cyrilzakka/clinical-trials huggingface dataset:
iCBT for GD and Comorbidities - a Pilot

The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.

Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of "Spelpaus".

If meeting criteria for the study, participants will be referred to the baseline/ pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will get access to the iCBT.

Eligibility Criteria:
Inclusion Criteria:

* Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT).
* Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD).
* Utilization of "Spelpaus" (3 months from treatment start).
* ≥18 years of age.
* Able to provide digital informed consent.
* Classified within pathways 2 or 3, as measured with the Gambling pathways Questionnaire (GPQ).
* Screen positive for at least one common mental diagnosis in addition to GD, assessed according to the Web Screening Questionnaire (WSQ).

Exclusion Criteria:

* Other ongoing psychological treatment for GD.
* Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score \>34 MADRS-S).
* Suicidality, screening of ≥4 points on item 9 of the MADRS-S
Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome

The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.

In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

In this perspective, the development of a product screening sleep related breathing disorders for physicians, cardiologists, internists (not specialized sleep experts) would fill this need. It allows for a reliable first screening for their patients in parallel with a routine cardiological examination. Imposing a minimal human and material, the ECG Holter recorder "VistaO2 FLUX" (NOVACOR, Rueil-Malmaison, France) is a device designed to meet these requirements. This device fits into the daily management of patients with cardiac arrhythmias or sinus/atrioventricular conduction disorders, and of patients suffering myocardial infarction (arrhythmic risk stratification, detection of silent myocardial ischemia).

Analysis of heart rate variability (HRV) has already shown interest in screening SAHS. We therefore wish to evaluate the performance of the analysis of data from the screening tool VistaO2 FLUX face what the gold standard synchronized polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* sleep apnea hypopnea syndrome suspicion
* written consent

Exclusion Criteria:

* pacemaker
* diabetes
* atrial fibrillation
* electrode allergy
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study

The objective of this study is to estimate the safety and performance of Journey II BCS TKS.

The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.

Eligibility Criteria:
Inclusion Criteria:

* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication
* The TKA occurred at least 12 weeks prior to enrollment
* Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

Exclusion Criteria:

* Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion

The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.

Postoperative dysphagia is the most common complication of anterior cervical fusion surgery. Previous studies showed that chewing gum helped to improve swallow frequency and latency. However, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. A randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. Dysphagia severity will be assessed using dysphagia short questionnaire (DSQ) score in the chewing gum group and control group during 7 days after surgery, and the changes in DSQ score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 years to 80 years.
* underwent anterior cervical fusion surgery for degenerative cervical disease.
* diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using Bazaz scale.

Exclusion Criteria:

* Patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease.
* Patients with preoperative dysphagia.
* Patients unable to chew, or unable to follow the directions for chewing gum.
* Patients unable to attend follow-up visits or finish the dysphagia questionnaires.
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* patients with acute hypoxemic respiratory failure

Exclusion Criteria:

* age \< 18 years
* hypercapnia (arterial carbon dioxide tension (PaCO2) \>45mmHg) at admission
* need for emergency intubation, including cardiopulmonary resuscitation
* recent esophageal, facial or cranial trauma or surgery
* severely decreased consciousness (Glasgow coma score \<11)
* cardiogenic shock or severe hemodynamic instability
* systolic blood pressure \<90 mmHg associated with decreased urinary output(\<20 mL.h-1) despite fluid repletion and use of vasoactive agents
* lack of co-operation
* altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures
* tracheotomy or other upper airway disorders
* severe ventricular arrhythmia or active myocardial ischemia
* active upper gastrointestinal bleeding
* inability to clear respiratory secretions
* more than one severe organ dysfunction in addition to respiratory failure
Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection inpatients allergic to penicillin.

Helicobacter pylori(H.pylori), which infects about 50% of the global population,has been recognized as a main risk factor of multiple gastric pathologies,especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children

This is a randomized, parallel study that will be conducted on pediatric patients with CKD.

The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.

Exclusion Criteria:

* A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions
Application of AI in Polypectomy

The aim of this study was to assess the performance of AI system in polypectomy


Eligibility Criteria:
Inclusion Criteria:

* to undergo colorectal polypectomy;
* agree to give written informed consent

Exclusion Criteria:

* patients with the contraindications to colorectal polypectomy;
* patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
* patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
* patients refused to participate in the trial;
* the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
* the procedure have to be terminated due to complications of anaesthesia.
Norwegian Adult Mental Health Registry

"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. The main purpose is to create a documentation basis for quality assurance, evaluation, and improvement of assessment and treatment for patients who are offered treatment for mental disorders in the specialist health service. The register uses automatic data capture from various existing data sources. New patients are automatically included, but given the opportunity for reservations from the register without affecting their services and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Residents in Norway aged 18 years or older assessed and granted right to treatment in specialized mental in- and out-patient settings

Exclusion Criteria:

* Persons who have reserved themselves against participation
* Persons already included in more specialized register for mental disorder and/or treatment
Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer

The goal of this clinical research study is to see if ovarian cancer patients who add Juice PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian cancer patients who receive only dietary counseling alone.

