cyrilzakka/clinical-trials huggingface dataset:
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged over 18 years old
2. Patients who have signed the informed consent form before any study related procedure
3. Primary achalasia of the cardia with Eckardt score \> 3
4. Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study
5. ASA score (American Society of Anaesthesiologists) 1 or 2
6. Patients affiliated to a social security health system

Exclusion Criteria:

1. Patients with age less than 18 years old
2. Patients without discernment with legal protection
3. Patients who will not be able to abide with study follow-up as judged by the investigator
4. Patients which cannot provide a written informed consent
5. Patient refusing to participate in the study, without informed consent
6. Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
7. Concomitant participation in other clinical trial
8. S2 sigmoid type primitive achalasia of the cardia
9. Pseudo-achalasia (esophageal carcinoma),
10. History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
11. History of esophageal strictures, systemic sclerosis
12. History of esophageal varices
13. History of endoscopic or surgical therapy of the esophageal achalasia
14. History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
15. History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)
16. History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP \< 60%, TCA \> 40 seconds, platelets \< 60000/mmc)
17. ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6
18. Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.
THRIVE-CAR-T Digital App

The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question\[s\] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.

This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) versus usual care in patients receiving chimeric antigen receptor T-cell therapy (CAR-T). The primary objective of the study is to determine if THRIVE-CAR-T is feasible and acceptable to patients. The exploratory objective is to assess the preliminary effects of THRIVE-CAR-T for improving patient-reported quality of life (QOL), psychological distress, and self efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Ability to understand English
3. Diagnosis of a hematologic malignancy
4. Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product

Exclusion Criteria:

1. Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment
2. Already participating in another supportive care clinical trial
Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders. Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight. The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age: 18 to 55 years (inclusive) at the first screening examination

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known coagulation disorders (eg von Willebrand's disease, hemophilia)
* Known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Known sensitivity to common causes of bleeding (eg nasal)
* Regular use of medicines
* Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
* Clinically relevant findings in the physical examination
* Clinically relevant deviations of the screened laboratory parameters from reference ranges
* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events

The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.

These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.

To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
* Age between 18 and 80 years.
* Signing of written informed consent.

Exclusion Criteria:

* History or presence of systemic arterial hypertension (treated or not)
* History or presence of ischemic heart disease and peripheral vascular disease.
* Presence of greater than mild valvular disease.
* Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
* Presence of severe anemia (Hb \<7 g / dL).
* Presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week.
* History or presence of severe or decompensated lung disease.
* Presence of percutaneous intrahepatic porto-systemic shunt (TIPS).
* Pregnancy.
Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.

Part 1: The pharmacokinetic (PK) phase Objective: To determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose.

Hypothesis: Detectable levels of Intranasal scopolamine (INSCOP) will be present in subject plasma within 15 minutes post-dose; mean time to Cmax (maximum plasma concentration) will be less than 1.5 hr.

Part 2: The Efficacy phase Objective: To determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (MS) countermeasure.

Hypothesis: The primary hypothesis is that the INSCOP spray will be more efficacious against MS than placebo, without statistically significant cognitive performance side-effects. Specifically, participants will tolerate significantly more provocative head tilts in the INSCOP condition than in the placebo condition.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles
* Normal weight for body size, based on Physical Readiness Test Body Composition Assessment (PPRTBCA) table
* Willing and able to comply with study requirements and restrictions; and read and sign the informed consent.

Exclusion Criteria:

* Known and/or documented drug allergies, especially to scopolamine
* Use of an investigational drug within 30 days of starting the study
* Smoking or use of tobacco products, including "chew" or "snuff", within six months
* Blood donation or significant blood loss within 30 days of starting the study
* Significant gastrointestinal disorder, asthma, or seizure disorders
* History of narrow-angle glaucoma
* History of urinary retention problems
* History of alcohol or other drug abuse
* Pregnancy or suspected pregnancy, or lactation
* Hematocrit values less than 41% for males and 37% for females
* Recent nasal, nasal sinus or nasal mucosa surgery
* Use of prescription, over-the-counter, or herbal medication in past 7 days
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma

This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin's Lymphoma.

Primary

• To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Hodgkin's Lymphoma, relapsing or refractory to a prior therapy.

Secondary

* To further investigate the safety profile of Aplidin® given as 1-hour weekly IV infusion in this patient population.
* To obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed aggressive lymphomas,
* Patient requires treatment because NHL relapses
* Measurable disease
* Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade \< 2 symptomatic peripheral neuropathy is allowed.
* Age \> 18 years.
* Performance status (ECOG) \< 2
* Adequate renal, hepatic, and bone marrow function (assessed \< 14 days before inclusion in the study)
* Left ventricular ejection fraction within normal limits.

