cyrilzakka/clinical-trials huggingface dataset:
A Study of EXG102-031 in Participants With wAMD

In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with wAMD.

Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. This Open-label, Dose-escalation Phase I/IIa Study is designed to evaluate the safety and efficacy of EXG102-031 intraocular Injection in participants with wet(Neovascular) Age-related Macular Degeneration（wAMD）.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 50 years of age;
2. Diagnosis of wAMD and current active lesion in the study eye at Screening;
3. An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
4. Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
5. The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.

Exclusion Criteria:

1. Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
2. Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
3. The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
4. Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
5. Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
6. Prior receipt of any ocular or systemic gene therapy agent.
Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: cTNM: stage III
* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases (including retroperitoneal lymph node)
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.

Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and/or females
* Age from 21 to 55 (inclusive)
* BMI ranges from 18 to 30 kg/m2

Exclusion Criteria:

* Previous participation in a PD 332334 study
* Pregnant or nursing females
* Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)
Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock

With a prevalence of more than 15% in ICU, septic shock today represents a real public health problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by an alteration of the body composition and in particular by a loss of muscle mass. In intensive care, there are indirect elements suggesting a link between loss of muscle mass and prognosis.

Muscle mass results from a balance between the pathway of proteolysis and that of protein synthesis, depending on many factors, not one of the most important are insulin. The protein PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates, constitutes an endogenous regulator of numerous intracellular signaling pathways, including that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed during sepsis leading clinically to impaired body composition including muscle body mass. Therefore, we propose to study the association between PTP1B and loss of muscle mass in patients in sepsis in resuscitation.

The intestinal barrier plays an essential role in protecting against microbial luminal flora and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of tight junctions, important actors in the intestinal barrier function. The increase in plasma zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal permeability (16). However, elevation of plasma zonulin has never been evaluated in septic resuscitation patients. This is why we propose the evaluation of the association between plasma zonulin and the loss of muscle mass in these resuscitation patients.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock or severe sepsis
* Age \> 18 years old
* Affiliation to a social security system
* Information and consent. If patient cannot give his consent, an emergency consent will be sign by trusted person
* Contraception for woman, of childbearing age

Exclusion Criteria:

* Pregnancy or breastfeeding
* Prisoners
* Patient with pacemaker or defibrillator
* patient participating to a clinical trial with the same primary outcome
Apollo Remote Observational Sleep Study

The purpose of this study is to examine how Transcutaneous Vibratory Stimulation (TVS) produced by the Apollo wearable affects sleep and cardiovascular function in a diverse real-world population of Apollo users.

The Apollo wearable is a consumer wellness device that offers a non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations (Transcutaneous Vibratory Stimulation) to the body.

In this observational cohort study, we will assess sleep and cardiovascular metrics measured during sleep by Oura ring in participants who use Apollo wearable device both historically (2 years in the past) as well as in the future (two years forward). Participants will not be required to make any changes to their activities of daily living or lifestyle except for the continued use of their Apollo wearable devices and answer periodic questionnaires through an online survey tool.

Participant data for days with and without using the Apollo wearable will be analyzed to identify the near term and long term effects of using a TVS device on sleep and cardiovascular signatures. Environmental and confounding data will be derived from the survey data and biometrics data from the wearables.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or more
* Use both the Apollo wearable and Oura ring

Exclusion Criteria:

* Inability to complete questionnaires written in English.
Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease patients. However, cardiovascular disease remains the major cause of morbidity and mortality in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in PD patients.

OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in PD patients.

HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of PD patients.

DESIGN \& SUBJECTS This is an open label randomized control trial. The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters. Patients will be randomized to active fluid management (treatment arm) or conventional management (control arm).

STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.

INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. For the control arm, patients will only receive dietary counseling. Patients will be followed for one year.

MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period.

DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization data will be compared by non-parametric Mann Whitney U test.

EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload in PD patients.

