cyrilzakka/clinical-trials huggingface dataset:
An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (BTC) remain to have proven value, highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases. The immunomodulatory effect of lenvatinib (Lenvatinib is an oral multi-kinase inhibitor) on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade. This one-arm, phase I/II study is designed to assess the safety and efficacy of the combined regimen of Durvalumab (anti-PD-L1 antibody), Lenvatinib and Paclitaxel albumin (nab-paclitaxel).


Eligibility Criteria:
Inclusion Criteria:

1.Subjects must have histologically proven unresectable pancreatic cancer or biliary tract cancer 2.18 to 75 years old. 3.Life expectancy of at least 6 months. 4.Eastern Cooperative Oncology Group performance status 0-2. 5.Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.

6.Subjects with Anti-PD-1/L1 antibody treatment history are eligible which must be disease progression.

7.Adequate organ function. 8.Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Prior organ allograft.
4. Women who are pregnant or breastfeeding.
5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon

Chronic obstructive pulmonary disease (COPD) has a significant impact on quality of life and is costly to the health care system. It has been demonstrated that a self-management program improves quality of life, but programs are not universally available and telehealth interventions can provide home-based support, but have mixed results.

The aims of this study are to (1) assess the feasibility and acceptability of a 6 weeks' educational program related to self-management with remote monitoring for Lebanese COPD patients; (2) pre-test its impact on quality of life, emergency visits, and rate of rehospitalization, and (3) to make recommendations for a future randomized trial.

This study aims to evaluate the feasibility, acceptability and pre-test the impact of a nursing consultation and tele-monitoring in Lebanon. It will be conducted at the Hôtel-Dieu de France (HDF) hospital, one of the largest university hospitals in Beirut, and will use quantitative and qualitative methods in pre- and post-intervention to collect data over a period of 3 months. Data will be collected by two researchers. A consent form will be signed by each participant prior to the intervention. Patients will be informed about the purpose of the study, the course of the intervention, and the freedom to withdraw from the study at any time. Their consent for the video recording will also be taken.

This study is the first to evaluate the application of telehealth to optimize COPD management in Lebanon. The results of this study will provide evidence regarding the efficacy and feasibility of this approach for Lebanese patients with moderate to severe COPD.

Eligibility Criteria:
Inclusion Criteria:

* Adult,18 years of age or older
* Male or female
* Outpatient
* With moderate (GOLD 2) or severe (Gold 3) COPD.
* Cognitively capable, with an adequate health status to participate in the study according to the clinical consensus between nurses and physicians.

Exclusion Criteria:

* Patients diagnosed with lung cancer
* Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange
Subconjunctival Bevacizumab Effect on Bleb Vascularity

Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.

A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.

trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.

a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.

during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* post uneventful trabeculectomy with mitomycin c application during surgery
* adult

Exclusion Criteria:

* usage of 5-fluorouracil in trabeculectomy
* post-operative complications
* ischemic heart disease
* s/p cerebrovascular accident
* allergy to bevacizumab
Cabergoline Before or After Oocyte Collection for Follicular Resolution

Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.


Eligibility Criteria:
Inclusion Criteria:

1. Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF.
2. Ability read and understand English sufficiently to obtain informed consent and complete a study diary.
3. Pre-implantation genetic screening (PGS) is allowed.
4. Egg donors are allowed.
5. Patients using a gestational carrier are allowed.
6. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.

Exclusion Criteria:

1. Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage.
2. Patients that would be unavailable for the follow-up ultrasound 5 days post-retrieval, such as patients that live far from the clinic (e.g. out of state).
3. Uncontrolled hypertension.
4. Ergot alkaloid hypersensitivity or allergy.
5. History of pulmonary, pericardial, retroperitoneal fibrotic disorders.
6. History of bipolar disorder, schizophrenia, or psychotic illness.
7. Breast feeding.
8. History of eclampsia or pre-eclampsia.
9. Severe hepatic dysfunction.
10. Current use of any dopamine receptor agonist or antagonist for any purpose, including, but not limited to, cabergoline (Dostinex), aripiprazole (Abilify), bromocriptine (Parlodel), methylphenidate (Ritalin), buproprion (Wellbutrin, Zyban), lisdexamfetamine (Vyvanse).
11. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.


