cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosed by a respiratory physician greater than or equal to (\>/=) 12 months prior to study enrolment
* Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1
* Documented bronchodilator response defined as \>/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (\<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline
* Current treatment with a total daily dose of \>/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1

Exclusion Criteria:

* Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility
* Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study
* Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1
* Ex-smokers with \>/=10 pack-year smoking history
* Prior treatment with bronchial thermoplasty
* Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study
* Pregnancy prior to participation or during the study
Characterization of Slow Coronary Flow

Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF.


Eligibility Criteria:
Inclusion Criteria:

* anginal pain
* laboratory markers
* pathological ECG for ischemia

Exclusion Criteria:

* obstructed coronary artery during catheterization
* very narrow coronary artery
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.


Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and the informed consent signed;
* 18-75 years;
* female who have given birth;
* pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
* preoperative staging cT1-3NanyM0
* body mass index \<30 kg/m2;
* willing to undergo laparoscopic right hemicolectomy

Exclusion Criteria:

* contraindications for laparoscopic surgery;
* emergency surgery due to acute intestinal obstruction, perforation or bleeding;
* distant metastasis;
* multiple colorectal cancer;
* has received preoperative chemoradiotherapy;
* with a history of other malignant tumors;
* unwilling to sign the informed consent or receive follow-up according to the study protocol.
Online Insomnia Treatment Program

The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.

Time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online CBT-I program.

To qualify, you must:

Be 18+ years old Have a diagnosis of insomnia or suspected insomnia Have access to the internet and an iphone, Android or other smart phone device

Coordinator Contact:

Cris Moreno (650) 721-7576 crismore@stanford.edu

Eligibility Criteria:
Inclusion Criteria:

* insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28)
* access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+
* 18 years of age or older
* available 15 mins per day to participate

Exclusion Criteria:

* Restless Legs Syndrome
* narcolepsy
* sleep apnea
* sleep walking
* bipolar disorder
* seizures disorder
* substance abuse
* frailty/risk of falling
* severe memory problems
* shift work
* change in antidepressant medication within past 2 months
* serious mental/physical health problem
* other ongoing psychological treatment w
* sleeping with pets.

Participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.
ASC - Autism Study

The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (C2C_ASC) in children with autism spectrum disorder (ASD) and gastrointestinal symptoms.

The ASC - Autism Pilot Study will be performed at the Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark. 10 children aged 6-14 years with ASD and gastrointestinal symptoms will be enrolled through the Child and Adolescent Psychiatry, Psychiatry Clinic South, Aalborg University Hospital, Denmark.

The participants will randomly be divied into two treatment groups:

1. participant 1-5 will be treated with 1 x 1000000 C2C_ASCs/kg body weight
2. participant 6-10 will be treated with 2 x 1000000 C2C_ASCs/kg body weight

C2C_ASC treatment:

The C2C_ASCs product will be diluted in 50 ml isotonic saline and infused in an arm vein within 15 min. In both groups there will for each participant be a week observation for SAE's related to the cell treatment before the next participant will be treated, if no SAE's have been detected.

The investigators hypothesize that the connection between gastrointestinal symptoms/leaky gut syndrome, increase local gastrointestinal and systemic elevated immunological and inflammatory activity, bacterial toxins in the blood and symptoms of ASD in children with symptoms of leaky gut syndrome can be reduced or normalized by modulating the immunological activity and inflammation by treatment with mesenchymal stromal cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder.
* Ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which disappeared or were reduced after dietary changes.
* Age 6 to 14 years.

Exclusion Criteria:

* Known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder.
* Known CNS-infection (now or previously) and/or HIV positivity.
* Primary immunodeficiency disorder or autoimmune cytopenia.
* Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other antiinflammatory medication (except nonsteroidal anti-inflammatory drugs).
* Epilepsy or known seizure disorder (now or previously).
Predictive Value of Albumin - Bilirubin Score and CRP - Albumin - Lymphocyte Index for HCC Prognosis After Radical Resection

Evaluate the predictive value of the CALLY index and ALBI grading for the prognosis of patients with hepatocellular carcinoma (HCC) after radical resection, so as to provide a reference for clinical treatment.

China bears a heavy burden of liver cancer. In 2022, there were 370,000 new cases and 320,000 deaths, ranking 4th in incidence and 2nd in mortality among malignant tumors. HCC, accounting for over 80% of primary liver cancer, also has high incidence and fatality rates. Radical resection, the main cure method, has a 5-year recurrence rate over 60%, so identifying recurrence risk factors is crucial. Previously, the Child - Pugh score was used for liver function evaluation, but its assessment of ascites and hepatic encephalopathy was subjective. Quantitative systems like MELD also had limitations. Over 80% of HCC develops from cirrhosis, and inflammatory and immunonutritional indices are important in cancer development. NLR, PLR, etc., show inconsistent predictive power, and the CALLY index, though better, needs improvement. Bilirubin is a key predictor, and ALBI grading can precisely quantify liver function, related to HCC recurrence and survival. This study combines ALBI and CALLY to create a four - dimensional system, expected to reflect HCC recurrence risk. As this combined prediction research is scarce, this study evaluates their predictive value for HCC patients after radical resection, guiding clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥ 18 years old (2) Postoperative pathological examination confirmed hepatocellular carcinoma (HCC) (3) No other anti-tumor treatment was received before surgery (4) Radical resection was performed, and the pathological examination under the microscope showed negative surgical margins.

