cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Soliris Expanded Access Protocol

This protocol provides participants with COVID-19 access to Soliris.

This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years of age and body weight ≥ 40 kg.
2. Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
3. Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
4. In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.

Exclusion Criteria:

1. Unresolved Neisseria meningitidis infection.
2. Known hypersensitivity to murine proteins or to an excipient of Soliris.
A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects

The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing in healthy Chinese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a Chinese male between 18 and 40 years of age
* Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
* Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used

Exclusion Criteria:

Clinically significant

* out of range values for hematology and clinical chemistry variables
* abnormality in physical examination or vital signs
* ECG finding Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.

The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth.

Cultures will be taken from the skin, subcutaneous, and from the implanted valve prostheses with a rayon swab.Graft and Felt material will, after being pressed subcutaneous for 15 sec, placed into prepared sterile bottles containing broth for aerobe and anaerobe cultures. Surgical gloves will be cultured.


Eligibility Criteria:
Inclusion Criteria:

* Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these.

Exclusion Criteria:

* Skin conditions such as eczema, psoriasis.
* Revision surgery
* Aortic surgery
Columbia Moves Physical Activity

The purpose of this study is to evaluate the effect of adding a team competition comprised of members of existing social networks to a technology-delivered program for enhancing physical activity among insufficiently active adults.

This 3-month randomized controlled trial is designed to investigate the efficacy and feasibility of a novel, technology-oriented physical activity intervention characterized by existing social networks and a team competition. Participants will be recruited via emails, fliers, and word of mouth. They will be randomized to a technology-mediated physical activity treatment (TECH) or a treatment which receives an identical intervention as TECH plus a study designed team competition for physical activity promotion (TECH+COMP).

Eligibility Criteria:
Inclusion Criteria:

* Insufficiently active as determined by a one-week, accelerometer-based physical activity measurement
* Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
* Between ages 18 and 65 years
* Access to computer with Internet connection
* Smartphone ownership (Android or iOS)
* Willing to be randomized to either one of the two study groups
* Part of a self-selected team of 3-8 eligible individuals
* Members of the same household cannot be part of separate groups
* Able to walk at least 1/4 mile without stopping

Exclusion Criteria:

* Currently lactating, pregnant, or planning to become pregnant during the length of the study
* Diagnosed with type 1 or type 2 diabetes
* Medical or physical contraindications or limitations for engaging in physical activity
* History of major medical or psychiatric conditions
* Currently participating in a physical activity program
Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

* Saliva plays a key role in the homeostasis of the digestive tract
* The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas
* There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure
* Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis (Laryngopharyngeal Reflux- LPR)
* Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in patients with GERD and LPR, but it is unclear if these are primary or secondary to the disease.
* Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease

Background \& Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. The pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary or secondary. The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared to that of 13 healthy controls. Salivary EGF concentrations were established using a commercially available Elisa kit.

Eligibility Criteria:
Inclusion Criteria:

* study group:

  * symptoms of reflux laryngitis (Reflux Symptom Index- RSI \>13) and videolaryngoscopic signs (Reflux Finding Score - RFS \>7),
  * positive 24 hour double probe esophageal PH monitoring;
* control group:

  * Reflux Symptom Index (RSI)\<13
  * Reflux Finding Score (RFS) \< 7

Exclusion Criteria:

* tobacco, alcohol or other inhaled drug use;
* chronic or acute rhinosinusitis;
* prior history of surgery to the digestive tract or salivary glands;
* prior or current diagnosis of head and neck or digestive tract tumors;
* chronic use of drugs known to alter salivary flow and irritate the larynx, such as, diuretics, anticonvulsants, antihistamines, and inhaled steroids
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)

The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with newly diagnosed brain metastases
* Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
* At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
* Number of brain metastases lower or equal to 5
* Indication of radiosurgery treatment
* Age ≥ 18 years old
* ECOG-PS 0-2
* Expected survival \> 3 months
* Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
* A non-opposition form must have been completed by the patient

Exclusion Criteria:

* Previous cancer (\< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
* Previous brain radiotherapy
* Neurological pathology with cognitive disorders existing before the study
* Having a contraindication for MRI
* Associated leptomeningeal disease
* Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
* Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
* Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"

In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

This fundamental study will therefore best describe current French practices for the management strategy of esophageal cancers after endoscopic treatment. Consequently, the interests of this study, national inventory, are multiple:

1. List a significant number of endoscopic treatments. In particular, by sub mucosal dissection in France, in order to strengthen scientific evidence of its efficacy, to assess its feasibility and complication rate.
2. Describe the therapeutic strategies currently in place during endoscopic treatment,
3. Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age
* Patient with histologically proven high-grade esophageal cancer (adenocarcinoma or squamous cell carcinoma) or dysplasia
* Patient with digestive endoscopy for endoscopic resection (mucosectomy or submucosal dissection) of a cancerous lesion (adenocarcinoma or squamous cell carcinoma) of the esophagus or high-grade dysplasia.
* Patient who received the study briefing note and agreed to participate

Exclusion Criteria:

* Failure to perform the endoscopic procedure
* Patient under guardianship or guardianship or under judicial safeguard measure
* Pregnant woman
* Patient with prior treatment for esophageal cancer.
Nitrous Oxide in the Treatment of Acute Suicidal Ideation

The primary aim of the NITOS study is to investigate the potential rapid antisuicidal effects of N2O in the transdiagnostic treatment of suicidal ideation. On day 1, patients will receive either nitrous oxide (50% N2O balanced with oxygen) or placebo (50% oxygen balanced with air). Seven days after the first inhalation, a second inhalation will be performed. All patients will receive N2O at least once during this trial. While the first inhalation will be double-blind, only the patients but not the raters will be blinded to the second inhalation (day 8). For mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques including analysis of hair and blood samples, and EEG.


Eligibility Criteria:
Inclusion criteria:

* Ability to give written informed consent
* Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide item (item #10) as well as a self-report Beck Scale for Suicide Ideation (BSS; Kliem et al., 2017) items #4 plus #5 score ≥ 2
* Plasma homocysteine level ≤ 14 µmol/l

Exclusion criteria:

* Organic, including symptomatic, mental disorders (F00-F09; lifetime diagnosis)
* Schizophrenia, schizotypal and delusional disorders (F20-F29; lifetime diagnosis)
* Mental and behavioral disorders due to psychoactive substance use. Nicotine and cannabis will be ignored (F10-F19)
* Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months
* Past intolerance or hypersensitivity to N2O
* Critical illness
* Severe cardiac disease
* Pregnancy or breastfeeding
* Pulmonary hypertension
* Chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin B12
* History or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the investigator
* Treatment with ketamine/esketamine during the last 4 weeks
* Treatment with opioid medications during the last 3 months
* Treatment with vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT) within the last 3 months
* Recent (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day
* Finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia

A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program.

To validate the diagnostic performance of the HeartTrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using EST.

Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis by the HeartTrends device for the detection of myocardial ischemia, as determined by stress echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* No known CAD
* Referral for EST due to either one of the following two indications:

  1. Chest pain syndrome or equivocal angina in subjects with intermediate pretest probability of CAD according to the 2002 updated guidelines for exercise stress examination.1 (See definition of intermediate pretest probability of CAD in Supplementary Appendix Table at the end of this document); or
  2. Asymptomatic subjects with diabetes mellitus referred to EST for risk assessment prior to initiation of an exercise program.
* Willing and able to provide written informed consent

Exclusion Criteria:

1. Acute Coronary Syndrome
2. Established CAD
3. Atrial fibrillation or flutter
4. Cardiac Pacemaker
5. Clinical diagnosis of heart failure
6. Severe COPD (FEV1\< 50% predicted value)
7. Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
8. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
9. Any illness that might reduce life expectancy to less than 1 year from screening
10. Left bundle branch block (LBBB), significant intra-ventricular conduction delay (IVCD) or significant (\>1mm) ST deviations on baseline ECG
11. Inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
12. Any significant valvular disease defined as:

Established valvular regurgitation or stenosis abnormality above moderate severity 13. BMI \>35 kg/m2 14. Recent (\< 6 months) history of pulmonary embolism

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EYEFILL® C. -US Viscoelastic Clinical Investigation

The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery.

EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery.

EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.


Eligibility Criteria:
Inclusion Criteria:

* Any race
* Older than 21 years
* Cataract requiring cataract extraction in at least 1 eye
* Clear intraocular media other than cataract
* Able to provide written informed consent
* Able and willing to comply with required follow-up schedule
* Competent to understand the procedure and the actions asked of him/her as a research subject

Exclusion Criteria:

* Monocular
* Ocular infection
* History of glaucoma, Ocular Hypertension (IOP \> 21 mmHg) likely to require IOP lowering medications, ocular condition requiring IOP lowering medication, condition preventing reliable Goldmann applanation tonometry, known steroid responder
* Previous intraocular surgery in the operative eye
* Previous serious corneal disease or known endothelial cell loss / damage (in operative eye)
* History of chronic or recurrent inflammatory eye disease (in operative eye)
* Evidence of retinal vascular disease (in operative eye)
* Uncontrolled diabetes or proliferative diabetic retinopathy
* Acute or chronic disease or illness that would increase the operative risk
* Allergy to anesthetics or other postoperative medications
* Known hypersensitivity to sodium hyaluronate or other components in viscoelastic
* Patient in any other clinical trial within the 30 days prior to the start of the study
Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.

Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.

Eligibility Criteria:
Inclusion Criteria:

* age \< 40 years
* \< 4 previous ovarian stimulations

Exclusion Criteria:

* allergy for acetylsalicylic acid
Expanded Access Program for GBM Subjects

This small-size patient population expanded access program is to provide access to investigational product RZ-001 for up to around 4 patients with human telomerase reverse transcriptase(hTERT)-positive Glioblastoma (GBM) who are not eligible to participate in the RZ-001-201 clinical study or in any other study involving the use of RZ-001

This expanded access protocol provides expanded access to RZ-001 to patients with glioblastoma. After provision of written informed consent, subjects will be evaluated for eligibility during the Screening period, a period of 28 days prior to the RZ-001 administration on Day 1. Subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from RZ-001 administration) survival follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females legally considered to be adults in the country in which they are participating in the study.
2. Histologically-confirmed Grade 4 astrocytoma, GBM, per The 2021 WHO Classification of central nervous system (CNS) Tumors.
3. Recurrent GBM with radiographic evidence of the PD (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on MRI, as defined by the mRANO (modified Response Assessment in Neuro-Oncology) criteria. Only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed.

Exclusion Criteria:

1. Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
2. Have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from Screening.
3. Have received radiotherapy within 12 weeks from Screening.
4. Have extracranial metastases of the tumor cells.
5. The subject is eligible for participation in any ongoing clinical study with RZ-001, or has already received RZ-001 in the past.
6. The subject is being transferred from an ongoing clinical study for which they are still eligible.
The Use of a Language Toolkit for Toddlers

To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers.

We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 14.5 to 18.5 months
* Below average expressive language
* Otherwise normal development

Exclusion Criteria:

* Other developmental delay
* Non-English primary language