cyrilzakka/clinical-trials huggingface dataset:
The Effect of Smoking on Thermoregulation

To the best of our knowledge, a possible relation between smoking and heat injuries or heat intolerance was never scientifically examined, although such a relation is logical according to the observations that smoking has a thermogenic effect, decreases physical fitness and affects the body's heat dissipation.16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will perform VO2 test and heat tolerance test (HTT) in different conditions.

16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers. They will arrive to our lab four or five times. During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency. During their second visit all subjects will go through the same test after exposure to nicotine. During the smokers' third visit they will go through the same test, after exposure to cigarette smoking. During the non-smokers third visit and the smokers fourth visit - they will go through an exercise heat tolerance test without prior smoking. During the fifth visit the smokers will go through an exercise heat tolerance test after exposure to cigarette smoking. During the smokers' sixth visit and the non-smokers fourth visit they will go through an HTT after exposure to nicotine.

Eligibility Criteria:
Inclusion Criteria:

* age 18-30
* healthy
* after medical checkup
* after signing concent form
* for the smokers: smoking 0.5-1.5 packs of cigarettes a day at least 2 years.

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* diabetes
* anhydrosis
* skin disease
* acute illness
* detoxification from nicotine
* allergy to nicotine
* smoking other then specified in the inclusion criteria
iPS Cells of Patients for Models of Retinal Dystrophies

The investigators are focused on inherited retinal dystrophies with an aim to further understand disease pathophysiology and to elaborate novel treatments, as, to date, there is no effective treatment to prevent blindness.

The main goal of this study is to generate human cellular models of healthy and disease retinas and perform studies to evaluate the efficiency of gene therapy approaches for different diseases.

Skin biopsies of volunteers are cultured to isolate fibroblasts that are then reprogrammed into iPS cells. Healthy and disease-specific iPS cells are then differentiated into retinal models.

This study should help to elucidate disease pathways and to provide proof-of-concept for various therapeutic approaches.


Eligibility Criteria:
Inclusion criteria :

* Signed informed consent and
* Choroideremia :

  * Males
  * CHM mutation
  * With multimodal Imaging anomalies in line with CHM
* All other presumed inherited retinal dystrophies with bilateral and symmetrical involvement with identified mutations in one of the Retnet gene
* All presumed inherited optic neuropathy with bilateral and symmetrical involvement with identified mutations
* And in all cases or pattern

  * Age from 5 to 70
  * with appropriate health insurance

Exclusion criteria :

* Patient under tutorship or curatorship
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy

Exclusion Criteria:

* Intracranial hemorrhage
TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

The goal of this clinical trial is to investigate the effectiveness of two rehabilitation programs for individuals who have undergone amputations and are experiencing phantom limb pain. The main question it aims to answer is:

- In individuals who have undergone amputations and are experiencing phantom limb pain, what is the effectiveness of a progressive rehabilitation program compared to a treatment program consisting of transcutaneous electrical nerve stimulation and cranial electrical stimulation on reducing pain intensity and pain interference?

A total of 208 participants will be randomized into two groups: progressive rehabilitation program and stimulation devices. The progressive rehabilitation program includes pain science education, sensory training, and left/right judgements, imagined movements and mirror therapy. The treatment program for the group receiving the stimulation devices includes transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both interventions will be delivered via eight, up to 1-hour telehealth sessions. Outcome measures will be assessed at baseline and weeks 12, 24 and 52.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing phantom limb pain for at least three months.
* Report at least one episode of phantom limb pain in the previous week.
* Report at least 4 points in pain intensity over the previous 7 days, assessed using the 11-point Numerical Pain Rating Scale.
* Be a resident in Australia for the intervention and follow-up period.
* Have access to the internet and smart device (e.g., mobile phone).
* Be proficient in English.

Exclusion Criteria:

* Bilateral amputation.
* Scheduled for major surgery during the study period.
* Pain in the intact limb.
* Vision impairment that would preclude successful participation.
* Auditory impairment that would preclude successful participation.
* Cognitive problems that would preclude effective participation in trial procedures (e.g., Alzheimer's, dementia).
* Previously diagnosed neurological disorders that affect the movement of the intact limb (e.g., stroke, Parkinson, Multiple Sclerosis).
* Completed Graded Motor Imagery in the order of left/right judgements, imagined movements, and mirror therapy.
* Have contraindications for the use of stimulation devices (e.g., pacemaker, spinal cord stimulator).
Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema

This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 or 2 diabetes.
* Subjects with clinically significant macular edema as defined by the ETDRS.
* A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart.
* Subjects with laser treatment status/history as follows: \[1\] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, \[2\] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula.
* The subject's ocular media had to be sufficiently clear to allow for quality fundus photography.
* If aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening.
* Subjects had to be males or non-pregnant females of at least 18 years.
* Subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an Informed Consent Form.

