cyrilzakka/clinical-trials huggingface dataset:
Alcohol Consumption After Bariatric Surgery

A large body of studies indicate an increase in alcohol use disorder (AUD) rates after bariatric surgery. However, little information exists on the evolution of other drinking patterns after surgery and the psychological predictors of problematic drinking postoperatively. The identification of these factors is necessary for the implementation of prevention strategies regarding postoperative problematic alcohol use. The aim of this research is to examine the evolution of various drinking patterns after bariatric surgery as well as the psychological factors associated with AUD and an increase in postoperative alcohol consumption.

Obesity affects 15.9% of the Belgian population and remains a difficult disease to treat with traditional weight loss interventions. Its high prevalence and the negative consequences it entails make it a public health concern. Bariatric surgery is associated with long-term weight loss and an improvement in obesity-related comorbidities. However, despite its success in achieving significant and lasting weight loss, numerous studies raise the emergence of unpleasant psychosocial problems after the operation, including an increase of regular alcohol consumption and prevalence of AUD. Some of these studies are longitudinal and include large samples. For example, in a prospective multicenter study, King et al., (2017) found that more than 20% of patients with a bariatric surgery present symptoms of AUD within five years after surgery. Moreover, some studies suggest that, among patients with postoperative AUD, some had never suffered from alcohol problems before surgery.

Given the severe negative consequences of AUD for the individuals who suffer from it, their family and the society, better understanding the factors involved in postoperative alcohol use problems is necessary. However, little is known about predictors of post-bariatric surgery AUD. Known risk factors are: male gender, smoking, regular alcohol consumption before surgery, younger age, recreational drug use, lower sense of belonging and ADHD symptoms. Information is lacking about the psychological risk factors for postoperative AUD and regarding the evolution of problematic drinking patterns other than AUD after surgery.

Given the previously cited gaps in the scientific literature, the present research's aims are to study the evolution of different drinking patterns after bariatric surgery as well as the psychological factors associated with AUD and increased alcohol consumption postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older at the time of surgery
* Having a body mass index (BMI) greater than or equal to 40 or a BMI greater than or equal to 35 with at least one obesity-related comorbidity
* Having a scheduled surgery date
* Fluency in French speaking
* Being able to complete the questionnaires, i.e. have access to a computer or a smartphone

Exclusion Criteria:

* Being a minor at the time of the operation
* Having difficulty reading or understanding French.
* Not having access to a computer or a smartphone to answer the questionnaires
TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

The aim of the study was to compare the efficacy of lid swabs containing tea tree oil (TTO) and chamomile oil and baby shampoo (BS) in the treatment of seborrheic blepharitis.

After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio using block randomization to lid wipes containing tea tree oil (TTO) and chamomile oil or baby shampoo (twice daily).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of seborrheic blepharitis

Exclusion Criteria:

* Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
* Patients younger than 18-year-old
* Patients who used any treatment for blepharitis within the 6 months prior to the examination
Development of Artificial Intelligence Models for Segmentation and Characterization of Prostate Cancer: a Single-center Retrospective Observational Study.

Prostate cancer is the second most common cancer in the male population. This pathology represents an oncological and public health problem especially in developed countries, due to a greater presence of elderly men in the population.

Medical imaging plays a central role in the staging and restaging of prostate disease. Magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) are among the methods commonly used in normal clinical practice for the characterization of prostate cancer. To date, the study of these images is limited to a qualitative visual analysis, however there is increasing evidence relating to the usefulness of introducing a quantitative (or semi-quantitative) analysis of biomedical images.

The current increase in available imaging data, and their quality, allows the application of artificial intelligence methods also in the medical field for the automation of tasks (e.g. automatic segmentation) and classification (e.g. tumor aggressiveness).

The extraction of quantitative data, and more generally the study of tumor lesions, requires manual segmentation by one or more doctors. This process requires very long times as each image must be processed individually; furthermore, the result also depends on the level of experience of the doctor carrying out the segmentation and this could create a source of heterogeneity, affecting the reproducibility of the segmentation.

