cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory

To investigate the safety and effectiveness of the ImplantLock device and its contribution to 8.0 mm long root-form endosseous implants stability under immediately applied continuous functional loading.

Primary Endpoints

* Serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Serious Adverse Event Form.
* Adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Adverse Event Form.

Secondary Endpoints

* Determine 8.0 mm long endosseous implant stability while using ImplantLock Device. Stability will be routinely assessed.
* Determine the ability to immediately apply continuous functional loading on 8.0 mm long endosseous implant while using ImplantLock Device. The ability to immediately apply continuous functional loading will be routinely assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female age 18 and up.
* Subject is schedule for endosseous implantation treatment.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed informed consent form.

Exclusion Criteria:

* Subjects suffering from a disease that might disturb bone regeneration healing process e.g. osteoporosis, anemia, etc.
* Acute infection requiring intravenous antibiotics at the time of screening.
* Bleeding disorders.
* Uncontrolled diabetes mellitus
* HIV positive or any other immunosuppressive disorder.
* Renal failure (Serum creatinine \>2.0 mg/dl).
* Subject with allergies to metal alloys.
* Coagulation disorder.
* Infection / abscess / pains in treatment target area.
* Pregnant or nursing woman.
* Resent history of alcohol or drug abuse (within the last 2 years).
* Subject is smoking.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol.
* Known cognitive or psychiatric disorder
* Concurrent participation in any other clinical study.
* Physician objection.
FibroLamellar Carcinoma: an International Registry Study

Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare (0.05 per 100,000) subtype of primary liver cancer which predominantly affects younger patients, median age of diagnosis 22-23 years. In patients with advanced stage disease the prognosis is poor, and even with aggressive surgery the 5 year survival is less than 50%.

Due to the very low incidence of FLC clinical trials are limited, and as these patients are excluded from most clinical trials there is a lack of consensus on the optimal systemic therapy to employ in this population group.

There are a number of chemotherapy compounds that have been investigated although these are single-institutional case series and/or registry-based studies. The majority of published registry studies are based in the United States hence it is important to describe the patterns of treatment in Europe which has different regulatory approvals for access to therapeutics. Our aim is to run a European multisite registry study detailing the clinical course of \>100 patients with FLC that have received systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmed diagnosis of FLC
* Written informed consent will be required for the prospective cohort
* Adults of \>18 years of age

Exclusion Criteria:

* Any non- histologic confirmed diagnosis of FLC
* Participants with insufficient clinical/ follow up data
Impact of Doula Support on Childbirth Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)

The purpose of this study is to evaluate the impact of doula support on childbirth outcomes of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC). Doulas are paraprofessionals who provide women with continuous physical and emotional support throughout the course of labour. They also conduct home visits in the prenatal and postpartum periods in order to provide women with information on childbirth-related topics and breastfeeding support. They do not perform clinical tasks. Their value lies in the psycho-social care that they provide. It is hypothesized that women who receive doula support alongside standard care will have a lower rate of epidural analgesia use and greater cervical dilation at time of epidural administration, as compared to those who receive standard care alone.

A two-armed randomized controlled trial will be conducted at BC Women's Hospital. The experimental group will receive both standard clinical care and doula support. The control group will receive standard clinical care without doula support. The main outcomes being looked at are use of epidural analgesia and cervical dilation at time of epidural administration. These outcomes have been chosen because of the association between the use of epidural analgesia and both a prolonged length of labour and the need for assisted deliveries (i.e. forceps assisted deliveries, vacuum assisted deliveries, and cesarean births). If it is found that providing doula support for women who are eligible for and attempting to have a VBAC reduces or delays the use of epidural analgesia, then it could be hypothesized that doula support for this population may also shorten the length of labour and reduce the need for assisted deliveries, thereby justifying ongoing research in this area.