Exclusion Criteria:

* Subjects who have had previous grid macular photocoagulation for diffuse macular edema.
* Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy.
* History of or current retinal detachment requiring surgical treatment or a scleral buckle.
* Diabetic Retinopathy that required immediate PRP.
* Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.).
* Glaucoma, or history of glaucoma in either the study eye or the fellow eye.
* Ocular hypertension, or history of ocular hypertension requiring IOP lowering treatment.
* A media opacity that precludes visualization and/or diagnosis of the status of the eye.
* Concurrent coumadin therapy or known bleeding diathesis.
* Subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease.
* Concurrent treatment with a new investigational drug.
* Subjects with a best-corrected visual acuity worse than +1.0 logMAR (20/200 or 35 ETDRS letters) in the fellow eye.
* Pregnant or lactating females.
* Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy.
* History of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device.
* Subjects with photophobia that will preclude the ability to do fundus evaluations.
Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)


Eligibility Criteria:
Inclusion Criteria:

* poor responders (age\>40, abnormal ovarian test, \</=4 oocytes in previous cycle with conventional stimulation)
* infertility, indication for IVF
* no contraindications for heparin
Effect of MD1003 in Spinal Progressive Multiple Sclerosis

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis criteria of secondary or primary progressive MS with clinical evidence of spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria (1996)
* Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5 to 5.5 and at least 0.5 point if EDSS from 6 to 7
* EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months)
* Informed consent prior to any study procedure
* Patient aged 18-75 years

Exclusion Criteria:

* Any general chronic handicapping disease other than MS
* Intensive physical therapy program within the 3 months prior to inclusion
* Impossibility to perform the TW25 test
* New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
* Pregnancy or woman with childbearing potential without contraception
* Evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain MRI performed the year before inclusion."
Effects on Experimental Dyspnea of High Flow Nasal Cannula

To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (HFNC).

This study will measure the effect of HFNC on an experimental model of dyspnea induced by thoraco-abdominal elastic strapping on healthy subjects at rest.

The study will also compare the effects on dyspnea of the administration of high flow nasal cannula with and without oxygen added.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* chronic pathology
* active smokers
* anxiety disorder
* allergy to latex
* protected adult
* woman declared herself pregnant
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI

  * ≥30.0 kilogram/square meter (kg/m²),
  * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

    * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
* Have had a history of chronic or acute pancreatitis.
"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".

Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.


Eligibility Criteria:
Inclusion criteria

1. Adult patients aged ≥ 18 years.
2. Acute supratentorial or carotid stroke. Exclusion criteria

1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:

1. Intraoperative technical limitations limiting or impeding the arterial re-opening
2. Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.
The Impact of Perioperational Malnutrition on the Cost on Gastroenterological Cancer Patients

Undernutrition is a state marked by energy and/or protein intake deficiency or mal-absorption, and is often described as protein energy malnutrition (PEM). Malnutrition is common in hospitalized patients worldwide. The prevalence of malnutrition in hospitalized patients range from 20% - 50%, depends on the varieties of diseases, health system, population and assessment tools. It is well documented in Western countries that malnutrition affects clinical outcomes negatively. Compared with well-nourished patients, patients with malnutrition stay longer in hospitals and related cost is significantly higher.

There is increasing evidence which indicates that appropriate nutrition support (e.g., standardized nutrition screening procedures, delivering nutrients with appropriate path, etc) may improve clinical outcome on malnutrition, along with cost saving.

To date, there is no study to document specifically the impact of malnutrition and related nutrition support on the health economics in China. Considering China now is on its way to establish public health security system and a diagnosis-related grouping system, the understanding of the cost effectiveness of nutrition support under the current clinical conditions is crucial.

