cyrilzakka/clinical-trials huggingface dataset:
T-cell Based Immunotherapy for Head and Neck Cancer

The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.

Exclusion Criteria:

* Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Multidisciplinary Approach to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes.

The study intervention was applying multidisciplinary approach consisting of an endocrinologist, a diabetes specialized nurse, and a clinical pharmacist to assess and improve diabetic foot care using a systematic screening, patients' risk categorization, therapy optimization, and tailored education.

This is a single-blinded Randomized Controlled trial (RCT) study involving diabetic patients with (T1DM) and (T2DM) attending endocrine/diabetes, as well as, diabetic foot specialized surgery clinics for routine follow-ups at Jordan University Hospital (JUH) between 17 July 2022 and 30 Dec 2022.

The study evaluated the impacts of multidisciplinary approach in improving diabetic foot care. The clinical pharmacist role was to assess disease control, and to identify patients' therapeutic and educational needs through well-structured three months follow-up interviews with patients and/or their family members.

Moreover, the study investigated the impacts of multidisciplinary approach on health-related Quality of Life (QoL) at baseline and at the end of the study. Economic outcomes were also investigated relating to hospitalizations, length of stay, and cost of treatments.

The control group received standard care by hospital staff.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years old.
* Diabatic patients with T1DM and T2DM attending endocrine/diabetic and/or diabetic foot specialized surgery clinics for routine follow-ups at Jordan University Hospital (JUH).
* Diabetic patients with or without previous Diabetic Foot Ulcers (DFUs) and/or amputation.

Exclusion Criteria:

* Patients who were attending the clinics at the time of recruitment with active diabetic foot lesions and/or ulcers.
* Patients who were taking corticosteroid medications.
* Patients who were admitted to the hospital (inpatient admissions).
* Pregnant women attending gestational DM clinics.
* Patients with cognitive impairments and/or incapable to provide consent.
Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty

A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

Local anesthetics are often given in a continuous fashion to block specific nerves after an operation for pain control. A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* American Society of Anesthesiologists (ASA) Physical Status I to III

Exclusion Criteria:

* Body mass index (BMI) \> 40
* Not able to communicate in ENglish
* Unable to obtain consent
* Infection over site of placement
* Severe respiratory disease
* Cognitive or psychiatric history that would make it difficult to assess pain score
* Complex regional pain syndrome
* Chronic pain condition such as fibromyalgia, neuropathic pain
* Preoperative opioid use greater than the equivalent of morphine 50 mg PO daily
* Allergy to any of the study drug
* Coagulopathy
Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.


Eligibility Criteria:
Inclusion Criteria:

Idiopathic hypersomnia patients

* idiopathic hypersomnia diagnosis
* complaints of excessive daytime sleepiness for \>1 year
* a night-time length \>10 h for 3 weeks before polysomnography as assessed by a sleep diary

Inclusion Criteria:

no idiopathic hypersomnia patients

* no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score \<10

Exclusion Criteria (both):

* Narcolepsy-cataplexy
* sleep irregularities and sleep deprivation symptoms
* lack of neurological or psychiatric diseases
* upper airway resistance syndrome
* periodic limbs movements
* cerebral lesion
* medication or drinks affecting sleep and wake state
The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital Institutional Review Board. The aim of this post-marketing study is to evaluate the safety and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.

The study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be obtained before volunteers enter screening period. If the volunteers meet all the criteria, they will be given a number to replace their name in the study. The participants will be randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
* Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
* Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
* Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections
* If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
* Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures

Exclusion Criteria:

* Have history or active dermal diseases, inflammation, or any related disease
* Had permanent or semi-permanent implantation on nasolabial areas
* Had invasive aesthetic treatments or surgeries history 6 months before the treatments
* Had physical or chemical aesthetic treatments 1 months before the study starts
* Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
* Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
* Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
* Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
* Have poor compliance with the study or follow-up schedule
Evaluation of Lower Extremity Tissue Perfusion With Polarized Laser Light

The aim of this study is to test the feasibility of using polarised green laser and CMOS camera in order to assess the tissue perfusion of lower extremity ulcers in patients suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen tension examination which is currently the "gold standard" examination.

An objective assessment of blood supply and oxygen delivery to the damaged tissue in patients with diabetic ulcer is very problematic with various currently accepted auxiliary examinations. These tests include measuring blood pressure ratio between the ankle or toes arm (ABI \\ TBI), Sonar Doppler examination of the lower limb arteries, and percutaneous tissue oxygen tension examination (TcPO2). Each of these tests, along with the obvious advantages esprit ability to assess a non-invasive blood as number of disadvantages.

As the blood supply to the tissue is the most important healing of the tissue regardless of the type of intervention chosen (conservative treatment includes systemic antibiotics or surgical debridement), there is clear necessity for a non-invasive test with high reliably assessing tissue perfusion in patients with diabetic ulcers.

Recently, a new a method for assessing multiple features in vital tissues using polarised laser light was introduced. The technique is based on tracking temporal changes of reflected secondary speckles produced in the skin when being illuminated by a laser beam. Change in skin's temporal vibration profile is generated by time varied oxygen concentration caused these temporal changes. This technology of nanometer motion sensing allows, according to studies already carried out, monitoring parameters such as blood pressure, pulse rate and heart rhythm, glucose concentration in the blood substances and alcohol, oxygen saturation and intraocular pressure.

