cyrilzakka/clinical-trials huggingface dataset:
Effect of Allopregnanolone on Stress-induced Craving

The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.

This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min. Sixty min. after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5 min. scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 min after (recovery).The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.

Eligibility Criteria:
Inclusion Criteria:

* Non-treatment seeking individuals with current DSM-5 AUD
* No current substance use disorder (except tobacco, alcohol, and marijuana)
* No current medical problems and normal ECG
* For women, not pregnant as determined by pregnancy screening, not breast feeding.

Exclusion Criteria:

* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
* History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
* Liver function tests (ALT or AST) greater than 3 times normal
* weight \>120kg
* renal impairment
* patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Enhanced Consent and Preparedness for Surgery Trial

To develop an audiovisual decision aid (AVDA) to improve the informed consent process. The investigators aim to examine the impact of a comprehensible AVDA that is written below the 8th grade reading level. The AVDA would be used for surgical consent compared to traditional verbal consent. Additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.

To address the limitations of consent, interventions have been developed to improve the quality of information provided to patients including written pamphlets, videos, and websites. Such interventions have been called decision aids. Decision aids may promote informed consent through greater knowledge and consistency of personal values or attitudes with an enacted choice. Providing adequate information increases satisfaction, more rapid symptom resolution, reduced emotional distress, reduced use of analgesia, and possibly shorter hospital admissions. Cochrane reviews have established that audiovisual decision aids enhance informed surgical consent, yet little data exists about the benefits of such aids in Female Pelvic Medicine and Reconstructive Surgery (FPMRS)4.

Eligibility Criteria:
Inclusion Criteria:

* Patients electing for surgical intervention of pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence by treating physicians in the Female Pelvic Medicine \& Reconstructive Surgery.

Exclusion Criteria:

* Patients ≤ 18 years old
* Non-English speaking patients
* Patients with video or audio impairments who are unable to view the AVDA
Old Blood and Postoperative Complications

The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent revision total hip replacement

Exclusion Criteria:

* Patients who were not given red blood cells
* Patients who were given two units of which one unit was old and one was new
High Resolution Anuscopy Study

The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.

High-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.

HRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.

At UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel
* 18 years or older
* Understands and able to speak and write in French, Dutch or English

Exclusion Criteria:

* None
Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation

Follitropin delta (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized.

As a standard practice for OHSS prevention at clinique ovo, women undergoing IVF will have a scheduled ultrasound and blood test on the sixth day of their stimulation treatment. However, with the determination of the Rekovelle and Menopur algorithm, the risks of OHSS before the tenth day have been considerably minimized.

The purpose of this study is to evaluate the necessity of programming an ultrasound and blood test prior to the tenth day of ovarian stimulation when women are on personalized doses of Rekovelle and Menopur duting an antagonist IVF cycle. Based on the results of the analysis, we will assess the economic impact that programming an ultrasound and blood test at day 10 might have.

Eligibility Criteria:
Inclusion Criteria:

* Women of 18 years of age or older having provided consent to chart access for scientific publication in the IVF consent form
* Antagonist IVF cycle using combination of Rekovelle and Menopur for stimulation according to the modified protocol employed at clinique ovo without deviation
* Presence of both ovaries

Exclusion Criteria:

* Second cycle of Duo-Stim IVF
Guideline Oriented Approach to Lipid Lowering in Asia-Pacific

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study.

Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

The study will be conducted over two phases.

In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period.

In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up.

Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice.

* Patient-and-clinician 'Cholesterol score card'. This passport-sized document will serve as a communication, engagement and activation tool for patients. It will be provided to participants at the commencement of the intervention and filled out at each study follow up visit. Participants will be encouraged to fill out sections at clinically-driven follow up appointments with their treating clinicians (e.g. general practitioner, cardiologist). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.
* Risk stratification for recurrent events. As part of the intervention, each participant will have their SMART Risk score of a recurrent event assessed using the 'U-prevent' online calculator. In addition, each participant's Lp(a) will be measured and presented graphically on a continuum of risk. Both of these risk assessments will be sent to the treating primary care clinician and a copy provided to the participant.

Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Admission for Type I myocardial infarction

Exclusion Criteria:

* LDL \<1.4mmol/L at baseline
* Unable to provide contact details of primary care physician/general practitioner
* Unable to provide written informed consent.
* Unlikely to survive \>12 months
Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology

This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.

This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.

The research within one patient will last a total of 16 weeks from the initial to the final examination. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a recreational athlete performing intensive sport activity loading patellar tendon (running, jumping, strength training etc.) at least 3 days in a week for minimum of 1 hour per session,
* is in age between 18-40 years,
* has a patellar tendon pain, which limits (at least in part) the quality of normal daily or sports activities,
* has clinical manifestation of patellar tendinopathy (pain and impaired function) confirmed by clinician,
* has symptoms only in one leg, the other one is asymptomatic.

