cyrilzakka/clinical-trials huggingface dataset:
Respiratory Muscles and Work of Breathing in Children

Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

Respiratory muscle testing by means of esogastric measurements may allow assessing the effect of pharmacological treatment by comparing respiratory muscle strength before and after a few months with treatment. Moreover, esogastric measurements can be used to better adapt mechanical ventilation or to determine the possibility of weaning from the respiratory support.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
* Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation
* Written informed consent

Exclusion Criteria:

* No social insurance
* Significant psychomotor retardation
* Absence of cooperation
* Significant agitation
* Hemodynamic instability
* Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations
Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma

RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight infections and cancer. These CTL can be manipulated in the laboratory so that they can target an individual's cancer.

PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own immune cells are collected by a procedure called a leukapheresis. The cells then undergo laboratory processing for three weeks. Part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. These extra genes are to "teach" the participant's own immune cells to become anti-tumor CTL that can attack the melanoma.

DETAILED OUTLINE: This is an early phase pilot/feasibility trial.

Study subjects will be sequentially accrued to three cohorts. Cohorts 1 and 2 will evaluate the safety and feasibility of infusing two different doses of CTL.

* Participants in all cohorts will undergo two CTL infusions 5 weeks apart.
* Procedures performed during the trial will include physical examinations, laboratory tests, delayed hypersensitivity testing, and skin biopsies.
* Between 5 and 8 days after the first CTL infusion, a biopsy or excision of a melanoma lesion may be performed.
* Three leukapheresis procedures will be performed: two to collect peripheral blood for CTL production and one for research purposes at the end of the clinical trial.
* Radiology tests (including CT scans) will be performed prior to infusion and about 4-5 weeks after the second CTL infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic melanoma: Either unresectable Stage III or any Stage IV
* ECOG of 0 or 1
* HLA-A\*0201 haplotype
* Baseline tumor biopsy MART1/Melan-A expression present (in \>10% of tumor cells)
* Patient provides consent for all required biopsies
* Adequate intravenous access for leukapheresis
* Absolute lymphocyte count \>500/ul at least once within 30 days of leukapheresis
* Life expectancy greater than 4 months in the opinion of the study clinician
* Negative pregnancy test

Exclusion Criteria:

* Administration of systemic corticosteroids within 28 days of planned leukapheresis
* Administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis
* Administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to Cohort 3
* Active autoimmunity requiring systemic immunosuppressive therapy
* HIV infection
* Previous enrollment on this protocol and infusion of MART1/Melan-A CTL
Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients

The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

Despite advances in pharmacology and in analgesic techniques, pain in burned patients is unwieldy yet, this occurs in such cases due to the complexity and intensity and the need for multidisciplinary medical team. The burn pain is classified as nociceptive, but can also present a neuropathic component. Overall this is a pain at rest and during movement, being aggravated by procedures like changing dressings. In the weeks after the burn there is intense pain due to injury and the management of the framework, which often involves dressing changes and other procedures such as surgery in donor area skin.

The use of opioids in high doses can lead to unwanted side effects.To reduce the adverse effects resulting from the use of opioids in high doses, we purpose the use of intravenous continuous infusion of ketamine. In controlling the pain of major burned patient there is evidence only of the use of ketamine in the form of intermittent boluses, especially during dressing changes or in the perioperative period. The use of ketamine in continuous infusion lacks evidence in this group of patients The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

Eligibility Criteria:
Inclusion criteria will be considered:

1. patients admitted to the burn unit of the Clinical Hospital with burnt body area of 25% or more;
2. aged between 18 and 60 years;
3. with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) I and II;
4. has no known allergy or any other contraindications of the drugs that are used in the treatment protocol;
5. hemodynamically stable, considering systolic blood pressure greater than 90 mmHg;
6. with preserved consciousness level, measured by the Glasgow coma scale, with a score equal to 15;
7. with the possibility of drug administration orally or by naso-gastric tube

Exclusion criteria will be considered:

1. patients younger than 18 or older than 60 years;
2. with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) III or higher;
3. with known allergy or any contraindications of the drugs that are used in the treatment protocol;
4. patients with q chronic pain or chronic analgesic users prior to burning in treatment;
5. hemodynamically unstable, considering systolic blood pressure below 90 mm Hg;
6. with changing level of consciousness;
7. without the possibility of administering drugs orally or by nasogastric tube.
Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopy

Exclusion Criteria:

* Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours
Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those who express their voluntary consent to participate in the trial by signing a written consent
* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults

This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent
* Female of childbearing potential who agree to use medically allowed methods of contraception during the study period
* Individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion Criteria:

* Individual being considered to be confirmed COVID-19
* Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP
* Individuals at high risk of exposure to SARS-CoV-2
* Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening
* Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease
* Individuals with serious medical or psychiatric disease
* History of SARS-CoV or MERS-CoV infection
* History of allergic reaction or hypersensitivity reactions to any of components of the IP
* History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination
* History of receiving organ or bone marrow transplant
* Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination
* History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
* History of vaccination with test vaccine substance
* Treatment with immunosuppressants or immune modifying drugs
* History of treatment with antipsychotics or opioid dependence
* Pregnant or lactating women
* Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Optimization of Postoperative Bowel Habits

Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.

Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients, and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period.

Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.

As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair

Exclusion Criteria:

* Women younger than 18 years old
* Those unable to provide consent
* Preexisting chronic laxative use
* Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury
Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section

This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained


Eligibility Criteria:
Inclusion Criteria:

* elective cesarean
* elective repeat cesarean

Exclusion Criteria:

* emergent or urgent cesarean
* PROM
* chorioamninitis
* placental abruption
* placenta previa or accreta
* known uterine fibroids
* women with known medical problems such as coagulopathy
Functional Lung Imaging With DECT and 4DCT

The basic premise of this pilot study is to enroll 40 patients over 3 years who have Stage II, III, or IV non-small cell lung cancer and are planned for definitive treatment with concurrent chemoradiation where a contrast enhanced 4DCT is planned.


Eligibility Criteria:
Inclusion criteria:

* Patients have histologic diagnosis of non-small cell lung cancer
* Patients have AJCC stage II, III or IV disease were the plan is to receive definitive concurrent chemoradiation to 60 Gy or higher
* Age \> 18 years of age
* Patients are able to provide informed consent
* No additional lung radiation is planned until after the 2nd CT on this study (i.e. patient does not have a solitary pulmonary nodule or second primary that the plan is to undergo SBRT)
* Patient must have adequate kidney function to receive IV contrast (following institutional policy supplied by radiology). The cutoff level for serum creatinine is 1.6 mg/dL
* Negative urine pregnancy test before every CT scan

Exclusion criteria:

* Allergy to IV iodine contrast
* Severe claustrophobia
* Further thoracic radiation therapy is planned.
Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.

Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or wheat.

Context: Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF).

Objective: We aim to evaluate 1) the effectiveness of a diet in curing AF; 2) the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or wheat.

Design: The study will have two different parts: the first to verify the effectiveness of the oligo-antigenic diet in chronic AF treatment; the second to search for a possible cause-effect relationship between the diet and the onset of the AF.

Setting: We will enrol consecutive adult patients with chronic AF who will refer to a Surgical Department of the University of Palermo for a 3-years period. Inclusion criteria are: evidence of CAF evaluated by an experienced rectal surgeon; patient age \>16 years. Exclusion criteria are: a diagnosis of inflammatory bowel disease, ongoing steroid treatment performed for any reason, an exclusion diet followed for any reason, and pregnancy. At the time of the first evaluation, routine laboratory tests, immunology tests, rectal biopsies and anal-rectal manometry will be performed.

Patients: patients, finally included in the study, will be randomized to one of the treatment groups.

Interventions: Enrolled patients will be randomized to receive a "true elimination diet" or a "sham elimination diet"; both groups will also receive topical nifedipine and lidocaine.

Main Outcome Measures: The patients will be evaluated every two weeks for CAF persistence or healing; anal pain will be scored on a visual analogue scale ranging from 0 (absence of pain) to 10 (intolerable pain). Anal-rectal manometry will be repeated at the end of the study period, in all patients who will be treated.

Eligibility Criteria:
Inclusion Criteria:

* evidence of chronic anal fissures evaluated by an experienced rectal surgeon
* patient age \>16 years.

Exclusion Criteria:

* a diagnosis of inflammatory bowel disease
* ongoing steroid treatment performed for any reason
* an exclusion diet followed for any reason
* pregnancy.
Efficacy of a Supervised Intervention Protocol on Rounded Shoulder Posture and Shoulder ROM Among Saudi Young Females

Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.

Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.

Randomized sixty female subjects with rounded shoulder posture into two groups: Group A performed active Stretching of PMi along with the strengthening of LTR muscle(n=30); group B performed dynamic Stretching of PMi muscle only. Scores of outcome measures were recorded before and post interventions on day 0, day10th, and day21st, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Young Adult Female having a PMLD test score of more than 2.5cm
* Aged between 20-30 years
* No history of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
* Showed self-cooperation for the study

Exclusion Criteria:

* Young Adult Female having a PMLD test score of equal to or less than 2.5cm
* History of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
* Showed non-cooperation for the study
Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients

To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation

Eligibility Criteria:
Inclusion Criteria:

* Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

Exclusion Criteria:

* younger than 18 years old
* women of child bearing potential
Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope

After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.

After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq , Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.

Eligibility Criteria:
Inclusion Criteria:

* pediatric

Exclusion Criteria:

* adult