cyrilzakka/clinical-trials huggingface dataset:
Multisensory Rehabilitation of Hemianopia

The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.

The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.

Eligibility Criteria:
Inclusion Criteria:

* adults (\<85) of either sex
* diagnosis of a stable homonymous hemianopia (\>6 months) with absence of hemineglect
* lesion encompassing at least primary visual cortex but sparing parietal cortex
* normal auditory and cognitive function
* willingness to participate in the three month program
* ability to perform the visual discriminations in their intact field

Exclusion Criteria:

* adults (\>85)
* normal auditory and cognitive function
* unwilling to participate in the three month program
* inability to perform the visual discriminations in their intact field
Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

The question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. Therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. One hundred patients will be randomized into two groups. Group A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.

The percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two Groups of Patients.


Eligibility Criteria:
Inclusion Criteria:

* Grade 2 ascites
* Serum creatinine less than 1.2 mtg/dl
* Serum sodium \> 130 mmol/l
* Serum potassium within 3.5 and 4.5 mmol/l
* At least five days after the withdrawal of diuretics
* A 90 mmol/day Na diet.

Exclusion Criteria:

* Any therapeutic paracentesis for ascites before inclusion
* Cardiac or respiratory disease
* Gastrointestinal bleeding, hepatic encephalopathy, bacterial infections in the last 4 weeks before inclusion.
* The use of NSAIDs or other nephrotoxic drugs in the last 4 weeks before inclusion.
Occult Carbon Monoxide Poisoning Detection by Pulsated Carboxymetry in an Emergency Department

In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths.

The severe forms are translated by neurological disorders even a coma or the death straight away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency.

Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.

This imposes a fast diagnosis for two reasons:

* For poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (HBCO), the more they risk not to detect it.
* The oxygen therapy decreases the duration of the poisoning and thus the tissular suffering.

Actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning.

Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005, MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way.

Lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.


Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years old consult in ED for :

* cephalalgia
* syncope
* weakness
* nausea
* vomiting
* asthenia

Exclusion Criteria:

* temperature over 38.5 °C
Clinical Features and Outcome in Patients With Osseomuscular Type of Wilson's Disease

The investigators aimed to observe the clinical features and outcome in patients with osseomuscular type of Wilson's disease from a large cohort during long-term follow-up


Eligibility Criteria:
Inclusion Criteria:

* genetically diagnosed WD patients

Exclusion Criteria:

* Deny follow-up
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Measurement Methodology Whole blood samples are collected by fingerstick. Samples tested immediately.

Using the supplied sample dropper, transfer specimen blood drop into the two sample wells. Wait 20-30 seconds. Add two drops of the supplied assay buffer (\~90µL) to the same sample wells Read result in 20 mins.

Primary end points will determine how accurate these tests are (p\<=0.02) by analyzing for:

Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.

An estimated 200 patients are to be enrolled as follows:

150 with a documented medical history of HIV, HBV, HCV or Syphilis. A combination of 2 or 3 conditions is acceptable.

HbsAg patients need to have a HbsAg on file \< 2 years. HIV and HCV or Syphilis patients only need one antibody test in their medical chart.

50 with no documented medical history of HIV, HBV, HCV or Syphilis and are considered normal.

Male or female subjects, ages ≥18 years.

Eligibility Criteria:
Inclusion Criteria:

a documented medical history of HIV, HBV, HCV or syphilis. A combination of 2 or 3 conditions is acceptable.

HbsAg patients need to have a HbsAg on file \< 2 years. HIV and HCV patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.

Male or female subjects, ages ≥18 years. Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-

Exclusion Criteria:

Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.

Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome

In this randomized controlled trial, we intend to determine whether electrical pudendal nerve stimulation is more effective than intravesical instillation in urethral pain syndrome.

