cyrilzakka/clinical-trials huggingface dataset:
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery

Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.


Eligibility Criteria:
Inclusion Criteria:

* ages 12-21 years
* attending high school or middle school (peak period for insufficient and delayed sleep)
* completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
* All must also be Tanner Stage 5

Exclusion Criteria:

* regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
* HbA1c ≥6.5%
* intelligence quotient (IQ) \<70 or severe mental illness
Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer

This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of colorectal carcinoma
* tumor located at right half of colon
* Undergoing laparoscopic right hemi-colectomy
* preoperative staging cT2-4aN0M0 or cTanyN+M0
* willing to participate and informed consent signed

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous colorectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Preoperative staging cT1N0 or cT4bNany
* Emergency procedure
Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia

Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward participation. Our study aims at assessing the awareness and willingness to participate in CR and identifying the barriers and influencing factors for participation.

A cross-sectional study was performed using an interview-based questionnaire composed of close-ended questions conducted by trained research coordinators. Descriptive statistics, univariate and multivariate analyses were applied.

Clinical Trials are essential for the identification of effective therapies in modern medicine. As the biomedical understanding of diseases increases, a growing number of new opportunities will require increasing numbers of patients agreeing to participate in a clinical trial

Public awareness about the need for clinical research and the benefit beyond participation is important. Although the main objective of clinical trials is to provide a high standard of care and help in advancement of medical knowledge, only a small portion of patients receive treatment as part of a formal clinical trial

Misconceptions about clinical trials are frequent, primarily due to lack of adequate information from the treating physician; the complexity of the study procedure; preferences of patients regarding a particular treatment or no treatment; uncertainty and the experimental nature of a clinical trial (additional side effects, less known about the treatment) and concern about confidential information are some of the significant barriers to participation. Healthy individuals and patients do not have the same perception, since patients have stressed and vulnerable feelings after diagnosis of their illness having a negative impact on patient's attitude towards a trial.

The ability to recruit patients for future clinical trials will depend, in part, on understanding the barriers of participation in clinical trials. Unfortunately, there is no data about the public awareness and attitudes toward participation in clinical trials in Kingdom of Saudi Arabia. It is the purpose of this study to address this issue to create some baseline data to increase the accrual rate of clinical trials.

Eligibility Criteria:
Inclusion Criteria:

Adult patient (18 years and above) with cancer diagnosis. Adult patients who are treated services at King Abdulaziz Medical City (KAMC), National Guard Health Affairs(NGHA) Riyadh Willing to complete the survey questionnaire

Exclusion Criteria:

Patients who refuse to complete the survey questionnaire
Prevalence and Factors of Sarcopenia and in Patients With Primary Sjogren's Syndrome

Sarcopenia is a progressive condition characterized by decline in muscle strength and muscle mass. Although the mechanism of sarcopenia has not been fully elucidated, it may be caused by protein-poor diet, vitamin D deficiency, hormonal changes, increase in inflammatory cytokine level and oxidative stress. For this reason, it is thought that determining the prevalence of sarcopenia in rheumatological diseases with chronic inflammation and protecting patients from possible comorbidities with appropriate interventions may be an important factor in maintaining and improving the functional levels and quality of life of patients.

The aim of our study was to investigate the prevalence and its associated factors of sarcopenia in individuals with primary Sjögren's Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary Sjogren's syndrome by an experienced rheumatologist according to European League Against Rheumatism (EULAR) ve American College of Rheumatology (ACR) criteria
* Being 40 years or older.

Exclusion Criteria:

* Pregnancy,
* Malignancy,
* Presence of other rheumatological diseases,
* Presence of diabetes mellitus
* Presence of neurological problems
* Presence of osteoarthritis
Endoscopic Submucosal Dissection Versus Gastrectomy

Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.

The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea, the detection rate of EGC has increased with mass screening for the prevention of gastric cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. The presence of lymph node metastasis has been reported to range from 2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year survival rate above 90%.

