cyrilzakka/clinical-trials huggingface dataset:
The Nolix Feasibility Efficacy and Safety Study

This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.

This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least \>-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 22 and above.
* Suffering from Stress Urinary Incontinence.
* Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study.

Exclusion Criteria:

* Age ≤ 21 years.
* Pregnant or planning to become pregnant during the study.
* Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
* Severely atrophic vagina.
* A history of Toxic Shock Syndrome (TSS).
* Active urinary tract or vaginal infection.
* Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
* Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
* Vaginal surgery within the last 3 months prior to entering the study.
* Has experienced difficulties with the use of intra-vaginal devices, including tampons.
* Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
International Big Data Centre in Emergency Medicine

This observational study aims to use electronic health records to build an International Big Data Centre in Emergency Medicine, within the Institute of Sciences in Emergency Medicine (ISEM) at the Guangdong Provincial People's Hospital. The main questions it seeks to answer are not limited to the following:

* Identify the relationship between Emergency Department Length of Stay (EDLOS), Mortality, and Adverse Events (AE)
* Identify the risk factors associated with high mortality and AE rate among patients who experience prolonged EDLOS
* Other research questions related to emergency medicine, such as building prediction and cluster models for acute diseases

The relationship between the emergency department length-of-stay (EDLOS), mortality, and adverse events (AE) rate remains unclear and underestimated. EDLOS is the time elapsed between the time of arrival and the time of the release of a patient admitted to ED. Mortality is defined as short-term (14 hours, 48 hours, 7 days, 15 days) and 30 days death of patients managed in the ED discharged or admitted. An AE is an event that can result whether from medical mismanagement or happen by accident and causes physical and mental harm to the patient during the stay and remains after leaving. To separate the mismanagement from accidental causes i.e., compliant management but the unfortunate situation or persons, this study will refer to indicators that are objectively measurable and can be compared at different times throughout the patient's stay in the ED.

The hypothesis is that a prolonged stay of the patients in the ED especially without diagnosis or decision of admission is associated with increased mortality and AEs. This project will test this hypothesis through a prospective international multicenter study in contributing to whether a prolonged EDLOS is associated with an increased rate of adverse outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Every patient who ever visited Emergency Department from 2011-2022

Exclusion Criteria:

* Patients with missing demographic (age, gender, etc.) and triage data
Research to Improve Smoke Alarm Functioning and Maintenance

The purpose of this study to evaluate whether (1) targeted smoke alarm education, (2) general fire safety education with a smoke alarm component, (3) basic fire safety education, or (4) an unrelated intervention is most effective way to improve smoke alarm maintenance and function.


Eligibility Criteria:
Inclusion Criteria:

* live within four target neighborhoods in Prince George's County, MD that are at high risk for residential fire and injury.

Exclusion Criteria:

* primary decision maker of home is less than 18 years old
* speak a language other than english or spanish
* nobody at home after six return visits to the home
Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets

The extracorporeal shock wave therapy (ESWT) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies.

The investigators main hypothesis is that the application of extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth should prevent further residual alveolar bone resorption and will enhance vital bone formation.

The investigators null hypothesis is that applying extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth has no influence in the alveolar bone remodeling process.

Therefore, the investigators main objective is to evaluate the efficacy of the ESWT in the prevention of alveolar bone resorption after an extraction with a volumetric exam through computer tomographies (CT) analysis. The investigators secondary objective is to determine the effect of ESWT in the internal bone healing process of these postextraction alveolar sockets, measuring the bone density in the CT (Hounsfield units) and the histomorphometric exam.

Methodology: randomized and open clinical trial with 20 patients (10 per group: with or without ESWT treatment) that comply the inclusion and exclusion criteria. In the first appointment the tooth extraction will be performed, while in the second visit (two weeks later), CT scan will be made to all patients and ESWT will be applied in the experimental group. Finally, in the third visit (ten weeks later), a new CT scan will be done and an implant will be placed in the zone taking previously a bone sample with a trephine bur.

The expected results are an improvement in the quantity and quality of the alveolar bone before the implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 - 65 years old.
* Non-smoking patients.
* Patients committed to rehabilitate the extraction socket with an implant.
* Lack of pathology in the surrounding area.
* Cooperative patients with serious commitment to follow the investigator's postoperative visits, who must sign the informed consent.
* Patients that need a conventional anterior maxillary single tooth extraction.

Exclusion Criteria:

* Systemic illnesses (ASA III or above) that could contraindicate a surgical intervention or modify the wound healing.
* Patients with cardiopathies.
* Patients taking hormones, calcium or oral or endovenous bisphosphonates.
* Patients with uncontrolled periodontitis / periimplantitis.
* Smokers.
* Patients with implant/s in the upper maxilla.
* Surgical extractions that require rising a flap or ostectomy.
* Bone defects larger of 2 mms in alveolar sockets due to cortical bone defect or resorption, fenestrations or/and dehiscences.
* Guided bone regeneration need.
* Periapical radiolucency larger than 2-3 mms.
Prenatal Test for Fetal Aneuploidy Detection

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18yrs or older
* Subject has a singleton pregnancy
* Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
* Subject is able to provide consent

Exclusion Criteria:

* Subject is pregnant with more than one fetus
* Subject (mother) has known aneuploidy
* Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
* Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged ≥ 18 to ≤ 65 years
* A diagnosis of C1-INH HAE or FXII/PLG HAE;
* For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-month period during the 3 months before Screening, as documented in the subject's medical record.

Exclusion Criteria:

* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic risk
* History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a current clinically significant coagulopathy or clinically significant risks for bleeding events
* Known incurable malignancies
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers

This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results;
* Pregnant or nursing female;
* History or active tuberculosis;
* Participated in investigational drug studies within 3 months;
* Used prescription or nonprescription drugs within 7 days or 5 half-lives.
Post-ATU Study of Nivolumab

Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).