Exclusion Criteria:

* Any contraindication for ESWT is present (according to International Society for Medical Shockwave Treatment (ISMST) consensus at https://shockwavetherapy.org),
* Patient is aware of any symptomatic mechanical tendon damage in the past (e.g., partial or complete rupture in relation to the injury),
* neurological, oncological, or systemic disease (e.g., neuropathy, lupus or rheumatic arthritis) coexists,
* is/was already treated for PT elsewhere (e.g., platelet-rich plasma therapy, physiotherapy)
* is using blood thinning medications or statins.
MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly

It has been shown that MBSR could be effective in different types of chronic pain in geriatrics, but more evidence in the interdisciplinary context is needed.

This study is conducted to develop and compile a mindfulness-based stress reduction (MBSR) program within a context of physiotherapy rehabilitation to manage chronic pain in the elderly in an Iranian clinical setting.

The 8-session MBSR treatment protocol was translated, revised for the Iranian elderlies, and compiled as a one-on-one therapy using a unique protocol with 20-session physiotherapy. 40 volunteers aged 65 or more with musculoskeletal chronic pain will be selected and receive the program for 8 consecutive weeks with a 3-month follow-up. Treatment satisfaction levels, adherence to treatment sessions, and patient-reported clinical outcome measures were used at baseline, immediately post-intervention, and three months following the intervention, measuring pain, anxiety, fatigue, sleep disturbance, pain interference levels, and kinesiophobia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or more
* Have chronic pain
* Have ability of reading and writing in Persian
* Visiting the clinic in which the study was took place

Exclusion Criteria:

* Dose not have any diagnosed Cognitive Impairment
* Failure to approve the consent form
A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 3 months
* Histological or cytological documentation of advanced solid tumors
* ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
* Adequate bone marrow, liver and renal function
* Women of childbearing potential and men must agree to use adequate contraception
Machine Learning Assisted Electrochemical Profiling to Provide Early Identification of Bloodstream Infections Pathogens

In the context of a bacteremia, although significant progress has been made in speeding up pathogen identification once a blood culture bottle turns positive, few cost-effective solutions have been proposed to improve the earlier stages of the process-specifically, from blood collection to bottle positivity. The investigators propose that transport time could be leveraged to grow and identify bacteria, enabling faster access to actionable results through innovative technologies. This project aims to develop a bacterial identification database by analyzing the electrochemical profile of bacteria growing within the blood culture bottle, using machine learning.


Eligibility Criteria:
Inclusion Criteria:

* patient requiring a blood culture sample as standard of care procedure
* body weight \> 50 Kg
* Patient for whom the collection of 2 to 4 additional blood culture bottles is feasible, depending on venous access
* patient who has not objected to participation in the project

Exclusion Criteria:

* Patient protected under the French Public Health Code (pregnant or breastfeeding women, patients under guardianship or curatorship, hospitalized under constraint, or deprived of liberty)
* patients with ongoing antibiotic treatment at the time of sampling
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.

Eligibility Criteria:
Inclusion Criteria:

Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

Exclusion Criteria:

no history of malignancy without severe extra-articular deformities
Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients

The purpose of this study is to report data with patients after bariatric surgery.

In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.

The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
* patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
* patients having a comorbidity that should be improved by the surgery
* Patients that are able to comprehend the risks and benefits and the surgical procedure
* patients having no glandular etiology for their obesity
* patients that have attempted to lose weight by conventional means
* patients that are willing to be observed over a long period of time

Exclusion Criteria:

* patients that can not obey one of the inclusion criteria
A Simulation Training Program for Person-Centered In-Home Dementia Care

This study primarily explores the impact of a person-centered dementia home care scenario-based training program on home care workers' empathy, care preparedness, competence, predictability, and rewards.


Eligibility Criteria:
Inclusion Criteria:

(A) Aged 20 years or older; (B) Employed as a full-time worker in a home-based long-term care service institution; (C) Willing to participate in this study.

Exclusion Criteria:

* Employed as a part-time worker in a home-based long-term care service institution
Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

Research objective to compare outcome(Length of stay, pain score, opioid drug use, Bowel function and complication ) of ERAS protocol and conventional care in pregnant women after elective cesarean section in Rajavithi hospital.

Research design is Randomized control trial. The pregnant women who go to elective cesarean section don't know the allocation. The group of ERAS protocol was separated from Conventional care in patient care unit.

The Pregnant are randomly in two group. In the ERAS group the pregnant receive the the intervention for preoperative care(Counselin, H2- antagonist and metroclopramide for prevent aspiration, Drink clear liquid until 2 hour before surgery), Intraoperative care (first generation cephalosporin in 60 minute before surgery, Clorhexidine for skin cleansing and Povidine for vaginal cleansing, regional anesthesia, keep warming, blunt expansion of uterine incision, do not peritoneal suture and subcuticular suture if less than 2 cm, local wound anesthesia.), post operative care ( Paracetamol and NSAIDs for for pain control, early remove catheter and ambulation, 5-HT3 antagonist for prevent nausea)

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital

Exclusion Criteria:

* Pregnant women who has preeclampsia with severe feature
* Pregnant women who has diabetes mellitus with uncontrolled blood sugar
* Pregnant women who has blood loss \> 1,500 ml after surgery
* Pregnant women who has chrioamnionitis.
* Pregnant women who has severe medical disease
* Pregnant women who has BMI \>= 40 kg/m2
* Pregnant women who has placenta adherence.