According to the 2017 edition of European Association of Urology Guideline, there is no specific treatment for urethral pain syndrome (UPS), and it is recommended this type of patients should be treated in a multi-disciplinary and multi-modal program. Since some mechanisms for the development of UPS suggest it may be a form of bladder pain syndrome (BPS) due to the intimate relation of the urethra with the bladder (both covered with urothelium), a combination of intravesical hyaluronic acid and lidocaine plus sodium bicarbonate, the more widely used regimen for BPS in China, is also applied to UPS here in China. However, the symptom relief of the intravesical irrigation won't last long and patients usually report recurrence in 2-3 weeks. Hence, the purpose of this study is to explore whether the electrical pudendal nerve stimulation（EPNS）, which has been proven effective in treating BPS, is more effective than intravesical instillation (intravesical hyaluronic acid and lidocaine plus sodium bicarbonate) in patients with UPS.

Eligibility Criteria:
Inclusion Criteria:

1. male or female patients aged 18 - 75
2. Occurrence of chronic or recurrent episodic pain perceived in the urethra, especially related to micturition, for more than 3 months; accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven infection or other obvious urethral pathology such as urethral diverticulum.
3. Negative in urine routine test or urine cultivation.
4. agreement to sign the written informed consent.

Exclusion Criteria:

1. Symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants.
2. A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis.
3. life threatening complication such as uterine, cervical, vaginal, or urethral cancer, bladder tumor, heart failure, cardiovascular disease, hemorrhagic disease, uncontrolled diabetes, and/or factors that can affect hemostasis.
4. Female patients with pregnancy or lactation.
5. Serious mental disorders.
Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function

Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function

The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.

Eligibility Criteria:
Inclusion Criteria:

1. Signed patient informed consent form (ICF).
2. Male or Female aged ≥ 18 years at the time of the signature of ICF.
3. Presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the WOMAC function scale.
4. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
5. Willingness to follow indications.

Exclusion Criteria:

1. Use of analgesics within the 24 hours prior to V0.
2. Damaged, infected, or ulcerated skin in the area of treatment.
3. Ongoing cutaneous allergies.
4. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy.
5. Patients suffering from muscular dystrophy.
6. Patients presenting with bone fractures or severe injuries (including locked knee).
7. Severely disabled arthritic patients using a wheelchair.
8. Allergy to device components (Sodium hyaluronate; SHPolypeptide- 6; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
9. Immune system illnesses.
10. Uncontrolled systemic diseases.
11. Known drug and/or alcohol abuse.
12. Mental incapacity that precludes adequate understanding or cooperation.
13. Participation in another investigational study.
14. Pregnancy or breastfeeding.
15. Patients with both knees affected/damaged.
Examining Cooking as a Health Behavior

The proposed pilot study will examine cooking as an intervention target for weight control in overweight adults. The study will also examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions. The study will utilize a cooking pedagogy designed to not just teach participants the basics of cooking different foods, but how to be efficient, mindful cooks. If cooking class participation positively impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a health behavior for multiple populations.

A two arm randomized control trial will examine whether the addition of an active cooking lesson versus a passive observed lesson to a behavioral weight loss intervention results in significantly greater weight loss. Additionally, the study will examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions.

Overweight and obese but otherwise healthy participants (n=64) will be recruited. Recruitment and study initiation will occur in two waves. Wave 1 aims to recruit 32 individuals who will then be randomized to 1) a 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking lessons; or, 2) the same 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking demonstrations. Both groups get the same intervention and the same counselor delivered intervention elements; the presence of active cooking lessons vs. passive observed cooking demonstrations is the only difference between conditions. Assessments will be conducted at 0, 3 and 6 months. Wave 2 (n=32) will follow the same process as Wave 1 approximately two months after Wave 1 is initiated.