In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. Thereafter, the result was adopted as expanded criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor recurrence rate.

Although curative resection is pathologically achieved by ESD, post-resection surveillance is needed to confirm the presence of nodal metastasis. Recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in EGC patients who underwent curative ESD. However, there is no comparative study about long-term outcomes after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between ESD and surgery groups.

Eligibility Criteria:
Inclusion Criteria:

* differentiated type mucosal cancer without ulceration, regardless of tumor size
* differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
* superficial (SM1 \< 500 μm) submucosal cancer ≤ 3 cm in diameter
* undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter

Exclusion Criteria:

* early gastric cancer in a remnant stomach
* gastrectomy due to metachronous lesions during follow-up period
* post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor
Brain Health Program for Older Adults with Subjective Cognitive Decline

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.

Eligibility Criteria:
Inclusion Criteria:

* Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older
* Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6
* Telephone Interview for Cognitive Status-41 ≥ 31
* Functional Assessment Questionnaire \< 9
* English fluency/literacy
* Ability and willingness to participate via live video
* No self-reported safety issues with initiating lifestyle changes during the study

Exclusion Criteria:

* Mild cognitive impairment, dementia, or neurodegenerative disease
* Psychotropic medications (e.g., antidepressant) change in the last 3 months
* Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia or schizoaffective disorder
* Current self-report of suicidal ideation
* Serious medical illness expected to worsen in 6 months (e.g., cancer)
* Use of digital monitoring device (e.g., Fitbit) in the last 3 moths AND unwillingness to stop using personal digital monitoring device for duration of program
* Mindfulness or mind-body practice (\> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in \< 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in \< 3 months
* Average daily step count \> 5,000 steps
* More than 30 minutes of exercise daily
Dental and Oral Finding in Israeli Children With Past Intrauterine Growth Retardation (IUGR)

oral status and early childhood caries (ecc) in israeli children with past IUGR


Eligibility Criteria:
Inclusion Criteria:

* children who were born and diagnosed with IUGR

Exclusion Criteria:

* children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy
Long-term Efficacy of Metacognitive Training for Depression (D-MCT)

Aim of the current study is to investigate the long-term efficacy of Metacognitive Training for Depression (D-MCT) and to explore whether previously observed effects at the 6-month follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at the 3-year follow-up.

Dissemination of treatment for depression is still unsatisfying: every second patient does not receive, refuses, or is waiting for treatment. Moreover, with a drop-out rate of almost 25% in routine clinical practice, and a 54% relapse rate for treatment responders within the two years after treatment termination, improving treatment is necessary. Metacognitive Training for depression (D-MCT), a low threshold, easy to administer group intervention was designed to fill this gap. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. It was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study. Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., in press). In this trial patients with depressive disorder were completing a psychosomatic outpatient treatment program and were randomly assigned to either D-MCT or general health training. Severity of depression and cognitive biases were assessed at baseline (t0), post treatment (t1) and 6 months (t2) later by raters blind to diagnostic status. Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months later, improvement in depression was significantly greater in the D-MCT relative to the health training group at medium effect sizes. A significantly greater number of patients in the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time. Aim of the current study is to investigate the long-term efficacy of D-MCT. For this purpose, an additional 3 year follow-up assessment (t3) is conducted. The Hamilton Depression Rating Scale (HDRS, 17-item version) total score serves as the primary outcome. Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, and ability to work serve as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria for the current study are:

* informed consent
* intention-to-treat-sample of the study Evaluation of Metacognitive Training for Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek et al., in press, Psychotherapy and Psychosomatics)
* age between 18 and 65 years
* diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI).

The exclusion criteria were:

* lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ \< 70).
California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of Tranexamic Acid (TXA) use in the civilian prehospital and in hospital setting in cases of traumatic hemorrhagic shock.