Eligibility Criteria:
Inclusion criteria:

* The patient has a primary diagnosis of schizophrenia
* The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
* The patient has had a duration of illness of at least one year.
* The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
* The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

* The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
* The patient is considered treatment resistant-Substance abuse-Prolactin level of \> 200 ng/mL at baseline
* Pregnancy
forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control

Observational Model: Other: A post-marketing evaluation of the safety of Forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

Patients with Type 2 Diabetes who are:

* Prescribed Forxiga for glycaemic management AND
* Who have the ability to provide informed consent

Exclusion Criteria:

Patients with whom use of Forxiga is contraindicated:

* Patients with Type 1 Diabetes
* Patients with moderate to severe renal impairment \[Creatinine clearance (CrCl) \<60 mL/min or estimated glomerular filtration rate (eGFR) \<60mL/min/1.73m²\]

Additional exclusion criteria:

* Age \>75 years
* Concomitant use of loop diuretics or pioglitazone
* Patients who are currently on another SGLT2 inhibitor
In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

Two different registration algorithms will be tested:

1. registration algorithm - centerline registration algorithm (Sintef, Trondheim) A catheter equipped with a position sensor records the travelled path of the instrument, which is assumed to be close to the centerline of the aorta. From the preoperative computer tomography scan (CT) the aorta is segmented and vessel centerline is extracted. The centerline from the position sensor recordings is registered to the extracted centerline of the preoperative CT.
2. 3D-3D registration algorithm (Syngo iPilot, Siemens Medical Solutions, Munich). Intraoperative cone-beam-CT (CBCT) is registered to the preoperative CT

Eligibility Criteria:
Inclusion Criteria:

* infrarenal or juxtarenal abdominal aortic aneurysm
* undergoing EVAR
* informed consent

Exclusion Criteria:

* under 18 years
A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy on the basis of medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs, and laboratory tests performed at screening
* Participant must have a body mass index (BMI); weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
* Participant must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic. If blood pressure is out of range, 1 repeated assessment is permitted after an additional 5 minutes of rest
* Participants must have normal values for alanine transaminase (ALT) and aspartate aminotransferase (AST) (less than or equal to (\<=) 1.0\*upper limit of laboratory normal range \[ULN\])
* Participant must have a normal renal function (estimated glomerular filtration rate \[eGFR\] greater than or equal to (\>=) 90 milliliter per minute per 1.73 meter per square (mL/min/1.73m\^2) determined by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)

Exclusion Criteria:

* Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease (example, glucose 6 phosphate dehydrogenase deficiency), coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, seizure disorders, or any other illness, that in the investigator's and/or sponsor's medical monitor opinion should exclude the participant or that could interfere with the interpretation of the study results
* Participant has a history of human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody positive, or tests positive for HIV-1 or -2 at screening
* Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides, or drug allergy diagnosed in previous studies with experimental drugs
* Participant has known allergies, hypersensitivity, or intolerance to lumicitabine, proton pump inhibitors (PPIs), H2 blockers or their excipients
* Participants with evidence of any active infection, or participants with presence of any febrile illness or symptoms of upper or lower respiratory tract infection in the 14 days before the (first) administration of study drugs
NEMO1:NEonatal Seizure Using Medication Off-patent

NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.


Eligibility Criteria:
Inclusion Criteria:-

* Male or female term baby with gestational age of 37-43 weeks and postnatal age \<48 hours
* One or more of the following:
* APGAR score \< 5 at 5 mins.
* Umbilical cord or first arterial blood sample pH \< 7.1 or base deficit \>16 mmol/L.
* Postnatal resuscitation still required 10 minutes after birth

  * Clinically evolving encephalopathy
  * Received one dose of standard anticonvulsive therapy (phenobarbitone,20mg/kg) for clinical or electrographic seizures.
  * EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of \>30 sec duration over 2 hr period within first 48 hr of life
  * Written informed consent of parent or guardian.
  * EEG monitoring has commenced within the first 48 hours of birth.