The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, which is defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy. Patients with clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) will be excluded. The investigators will also exclude patients who are in overt pulmonary edema and required urgent medical care, who have cognitive impairment or problem of communication, unlikely to survive for more than three months, have mechanical problems of the dialysis catheter, or have active peritonitis or peritoneal failure.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy

Exclusion Criteria:

* clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion)
* overt pulmonary edema and required urgent medical care
* cognitive impairment or problem of communication
* unlikely to survive for more than three months
* mechanical problems of the dialysis catheter
* active peritonitis or peritoneal failure
Words Generation in Compulsives Gamblers and Parkinson's Disease Patients

The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system.

Thanks to the words generation test, which reflects the cortico-subcortical loop functioning, involved in motivation, we want to evaluate and compare using tools (words generation and behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic disorders which were explored in another study.

The main objective of this study is to evaluate performance during words generation in gamblers and healthy volunteers compare to those of PD patients with and without hyper-dopaminergic behaviors collected during another study.

2 groups of subjects will be recruited for the study: 20 compulsive gamblers and 20 healthy volunteers

Each subject will realize twice each test during 2 sessions with one hour in between :

During the session 1 :

* The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
* The test of Stroop that assesses selective attention

During the session 2:

* The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
* The task of the casino (Iowa Gambling Test)
* The task of landing
* The test of Stroop

We supposed that the performance of compulsive gamblers in words generation test will be higher than those of healthy volunteers, themselves superior to those of PD patients with a hyper-dopaminergic behavior, themselves superior to those of PD patient without hyper-dopaminergic behavior.

Eligibility Criteria:
Inclusion Criteria:

For healthy volunteers :

* Subject from 30 to 75 years old (Male and female)
* Subject with French mother tongue
* Subject who give their informed and signed consent.
* Subject affiliated to a social protection program

For compulsive gamblers :

* Subject from 30 to 75 years old (Male and female)
* Subject with French mother tongue
* Subject with at least 5 criteria of 10 DSM IV diagnostic criteria for pathological gambling
* Subject who give their informed and signed consent.
* Subject affiliated to a social protection program

Exclusion Criteria:

For healthy volunteers and compulsive gamblers :

* Presence of apathy defined as a score greater or equal to 14 on the scale of Starkstein
* Presence of severe depression defined as a score greater or equal to 25 on the scale BDI (Beck Depression Inventory)
* Presence of dementia defined as a score below 25 on the MMSE
* Subject with vision problems making it impossible for the tests
* Pregnant women
* Subject under tutelage, curatelle or law protection
* Subject included in an other clinical study
Consolidation & Interference in Multiple Sclerosis

The purpose of this research study is to investigate whether minimizing interference improves memory in multiple sclerosis.

The ability to form new long-lasting memories is important for successful independent living and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis (MS) have difficulty remembering new information and this is likely associated with poor acquisition of new information. There are only a limited number of studies that have investigated memory consolidation in MS. The current study will investigate the role of interference during the consolidation time period of memory formation.

Eligibility Criteria:
Inclusion Criteria:

* If you are between the ages of 18-65.
* If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
* If you have MS, you have not had a flare up of MS symptoms in the past month.
* You do not have other neurological issues such as, Epilepsy or Stroke.
* You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
* You do not have a significant history of drug or alcohol abuse.
* You can read and speak English fluently.
* You are not currently taking steroids.

Exclusion Criteria:

* You are younger than 18 years old.
* You are older than 65 years old.
* You have had a prior stroke or neurological disease other than MS.
* You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
* You have a significant alcohol or drug abuse history.
* You are currently taking steroids.
Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Aged up to 18 years
* patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain.
* Decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine

Exclusion Criteria:

* history of intracranial expansive processus, surgery or vascular disease
* infectious state on probe placement
* unilateral anophthalmia
Low Dose Heparin Factorial Trial

An open label 2x2 factorial randomized trial is planned to determine the difference in mean hemostasis time between low dose heparin (LD) i.e between 2000-3000 IU and standard dose heparin (SD) i.e. 5000 IU with or without catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc. S Korea) used in conjunction with TRB (InnoSEAL+TRB \[I+TRB\]) among patients who are undergoing left heart cath at Tabba Heart Institute.