AI-based automatic segmentation methods can be applied to medical images for the localization of tumor lesions, thus exceeding the limits of manual segmentation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological diagnosis of prostate cancer;
* Patients who performed a PET exam with 68 Ga-PMSA.

Exclusion Criteria:

* CT and MR images with artifacts that preclude interpretation of results.
Quitting Caffeine for Better Glucose Metabolism

This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2 diabetes. Evidence suggests that caffeine may impair the control of glucose levels, especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot study will follow a small number of type 2 diabetic patients for three months after a brief intervention designed to help people quit caffeine. Data on success with maintaining abstinence and on changes in glucose control will be collected.


Eligibility Criteria:
Inclusion Criteria:

* 6-month history of type 2 diabetes
* impaired chronic glucose control (HbA1c \>= 7%)
* daily consumption of 250 mg caffeine or more in coffee, tea, and other caffeinated beverages

Exclusion Criteria:

* use of exogenous insulin
* use of non-diabetes medications that impact glucose metabolism
* medical of psychiatric history that prevents participation or increases risk
* current pregnancy
* current participation in other clinical trials
* deemed unable to comply with the study protocol for other reasons
Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia

* Tuberculosis ( TB ) remains a major global public health problems and actions to ensure the diagnosis and complete treatment of all cases is the priority for the control of this disease. Despite the availability of effective anti-tuberculosis medications, there are still high levels of nonadherence to treatment. The nonadherence increases the morbidity and mortality of patients, decreases the cure rate, increases the community transmission and the increase of chronically ill patients enables the emergence of multi - drug resistant and increases treatment costs.
* Despite the knowledge about different forms of cost-effective delivery of DOT (directly observed treatment), recognition of the need to establish the DOT strategy related to the context from local studies, in Colombia and in Cali we hadn't had made studies similar than this one that establish the cost and results of the current DOT delivery strategy and to identify other ways to improve adherence and cure rate for the TB patients at reasonable cost for both: health services and families
* Therefore, this research aims to compare the cost -effectiveness of current DOT delivery method with an alternative extra- institutional delivery of anti -TB treatment in urban areas of Cali. A cost-effectiveness study was conducted from the institutional and familiar perspective with prospective information collection.

We compared two strategies for anti- TB treatment delivery: one institutional in which patients went to health institutions to receive treatment and other extra- institutional in which the medication was delivered in the place of choice for treating patients.

Measuring the effectiveness ( compliance and cure ) was made from a controlled clinical trial , randomized , partially blinded . The measurement of family and institutional costs , direct and indirect , will be based on the activities.

Eligibility Criteria:
Inclusion Criteria:

* Male and female (non-pregnant)
* 15 years of age and older
* Living in urban area (Cali)
* New diagnosed patients (TB)
* In conditions to give survey information
* Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis

Exclusion Criteria:

* Not written informed consent
Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.

Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to individual CPT treatment. The public policy implications of the results of this trial are significant. If both treatment formats are equivalent or if group treatment is better, then group treatment would be a more efficient and cost-effective therapy modality in most cases. On the other hand, if individual therapy is found to be superior, the investment of greater resources into individual therapy will be justified in order to provide the most effective treatment for PTSD to military personnel. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Three hundred (300) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized between group and individual CPT-C.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD
* Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)
* Person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
* Be over the age of 18
* Speak and read English
* Be stable on any psychotropic medications they may be taking.

Exclusion Criteria:

* Current suicide or homicide risk meriting crisis intervention
* Active psychosis
* Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)
ScanNav Anatomy PNB Data Collection Study 2024

Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
* A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
* A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Exclusion Criteria:

* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  * etanercept - within 4 weeks prior to randomisation
  * adalimumab, infliximab - within 8 weeks prior to randomisation
  * ustekinumab - within 16 weeks prior to randomisation
  * other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
* Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)
* Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
* Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
* Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
* Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
* Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
* Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding
Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY

Prospective multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).