Eligibility Criteria:
Inclusion Criteria:

* Women who have had at least one prior cesarean birth, are eligible for VBAC, and plan to attempt a VBAC after counseling at the Best Birth Clinic.
* Singleton gestation.
* Cephalic presentation.
* Term gestation (37-42 weeks at time of delivery).

Exclusion Criteria:

* Women who have a pre-existing medical condition that would be an indication for an elective cesarean birth.
* Women who plan to privately hire a doula regardless of placement in either arm of the trial.
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia

This research aims to facilitate the successful implementation of the new Heart and Stroke Foundation of Ontario dysphagia screening model for acute stroke patients. The objectives will be 1) to determine the natural history of dysphagia screening skill decay, and 2) to assess the benefit of independent web-based practice and periodic feedback on screening skill maintenance. We will enrol a convenience sample of nurses who currently work with stroke patients but who have had no prior formal training with dysphagia screening.

The study will consist of 2 phases: A) an initial pilot phase followed by B) a prospective randomized controlled study. During Phase A, three new web-based, self-instructed skill refresher courses will be developed to help nurses maintain the skills they will learn in an 8-hour workshop on dysphagia screening. During Phase B, nurses will receive the 8-hour workshop and one-on-one evaluation by a speech-language pathologist (SLP). Following training, competent screeners will be randomized into one of two groups: Group A - Control group with no refresher course or periodic feedback from SLP; Group B - Web-based skill refresher courses only. Nurses will be evaluated at several timepoints throughout Phase B to assess theoretical dysphagia screening knowledge and skills.


Eligibility Criteria:
Inclusion Criteria:

* Nurses who care for acute stroke patients
DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry

The purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available DyeVert Systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.

Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media volume (CMV) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV monitoring and minimization during angiography procedures thereby reducing total CMV to the patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI. The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available DyeVert Systems among a large, real-world population of patients undergoing coronary and peripheral angiography.

Eligibility Criteria:
Inclusion Criteria:

* DyeVert Group Patients: Patient underwent a diagnostic and/or interventional angiography procedure in which the DyeVert System was used in a majority of the case
* Patient is willing and able to provide appropriate informed consent (if required)

Exclusion Criteria:

* Required data was not collected or is not available
* In the Investigator or Sponsor's opinion, the patient is not considered to be suitable
Community-Partnered Participatory Development of Mobile Interventions

The purpose of the study is to test an experimental method, a text-messaging app called B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation of a Resiliency Course, developed by community members known as Building Resiliency and Community Hope.

In phase 1, the investigators held a series of in-person and virtual workshops with the Partnered Research Center for Quality Care (PRC) community partners to co-develop mobile interventions to address community priorities. The goal of the workshops was to develop novel mobile interventions based on stakeholder input. The specific intervention to be developed was determined based on stakeholder input regarding community priorities during the workshops. Workshops were audio and/or video recorded to document the process. One of the tools used in this process was the Chorus Participatory Mobile Framework created at the Center for Health Services and Society at UCLA. Chorus is a web application that allows users to easily create mobile (text messaging and interactive voice) applications in real-time without requiring any server programming. The investigators used this framework during the workshops to develop and test the application in real-time. Participants were also given phone numbers to call or text in to the intervention that they co-developed for the purpose of testing, providing feedback, and guiding future development.

In phase 2, the investigators will conduct a pilot randomized control trial of the B-RESILIENT tool developed during the workgroup phase 1. Investigators will enroll 30 adults in South Los Angeles to participate in a randomized, wait-list trial. The study group will receive the intervention for 4 weeks, followed by the wait-list group for another 4 weeks. Investigators will conduct baseline and follow-up surveys, as well as in-person or telephone workgroups, to assess the tool's usability and feasibility for supporting management of mood and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Speak English
3. Endorse one item on the PHQ-2
4. Are able to be contacted by phone or email, and have a cell phone that receives text messages
5. Have internet access

Exclusion Criteria:

1. Under age 18 years
2. Endorse no items on PHQ-2 screener
3. PHQ-8 score of 15 or greater on the baseline interview
4. No cell phone and internet access
5. Currently homeless
6. Has a prior diagnosis of schizophrenia, psychosis, bipolar disorder
7. Current alcohol and substance abuse
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia

To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.

