusing drugs or alcohol
* Have a major psychiatric disease
* Use of antidepressant (patient with minor depression or under controlled with drug can be included)
* Have suppressed immune system or taken a immunosupressive treatment, including cortisone.
* Have malabsorption, gastric outlet obstruction that affects the absorption of drug
* Must use of drug ketoconazole, iron salts, digoxin, ampicilin esters , anticoagulants, antineoplastic agents
* Women who are pregnant or of childbearing
* Have gastroparesis
* Current or a history of cancer, with the exception of fully excised skin carcinoma (Malign Melanoma will be excluded).
* Have severe concomitant disease (i.e. uncontrolled or insuline dependent diabetes mellitus, symptomatic bladder stone (patients have asemptomatic, not undergone colesistit, stone \<3cm and polib \<1cm can be included), active or unhealed gastric or duodenum ulcer, Zollinger Ellison syndrome, primary esophageal motility disorder, pancreatitis, inflammatory bowel disease, chronic hepatic disease, severe lung disease, uncontrolled kidney failure, cardiac failure, cerebrovascular disease, epilepsy) which affects the conduct and result of study.
An Evaluation of Exercise Tolerance in Asthmatic Patients

To evaluate exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

- 40-50 YEARS

Exclusion Criteria:

* NO EXCERBATIONS
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs

The purpose of this study is to determine specific changes in muscle secretory profile (myokines, miRNA) in association with neurodegenerative disease progression and metabolic dysfunction. Next the investigators would like to determine the shift in the muscle secretory activity induced by regular exercise intervention, which the investigators think could be translated into the beneficial changes in clinical phenotypes, determined by neuroimaging, cognitive function tests and metabolic phenotyping.

Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in University Hospital Bratislava and in Institute of Experimental Endocrinology Slovak Academy of Sciences will be employed.

Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Diagnosed with Parkinson disease
3. Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)

Exclusion Criteria:

1. Serious systemic cardiovascular, hepatic, renal disease, cancer.
2. Lack of compliance.
Evaluation of MuLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly.

The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated.

Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.


Eligibility Criteria:
Inclusion Criteria:

* Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre;
* Written consent to participate in the research.
* Compulsory membership of a social security scheme

Exclusion Criteria:

* Patients with a non-continuous trans ileal urinary diversion ;
* Patients with enterocystoplasty;
* Untreated bacteriuria at the time of urodynamic assessment and urine sample collection;
* History of urinary tract tumour;
* History of histologically proven interstitial cystitis;
* Persons under legal protection (safeguard of justice, curatorship, guardianship);
* Persons deprived of their liberty.
* Women claiming to be pregnant
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, \>= 18 years old
* Bile duct or gallbladder cancer invading CBD or distal CHD
* Pancreatic cancer with mid or distal CBD invasion
* Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
* First attempt of endoscopic biliary metallic stenting
* Negative history of biliary tract surgery
* Life expectancy at least longer than 4 months (Karnofsky score \>60%)

Exclusion Criteria:

* Ampullary cancer
* Klatskin tumor
* Combined intrahepatic bile duct cancer
* Patient with hemobilia
* Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days
Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

During the last couple of years, a growing number of wearable devices evolved to provide accurate, cheap and non-invasive monitoring of vitals parameters.This connected care technology could be helpful for treatment and care during a pandemic such as COVID-19. The use of these non-invasive remote monitoring devices can help health care providers to assess patient's vital signs and symptom progression, reducing reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.

Several cuff-less blood pressure monitoring devices have emerged in patient care using photoplethysmography. PPG utilizes an infrared or visible light to measure peripheral volumetric variations of blood circulation and its waveform has been proven to have a good correlation with BP waveform.Nonetheless, the accuracy of these instruments is of fundamental importance.

Several validation procedures for assessing the precision of BP monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, International Organization for Standardization and European Society of Hypertension. Adherence to these guidelines are essential to ensure the effectiveness of BP measurement of the wearable devices.

Therefore, the investigators propose to test wearable low-noise, low-power SENBIOSYS photoplethysmography signals for estimation of BP.