Eligibility Criteria:
Inclusion Criteria:

* only individuals who are cooking (from scratch) no more than 3 meals at home per week will be eligible.
* must have a computer or smart device with internet access (at home or work) in order to track their diet and exercise behaviors,
* potential participants will be required to demonstrate some ability to comply with study intervention procedures to be eligible (specifically, they must complete an online dietary self-monitoring diary for 3 days)
* must be at least 18 years old and have a BMI between 25-50 kg/m2
* must agree to be randomized to either study arm and available for both scheduled meeting times in person on the University of Vermont campus

Exclusion Criteria:

* pregnant or planning to become pregnant in the next 6 months or lactating
* physical conditions that would preclude exercise
* medication affecting weight loss
* currently enrolled in another weight loss program
* currently cooking more than 3 meals from scratch at home per week
Early Screening for Gestational Diabetes Mellitus

The working hypothesis of this proposal is that screening for gestational diabetes mellitus as early as the 1st trimester is efficient for detecting the forthcoming presence or absence of gestational diabetes mellitus. The investigators long-term goal is the prevention of gestational diabetes mellitus onset i.e. the prevention of progression to gestational diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st trimester screening criteria is needed.

The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of gestational diabetes mellitus onset.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs
* Gestational age between 6 and 13 weeks from last menstrual period,
* Alcohol \< 2 drinks/day
* Not involved in regular high intensity physical activity
* Singleton pregnancy
* Otherwise good health status.

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Taking drugs interfering with glucose metabolism
Long-term Treatment With the Ketogenic Diet in Epilepsy

This study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications. We will assess patients with epilepsy or one of two rare metabolic diseases; glucose transporter type 1 deficiency syndrome (GLUT1 DS) or pyruvate dehydrogenase complex deficiency (PDHD).


Eligibility Criteria:
Inclusion Criteria:

* Treatment with the ketogenic diet at the National Centre for Epilepsy (SSE) for 5 years or more
* Able to travel from The National Centre for Epilepsy - SSE (Sandvika) to Rikshospitalet (Gaustad) to perform procedures to investigate cardiovascular risk factors
* Willing to draw extra blood for research purposes
* Willing to sign informed consent and participate in the study in accordance with the study protocol
* Willing to sign informed consent for blood samples to be included in research biobank at the Department of Neurology, Oslo University Hospital

Exclusion Criteria:

* Non-compliance with the dietary treatment for 6 months or longer or more than once per month
* Not possible to communicate with parents in Norwegian or English without interpreter
* Patient not able to cooperate and lie still for about ten minutes during the carotid ultrasound examination
* Psychiatric/mental illness, alcohol or drug abuse or other factors making it impossible to pursue the study protocol
Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems. In fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. By inference, it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. In this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.


Eligibility Criteria:
Inclusion Criteria:

* less than 24 hours after the onset of myocardial infarction symptoms
* ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
* myocardial necrosis, as evidenced by increased CK-MB and troponin levels

Exclusion Criteria:

* use of statins for the last 6 months before myocardial infarction
Convalescent Plasma for COVID-19 Patients

The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. The first phase is to test the safety of CP therapy.

Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic worldwide with a vast number of deaths such as severe acute respiratory syndrome-SARS (2003) with 8098 people infected and 774 people died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever, fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical presentation of respiratory distress, and increasing frequency of cardiovascular manifestations has become evident.

In this context, the investigators propose to evaluate the safety of intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation This is a single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.

Written informed consent will be obtained all eligible subjects prior to participation.

Convalescent plasma will be obtained from male donors, nulliparous females, or female donors negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* SARS-CoV-19 PCR positive
* Medium stage
* Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive

Exclusion Criteria:

* Patients with a history of autoimmune disease or IgA deficiency
* Patients with a history of allergy
* Multi-organ/system failure
* Pregnant or breastfeeding at the time of study
* Cancer, history of heart failure, stroke, bronchial asthma
* Multi-organ/system failure with indications for dialysis, severe hypoxia, failure with conventional treatment methods, indications for ECMO.
* The patient is infected with multidrug-resistant bacteria.
* The patient is participating in another study.
* Time from onset to screening\> 21 days