Exclusion Criteria:

* (1) Complicated with other malignant tumors. (2) Incomplete clinicopathological data and prognostic information. (3) Received preoperative anti-cancer treatment. (4) Follow-up less than 1 month after hepatectomy. (5) Patients with surgical contraindications before surgery, such as portal vein tumor thrombus and distant metastasis.
Perception of Baby's Painful Cry in fMRI

Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Using modern tools of sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. For that, Adults will be tested inside a fMRI magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. The cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). To test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). The hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. This process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. The experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged between 18 and 50
* Contact-less with children
* right-handed
* Giving their written informed consent
* Subject who agreed to communicate MRI results to their attending physician
* French Social Security affiliation

Exclusion Criteria:

* any contraindications to pass an fMRI test
* Pregnant woman
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)


Eligibility Criteria:
Inclusion Criteria:

* Women with genuine stress urinary incontinence.
* Mixed urinary incontinence with predominant stress element.
* Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.

Exclusion Criteria:

* Mixed incontinence with predominant Urge urinary incontinence.
* Recent pelvic surgery (less than 3 months).
* Neurogenic lower urinary tract dysfunction.
* Previous surgery for stress urinary incontinence.
* Pregnancy
* Less than 12 months post-partum.
* Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts)
* Genito-urinary malignancy.
* Current chemo or radiation therapy.
Retrospective Review of Gastrointestinal System Endoscopy Procedures

The aim of the study is retrospectively evaluating all features of endoscopic and pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.

Gastrointestinal system endoscopy has an important place in the diagnosis and treatment of many diseases related to this system and provides an alternative to current surgical methods with its ever-expanding field of application. Upper and lower gastrointestinal endoscopy procedures are performed with many indications, such as new complaints in the gastrointestinal tract at the age of 50 and over, family history of gastrointestinal malignancy. In addition, the importance of endoscopy is gradually increasing as tissue and cell samples can be taken for histopathological studies and endoscopic treatment of some diseases.

The aim of the study is to review patients' indications, distribution by age and gender, frequency of lesions diagnosed on endoscopy, prevalence, size, histology and location of polyps detected and excised, results of endoscopic and pathological diagnoses.

The study population consists of the patients who were examined at the Istanbul Sultanbeyli State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.

The patients' data will be scanned retrospectively by accessing their files from the computer database.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years old)
* Patients who have undergone the procedure in our endoscopy unit

Exclusion Criteria:

* Under 18 years old
* Patients whose information cannot be accessed in the system records.
Osseointegration With a New Hydrophilic Surface

This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.

Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.

Eligibility Criteria:
Inclusion Criteria:

* Any healthy patients
* Aged 18 years or older
* Requiring at least two implants to be rehabilitated with a fixed implant supported restoration
* Full mouth bleeding and full mouth plaque index lower than or equal to 25%
* Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany).

Exclusion Criteria:

* Positive medical findings
* Psychiatric therapy
* Pregnancy or nursing
* Smoking more than 10 cigarettes per day
* Insertion torque \< 35 Ncm
* Untreated periodontitis
* Acute and chronic infections of the adjacent tissues or natural dentition
* Previous radiotherapy of the oral and maxillofacial region within the last five years
* Post-extractive implants (at least three months after tooth extraction)
* Absence of teeth in the opposing jaw
* Severe clenching or bruxism
* Severe maxillo-mandibular skeletal discrepancy
* Poor oral hygiene
Study to Assess the Safety and Effectiveness of NMRA-335140-501

This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.


Eligibility Criteria:
Key Inclusion Criteria:

Rollover participants are eligible for the study if the following inclusion criteria are met:

* Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
* Signed an informed consent form (ICF) for this study.
* Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
* Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.

Key Exclusion Criteria:

Rollover participants are excluded from the study if any of the following exclusion criteria are met:

* Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder \[excluding nicotine\]).
* Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
* Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
* Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
* Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
* Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.
* Considered by the Investigator to be inappropriate for any other reason.
Characterization of Smoking Habits Patterns in Medical Doctors of a Central Hospital in Portugal - What Has Changed After 15 Years? A Comparative Cross-sectional Study

Abstract: Tobacco dependence remains one of the primary health care concerns worldwide. Attitude of healthcare professionals towards smoking is crucial for any long-term prevention and smoking cessation program.

Objectives: Analyze smoking habits of medical doctors from a central hospital in Lisbon (2014), comparing results between medical versus surgical specialities. Results were compared with those obtained in 1999.

Design and setting: A voluntary and anonymous questionnaire was distributed to all physicians for a period of 4 months. The questions included sociodemographic data, smoking habits characterization, attitudes towards smoking, importance attribute to smoking cessation programme in the hospital and knowledge of the 2008 country law.

Participants: All medical doctors working in the central hospital studied between 1/1/2014 and 30/6/2014 Outcome measures: The primary outcome measure was to characterize the smoking habits of medical doctors. Secondary outcomes included comparison of results between surgical and medical groups and with those obtain in a similar study in 1999.


Eligibility Criteria:
Inclusion Criteria:

* All medical doctors working in the central hospital studied between 1/1/2014 and 30/6/2014

Exclusion Criteria:

* Not a medical doctor