cyrilzakka/clinical-trials huggingface dataset:
Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of gentamicin side effects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 7 and up can participate in the 14 day IV gentamicin trial. Male or female, aged 18 and up can participate in the 3 month IV gentamicin trial.
* Been diagnosed with recessive dystrophic epidermolysis bullosa (RDEB) and with a nonsense mutation in the COL7A1 gene.
* Immunofluorescence evaluation of skin biopsies reveals absence or decreased intensity of C7 expression at their DEJ (dermal epidermal junction) compared with normal human skin biopsies.
* Cultured fibroblasts from patient skin synthesize and secrete full-length, 290kDa C7 alpha chains in the presence of supplemented gentamicin (400 μg/ml in culture).
* Ability to sit or lie down for over 30 minutes for IV infusions. For those in the 3 month trial, to be willing to continue treatment at home under the supervision of licensed and trained infusion nurses.

Exclusion Criteria:

* Recent exposure to gentamicin within the past 6 weeks.
* Pre-existing known auditory impairment.
* Pre-existing known renal impairment.
* Pre-existing known allergies to aminoglycosides or sulfate compounds.
* Pregnancy or lactation
* Current use of medications with known ototoxicity or nephrotoxicity.
* Current enrollment in another experimental clinical trial involving systemic treatment with C7 or C7 producing products for the treatment of RDEB.
Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

The study will be a pilot interventional case series aiming to treat 30 patients with Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The doctor is informed of the procedure on the day of.


Eligibility Criteria:
Inclusion Criteria:

* A pterygium will be defined as a wing-shaped growth of fibrotic connective tissue onto the cornea originating from the nasal conjunctiva.
* Only patients older than 21 years will be included.
* No gender criteria are applied.
* Only individuals with the mental capacity to provide informed consent will be included.

More specifically, all the following inclusion criteria must be met:

* Patients have primary pterygium encroaching onto the cornea by a minimum of 1 mm.
* Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
* Patients are willing and able to return for scheduled follow-up examinations for 12 months after the surgery.

Exclusion Criteria:

* Patients with prior history of pterygium surgery.
* Patients with a prior history of glaucoma filtration surgery.
* Patients with optic atrophy.
* Patients with ocular pathology or disease that might confound the outcome or increase the risk of adverse events.
* Patients with a prior history of vitrectomy.
* Patients with central corneal scarring.
* Patients with residual, recurrent, active or uncontrolled eyelid disease.
* Patients with any conjunctival scarring other than pterygium, that could affect surgery outcome.
* Patients with anterior segment pathology.
* Patients with any corneal abnormality.
* Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
* Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
* Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
SynCardia Freedom Driver System Study

The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are implanted with the TAH-t and are clinically stable.

Exclusion Criteria:

* Patients who are implanted with the TAH-t and are not clinically stable.
The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study

This study is based on the National Center for Integrated Traditional Chinese and Western Medicine, utilizing the centralized advantages of our department and integrating multiple disciplines (general surgery, endocrinology, nutrition, sports, and traditional Chinese medicine). It focuses on the effectiveness of gastric bypass stents in treating patients with postoperative obesity after laparoscopic sleeve gastrectomy, as well as in patients with simple obesity. This will improve the prognosis of patients and reduce the medical burden.


Eligibility Criteria:
Inclusion Criteria:

* 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI \< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities.

  2、For those with simple obesity, 27.5 ≤ BMI \< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity.

  3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulin secretion capacity.

Exclusion Criteria:

* 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, but whose pancreatic beta-cell function is largely lost, with a BMI \< 25.0; 3、Age \< 16 years or age \> 65 years; 4、Pregnant women with diabetes and patients with certain special types of diabetes; 5、Those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、Those whose expectations for the surgery are not realistic; 7、Those unwilling to assume the risks of potential surgical complications; 8、Those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、Those in poor general health, who are unable to tolerate general anesthesia or surgery.
Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease

For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.

This study aims to verify the intervention effect of AID on IBD patients, promote the promotion of AID model, and provide new ideas for the prevention and treatment strategies of IBD patients.

In this study, 66 IBD patients who met the inclusion criteria were divided into experimental group and control group by randomized controlled trial method. The experimental group was based on routine nursing measures, and the intervention group taught patients to take anti-inflammatory diet and use the anti-inflammatory diet mini-program developed by the researcher, daily anti-inflammatory diet, intervention time was 8 weeks, and observed the inflammatory indicators (white blood cells, neutrophils, erythrocyte precipitation, CRP), quality of life, anxiety and depression, self-efficacy and other conditions in the blood results of the patients before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;
2. The patient has clear consciousness and certain understanding, language expression and writing ability;
3. Patients participated in this study knowingly and voluntarily;
4. At least 18 years old.

Exclusion Criteria:

1. cognitive impairment, mental illness, accompanied by mental disorders;
2. Alcohol and drug abusers.
3. The patient could not participate in the researcher due to the deterioration of the condition;
4. Patients who voluntarily quit due to other reasons;
5. Those who did not complete the assessment scale during the experiment.
Nudging High-acuity Emergency Department Patients to Schedule a Follow-up Visit

The goal of this campaign is to reduce unnecessary emergency department (ED) visits by encouraging patients with high acuity visits to follow up with an appropriate primary care provider (PCP) or specialist and therefore obtain appropriate care outside of the ED. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message and information added to the patient's after visit summary, and will include a contact number to schedule and hyperlink to allow self-scheduling. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients followed through on the calls to action in the messages differently across conditions.