Eligibility Criteria:
Participants fulfilling the following inclusion criteria are eligible for the study:

* Age ≥ 18 years
* Patients referred for coronarography
* Patient in the intensive care unit requiring invasive blood pressure monitoring and with an arterial catheter in place at the time of inclusion to the study

The presence of any of the following exclusion criteria will lead to exclusion of the participant:

* Unable or unwilling to provide written informed consent
* Coronarography in patients with myocardial infarction
* Patient with suspected or certified COVID-infection
* Patients with atrial fibrillation
Vitamin Therapy in Concussion Management: A Randomized Control Trial

The purpose of this study is to assess the efficacy of vitamin therapy in concussion when compared to placebo with respect to multiple endpoints including symptom severity, cognitive performance on computer based neuropsychological testing, post-concussion balance assessment, and post-concussion vestibular-oculomotor function.

To date, very little data exists on the use of vitamin supplementation to aid in the recovery of concussion. Data previously published shows potential benefit of certain vitamins in the management of migraine headache. These vitamins, Vitamin B2 (Riboflavin), Magnesium, Co-Enzyme Q-10, and Omega-3 fatty acids, at dosages described in the literature, are being used based on the migraine literature findings and anecdotal evidence to help treat complaints of headache in concussion management.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 11-22
* Concussion within 7 days of enrollment
* Presenting for treatment at Rothman Institute or Jefferson Concussion Center

Exclusion Criteria:

* Subjects with recent prior concussion within the past 30 days
* Subjects with a history of moderate to severe TBI requiring hospitalization or resulting in prolonged symptoms (\>3weeks).
* Subjects with known neurologic diagnosis associated with impaired cognitive function other that Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
* Subjects with know allergy to algae, omega-3 fatty acid, or any component of the formulation.
* Subjects currently requiring anticoagulants (ie- Warfarin), anti-platelets (ie- Aspirin, Plavix), or any non-steroidal anti-inflammatory drugs (ie- Ibuprofen, Naprosyn).
* Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 X normal).
* Subjects with a current lower extremity injury that will affect postural stability testing.
* Subjects who are pregnant and/or breast feeding.
cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation

The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.

The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.

The main research content is to screen the cfDNA methylation index that can monitor the efficacy of stage I lung cancer ablation and compare the similarities and differences of cfDNA methylation in patients with stage I lung cancer after surgery and ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-85 years old;
2. The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA;
3. patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation
4. Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent.

Exclusion Criteria:

1. The patient is generally in poor condition and cannot tolerate the examination;
2. patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures;
3. patients with poor compliance;
4. Researchers believe that it is not appropriate to participate in this trial.
Ramelteon for a Nap Prior to a Night Shift

Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses:

1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and
3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35 years;
* Non-smoking for at least 6 months;
* Healthy (no medical, psychiatric or sleep disorders);
* No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
* Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
* Body mass index of \> 18 or \< 30 kg/m∧2;
* No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
* Habitual caffeine consumption \< 300 mg per day on average;
* Habitual alcohol consumption \< 10 alcoholic units per week on average.

Exclusion Criteria:

* History of alcohol or substance abuse;
* Positive result on drugs of abuse screening;
* Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
* Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
* Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
* History of intolerance or hypersensitivity to melatonin or melatonin agonists;
* Pregnancy or lactation;
* Shift work;
* Transmeridian travel (2 or more time zones) in past 2 months;
* Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy

A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include platinum based chemotherapy)


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy
* Measurable disease (RECIST 1.1)
* ECOG 2 or less
* Life expectancy greater than 3 months
* Adequate organ function
* (Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged

Exclusion Criteria:

* Suitable for local therapy
* Did not have prior platinum chemotherapy
* Immunodeficiency; immunosuppressive treatment
* Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1
* Other cancer treatment within 2 weeks prior to Day 1
* Other malignancies (some exceptions)
* CNS metastases; carcinomatous meningitis
* Active temporal lobe necrosis or on steroid treatment
* Autoimmune disease
* Active, non-infectious pneumonitis
* Active infection requiring systemic treatment
* Hepatitis