cyrilzakka/clinical-trials huggingface dataset:
Low Dose Vasopressin in Traumatic Shock

Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:

* Patient is a male or female patient presumed to be at least 18 years of age;
* Patient has a systolic blood pressure \< 90 mmHg;
* Patient has clinical evidence of acute traumatic injury;
* Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg

Exclusion Criteria:

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:

* Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
* Patient has received greater than 4 liters fluid since time of injury;
* Patient is enrolled in another shock trial;
* Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
* Female patient is pregnant by report or suspicion;
* Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.


Eligibility Criteria:
Inclusion Criteria:

decreased serum testosterone concentration below the normal range (serum T \< 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes

Exclusion Criteria:

previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

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A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase \[COMT\] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).

PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female PD patients of any race aged 30 to 80 years
2. PD diagnosis consistent with the UK PD Society Brain Bank criteria.
3. Stable doses of anti PD drugs for at least 30 days
4. PD patients with well-defined morning "OFF" and a good response to LD
5. MMSE score \> 26
6. No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion Criteria:

1. Atypical or secondary Parkinsonism.
2. Acute psychosis or hallucinations.
3. Subjects treated with neuroleptics
4. History of melanoma or significant skin disorders.
5. Prior neurosurgical procedure for PD.
6. Patients with a history of drug abuse or alcoholism
7. Clinically significant ECG abnormalities.
8. Renal or liver dysfunction
9. Subjects who have participated in another clinical study within 30 days
Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.

10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

Eligibility Criteria:
Inclusion Criteria:

* Patients asking for epi-LASIK surgery
* Patients with stable refraction in the last year
* Patients without systemic and ocular disease
* Patients with 500 microns in pachymetry
* Normal topography

Exclusion Criteria:

* Patients cannot attend their appointments
* Residual, recurrent or active ocular disease
* Previous ocular surgery except LASIK
* Autoimmune or connective tissue disease
* Pregnancy
MBCT for Psoriasis Patients With Anxiety and Depression

This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression.

An adapted MBCT intervention will be offered to people with psoriasis with depression and/or anxiety. 8-week long MBCT therapy will be held between August 2021 and Jan 2022, based on the adapted protocol. The MBCT intervention will consist of 30-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, anxiety and/or depressive symptom severity(SAS/SDS), PASI,DLQI,(as measured with standardized, validated scales) will be compared baseline and weeks 2;4;8;12;16;20;24. Itch intensity ,itch perception ,quality of sleep, hours missing at work ,helpfulness of common itch therapies serve as the secondary outcome, using a paired t-test.

Eligibility Criteria:
Inclusion Criteria:

* the age ranged from 18 to 70 years old
* fulfilled the Classification Criteria for Psoriasis
* the score of the SDS \> 50 and / or SAS \>50
* Participant has normal or corrected to normal vision and hearing
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Participant has insufficient manual dexterity for the computerized tasks
* severe systemic diseases
* patients with severe mental illness or taking psychotic drugs
* Pregnancy
* No access to the internet
Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome

A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.

The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb

Exclusion Criteria:

* contra-indication of a nerve block,
* contra-indication of the use of the pain monitor
Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)

Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear.

Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear. It would involve an alteration of striatal-cortico-thalamic cortical circuits resulting in dopaminergic dysfunction. But glutamatergic hypothesis is also discussed from pharmacological, biochemical and genetic arguments. Exploration of glutamatergic system can be done in humans in vivo using a new radiotracer: the \[18F\] FNM (Fluoroethylnormemantine), a derivative of memantine. In the present study, aim of the study 1) to show the glutamatergic system "in vivo" in patients with Tourette's syndrome and 2) to perform correlations between various motor and behavioral symptoms and the pattern of brain fixation for this radiotracer. To do that, a pilot study will be conducted in 12 patients with Tourette's who will be evaluated in terms of motor (tics) and behavioral (OCD, anxiety, depression, impulsivity) symptoms. Each patient will have a PET-scan exam and a brain MRI exam. Data analysis will be carried out from two different approaches: first by region of interest, and secondly, without topographic a priori with the Statistical Parametric Mapping (SPM) software.

Eligibility Criteria:
Inclusion Criteria:

* Gilles de la Tourette syndrome according to the American Psychiatric association criteria (5 th ed, American Psychiatric association (APA), 2013)
* Aged 18 and over
* Patients treated with 2nd-generation neuroleptics for at least 3months
* Signed consent form

Exclusion Criteria:

* contraindications for MRI exam
* claustrophobia
* person under exclusive period for another study
* pregnant women
* patients under non-authorized treatment (1rst generation neuroleptics) or non-treated by neuroleptics
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.


