cyrilzakka/clinical-trials huggingface dataset:
Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Although different suture materials are available for various dental procedures, clinicians commonly neglect to select sutures based on their mechanical properties and capabilities. Instead, clinicians rely on their clinical experience to determine which suture material will suffice for wound closure and healing. To our knowledge, there have been no published studies detailing the results of mechanical testing on sutures after clinical application. The aim of this study is to clinically, histologically, and mechanically assess the four common sutures used in periodontal and dental surgery, with the hopes of providing clinicians with a guide that will allow them to choose sutures based on the clinical, histological, mechanical properties that best fit the stress and strain applied to the wound.


Eligibility Criteria:
Inclusion Criteria:

Subject must have read, understood and signed the informed consent form. Subject must require either open flap debridement surgery or implant placement (one to three consecutive teeth replacement) surgery.

Subjects must be males or females who are a minimum of 20 years of age. No history of periodontal or implant surgery at the investigational area site within the past 12 months.

Periodontal probing depths ≥5 mm interdentally at the implant site. Subjects that received single interrupted sutures for flap closure following surgical procedures.

Exclusion Criteria:

* Subject is part of a vulnerable population will be excluded. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.

Subjects with a systemic disease that would preclude periodontal surgery. Subjects who are smokers or chew tobacco. Subjects that received periodontal dressing on the surgical area. Subjects with the presence of acute infectious lesions in the areas intended for surgery.

Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results.
Nicardipine Versus Labetalol During Intubation

The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Patients with heart failure or coronary artery disease 2-3 degree atrio-ventricular block or severe bradycardia (\< 45 beats/min) asthma, bronchial spasm or chronic obstructive pulmonary disease patients with anticipated difficult intubation (Mallampati class III, IV) severe hepatic or renal dysfunction allergy or contraindication to study medication
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas.

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas, with either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations.

Cohort A will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the dose in the confirmatory part of the study (Cohort B). The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.

In both cohorts, there will be a screening period of up to 8 weeks, a treatment period, a 4-week safety follow-up period after the end of treatment, and a 6-month post-study follow-up. The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study. At the end of the study period, participants may be offered participation in an open-label extension (OLE) period.

In Cohort A, adult participants will be randomized to one of two dose levels of REC-2282.

In Cohort B, participants will be randomized to REC-2282 treatment (dose to be determined from Cohort A) arm or placebo arm in a ratio of 2:1.

Eligibility Criteria:
Inclusion Criteria:

1. ≥12 years of age and weighing at least 40 kg
2. Progressive meningioma that is amenable to volumetric analysis
3. Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)
4. Adequate bone marrow function
5. Has provided written informed consent/assent to participate in the study

Exclusion Criteria:

1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening.
3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
4. History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
5. Received another investigational drug within 30 days prior to screening
6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of IMP.
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)

The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.

In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.

With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65
* Confirmed diagnosis of PFO by transthoracic and transesophageal echocardiography
* A history of cryptogenic stroke (CS) or transient ischemic attack (TIA)

Exclusion Criteria:

* Confirmed pregnancy
* Confirmed diagnosis of intracardiac thrombosis
* Confirmed diagnosis of pulmonary hypertension
* Confirmed diagnosis of rheumatic heart disease, or valvular heart disease
* Past medical history of myocardial infarction, unstable angina and intracranial hemorrhage
Acupressure for Constipation in the Elderly

This study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals.

The study is a qualitative and quantitative mixed method, double-blind, randomized, placebo-controlled, pretest-posttest control group study. In this study; a total of 81 elderly individuals over the age of 65 and diagnosed with constipation in a family health center were included, 41 individuals in the acupressure group and 40 individuals in the placebo control group. Ethics committee approval, informed voluntary consent of the elderly and all other necessary permissions to conduct the study were obtained before the study.

The data of the study were collected using the Individual Identification Form, the Constipation Assessment Scale (CAS), the Constipation Quality of Life Scale (PAC-QOL), the Visual Analog Scale (VAS), the Individual Follow-up Form and the Semi-Structured Interview Form. Acupressure was applied to individuals in the acupressure group every day for 12 days, and placebo acupressure was applied to individuals in the placebo acupressure group at the same time and in line with the same protocol. In addition, individual in-depth interviews were conducted with the individuals in the acupressure group after the applications were completed.

Quantitative data were evaluated using the IBM SPSS Statistics for Windows 24.0 package program. In the evaluation of quantitative data; Independent groups t test / Mann Whitney U test, dependent groups t-test, two-way mixed pattern ANOVA, multiple regression analysis (enter method) were used and p\<0.05 value was considered statistically significant. In the evaluation of qualitative data, descriptive and content analysis methods were used.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and over,
* Able to answer cognitive questions
* Able to do daily tasks unaided
* Experiencing two or more of the Rome IV criteria

Exclusion Criteria:

* Communication and adaptation difficulties,
* Malignant, intestinal obstruction, fecal incontinence, diarrhea, irritable bowel syndrome, abdominal infection, etc. have a contraindication to continue the intervention, addicted to bed
* Chronic pain requiring long-term analgesic intake and using psychiatric medication,
TMS Modulation of Insula-related Brain Networks.02

The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* between the ages of 18-55
* right-handed

Exclusion Criteria:

* significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
* current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
* meet DSM-5 criteria for current substance use disorder other than nicotine
* use of psychoactive medications that would result in a positive urine drug screen
* Current use of medications known to lower the seizure threshold
* positive breath alcohol concentration
* presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
* among women, a positive urine pregnancy test
* vision that cannot be corrected to 20/40
The Perception of the Estomy-Individual Regarding of Its Situation

The present work had as purpose to analyze estomy-individuals according to the feelings of their current situation.