Enrollment will conclude when either 7500 participants have been enrolled or after 120 days, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* ED visit rated as high acuity (level L2 or L3)
* Discharged from ED in past 24 hours
* Attributed to a Geisinger PCP in Community Medicine Service Line

Exclusion Criteria:

* Have an appointment scheduled within 7 days following discharge with a primary care provider or specialist
* Institutionalized
* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the electronic health record or because the patient opted out
* Admitted to hospital
* Eloped from ED
* Left ED without being seen
* Deceased prior to messaging
Self-management Program in Chronic Neck Pain

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. No previous study has used foam roller in patients with neck pain. In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction. It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain (at least 6 months' duration) not related to trauma .

Exclusion Criteria:

* Whiplash related neck pain
* Previous cervical surgical intervention
* Cognitive impairments which prevent them to follow instructions
* Visual or acoustic limitations
* Physical therapy in the previous six months
Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
* Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy

Exclusion Criteria:

* Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
* Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
* History of prior liver transplantation
* Active or prior systemic therapy for HCC
Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension

The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension

Exclusion Criteria:

Patients with the following conditions

* Patients with a history of hypersensitivity of this product
* Women in pregnancy (included the possibility of pregnancy)
* Patients with severe biliary obstructive disorders or severe hepatic insufficiency
3-months Success Rate of Direct Pulp Capping With Biodentine®

Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.

Context : When a pulpal exposure happens on a vital tooth (without irreversible inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2, MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct pulp capping is poorly documented.

Objective : The main aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping.

Method : The patient's non-opposition is obtained after a loyal explanation of the study in order to collect clinical data, if a pulpal exposure (\<2mm) happens on a vital tooth during decy excavation.

The operator registers the following data: age of the patient, type of the concerned tooth, volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then realized.

A statistical analysis will be performed to determine the success rate (binomial distribution with p=0.05). The predictive factors of success or failure will be analyzed with a logistic regression (with p=0.05).

Eligibility Criteria:
Inclusion Criteria:

* adult patients with a small pulp exposure (\<2mm) created during decy removal on a vital tooth
* absence of spontaneous pain, of fistula, of swelling, of mobility, of periodontal enlargement, of resorption, of periapical pathosis, of furcation defect, on this tooth
* normal periodontal probing around this tooth
* cold vitality test : positive but non increased on this tooth

Exclusion Criteria:

* patient with at risk of endocarditis,
* patient with allergic reactions to a product used in the protocol,
* patient with a lack of oral hygiene,
* tooth with spontaneous pain, fistula, swelling, increased mobility, periodontal enlargement, resorption, periapical pathosis, furcation defect, pulpal necrosis, pulpal irreversible inflammation, excessive dental destruction, very abundant pulp bleeding, impossible set-up of the rubber dam
* tooth with a pulp exposure \>2mm
ReadMap: Reading in Stroke Alexia and Typical Aging

Loss of reading ability due to stroke, called alexia, likely affects over a million Americans at any given time and causes difficulty performing many daily life functions, such as paying bills, using email/text, reading for pleasure, and reading signs in the community. Understanding the brain and cognitive basis of alexia could improve diagnosis and treatment of this important problem. In this study, the investigators will perform a large-scale behavioral and brain imaging study of stroke survivors and typical older adults to improve our understanding of the brain and cognitive basis of reading in both of these groups.

Participants will complete a battery of tests of reading, speech, language, and thinking abilities. In addition, some participants will complete an MRI. Sessions will be completed across approximately 2-6 weeks, but may be extended depending on participants' schedules and availability. Some participants will be invited to repeat these procedures once or twice in approximately 3-12 months to monitor for changes in reading abilities and MRI measurements over time.


Eligibility Criteria:
Inclusion criteria:

Stroke Survivors:

* Age \>= 18
* Learned English at 8 years or younger
* Brain injury resulting from stroke

Controls:

* Age \>= 18
* Learned English at 8 years or younger

Exclusion criteria for all groups:

* History of other brain disorder that could interfere with our ability to interpret results (e.g., Multiple sclerosis, dementia, head injury causing loss of consciousness)
* Severe psychiatric condition that would interfere with participation in the study
* History of diagnosed learning disorder
* Hearing or vision loss that interferes with performance on behavioral tests even after correction with glasses/hearing aids.
* Inability to follow study procedures despite maximal support

Additional exclusion criteria for MRIs:

* Presence of metal in the body that is incompatible with MRI
* Pregnancy
* Claustrophobia
Step Up Versus Step Down in Controlled Ovarian Stimulation

The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.


Eligibility Criteria:
Inclusion Criteria:

* Women with unexplained sterility with needs of intrauterine insemination.

Exclusion Criteria:

* Contraindications to intrauterine insemination.
Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged 18-50 years old
* Women, aged 18-50 years old

Exclusion Criteria:

* Non-lactating women, aged 18-50 years old
* Non-pregnant women, aged 18-50 years old
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.

All trial participants will receive SOC\*.

Randomization will be 1:1 between:

* Treatment arm: allogenic MSC.
* Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC).

  * SOC can include any medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.).

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible.
2. Adult patients ≥18 years of age at the time of enrolment.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigenic tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor.
4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
5. Patients requiring invasive ventilation are eligible within 72 hours from intubation.
6. Eligible for ICU admission, according to the clinical team.

Exclusion Criteria:

1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
2. "Do Not Attempt Resuscitation" order in place.
3. Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
4. History of a moderate/severe lung disorder requiring home-based oxygen therapy.
5. Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
6. Current diagnosis of pulmonary embolism.
7. Active neoplasm, except carcinoma in situ or basalioma.
8. Known allergy to the products involved in the allogenic MSC production process.
9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
11. Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.