The Cal-PAT study is a multi-centered, prospective, observational cohort study. From March 2015 to July 2017, patients ≥ 18-years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified were considered for TXA treatment by first responders in the prehospital setting and physicians in hospital. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, injury severity scores, and mechanism of injury. The primary outcome measured was mortality. Secondary outcomes measured included the total blood products transfused, the hospital and intensive care unit length of stay, and the incidence of known adverse events associated with TXA.

Eligibility Criteria:
Inclusion Criteria:

* Blunt or penetrating trauma with signs and symptoms of hemorrhagic shock
* Systolic blood pressure less than 90 mmHg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers
* Any sustained blunt or penetrating injury within 3 hours
* Patient who are considered to be at high risk for significant hemorrhage

  1. Estimated blood loss of 500 milliliters int he field accompanied with HR \>120
  2. Bleeding not controlled by direct pressure or tourniquet
  3. Major amputation of any extremity above the wrists and above the ankles

Exclusion Criteria:

* Any patient under 18 years of age
* Any patient with an active thromboembolic event (within the last 24 hours) i.e. active stroke, myocardial infarction, or pulmonary embolism
* Any patient with a hypersensitivity or anaphylactic reaction to TXA
* Any patient more than 3 hours post injury
* Traumatic arrest with \> 5 minutes CPR without return of vital signs
* Penetrating cranial injury
* Traumatic brain injury with brain matter exposed
* Isolated drowning or hanging victims
* Documented cervical cord injury with motor deficit
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

1. unknown adverse drug reactions (ADRs);
2. occurrence of ADRs;
3. factors that are likely to affect safety and efficacy;
4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy participants from 12 to 17 years of age with:

  * Partial seizures (with or without secondary generalized seizures)
  * Primary generalized Tonic-clonic seizures

Exclusion Criteria:

* Participants previously treated with Fycompa
The Remote Monitoring of Gout Feasibility Study

In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.

In this feasibility study various outcome measures will be assessed to determine whether the app (Urika) is viable, practical, and useful. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female \>18 years of age at screening
* Patients with a clinical diagnosis of gout
* Patients who fulfil the American College of Rheumatology (ACR)/EULAR classification criteria
* Serum urate level \>360 μmol/L at inclusion
* Having a smartphone/tablet

Exclusion Criteria:

* Contraindication for urate lowering therapy
* Unstable medical conditions (e.g,, uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance \<45 mL/min); severe infection or gastrointestinal bleed
* Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
* Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study

The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.

The cobalt-chromium prosthetic abutments are designed to be installed between the implant and prosthesis. CoCr abutment coping, CoCr abutment for crown set, block and CARES® are devices with indication for prostheses.

Data from the scientific literature support the safety and intended performance of these abutments. An observational clinical study design was chosen to augment the clinical data derived from the use of these devices in accordance with the IFU (Instruction for Use) in the daily clinical practice setting, as well as to assess the long-term prosthetic survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients who had GM dental implants from JJGC installed at the ILAPEO College, between 2018 and 2022
* Patients who are using a healing abutment or cover screw and are able to install single-unit, screwed or cemented prostheses, in the maxilla or mandible, which require abutments with greater transmucosal height (due to reduced interocclusal height and/or bone loss)
* Patients presenting antagonist teeth to the implant region

Exclusion Criteria:

* Patients presenting contraindications according to the IFU (instructions for use)
* Patients who require the installation of more than 3 single-unit prostheses with CoCr abutments.
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment

14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6 patients and treated using Herbert bone screw, and group B has 6 patients and treated using lag screw.

Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.


Eligibility Criteria:
Inclusion criteria

* Patients suffering from recent, uninfected anterior mandibular fracture.
* Adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months.
* Fracture that demands open reduction and internal fixation.

Exclusion criteria

* Medically compromised patients contradicting operations.
* Existence of infection at the fracture line.
* Pathological fracture.
* An old fracture.
* Completely edentulous patient