This multicentric prospective randomized Phase III trial is aimed to verify if the use of uterine manipulator for laparoscopic/robotic treatment of early stage endometrial cancer can influence the impact of peritoneal cytology and lymph vascular space invasion (LVSI) and the outcomes in terms of perioperative and oncological (disease free survival - DFS, overall survival - OS) outcomes.

Eligibility Criteria:
Inclusion Criteria:

For patients

* Age \> 18 \< 80 years
* Patient's informed consent
* American Society of Anesthesiologists: \< class III or IV
* No actual pregnancies
* Body Mass Index (BMI) ≤ 35

For diseases

* Early stage endometrial cancer (IA-IB)
* Endometrioid histotype (G1-G2)

Exclusion Criteria:

For patients

* Age \> 18 \< 80
* Actual pregnancies
* Previous gynecological cancer

For disease

* Type II endometrial cancer histotype
* Grade 3 endometrial cancer
* Advanced stage endometrial cancer (II - IV)
* Previous radiotherapy on the pelvic field
* Uterine size larger than conform 12 weeks gestation or 9 cm in horizontal
* Necessity of laparotomic procedures
Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Requested and consented for pregnancy termination by medical abortion
* Willing and able to complete multiple electronic surveys

Exclusion Criteria:

* Previous participation in this trial
* Current use of pregabalin or gabapentin
* Contraindication to medical abortion with mifepristone and misoprostol
* Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin
* Unable to understand and sign written informed consents in English
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea

Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently.

In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator


Eligibility Criteria:
Key Inclusion criteria:

* male or female patients of 18 years of age or older, scheduled or expected to receive at least two cycles of chemotherapy over at least a two- month period as primary or adjuvant therapy for any malignancy,
* have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment

Key Exclusion criteria:

* females who are pregnant or lactating,
* current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance,
* known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound,
* history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome,
* WBC \< 3000 /L, Platelets \< 75,000 /L, serum creatinine \>2.0 mg/dL
Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures when first seeking the operation, one group only diet. The investigator is researching how much additional preoperative weight loss is possible with the drug admitted preoperatively.

The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures, one group only diet. Each group will have a waiting period of 6 months until the operation will be done. The investigator wants to elaborate how much additional preoperative weight loss is possible with the drug. The greater the preoperative weight loss, the lower the risk of the operation.

After one year, the investigator will also check whether the weight loss has been maintained and whether the preoperative Saxenda continues to lose even more weight after the operation.

All patients looking for bariatric surgery with health insurance via Österreichische Gesundheitsklasse and BMI\>35kg/m2 will be asked to take part in this study.

Patients with previous bariatric surgeries or contraindications against liraglutide will be excluded from this study.

Eligibility Criteria:
Inclusion Criteria:

- Patients seeking bariatric surgery

* BMI \> 35.0 kg/m2
* Health insurance via Österreichische Gesundheitskasse
* Willingness to be assigned to either of the two groups
* Willingness to adhere to preoperative dietological measures
* Follow-up anticipation with blood draws and body weight scans using Secca scale
* Written informed consent

Exclusion Criteria:

* Patients with previous bariatric surgerys

  * Patients aged below 18 years
  * Patients with BMI \< 35 kg/m2
  * Patients with psychiatric disorders
  * Patients not willing to adhere to preoperative dietological measures
  * Patients with contraindications against Saxenda
  * Patients who have health insurance other than Österreichische Gesundheitskasse
Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes

Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited.

Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited. The patients were divided into seven groups according to their admission Modified Functional Ambulation Category (MFAC). The between-group difference in length of stay (LOS), functional outcomes at admission and discharge including Modified Rivermead Mobility Index (MRMI) and Modified Barthel Index (MBI) as well as MRMI gain, MRMI efficiency, MBI gain and MBI efficiency were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received and completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.

Exclusion Criteria:

* Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received but cannot completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.