cyrilzakka/clinical-trials huggingface dataset:
Validation of Rehab Assessments in Myositis Patients

The aim of the study is to evaluate the psychometric properties (content and construct validity, reliability, measurements error, as well as possible floor and ceiling effects) of both the assessments MMT8 and the myositis activity profile in patients with IM.

This study evaluates the validity and reliability of two health related instruments that assess disease relevant functions and disabilities in patients with IM: the manual muscle testing 8 (MMT8) and the myositis activity profile (MAP). This study is needed to determine the psychometric properties of these two assessments. Provided that both the MMT8 and the MAP show good psychometric properties, these assessments could be used in the rehabilitation process and intervention programs of patients with IM to determine progress in muscle strength and activity in daily life.

Methodology: Reliability (Test re-test study and validity (cross sectional study) of a short form of MMT 8 and a questionnaire to assess difficulties in activities of daily life (MAP) in myositis patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of polymyositis or dermatomyositis or inflammatory myositis associated disorders (e.g. Scleroderma, Systematic lupus erythematosus, Sjögren's syndrome)
* Age over 18
* Sufficiently understanding of German language
* able to understand and follow verbal and written instructions
* signed informed consent to participate in the study

Exclusion Criteria:

* Diagnosis of inclusion body myositis
* Pulmonary hypertension
* Osteoporosis
* Severe cardiovascular and/or pulmonary disease
* Pain syndrome
* Paresis

Inclusion Criteria aged and gender matched healthy controls (Systematic lupus erythematosus, Sjögren's syndrome)

* Age over 18
* Sufficiently understanding of German language
* able to understand and follow verbal and written instructions
* signed informed consent to participate in the study
A Study to Compare CSF Flow Metrics Across Platforms

The purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time.


Eligibility Criteria:
Inclusion Criteria:

- A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.

Exclusion Criteria:

- Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.
Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send'

Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery. Recently, Rotunda Maternity Hospital have started using two fasting protocols at the Rotunda prior to elective caesarean section, one uses carbohydrate drinks, and the other encourages women to sip water until they are called to the operating theatre. The evidence to support the use of either one is very limited. This study would help streamline one of the protocols.

This is a study focused on comparing fasting policies that are in use at the Rotunda.

Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience.

A 'Sip til send' fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery. This policy was implemented at the Rotunda in 2022 and was studied prospectively, investigators demonstrated improvements in the comfort that women experience in their perioperative journey, compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre.

It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries, but there is very limited evidence in obstetrics. The Rotunda is increasingly providing women with carbohydrate drinks prior to CD. These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery (ERAS) package. There is little evidence to support the use of carbohydrate drinks, but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting.

Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively. Carbohydrate reserves are rapidly exhausted, causing hypoglycemia, increased urine nitrogen secretion (indicating muscle catabolism), and increased urinary ketone body concentration. It has been recommended that Mothers in their third trimester avoid skipping meals.

Investigators wish to study the effects of integrating carbohydrate drinks into the current 'sip til send' fasting protocol and determine if these women benefit from either protocol.

Eligibility Criteria:
Inclusion Criteria:

* Elective caesarean section for singleton pregnancy under neuraxial anaesthesia.
* Subjects able to give informed consent and willing to comply with the study protocol.
* Subjects must be greater than 18 years old

Exclusion Criteria:

* Diabetes Mellitus - including gestational diabetes.
* Known foetal abnormality.
* Planned general anaesthesia.
* Elective caesarean delivery at a gestation of less than 37 weeks.
* Low birth weight 2.5 kg (IUGR)
* BMI greater than 45 kg/m2
* Women with severe gastro-oesophageal reflux disease
SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY

Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the developed questionnaire scale. The questionnaire consisted of 5 degrees of assessment of kidney mobility and each question was scored from 1 to 5, 1 being very mobile (extremely poor conditions for dusting) and 5 completely immobile (Ideal conditions for dusting). After this assessment modified technique of general anesthesia was applied called combined respiratory support which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high frequency jet ventilation through endotracheal tube with a respiratory cycle frequency of 300 per minute and maintained during retrograde intrarenal surgery. At the beginning of combined respiratory approach, surgeons were once again asked to assess the mobility of the operative field and the conditions for laser lithotripsy. Main ventilation parameters were recorded and compared in both regimens.