It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.

In order to reach goals of this study, collaboration had been established between BMS and the RIC-Mel network (network for Research and Clinical Investigational Research on Melanoma) (NCT03315468).

The RIC-Mel network has set up a national database in order to reference the active file of melanoma patients in France. The RIC-Mel database, supported by Nantes University Hospital, had been approved by French authorities (CCTIRS and CNIL). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris). Nowadays, 49 centres located all over the country are participating, with more than 19,000 melanoma patients included in the database. The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group (GCC) of the French Society of Dermatology .

Based on this, BMS and the RIC-Mel network had established a partnership to set up a study in order to estimate the overall survival of melanoma patients treated by Nivolumab during the French ATU program.

Data are collected in the RIC-Mel database by participating centres. Information of centres, follow-up of activity, data reviewing and extractions are realized by the RIC-Mel network. Data analysis is performed by BMS following a developed statistical protocol.

Patients included in the study were patients with unresectable or advanced metastatic melanoma, which received at least one of Nivolumab, dispensed during the French ATU program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable or metastatic melanoma cared in participating sites,
* Patients included in French nivolumab ATU program,
* Patients treated by at least one perfusion of nivolumab,
* Patients agreed to participate to the study.

Exclusion Criteria:

* Patients with unresectable or metastatic melanoma not included in French nivolumab ATU program,
* Patients having initiated Nivolumab after the 31th December 2015,
* Patients disagreed to participate.
Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. However, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. Therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.


Eligibility Criteria:
Inclusion Criteria:

* Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.

Exclusion Criteria:

* Emergent surgery
* Symptomatic carotid artery stenosis or carotid artery stenosis of ≥50%
* Preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.
The Exercise And Colorectal Cancer Treatment Trial

This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.

This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein and interleukin-6. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation in peripheral blood mononuclear cells and tumor fraction.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically-confirmed stage I-III colorectal cancer
* Completed surgical resection
* Completed chemotherapy (if applicable)
* Completed radiotherapy (if applicable)
* Provide written approval by physician or other qualified healthcare provider
* No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)
* Readiness to exercise \[as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)
* Allow the collection and storage of specimens and data for future use
* Willing to be randomized

Exclusion Criteria:

* Evidence of metastatic colon cancer
* Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)
* Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention
* Current body mass greater than or equal to 181 kg
* Unable to provide a baseline fasting blood sample
* Unable or unwilling to give informed consent
* Unable or unwilling to be randomized
* Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)
Cephea Transseptal Mitral Valve System FIH

To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.


Eligibility Criteria:
MVARC
Efficacy of the Tony Robbins Rapid Planning Method (RPM)

This study will consist of an experimental group and a control group. Approximately 150 adult males and females from the ages of 19+ will take part in this study. Subjects will be divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from our internal database of subjects who have previously shown interest in studies and from userinterviews. Subjects in the experimental group (RPM Group) will be admitted to the Tony Robbins Rapid Planning Method (RPM) virtually at no cost, while the subjects assigned to the control group, will not attend the event, but instead be required to regularly complete journaling involving a to-do-list of their weekly work tasks. Psychological assessment surveys will be taken before the event, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention. The control group will take the psychological assessment before beginning journaling, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention.

For the journaling control group, subjects will be asked to write a weekly to-do-list at least once weekly at the beginning of the week. And at least read, or refer to their journal on a daily basis as direction for the work activities of the day.

The 3-day RPM (Rapid Planning Method) event by Tony Robbins involves online seminar based training sessions designed to enhance participants' productivity, goal-setting abilities, and time management skills. On the first day, subjects engage in virtual workshops focused on establishing clear, specific, and achievable goals through the RPM framework, which emphasizes purpose-driven planning. Day two consists of interactive virtual sessions where participants develop personalized action plans, incorporating Robbins' strategies for prioritizing and organizing tasks. Throughout the event, participants partake in motivational exercises aimed at increasing engagement, self-efficacy, and clarity of vision. The final day includes collaborative virtual activities where subjects practice RPM techniques in real-world scenarios, receive feedback, and refine their plans.

Psychological assessment surveys will be taken before the event, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention. The control group will take the psychological assessment before beginning journaling, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Ages 19+
* Male and Female
* English literate
* Willing to sign the study informed consent form
* Experimental group: must participant in Tony Robbins Rapid Planning Method (RPM)
* Control group: must be willing to journal regularly

Exclusion Criteria:

* Excluded from the experimental group if you DO NOT participate in RPM
* Excluded from the control group if you DO participate in RPM, or any other Tony Robbins sponsored event during the study intervention
Umbrella Study for Analysis of Data Related to Patients With Cancer

This study is a multisite, minimal risk, non-interventional study using patient electronic health record data collected as part of standard of care to answer cohort-based research questions and create robust real-world data sets.

One key purpose of the Study is to collect data that may be used for a wide range of scientific questions and real-world insights.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be diagnosed with cancer
* Medical records available to meet cohort requirements

Exclusion Criteria:

- None
Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women

Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women (pre and post-menopausal) aged 18-40 years
* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
* Are able to understand the nature of the study
* Able to give signed written informed consent
* Signed informed consent form

Exclusion Criteria:

* Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
* Hypertensive, as defined as SBP superior or equal to 140 mmHg
* Obese participants, defined as BMI superior or equal to 30 kg/m2
* Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
* Abnormal heart rhythm (lower or higher than 60-100 bmp)
* Allergies to berries or other significant food allergy
* Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
* Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
* Subjects who reported participant in another study within one month before the study start
* Subjects who smoke an irregular amount of cigarettes per day
* Pregnant women or planning to become pregnant in the next 6 months
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.