The present work had as purpose to analyze estomy-individuals according to the feelings of their current situation. It is about a descriptive research of qualitative approach that took place in September, 2006. The population under study was composed by five estomy patients participants in a Grupo de Atenção dos Estomizados, which has multi-disciplinary character, at the Universidade da Região da Campanha (URCAMP) in the city of Bagé in South Brazil. The collection of data was given through not structuralized interviews and with the estomy-individuals, after the same ones read and signed the term of informed free ssent. The data form analyzed through the method of analysis of categories. Each one received a denomination with capital letters from the alphabet (A, B, D, and E) for their identification. The most significant categories in the answers from the ones being tested were manifestations and feelings of daptation, resignation and affective bond.The manifestation of anger and suffering shown by subjects D and E were only mentioned in this study, not being considered categories. The feeling shown by subjects A, B and C show an acceptance of their reality as rehabilitated from a surgical procedure, in the attempt of decreasing the psycho suffering caused by the mutilation and adaptation to the new status quo, fact which was observed for not appearing in the answers feeling such as revolt and guilty, which are mentioned in the review of literature as characteristics of subjects who suffered a surgical intervention. It is noticed that family support is a determinant fact to accept the new reality. The study contributed to know the subjectivity of the estomated, opening possibilities to improve the attention to health by the multi-professional staff.

Descriptors: Perception; emotions; Adaptation; estomia

Eligibility Criteria:
Inclusion Criteria:

* Estomizados registered in the Single Health System users group's support of the University.

Exclusion Criteria:

* Estomizados unable to come to the group of support for health reasons.
Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life.

The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals.

The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years old
* Individuals must be symptomatic with respiratory symptoms
* Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
* Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
* Individual must be able to perform pre and post bronchodilator spirometry to measure lung function

Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):

* Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT.

Exclusion Criteria:

* Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
* Individuals currently under the care of a Respirologist.
* Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
* Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
* Individuals who are in the third trimester of pregnancy
* Individuals involved in another interventional trial
Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy

Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies refractory to drug treatment lead to increased morbidity, mortality and high costs for public health (representing 75% of the costs associated with epilepsy is among the most costly diseases in Neurology). The only curative therapy is surgical removal or disconnection of the epileptogenic network. To do this, a comprehensive presurgical evaluation is essential to accurately define the location of the epileptogenic zone (EZ) and its relationship with the functional areas that must be preserved. This approach requires in some cases intracerebral EEG recordings. This latter technique, expensive and invasive, remains at present, the standard method in the location of the ZE. In this context, the development of non-invasive and inexpensive methods is a priority in the field. Moreover, many fundamental studies have shown changes in ion homeostasis including sodium associated with hyperexcitability related to epilepsy. The investigators team at CEMEREM, CHU Timone, specialized in the development and validation of innovative methods in MRI, has developed an in vivo sodium MRI acquisition and processing of data unique in France, capable of quantifying the intracerebral sodium concentration in three dimensions in a completely non-invasive and non-irradiating manner


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting a drug-resistant partial epilepsy for which an indication is indicated after préchirugical balance assessment.
* Patient not presenting a psychiatric disease chronicles, an demential syndrome,
* Patient not presenting contraindication to the realization of an examination by MRI

Exclusion Criteria:

* Patient suffering a not operable shape of partial epilepsy or a generalized epilepsy
* Patient suffering an evolutionary associated serious illness (cancer, autoimmune disease, hepatic insufficiency)
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects with Parkinson's Disease

The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts.This study will be held in approximately 5-6 study sites in North America

This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083 compared with sham surgery. Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.

SS1 Cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. SS2 and SS3 will undergobilateral implantation of DSP-1083 in a single surgical procedure.

Eligibility Criteria:
1. Men or women aged ≥ 40 and \< 70 years with a clinically establisheddiagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
2. Subject has a diagnosis of PD for ≥ 5 years.
3. Subject has suboptimal control of PD symptoms, or intolerable side-effects with optimized oral antiparkinsonian medication regimen for ≥ 3 months, including treatment with L-DOPA and at least one medication that increases the effects of L-DOPA .
4. Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
5. Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off medication state.
6. Subject has a pretreatment 18F-DOPA PET scan consistent with PD.
7. Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III and the Hauser patient daily diary.
8. Subject must meet the following ethnicity criteria:

   * SS1 will either be Asian defined as having both parents and 4 grandparents who are ethnically Asian, or non-Asian.
   * SS2 and SS3 will be Asian defined as having both parents and 4 grandparents who are ethnically Asian.
   * Cohort 2 subjects will be of any ethnicity.
9. Subject is approved by the Sponsor Eligibility Committee following review of all required information collected during Screening and prior to surgery on Day -1.
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.

This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol.

Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs.

Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA).

Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.

Eligibility Criteria:
Inclusion Criteria:

1. The subject completed study SOM-029 (SUPRA).
2. The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.
3. In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.

Exclusion Criteria:

1. The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.
2. Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.
3. The subject is pregnant or plans to become pregnant during the course of the study.