Eligibility Criteria:
Inclusion Criteria:

Parts 1A, 1B, 1C:

* Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Part 1D:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.

All Parts:

* Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Prior organ or tissue allograft
* Leptomeningeal metastases
* Untreated CNS metastases
* Serious or uncontrolled medical disorders

Other protocol-defined inclusion/exclusion criteria apply
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer

The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
* Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
* Subject must have an intact bladder
* Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
* Subject must be able to provide a minimum of 25 mL of urine for study purposes.
* Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
* Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.

Exclusion Criteria:

* Subject had a history or current diagnosis of any basal or squamous cell cancer.
* Subject had a known diagnosis of any autoimmune disease.
* Subject had known diagnosis of HIV, HCV or HBV
* Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
* Subject is currently pregnant or lactating.
* Subject had surgery within 30 days prior to enrollment
* Subject has known allergy to benzalkonium chloride.
* Subject participated in an investigational drug or device trial within 30 days prior to enrollment.
Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling

One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.


Eligibility Criteria:
Inclusion Criteria:at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.

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Exclusion Criteria:progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol

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Cognitive Impairment and Outcome of Acute Ischemic Stroke.

The aim of this study is to assess the use of ASPECTS and stroke biomarkers to predict the outcome and cognitive impairment in acute ischemic stroke.

150 patients (79 males, and 71 females with a mean age of 64.05±11.55 years) were included in this study presented by acute middle cerebral artery territory ischemic stroke. Vascular risk factors were determined from the history taking. Assessment of GCS and NIHSS at the initial presentation was done to assess the stroke severity. Cognitive functions were evaluated in all study participants by the Montreal Cognitive Assessment (MoCA) Arabic version. An initial and follow up non-contrast CT brain was done after 7 days which were assessed by ASPECTS. Functional outcomes in stroke cases were assessed after three months by Glasgow Coma Scale, National Institutes of Health Stroke Scale and modified Rankin Scale. Biomarkers of cognitive impairment like ESR, CRP, S100B, MMP9 and glutamate were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* First attack of acute MCA territory infarction within 2 days from the onset.

Exclusion Criteria:

* previous stroke,
* presence of anterior cerebral artery infarction,
* posterior cerebral artery infarction, and
* venous infarction.
Moisturizing Effect of Two Dexpanthenol Formulations

The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Phototype: I to IV according to Fitzpatrick scale
* Subjects with dry skin on their forearms

Exclusion Criteria:

* Pregnant or nursing women
* Subjects registered as being in exclusion period in the French Health Minister file of subjects
* Subjects with hypersensitivity to one of the test products
BlueWind Reprieve System for the Treatment of PNP

The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components.

The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female aged 18 - 80.
* Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires.
* Diagnosis of chronic neuropathic pain due to peripheral neuropathy.
* Documented pain attributed to neuropathy for at least 6 months.
* Pain intensity with an average daily VAS score of at least 6, demonstrated by 3 ratings per day across 7 days.
* Patient refractory to conservative treatments including pain medication, for at least 6 months.
* Stable pain medication for at least 4 weeks prior to study enrollment.

Exclusion Criteria:

* Previous participation in another study with any investigational drug or device within the past 90 days.
* Any active implant (cardiac or other).
* Any metal implant in the area of BlueWind device implantation site.
* Current pregnancy or attempting to get pregnant (female patient).
* Any clinically significant neurologic disorders (except PNP).- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
* Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases.
* Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
Human Phototoxicity Test

To determine the phototoxic potential of a topically applied article in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing liver transplantation
* 18 to 65 years

Exclusion Criteria:

* pregnant patients
* primary diagnosis of Acute liver failure and acute on chronic liver failure
Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.

The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.

After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.


Eligibility Criteria:
Inclusion criteria:

* COPD exacerbation, admitted to the respiratory units
* Informed consent
* Age \< 80
* No critical comorbidity compromising outcome up to one month.
* No suspect of malignancy

Exclusion criteria:

* Patient is involved in a rehabilitation program with a frequency \>1/wk during one month after inclusion in the study
* NIMV or ICU on admission
* Patient scheduled for procedure (LTX/LVRS) within one month after discharge
* Readmission \<14 days after previous hospitalization
* Significant pathology that would hinder the participation in resistance training (gonarthrosis, arthritis to be judged by the investigator)
* Clinical signs of pulmonary hypertension