Eligibility Criteria:
Inclusion Criteria:

* Kidneys stones with indications for retrograde intrarenal surgery

Exclusion Criteria:

* Patients with ASA class of greater than 3
* Patients with active urinary tract infection were excluded from the study
Natural Killer (NK) Cell Therapy in Locally Advanced HCC

This Phase 2a trial will evaluate the safety and efficacy of NK cell therapy combined with the hepatic artery infusion chemotherapy (HAIC) in patients with intermediate and/or locally advanced hepatocellular carcinoma (HCC). We hypothesized that 5-fluorouracil (FU) with immunomodulatory functions would relieve the immunosuppressive microenvironment from the myeloid-derived suppressor cells (MDSCs), thereby enhancing the anti-tumor activity of NK cells. Thus, the subsequent infusion of autologous NK cells (VAX-NK/HCC) following HAIC treatment may further improve the anti-tumor activity in patients with advanced HCC.

Primary Objective I. To assess the objective response rate (ORR) of administering VAX-NK/HCC, autologous NK cells combined with HAIC in patients with locally advanced HCC.

Secondary Objectives I. To assess the efficacy of administering VAX-NK/HCC combined with HAIC. II. To assess the safety of administering VAX-NK/HCC combined with HAIC. III. To assess the immune responses of administering VAX-NK/HCC combined with HAIC.

OUTLINE: This is a Phase 2a study. Patients receive HAIC treatment every 4 week for up to 4 cycles followed by ex-vivo expanded autologous NK cell infusions. The NK cell treatment repeats every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed until the disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with intermediate and/or locally advanced HCC histologically confirmed by biopsy or by typical radiological findings.
* Subjects who were not suitable for or failed curative treatments such as surgical resection, local ablation therapy, transarterial chemoembolization (TACE), sorafenib, atezolizumab, bevacizumab, etc.
* Child-Pugh liver function class A or B.
* Subjects' ECOG performance status of 0 or 1.
* The presence of macrovascular invasion.
* Adequate liver, renal, and hematologic functions.

Exclusion Criteria:

* Subjects who received the immune cell-based therapy within 6 months before the screening visit.
* Subjects with a history of a malignancy other than HCC within the last 5 years, liver transplantation, and hypersensitivity to 5-FU or cisplatin.
* Subjects with extra-hepatic metastases.
* Subjects who have ongoing autoimmune disease.
* Female subjects who are pregnant or lactating or women of child-bearing potential but unable to take adequate contraception.
TRAUMA HELP: Healing and Analgesia With Propranolol

The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a trauma center after injury.

The main purpose of this pilot study is to investigate Propranolol's utility in the trauma population. Specifically, to see if it reduces pain scores post-injury.

Eligibility Criteria:
Inclusion Criteria:

* at least one fracture
* ages 18-60 yrs
* pain score \>= 4
* speak and read English

Exclusion Criteria:

* gunshot, stab wound, or assault
* paraplegia/quadriplegia
* pregnancy
* psychotic, suicidal, or homicidal
* hepatic, kidney failure
* clinically unstable or intubated at time of recruitment
* hyperthyroidism
* propranolol use within the last 6 months
* significant bradycardia
* cancer (except basal cell)
* peripheral vascular disease
* heart block \> 1 degree
* breastfeeding
* congestive heart failure
Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement

In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* BMI between 21 and 30 kg/m2

Exclusion Criteria:

* Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.
* Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).
* Known allergy to milk and milk products.
* Known galactosaemia.
* Current or recent (within past three months) smoking.
* Known or suspected Diabetes Mellitus.
* Current infection or fever in the last 7 days at the discretion of the physician.
* Use of antibiotics within 3 weeks of study entry.
* Current use of corticosteroids or hormones.
* Current use of antacids or any medication influencing gastric acid production.
* Requirement for any nutritional support.
* Unplanned body weight loss \> 5% in the past 3-6 months.
* Adherence to any specific diet (e.g. weight loss, vegetarian).
* Use of protein containing or amino acid containing nutritional supplements within one week of study entry.
* Alcohol or drug abuse.
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
* Participation in any other study with investigational products concomitantly or within 4 weeks of study entry.
Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patients with American Society of Anesthesiology (ASA) scores of 1 to 4
* Patient schelduled for carotid endarterectomy