Secondary objectives include testing the difference in radial artery occlusion (RAO), and hematoma (III, IV grade) and composite outcome (RAO+hematoma).

Eligibility criteria:

Hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (CAG) using 6 F sheath will be included. Patients who had STEMI, are on anticoagulants after procedure or on an ongoing anticoagulation therapy, have ipsilateral arteriovenous fistula, RAO at baseline, Barbeau's class D will be excluded.

Intervention:

After written consent, first randomization will be done to the heparin arm. If participant falls in LD heparin group, he/she will receive IV heparin 2000-3000 IU (\<60 Kg-2000 IU; 60-80 Kg-2500 IU; \>80 Kg-3000 IU) at the start of CAG and if SD then 5000 IU of heparin will be administered. Second randomization will be done to allocate the participant in I+TRB or TRB alone arm.

In I+TRB arm, after the completion of CAG, at radial artery site, the sheath is pulled 2-3cm and the area surrounding the puncture site is cleaned, dried and InnoSEAL is placed over the puncture site. A transparent adhesive clear dressing is placed over the InnoSEAL and TRB is applied over the dressing.

In TRB arm, TRB alone will be applied over the puncture site. In both the arms, 10 cc air will be inserted in TRB at the start of the protocol, then at 10, 20, and 30 minutes after the procedure 2cc, then 4cc, and then 6cc or remaining air will be withdrawn. If patient oozes or bleeds from radial site in between the protocol, 2 cc air or more will be inserted to control the bleeding. After reaching 0cc air in TRB, deflated TRB will be observed for 15 minutes. The TRB will be removed and access site will further be observed for 15 minutes for hematoma, oozing/bleeding.

At each air draw, reverse Barbeau's test will be done to check the radial artery occlusion. If radial pulse is found absent after removing TRB, then radial artery colored doppler ultrasound will be done to confirm the radial artery occlusion.

The time from the removal of radial sheath till removal of TRB will be recorded as the compression time needed to achieve hemostasis at the radial access site.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (CAG) using 6 F sheath will be included.

Exclusion Criteria:

* Patients who had STEMI, are on anticoagulants after procedure or on an ongoing anticoagulation therapy, have ipsilateral arteriovenous fistula, RAO at baseline, Barbeau's class D will be excluded.
Itch Relieving Effect of Botox: a Study in Healthy Subjects

The purpose of this study is to determine if Botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers.

Several studies have shown that botulinum toxin type A (BoNT/A) has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors, such as substance P and glutamate. For instance, subcutaneous BoNT/A improves itch accompanied to hand eczema, dermatitis, lichen simplex, and rhinitis. Furthermore, a double-blind, placebo-controlled study showed that BoNT/A reduced histamine itch intensity in healthy men. Since acetylcholine has been shown to mediate itch in atopic dermatitis, this study aims to test the itch relieving effect of BoNT/A on a non-histaminergic model for chronic itch. This non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 (PAR2) receptors, which play a role in the itch of atopic dermatitis, also making this model better suited to test the efficacy of BoNT/A to relive chronic itch.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers between 18 and 50 years of age.
2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
3. No history of chronic itch or pain.
4. Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
5. Must abstain from the use of moisturizers on the arm.

Exclusion Criteria:

1. Individuals under 18 or over 50 years of age.
2. Inability to complete the required measures.
3. The presence of an itchy skin disease.
4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
6. Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
7. Use of emollients on the arms a week prior to the study and throughout the study.
8. Use of anti-depressants, anti-psychotics, and illicit drugs.
9. Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
10. Use of Botulinum toxin in the last year.
11. Known allergies to Botox.
12. Pregnant women. (Women of child bearing potential will undergo an human chorionic gonadotrophin (hCG) pregnancy test before Botox application).
13. Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
14. Infection at the injection site.
15. Cardiovascular disease.
16. Neuromuscular disorder (e.g., amyotrophic lateral sclerosis, myasthenia gravis, or Lambert-Eaton syndrome).
17. Compromised respiratory function.
18. Dysphagia.
19. History of urinary tract infection.
20. History of urinary retention.