Exclusion Criteria:

* Suspected or confirmed brain malformation, inborn error of metabolism,genetic syndrome, or major congenial malformation
* Congenital (in utero) infection (TORCH).

  * Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours.
  * Total serum bilirubin \> 15 mg/dl (255 micromol/l) at inclusion.
  * On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / pentobarbitone for intubation.
  * Anuria/renal failure defined as serum creatinine \> 200 micromol/l.
  * Severe electrolyte depletion (Na \<120 mmol/L, K \<3.0 mmol/L)
Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition

This study aims to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy adults.

This study will employ a double-blind, randomised, placebo-controlled crossover design to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy older adults. A total of 30 participants will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day Ecologic Barrier©) or a matched placebo in the first arm, before having a 4 week washout period and continuing with 8 weeks of the second treatment not consumed within the first arm. Outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. These will include cognitive measures of affective processing, immediate and delayed verbal memory, visuospatial working memory and executive functions, and mood measures of depressive symptoms, cognitive reactivity, anxiety, stress and general mood. In addition, faecal samples will be collected at all timepoints in order to explore faecal microbiota profiles before and after probiotic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 65 - 80
* Agree not to not consume probiotic or prebiotic supplements or live yoghurt throughout the course of study.
* Proficient in the English language

Exclusion Criteria:

* Already a habitual user of probiotics
* Antibiotic treatment within last 3 months
* Current diagnosis of and not currently receiving treatment for mental health disorder
* Gastrointestinal disorder
* Allergic to any ingredient of the active or placebo treatment
* Regular smoker
* Diabetes mellitus
Impact of Nutritional Status on Clinical Outcome in PICU

Malnutrition is believed to be associated with clinical outcomes in ill patients and several studies have shown that nutrition status play a major role in disease prognosis in adults .

Different authors have described an increase in morbidity and mortality attributable to malnutrition, as it lead to state of partial immunosuppression, delay wound healing ,causes muscular atrophy and increase length of stay.

Several studies have investigated the predictive role of an extremely low body weight on disease prognosis and outcomes among general and critically ill children .They enrolled all patients consecutively admitted to pediatric intensive care unit PICU) , therefore , being underweight may have resulted from endocrine diseases, genetic syndromes or other systemic underlying illnesses .

The impact of low body weight on outcomes of acutely critically ill but previously healthy children is still unknown.

Many studies evaluate the clinical status and outcome by pediatric index of mortality (PIM2) as a popular and reliable predictive score .

In this study, we will investigate the impact of being underweight or proper weight on mortality and morbidity among acute critically ill children with no genetic, endocrine, or chronic systemic illness at PICU admission

Eligibility Criteria:
Inclusion Criteria:

1. All children admitted to PICU with nutritional disorders
2. Children with acute diseases and anthropometric measurements taken within first 24hours

Exclusion Criteria:

1-children with underlying chronic diseases (eg cerebral palsy ,type 1 or 2 diabetes , epilepsy, metabolic diseases, inflammatory bowel disease , liver cirrhosis , immunodeficiency , autoimmune disordes , malignancy , chronic kidney disease) and postoperative patients.
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.


Eligibility Criteria:
Inclusion Criteria:

* +10.00D to -20.00D of absolute spherical ametropia
* Must be part of the Bausch \& Lomb research clinic
* Snellen visual acuity must be correctable to 20/25

Exclusion Criteria:

* No more than -6.00D of refractive astigmatism
An EORTC Study Updating the QLQ-BR23 to BR45

Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible.

According to sample size calculations, we will include a total of N =490 patients from 12 countries.

Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).


Eligibility Criteria:
Inclusion Criteria:

* Adult females aged 18 years or over
* Histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour
* Receiving or have previously received curative or palliative treatment.
* Able to understand/speak English and complete the questionaires
* Have the capacity/mental fitness to give written informed consent and complete the questionnaires.

Exclusion Criteria:

* Male gender or transgender
* Inability to understand/speak English and complete the questionnaire
* Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.