In this study the investigators will examine, non-invasively, the tissue around the lower limb ulcers of 30 diabetic patients, beginning with the TcPO2 examination followed by the polarised laser light and complementary metal-oxide semiconductor (CMOS) camera examination, and analysing the data in order to determine the ability of the latter method for assessing the tissue oxygen pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic diabetic ulcers

Exclusion Criteria:

* Patients after amputation of some part in the lower limb
* Patients with acute infection on bony involvement
Effect of Hyoscine and Promethazine on Labor Pain

It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. So the investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on length of active phase of the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 yrs,
* primiparous,
* having single fetus with cephalic presentation, gestational age 37-42 weeks,
* having no medical diseases,
* having no history of hospitalization due to psychological diseases,
* having no addiction to cigarette,
* having no complications during pregnancy such as hypertension,
* BMI\< 26

Exclusion Criteria:

* bleeding
* CPD
* use of PG or Oxytocin
* fetus distress
Pancreatic Cancer Evolution Upon Treatment

This project aims at evaluating the different subtypes of pancreatic cancer on EUS-tissue acquisition of pancreatic cancer patients, and their possible modifications throughout time. The study takes advantage of a systematic evaluation of pancreatic cancers through diagnostic EUS-guided fine needle biopsy (FNB) sampling of the mass performed during a restaging EUS. FNB samples represent a valuable source of cancer cells, both for the histological diagnosis and as the source of tumor macromolecules, including DNA and RNA.

Study design This is a prospective study enrolling patients with non-metastatic pancreatic cancer who already underwent diagnostic EUS with tissue acquisition and rapid on-site evaluation (ROSE) by cytologist positive for pancreatic cancer, with a first sample acquired for diagnostic purposes and a second sample stored for RNA extraction acquired with the already approved protocol BIOGASTRO.

As recommended by guidelines, patients will follow the standard pathway of treatment, being sent to chemotherapy and will then undergo restaging of the lesion and re-evaluation of vascular invasion by CT and EUS. During this second session of EUS a new specimen of the tumor will be sampled for diagnostic purposes, with a second pass undergoing for RNA extraction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Willing to sign informed consent
* Patient with CT scan or MRI or EUS defining the lesion as locally advanced
* Patient who already underwent EUS-TA for solid lesion of the pancreas positive for pancreatic ductal adenocarcinoma (PDAC)
* Patient undergoing neoadjuvant chemotherapy
* Patient primarily followed at San Raffaele Hospital

Exclusion Criteria:

* Patients not willing to sign informed consent
* Pregnancy and breastfeeding
* Cytology positive for malignancies other than PDAC
* Patient undergoing progression at re-staging CT scan
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure

The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.

A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.

Treatment period: 7 days, follow-up: 1 month

The primary objective of this study is to assess the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. The subject aged ≥ 18 years, men or women.
2. The subject has a diagnosis of chronic left heart or right heart failure (a past medical history of left heart failure caused by coronary heart disease, hypertension and dilated cardiomyopathy, or a medical history of right heart failure caused by pulmonary artery hypertension (the 1st type of diagnostic classification, WHO conference, Venice, 2003) and left heart disease (the 2nd type) ;the case number of right heart failure is about 30% of the total case number).
3. The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
4. NYHA-FC is Class II- IV (Class II cases \< 20%, except the refractory terminal heart failure patients).
5. The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
6. CI \< 2.5 L/min/m2 or CO \< 4L/min (right heart failure)
7. The subject has signed the ICF.

Exclusion Criteria:

1. Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
2. Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
3. Subjects will leave the hospital in 7 days.
4. Subjects with severe cerebral apoplexy (life threatening).
5. Subjects with AMI or acute pulmonary embolism.
6. Subjects with uremia and did not undergo dialysis.
7. Subjects with COPD.
8. Subjects with severe anemia (Hb≤60g/l).
9. Subject who is receiving other metabolism improving drugs within one month (such as trimetazidine dihydrochloride tablets and 1, 6- fructose diphosphate.
10. Subject with other severe disease and his/her life expectancy \<12 months.
11. Subject who has participated in other clinical trial within 3 months or is participating in other study.
12. Subject who has received L-carnitine treatment within 1 month.
13. Subject who is allergic to L-carnitine and its derivatives.
14. Subject is receiving other cardiotoxic drugs.
15. Subjects with medical history of epilepsy.
16. Subject who is a drug or alcohol abuser.
17. Subject who has received PCI, CABG or vascular remodeling.
18. Subject with arrhythmia that the investigator thinks unsuitable to include.
19. The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
20. The subject has not signed the ICF.
Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response

This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients.

This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 400 patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18-65 years of age, inclusive.
* A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
* HAM-D score ≥ 22.
* HAM-D item 1 (depressed mood) score ≥ 2.
* Patients must be able to provide written informed consent to participate before beginning any trial related activities.
* Patients must be able to speak, read and understand English and possess the ability to respond to questions and follow simple instructions.

Exclusion Criteria:

* A current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder (Generalized Anxiety Disorder, Social Phobia or Simple Phobia will be allowed).
* A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
* Criteria for any of the following DSM-IV-TR MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern.
Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients

The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.

Patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. Opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. Reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population.

This is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. This study's primary objective is to evaluate the cryoSPHERE probe for ablation in pain control after surgery (measured using opioid medication). The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation.

We plan to recruit 75 patients who will receive the cryoSPHERE probe and compare them to 75 patients who did not receive the cryoSPHERE probe. The experimental group will receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine. The historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyroSPHERE probe.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18-90 years of age
* Diagnosis requiring robotic-assisted thoracoscopic surgery
* Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment
* Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.

Exclusion Criteria:

* Previous major surgery at the operative site (thoracotomy)
* Allergy to aluminum
* Allergy to plastics
* Allergy to bupivacaine
* Shingles disease
* Demyelinating illnesses
* Involvement with other interventional studies