Exclusion Criteria:

* Prior therapy with Aplidin®.
* Concomitant therapy with any anti-lymphoproliferative agent
* Acute lymphoblastic leukemia.
* CNS lymphoma.
* HIV-associated lymphoma.
* Prior gene therapy with viral vectors.
* More than three previous lines of systemic biological agents or chemotherapies. Wash-out periods since the end of the precedent therapy less than:

  * 6 weeks for nitroso-urea or high dose chemotherapy
  * 3 weeks for other chemotherapies or biological agents
  * 4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
  * 4 weeks for major prior surgery
  * 30 days for any investigational product
  * 4 weeks for immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation.
* Pregnant or lactating women.
* Men and women of reproductive potential who are not using effective contraceptive methods
* History of another neoplastic disease. Exceptions: Non-melanoma skin cancer,cCarcinoma in situ of any site,any other cancer curatively treated and no evidence of disease for at least 10 years.
* Known cerebral or leptomeningeal involvement.
* Other relevant diseases or adverse clinical conditions
* Treatment with any investigational product in the 30 days period before inclusion in the study.
* Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol
* Limitation of the patient's ability to comply with the treatment or follow-up protocol.
Loop Resection or Cold-cup Biopsy? a Study Comparing the Accuracy of Muscle Samples During Bladder Tumor Surgery

In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.


Eligibility Criteria:
Inclusion Criteria:

* • All patients requiring cystoscopy plus loop resection of bladder tumor.

Exclusion Criteria:

* • Patients who underwent cystoscopy and no loop resection

  * Patients who underwent cystoscopy and only cold-cup biopsy
Non-fatal Outcome After Trauma

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population.

Patients aged 18 years and older admitted in a hospital in Brabant after a trauma, independent of severity or type of injury are included in the study. Patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region Brabant will be excluded. Socio-demographic characteristics, functional and psychological outcome and Health Related Quality of Life (HRQoL) shortly after trauma will be measured. Subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. Outcomes will be assessed using questionnaires. The primary outcome parameters are: short and long term HRQoL, functional and psychological outcome, and Healthcare and societal costs in injured patients. Secondary outcome measures are Return to Work and health care consumption.

Eligibility Criteria:
Inclusion Criteria:

* patients seen at the ED which are admitted to the ICU or ward after getting injured
* all types and severities of injury (Injury Severity Score (ISS) 1-75)
* a minimal age of 18 years old
* sufficient knowledge of the Dutch language

Exclusion Criteria:

* patients who are dead on arrival or decease in the ED
* pathological fracture (i.e., the bones are weakened by disease, for example by a tumor)
* patients who die in the hospital will drop out the study and will not be included in the analyses
A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants

This is an open-label, non-randomized study to determine the excretion kinetics and mass balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing approximately 100 microcuries of \[14C\] labeled GDC-0810 using conventional absorption, metabolism, and excretion (AME) methodology. The entire duration of the study is up to approximately 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with non-child bearing potential, non-pregnant, non-lactating and either post-menopausal or surgically sterile.
* Negative pregnancy test result at Screening and at Day -1.
* Body mass index of 18.5 to 29.9 kilogram per square meter.
* Healthy condition documented with no clinically significant findings from laboratory evaluations, medical history, 12-lead electrocardiograms, and vital signs.

Exclusion Criteria:

* Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastric, neurological, or psychiatric disorder.
* History of significant hypersensitivity or allergy to any drug.
* Uncontrolled hypothyroidism.
* History or presence of clinically significant abnormal electrocardiogram.
* History of venous thrombosis, endometrial disorders, thrombophilic condition, inflammatory bowel disease, chronic diarrhoea, active or latent tuberculosis, and Gilbert's syndrome.
* Major surgical procedure or significant traumatic injury within 3 months prior to study participation.
* Participation in more than one other radiolabeled investigational drug study within 12 months prior to Check-in (Day -1).
* Exposure to significant radiation occuring within 12 months prior to Check-in (Day -1).
* Any acute or chronic condition that would limit the participant's ability to participate in the clinical study.
* Failure to satisfy the Investigator of fitness to participate for any other reason.
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
* Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Exclusion Criteria:

* Any meningococcal B or C vaccine administration
* Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
* Any ascertained or suspected disease caused by N. meningitidis
* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
* History of severe allergic reaction after previous vaccinations
* Recent significant acute or chronic infection
* Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
* Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
* Any impairment/alteration of the immune system resulting from (for example):

  * Receipt of any immunosuppressive therapy at any time since birth
  * Receipt of immunostimulants at any time since birth
  * Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
* Participation in another clinical trial
* Family members and household members of research staff
* History of seizure
* Any contraindication to paracetamol
Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older

The purpose of this study is to evaluate the prevalence of vitreomacular adhesion (VMA) in patients 40 years and older using Spectral Domain Optical Coherence Tomography.

As a function of age, liquefaction of the vitreous body results in separation of the vitreous cavity from the retina. This posterior vitreous separation may be incomplete, leading to areas of residual VMA. These adhesions can result in maculopathies such as vitreomacular traction syndrome, macular hole, epiretinal membrane, cystoid macular edema, diabetic macular edema, neovascularization in diabetic retinopathy and retinal vein occlusion, exudative age-related macular degeneration, and myopic traction maculopathy. VMA may lead to pathological sequelae due to the static and dynamic anteroposterior tractional forces to the surface of the macula. The resultant complication will depend on the size and strength of the traction, with smaller areas of adhesion leading to greater traction. Identifying the prevalence of vitreomacular adhesion and its associated complications will yield valuable, new epidemiologic data, leading to improved diagnosis and management of patients with this condition. The prevalence of vitreomacular adhesion in specific age groups has not been investigated.

Eligibility Criteria:
Inclusion Criteria: 40 years and older

* Clear media

Exclusion Criteria: Less than 40 years of age

* Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection
* Dense media opacity