This study aims to investigate the prevalence of perioperational malnutrition in gastroenterological cancer patient, the nutrition support status and related health economic effects.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* With gastroenterological cancer
* Will receive resectional operation
* Consent informed

Exclusion Criteria:

* With severly cardiac, pulmonary, liver or renal disease
* With endocrine or metabolic disease
* With dyslipidemia
* Without consent
Validation and Predictive Equation for Sit-to-stand Test in Children

Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.


Eligibility Criteria:
Inclusion Criteria:

* participation in the national physical education program at school
* free of physical activity during one hour preceding the experiments

Exclusion Criteria:

* diagnosis of chronic lung, cardiac or neuromuscular disease
* BMI higher than 85th percentile for children of the same age and sex
* a motor disability based on parents' answer to standardized questions.
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.

During the study period, preterm infants admitted to NICU were included. Infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study.

Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).

Eligibility Criteria:
Inclusion Criteria:

* Infants below 32 gestational age and requiring parenteral nutrition

Exclusion Criteria:

* Infants with congenital anomalies, infants above 32 gestational age
Immunologic Signatures Following Surgery for Pancreatic Cancer

The goal of this pilot study is to evaluate and describe the immunologic and overall outcomes of subjects who undergo routine pancreatectomy with or without irreversible electroporation (IRE) for pancreatic cancer. Immunologic markers in the blood will be measured at several time points before and after surgery to determine if surgical approach is associated with different immunologic responses. Secondary outcomes will include mortality and morbidity; operative time; blood loss and transfusion requirements; and oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and overall survival. Analysis of immune response will help the investigator determine whether to expand the pilot into a larger study.

Subjects will have blood draws at the following timepoints: Pre-op, 1-2 days post-op, 3-5 days post-op, and 1-4 months post-op. At each timepoint, three 8.5mL ACD (yellow top) vacutainer tubes will be drawn by the Biobank and Translational Research Core (BRTC), study personnel, or hospital phlebotomists. The blood will be processed for PBMC isolation by BRTC for Dr. Weinhold's laboratory and will be viable within 8 hours of draw. These timepoints for blood draws are at the same time as usual operative care and will not require additional visits on the part of the subject.

For this study we will extensively utilize several polychromatic flow cytometry (PFC) platforms to follow activation, maturation, exhaustion, and proliferation patterns within CD4+ and CD8+ subsets of T-cells. We will also utilize an intracellular cytokine staining (ICS) platform in efforts to detect anti-tumor associated antigen (TAA) responses by CD4+ and CD8+ T cells from peripheral blood mononuclear cells (PBMC) as well as lymphocytes infiltrating the patient's tumor. These assays are designed to measure antigen-driven intracellular production of IFN-γ, TNF-α, and IL-2, as well as the degranulation marker CD107. This strategy enables us to not only document individual cytokine responses, but to also assess (through Boolean gating) changes in relative polyfunctionality of the responses.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age and at least the minimum age of majority according to applicable State or Country Law.
* Subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and pancreatectomy for diagnosis of cancer
* Subject is willing and able to undergo additional blood draws

Exclusion Criteria:

• Subject is not a suitable candidate for surgery, or surgery is unable to be completed
Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders

Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. The improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. It therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, PEERS, in France to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders.


Eligibility Criteria:
Inclusion criteria:

* Aged between 12 and 30 years, included at the start of the social skills program.
* Patients with rare neurodevelopmental diseases
* Patients benefiting from the social skills program
* Appropriate level of verbal elaboration
* Patient with a family member or a friend also participating in the social skills program

Non-inclusion criteria :

* Opposition of the patient or, if a minor, of his/her parents to participation in the study
* Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders.
* Severe intellectual disability
Indications and Outcomes in Kidney-ureteral Pediatric Lithiasis: Experience of Parma

Incidence of paediatric urolithiasis is increasing in Europe and North America. Nowadays the management of stone disease is a common practice in not endemic country. The surgical's treatment is based on similar techniques as for adults. In the last years due to miniaturization of endoscopic instruments endourology has become the best approach to treat urinary stones in children. The investigators have retrospectively reviewed experience from 01/01/2000 to 28/02/2019 in children ≤ 16 years old affected by urinary stones who underwent rigid and flexible ureterorenoscopy and pecutaneous nephrolitotripsy procedures and recorded clinical data, overall success rate and complication.


Eligibility Criteria:
Inclusion Criteria:

* 0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases

Exclusion Criteria:

* none