A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.

Exclusion Criteria:

* Subject has recent history of known clinically significant abnormal laboratory findings.
Transcranial Magnetic Stimulation Effects on Nicotine Craving

The proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine craving and cue-reactivity among adult regular smokers.

This pilot protocol proposes to test and further develop TMS for the purpose of studying brain function in nicotine users.

Specific Primary Aims include:

Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of TMS in cigarette smokers.

Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rTMS will impact measures of craving and the reinforcing effects of nicotine.

Design:

The study was a randomized, blind, sham-controlled crossover study in which participants will involve two study visits. Participants will have an initial assessment about tobacco use habits and craving patterns. Participant will look at images related to and not related to cigarette smoking.

Participants will receive two different types of brain stimulation with repetitive TMS (10 Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed before and after each stimulus experiment.

Participants will be measured cortical excitability with TMS before and after each stimulus experiment.

Eligibility Criteria:
Inclusion Criteria:

* Right handed males and females, between the ages of 18 and 50
* Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year
* Mentally capable of reading, writing, giving consent, following instructions

Exclusion Criteria:

* history of seizures
* taking medications that lower seizure threshold
* implanted metal devices (e.g., pacemakers, metal plates, wires)
* pregnant
* history of brain surgery or history of loss of consciousness \>15 minutes
* any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders)
* Current substance use disorders other than nicotine and caffeine use, in the past 30 days
* Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring
Effects of Butyrate Against Pediatric Obesity

Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents with diagnosis of obesity (BMI \>95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)

Exclusion Criteria

* Age at enrollment \<5 or \>17 years
* BMI \<95° percentile for age and sex
* Patients under pharmacological treatment for obesity (metformin)
* Patients assuming vitamin E,
* Patients assuming pre-, pro- or synbiotics
* Simultaneous presence of other chronic diseases unrelated to obesity:

  * cancer,
  * immunodeficiency,
  * cystic fibrosis,
  * allergies,
  * celiac disease,
  * autoimmune diseases,
  * neuropsychiatric disorders,
  * type 1 diabetes,
  * inflammatory bowel diseases,
  * malformations of urinary or gastrointestinal or respiratory tract,
  * chronic lung diseases, genetic and metabolic diseases,
  * chronic hematological diseases.
* History of surgery for the treatment of obesity
* Any medical condition that may interfere with participation in this study
* Participation in other clinical trials still in progress
Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section

The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.

Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).

PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.

The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 35 years old.
* American Society of Anesthesiologists (ASA) physical status II.
* Undergoing caesarean section under general anesthesia.

Exclusion Criteria:

* Medical history of alcohol or drug abuse.
* History of allergic reactions or intolerance to any study medications.
* BMI \> 40 kg/m2.
* History of nausea and/or vomiting within 24 h prior procedures.
* History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
* History of chemotherapy treatment within 4 weeks prior to surgery.
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter

Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is considered the gold standard for cardiac output (CO) monitoring. In this prospective study, we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory CHF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CHF

Exclusion Criteria:

* Pregnant women
* Pediatric patients
* Inability to sign an informed consent form
Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.

Eligibility Criteria:
Inclusion Criteria:

* being over the age of 40
* male gender
* transrectal ultrasound guided prostate biopsy for the first time
* agreeing to participate in the study

Exclusion Criteria:

* presence of any contraindication for prostate biopsy
* any analgesic used 24 hours before prostate biopsy
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic prostate cancer
* Men to receive Gonadotropin-releasing Hormone-agonist therapy

Exclusion Criteria:

* Other cancers except skin cancer
* Evidence of metabolic bone disease
* Prior use of bisphosphonates