Before starting the study, patients will have a dietary pattern evaluation, physical exam, blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.

Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure the levels of some proteins that can be linked to ovarian tumors.

Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One group will receive free of charge nutritional counseling for 6 months, while the second group will receive free of charge daily supplements . These supplements will be made up of a combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.

All patients will have their eating patterns monitored for six months. Patients will come to the clinic at least every three months as part of their normal treatment schedule. Each visit will take 3 hours and will include a physical exam, blood tests, and anthropometric measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some visits, dietary and quality of life assessments will also be done.

With the exception of the first interview, nutritional counseling will be mostly done by a 30 to 60 minute telephone call once a week for two months. Counseling will also be done once every other week for two months and then once a month for two months.

Participation in this study will be stopped if patients have to start being fed by vein, patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are diagnosed with a condition requiring a restricted diet, patients begin medication that is incompatible with a high fiber diet, or patients have severe side effects.

This is an investigational study. A total of 50 patients will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) \> 19.5
2. Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
3. In first clinical remission. (CA125 \< 35)
4. \> 21 years of age.
5. CT scan of abdomen/pelvis without evidence of ovarian cancer.
6. Ambulatory/mobile and able to eat/not on parenteral nutrition.
7. Life expectancy of at least 6 months.
8. Informed consent signed indicating patient's knowledge of the investigational nature of the study.

Exclusion Criteria:

1. Evidence of bowel obstruction.
2. Pregnant or lactating.
3. Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated.
Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care

Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).

Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.

The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes

Exclusion Criteria:

* last dental visit\<1 year
* patient unable to give consent
Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)

The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.

Sleep research has confirmed the association of sleep (REM sleep and slow-wave sleep) with memory and cognitive function in general. There are changes in the quantity of REM sleep after certain forms of anesthesia, especially with barbiturate, as shown in mouse model. This study is designed to be the first explorative clinical studyl to measure changes in sleep architecture in surgical patients undergoing different types of anesthesia (general anesthesia and spinal anesthesia) and its potential associations with the development of postoperative delirium and postoperative cognitive dysfunction. Additionally, parameters will be collected, that from recent research are suspected to be reliable markers for systemic inflammation that might account for delirium and cognitive dysfunction after surgical interventions.

Patients were stratified into two groups: age (≤ 65 years; \> 65 years) and benzodiazepine premedication (yes/no).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age 50 years and above
* Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin

Exclusion Criteria:

* Lacking willingness to save and hand out data within the study
* Missing informed consent of the patient
* Participation in other prospective interventional study 10 days before study inclusion and during the study period
* Patients with diagnosed and treated sleep disorders
* Patients with psychiatric diseases
* Patients with injuries or operations of the enteral tract and the esophagus respectively in the last four weeks before the hip surgery
* Allergies to any substance of the electrode fixing material
* Dermatoses in the area of the electrodes to be fixed
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)

The purpose of this study is to assess the efficacy of QBX258, a compound developed by Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with stage I-II breast cancer related lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-70 with unilateral stage I or II BCRL
* Volume difference of at least 300 mL between the normal and lymphedematous limb based on perometry evaluation
* BMI of 18-30
* No current evidence of breast cancer
* At least 6 months postop from axillary lymph node dissection

Exclusion Criteria:

* Bilateral lymphedema or history of bilateral axillary lymph node dissection
* Recent history of cellulitis in the affected extremity (within last 3 months)
* Recurrent breast cancer or other malignancy
* Current (within last month) use of chemotherapy for breast or other malignancy
* Current (within last 3 months) use of radiation for breast or other malignancy
* Recent (within last month) or current intensive MLD and/or short stretch bandage use
* Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
* Pregnant or nursing (lactating) women
* Stage III lymphedema
* Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
The Effect of Anesthesia Type on Pulmonary Function

The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery.

Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary function tests will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age
* Undergoing non-abdominal surgery under anesthesia in supine position

Exclusion Criteria:

* Pulmonary disease
* Hematological disease
* Undergoing Abdominal surgery
* Non-supine position during surgery
* Nicotine Abuse
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients

Stroke is the third common cause of adult disability in dveloped countries. Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals. The current cohort study focuses on those patients with SAFE \<8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population.


Eligibility Criteria:
Inclusion Criteria:

* First stroke with hemiparesis or hemiplegia with SAFE \<8

Exclusion Criteria:

* contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent