cyrilzakka/clinical-trials huggingface dataset:
Reverse Shoulder Prosthesis Prospective Multi-Center Study

The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).

Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a total shoulder joint replacement
* Subject must be diagnosed with one or more of the following conditions:

Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery

* Subject has a functional deltoid muscle
* Subject's joint must be anatomically and functionally suited to receive the selected implant
* Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures
* Subject is not pregnant

Exclusion Criteria:

* Subject has a non-functional deltoid muscle
* Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
* Subject is pregnant
* Subject has an active infection or sepsis
* Subject has loss of ligamentous structures
* Subject has a history of alcoholism or other addictions (current or past)
* Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
* Subject has severe glenoid bone loss
* Subject has known materials sensitivity (to metals)
* Subject is younger than 60 years of age (\< 60 years of age) at consent
Dermacyd in Odor Reducing.

Primary Objective:

- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional

Secondary Objective:

- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.


Eligibility Criteria:
Inclusion criteria:

* Perfect mucosa in the product analysis region
* Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
* Bacterioscopy describing the vaginal flora
* Negative Trichomonas vaginalis test
* Negative Whiff test
* Willingness in using preservative in the sexual intercourse during the study period
* Use the same category cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Use of antiinflammatory / immunosuppression / antihistaminic drugs
* Atopic or allergy history to cosmetic products
* Active cutaneous disease (local and/or disseminated) in the evaluated area
* Disease which can cause immunosuppression, such as diabetes, HIV, etc.
* Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
* Intense solar exposure (to get a tan) during the 15 days before the evaluation
* Gynecologic treatment until four weeks before the evaluation
* Any vaginal infection detected during the inclusion
* Other conditions considered by the investigator as reasonable for exclude the patient in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Care Anywhere With Community Paramedics Program to Reduce Hospitalization

The purpose of this research is to compare the effectiveness of the Care Anywhere with Community Paramedics program with usual care in a pragmatic randomized controlled trial. The goal of the Care Anywhere with Community Paramedics program is to prevent or shorten hospitalizations among patients who are being treated in the clinic/ambulatory setting ("prehospital setting"), emergency department, or hospital and are clinically appropriate to be cared for at home with community paramedic services.

This pragmatic randomized controlled trial will randomize, with 1:1 allocation, 240 adults being treated in the pre-hospital setting, emergency department or hospital to either availability of the Care Anywhere with Community Paramedics (CACP) program or to no availability of the CACP program (i.e. usual care). Patients randomized to the CACP program will be able to receive in-home medical care - as ordered by their treating clinicians - from the Mayo Clinic Ambulance Community Paramedic Service. Primary outcome is going to be days alive spent at home without hospitalization (excluding planned admissions), emergency department visits, or skilled nursing facility care.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18 years) patients currently admitted to the ED, hospital or are in a pre-hospital setting but being considered for referral to the ED or hospital in Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting.
* Must reside within approximately a 40-mile radius of Rochester, MN or within the service radius of Barron, WI.
* Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home

Exclusion Criteria:

* Referring clinician and the community paramedic service do not believe the patient to be clinically appropriate for outpatient care with the CACP program.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
* Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service.
* Living conditions unsafe for CPs to enter (patient refuses to secure weapons or animals prior to CP's arrival).
* Enrolled in the trial during an earlier hospitalization or ED visit.
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients

This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease


Eligibility Criteria:
Inclusion Criteria:

* Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
* Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
* Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).

Exclusion Criteria:

* Requiring hospitalization at time of screening, or at time of study drug administration.
* Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.
* Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
* Any co-morbidity requiring hospitalization or surgery within \<7 days, or that is considered life-threatening within 29 days.
* A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.
* Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.
* Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study.
* Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.
* Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells \<200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study.
* Subjects at high risk for of COVID-19 related complications or mortality
Magnesium vs Placebo for Tonsillectomy

This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.

Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).

The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.

The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon
* American Society of Anesthesiology (ASA) patient classification of I-III

Exclusion Criteria:

* Physical or developmental delay
* Psychiatric illness
* Current use of sedative or anticonvulsant medication
* Pre-existing renal disease
* Pre-existing cardiovascular disease
* Regular use of analgesic medication
* Having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)
Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.

Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.

Prospective randomized controlled study with two study arms.

Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.

Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)

After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.

Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.

Study enrollment was prematurely terminated on 30. Apr 2009. Already enrolled patients will be followed for 24 months according to protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for elective or early elective open repair of aortic aneurysm

Exclusion Criteria:

* Emergency surgery
* EVAR (endovascular procedure)
* Patients with previous midline laparotomy
* Patients with in situ abdominal mesh after previous hernia repair
* Patients with large diastasis of abdominal wall
* Allergy to penicillin
* Women before menopause (mesh can interfere with potential future pregnancies)
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

* To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
* To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
* To evaluate tumor response

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy
* Requiring at least grade 2 weeks of radiation therapy
* Solid tumors of the central nervous system, head and neck area, and cervix
* World Health Organization (WHO) performance status equal to or less than 2

Exclusion Criteria:

* Equal to or greater than grade 2 peripheral neuropathy
* Myocardial infarction within 6 months
* Hypersensitivity to bortezomib, boron, or mannitol
The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology

The purpose of this study is to determine whether sacral surface electrical stimulation is effective in the treatment of assisted reproductive technology.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of infertility
The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes

This is an academic research study aiming to explore the relationships between equanimity, mindfulness, self-compassion, and mental health outcomes, and to examine the reliability and validity of the new measures in Hong Kong.

The current research aims to validate two new measures, the Equanimity Scale (ES-16) and the Sussex-Oxford Compassion for the Self Scale (SOCS-S) in Hong Kong. Standard procedures of forward-backward translation of the ES-16 and SOCS-S were employed. Adults aged 18 or above will be recruited in the community to fill out a set of questionnaires two times on equanimity, mindfulness, self-compassion, and mental health outcomes (i.e., depression, anxiety, stress, wellbeing). Relationships between these variables will be explored. To assess test-retest reliability, participants will be invited to fill out the same set of questionnaires on a total of two time points: baseline and two-week post-baseline.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* can read and type Chinese
* have means to access online surveys

No Exclusion Criteria
COMparison Between All immunoTherapies for Multiple Sclerosis.

The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).

This is a prospective non-intervention observational prospective cohort study assessing the long-term safety and efficacy of RTX treatment in MS compared with other common MS DMTs regarding both clinical and radiological parameters in a real-life population of patients with MS.

A number of parameters will be assessed annually. These include baseline demographics, previous drug history and reasons for discontinuation, disability status (expanded disability status scale), relapses, safety and adverse events (AE), contrast enhancing T1 and newly appearing T2 lesions on magnetic resonance imaging, as well as a panel of patient reported outcome measures: Symbol Digit Modalities Test (SDMT); MS impact scale-29 (MSIS-29) Fatigue Scale for Motor and Cognitive Functions (FSMC), EuroQol-5 Dimensions (EQ-5D), the MS check scale and Treatment Satisfaction Questionnaire 9 (TSQM-9).

Retrospective data entered in medical charts and the Swedish MS registry will be included together with prospective annual structured follow up from inclusion into the study for a minimum of three years (three to nine years).

In a substudy - Covid Enhancement study - analyses will be performed regarding the effect of COVID-19 on people with MS as compared to non-MS individuals and also if there is any indication that a particular DMD is associated with a risk to contract a more severe COVID-19. The analyses will primarily be performed in official health care databases.

Eligibility Criteria:
INCLUSION CRITERIA:

The study population consists of all patients with Clinically Isolated Syndrome (CIS) or RRMS who;

* Initiate a first MS DMT (treatment naïve), or Initiate a second ever DMT, of a different drug class than the first, regardless of time between drugs or reason for discontinuation("switchers") from 1st Jan 2011 to 30st June 2018, and
* Are followed at any of the University clinics of Sweden, and
* Consent to participation in COMBAT-MS core, and
* Are expected to be capable to follow study assessments.

EXCLUSION CRITERIA:

- Patients with progressive forms of MS at start of therapy are not eligible
Cell-Based Noninvasive Prenatal Testing

The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.


Eligibility Criteria:
Inclusion Criteria for healthy pregnant subjects:

* Pregnant
* 18 years or older
* 65 or younger

Exclusion Criteria for healthy pregnant subjects:

* Acute illness
* Unavailability of maternal blood sample of at least 30 ml
* Language barrier (non-English speaking )
* Maternal age of less than 18 years, or over 65
* Higher order multiple pregnancy (triplet or greater)
PillBot™ - Remotely Controlled Capsule Endoscopy

The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD
* Willing and able to complete study follow-up requirements
* Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain

Exclusion Criteria:

All patients who meet any of the following criteria should not be enrolled into the study:

* Coagulopathy with INR \> 1.5, thrombocytopenia with platelet counts \< 50,000
* Active bleeding
* Need for therapeutic procedures during endoscopy
* Lactation
* Dysphagia, or other swallowing disorders
* Known esophageal diverticulum or stricture
* Swallowing disorder
* Known luminal, gastrointestinal strictures
* Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent Computed tomography enterography (CTE) or Magnetic resonance enterography (MRE), MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule
* History of esophageal, gastric surgery or intestinal surgery
* Esophageal or GI motility disorder
* Known or suspected gastrointestinal obstruction, significant intestinal strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
* Current participation in another investigational drug or device treatment study
* Pregnant or wishes to become pregnant during the study follow-up period
* Patient with implanted medical device that would be potentially affected radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators)
* Severe psychiatric, neurological, cardio-vascular, or renal disorders
* History of allergy or intolerance to materials used to make the PillBot
Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy

To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.

In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.

Eligibility Criteria:
Inclusion Criteria:

1. 18≤Male or female age ≤85 years old;
2. patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Male or female \<18 years old, or Male or female \>85 years;
2. The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
3. The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
4. The patient has a history of allergies to drugs or food.
5. The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
6. Lactation or pregnant women.
7. Refusal to sign the informed consent form.
8. Others who do not take this test.