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient has a contra-indication for a treatment necessary for this study
* The endarterectomy does not require a shunt
* ASA score of 5
* Patient presenting with symptomatic gastric-oesophagien reflux
* Patient has neuro-endocrine cancer
* Patient has hypersensivity to one of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, senon, paracetamol, tramadol
* Patient suffering from obstructive respiratory insufficiency (chronic obstructive pulmonary disease, asthma)
* Patient with coronary disease with severely altered cardiac function
* High intracranial pressure
* Patient requiring high concentrations of oxygen (SpO2 \< 92% normal air)
* Patient with neuro-sensorial deficit that, in the absence of a prothesis, prevents reading, writing, or responding to simple orders
* Patient suffering from myopathy or recent rhabdomyolysis
* Patient with psychiatric pathology or chronic alcohol consumption or consumption of another substance that interferes with understanding
* Lack of contraception for women of child-bearing age
* History of or suspected malignant hyperthermia
* Patients with liver damage, jaundice, unexplained fever or eosinophilia after administration of a halogenated anesthetic
* Patient has undergone a recent multiple trauma (\<1 month)
* Patient who received general anesthesia within the past 7 days
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours

This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.

Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female subject;
* Glioma or brain metastasis operated on in our institution, histologically confirmed (WHO classification 2016);
* Subject with a frozen tumour sample \< 5 years old;
* Subject for whom all clinico-radiological data are available;
* Subject affiliated to a health insurance scheme;
* Subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample.

Exclusion Criteria:

* Patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision
* Biological samples not available and/or in insufficient quantity for analysis
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.

Participants will receive single-dose of either test or reference octreotide microsphere formulations.

Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-28 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
* In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
* Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
* Fully understood and voluntarily signed the informed consent form
* With high compliance

Exclusion Criteria:

* With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
* With gastrointestinal disease
* Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
* With alcohol consumption \> 2 units/d within 6 months before screening
* With cigarette consumption \> 5/d within 3 months before screening
* Donated or lost blood \> 400 mL within 3 months before screening
* Hospitalized or received surgery within 3 months before screening
* Received study drug of other clinical trial within 3 months before screening
* Received prescription drug within 14d before dosing
* Received over-the-counter drug or herb within 48h before dosing
* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing
* Consumed alcohol within 48h before dosing or positive for breath alcohol test
* Cannot consume standard meal
* Intolerable to venipuncture
* Cannot receive intramuscular injection in the glute
* With vitamin B12 deficiency
* Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing
* For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing
* Other reason judged by investigators
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.

The incidence of Urinary tract infections (UTIs) is very high in kidney transplant patients. Most UTIs occur during the first six months (82% within the first three months) of kidney transplantation and are frequently recurrent. The component D-mannose of our authorized food supplement acts by inhibiting the adherence of E.coli to the urothelium. It also has a controlled release formula that ensures the presence in urine of D-mannose and the other components during 24 hours. This is the reason why this experimental study aims to demonstrate that the oral intake of this food supplement is effective in the prevention of UTIs in kidney transplant patients.

The study tries to analyze the impact of a food supplement (Manosar®) on the incidence of urinary infections in patients undergoing kidney transplantation.

The patients will be randomly distributed (1: 1 ratio) into two treatment groups of 30 patients each. In one group, they will be treated with Manosar®, and in the other group they will be treated with Proanthocyanidins. All patients will be followed for 6 months, being the first three months of the study drug administration.

This experimental study is double-blinded and there are 7 monthly study visits. Properties of D-mannose and Proanthocyanidins make interesting to evaluate the clinical benefit of the use of food supplements with D-mannose and Proanthocyanidins in order to prevent the UTIs without antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years.
* Recipients of a cadaveric donor kidney transplant.
* Patients who are trained to give their informed consent.

Exclusion Criteria:

* Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
* Recipients of a transplant of an organ other than the kidney.
* Patients with Bricker or Studer neobladders.
* Patients in need of intermittent self-catheterization prior to kidney transplantation.
* Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
* Pregnant or lactating patients.
* Having participated in clinical trials in the previous 3 months or participating in another clinical study promoted by the pharmaceutical industry, in which the promoter already establishes the treatment for UTI.
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient requires treatment of a life-threatening wound requiring grafting.
* Patient has inadequate available skin to harvest for conventional skin grafting.
* The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition.
* In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device.
* Patient is hemodynamically stable.
* The patient (or legal representative) is able to read and understand instructions and give informed consent.

Exclusion Criteria:

* The patient has active infection at the proposed ReCell treatment site.
* The patient is unable to follow the protocol.
* The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.