cyrilzakka/clinical-trials huggingface dataset:
Women's Post Traumatic Stress Disorder (PTSD) Research Study

The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.

The investigators are trying to understand if there is a relationship between the experience of traumatic events such as those experienced by people with post traumatic stress disorder and reactivity to startling noises or mild threats. So, the investigators are looking at startle reflex, heart rate, and stress hormone responses to short noises and small shocks in people exposed to trauma and who either do or do not have PTSD. Additionally, the investigators will be looking at how the menstrual cycle impacts these processes. The investigators know that women have twice the risk for developing PTSD and some research suggests that stress hormones change during the menstrual cycle and may have an effect on risk.

Eligibility Criteria:
Inclusion Criteria:

* Women, ages 18-55 years old who have a regular menstrual cycle and who can come in to participate in the afternoon

Exclusion Criteria:

* Long-term medications, oral or steroid contraceptives, irregular menstrual cycle
Contribution of Hypnosis on Image Quality in Cardiac MRI

The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.

Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.

In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.

However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.

Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.

The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.

Eligibility Criteria:
Inclusion Criteria:

* Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE \< 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
* 18 years and older
* Highly effective contraception for women of childbearing potential, maintained during research procedures
* Informed consent
* Affiliated or beneficiary of health insurance

Exclusion Criteria:

* Contraindications to MRI and gadoline contrast medium
* Hearing impaired patients
* Patients who do not speak French
* Women who are pregnant or lactating
* Inability to agree to participate to the study
* Patient under legal protection
Outpatient Treatment of Patients With Morbid Obesity - a Two-year Follow up

This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate.

What is the effect of two years of outpatient treatment for lifestyle change for weight markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults with morbid obesity?


Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 - 60 years, both sex
Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?

To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track THA and TKA

Postoperative urinary retention (POUR) is a well known complication of fast-track total hip (THA) and knee arthroplasty (TKA), and even though medical options have been attempted, bladder catheterisation remains the only well-documented capacity to prevent and / or treat POUR.

It was previously standard to use fixed urinary catheter (KAD), the first 24-48 hours postoperatively to prevent POUR by THA and TKA, while more recent studies now recommend intermittent urinary catheterization in the postoperative period.

However, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of POUR by fast-track THA and TKA.

Purpose:

To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD,catheter a demure) for up to 24 hours of fast-track THA and TKA

End Points:

1. The number of patients in need of re-catheterization due POUR
2. The number of patients in which the removal of KAD was not carried out within 24 hours.
3. The number of urinary tract infections from surgery to postoperative day (POD) 30
4. The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
5. The number of urological-related readmissions (including urosepsis) within POD 30

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all the following criteria to be eligible to enroll in the study:

  * Age \>50 years.
  * Patients scheduled for primary THA or TKA.
  * Patients who have given verbal consent to participate in the study.

Exclusion Criteria:

* Patients who meet one or more of the following criteria may not be included in the study:

  * Patients who can not cooperate with the study.
  * Patients who do not understand or speak Danish.
  * Patients who are permanent catheter carriers or use disposable bladder catheterisation.
  * Patients on hemodialysis.
  * Urine Derivative patients.
  * Pregnancy or childbirth within 6 months.
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction

The study is a randomized controlled pilot trial to evaluate whether withdrawal of spironolactone is safe and associated with re-deterioration of left ventricular function in patients with heart failure with improved ejection fraction. The aim of current trial is to test the hypothesis that withdrawal of spironolactone would not be associated with relapse of significant clinical deterioration of left ventricular systolic function.


Eligibility Criteria:
Inclusion Criteria:

* Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up
* Age between 19 and 80 years old
* Prior diagnosis of heart failure with reduced left ventricular ejection fraction (LV EF ≤ 35%) and on medical therapy including spironolactone combined with angiotensin-converting enzyme or angiotensin receptor blocker or antiotensin receptior neprilysin blocker, beta-blocker.
* LV EF ≥ 50% documented with echocardiography performed within a month
* Documented result of BNP or NT-proBNP level within a month

Exclusion Criteria:

* Dyspnea ≥ New York Heart Association (NYHA) functional class III
* Patients who need to discontinue spironolactone owing to prior adverse event
* Primary valvular heart disease with at least moderate degree
* Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
* Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
* Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
* Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
* Pregnant and/or lactating women
* Life expectancy less than a year
* Patients who are not suitable to enrollment by investigator's discretion
EMD for Treatment of Proximal Class-II Furcation Involvements

The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).

Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
* Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
* Presence of one proximal class-II furcation presenting probing depth \> 4 mm and bleeding on probing ;
* Good general health;
* Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

Exclusion Criteria:

* Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
* Have used antibiotics and anti-inflammatories in the last six months;
* Smoke ≥ 10 cigarettes/day;
* Pregnant or lactating;
* Chronic use of medications that may alter the response of periodontal tissues;
* Indication of antibiotic prophylaxis for dental procedures;
Bone Density and Marginal Bone Height Changes Around Dental Implants

The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. The oral rehabilitation of a long anterior mandibular edentulous span with a fixed or removable implant-supported prosthesis using appropriate prostheses have been a target in oral implant research for the last year. The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Cone beam computed tomography (CBCT ) has also been used extensively for the follow-up of dental implants and is considered one of the tools for assessing implant success

This study will be conducted on 6 patients having mandibula Kennedy Class VI (anterior edentulous span) Each patient will receive 5 dental implants in the interforaminal area. The patients will be randomly categorized into two groups. According to the final restoration they will receive.

Group I: will receive a digital milled implant supported overdenture. While Group II will receive implant supported fixed bridge.

The marginal bone height changes and bone density around the dental implants will be evaluated at the time of prosthesis insertion, after one and three month.

Research Procedures:

1. Patient selection: will be following inclusion and exclusion criteria.
2. 5 implants will be installed in the interforaminal area for each patient.
3. Digital impression, bite registration, try in and delivery of the final prosthesis for each group will follow the conventional methods.
4. The marginal bone height changes and bone density around the dental implants using CBCT will be evaluated at the time of prosthesis insertion, after one and three month.
5. Statistical analysis: Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.

Eligibility Criteria:
Inclusion Criteria:

* non smokers
* Patients having long anterior mandibular edentulous span.
* Highly cooperative and motivated patients.
* Patients Systemically free from any immunosuppressive diseases.
* Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
* Patients not receiving any Radiotherapy or chemotherapy treatment.

Exclusion Criteria:

-Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions, and foreign bodies.
Familial Breast Cancer in China

This study is a retrospective descriptive study to collect clinical data (mainly including medical records and follow-up information, etc.) of breast cancer patients with genetic variation who were first diagnosed and treated in a number of hospitals in China during the period from January 1, 2015 to December 31, 2024, and to establish a retrospective cohort of familial hereditary breast cancer. To analyze the clinical features, diagnosis and treatment and survival prognosis of patients with familial hereditary breast cancer. To explore the main factors affecting clinical diagnosis and treatment and survival prognosis of patients


Eligibility Criteria:
Inclusion Criteria:

* Familial inherited breast cancer with genetic variants, including but not limited to mutations in the BRCA1, BRCA2, TP53, and PALB2 genes
* The patient had no major organ dysfunction
* ECOG score 0-1

Exclusion Criteria:

* There are serious dysfunction of vital organs (heart, liver, kidney)
* Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
* In other acute infectious disease or chronic infectious disease activity period
* A history of uncontrolled seizures, central nervous system disorders, or mental disorders
Enoxacin for Amyotrophic Lateral Sclerosis (ALS)

The study will assess the safety of the drug enoxacin at specific dose levels in adults with ALS.

Participants will be randomized to one of three doses of enoxacin (200, 400, or 600mg twice daily) for 30 days. On day 1, 7, 14, 21, and 30 of treatment and at a follow-up visit 14 days after the last dose, participants will be assessed for safety measures and blood will be collected to assist with the determination of enoxacin pharmacokinetics (PK) and pharmacodynamics (PD). On day 1 and day 30 of dosing, participants will only take one dose of study medication (the morning dose) to assist with determination of enoxacin single dose PK over a 24-hour period. A lumbar puncture (LP) to collect cerebrospinal fluid (CSF) for PD assessments will occur on day 1 and day 30.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of familial or sporadic ALS
* FVC of ≥ 50 percent predicted
* If female, is not breastfeeding and is not pregnant
* Has been on a stable dose of riluzole, or has not taken riluzole, for at least 30 days prior to screening
* If taking concomitant edaravone at study entry, must have completed at least one cycle of edaravone therapy prior to screening
* Not currently taking and has not taken for at least 30 days prior to screening any Theophylline containing medications, clozapine, or duloxetine
* No active infection in the 30 days prior to randomization
* Has not taken any fluoroquinolone antibiotics for at least 30 days prior to screening

Exclusion Criteria:

* Hypersensitivity/allergy to fluoroquinolones
* Diagnosed with another neurodegenerative disease
* Significant pulmonary disorder not attributed to ALS, central nervous system disorder associated with seizures, myasthenia gravis, active rheumatologic disease, tendinopathy, or any severe uncontrolled medical condition (other than ALS)
* Severe renal impairment or impaired liver function
* Baseline prolongation of QT interval/corrected QT interval (QTc) at screening, treatment with any agent that may prolong Qt/QTc interval, or history of any other at-risk other cardiac condition
* Currently enrolled in another clinical trial involving an experimental drug or device
Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.

The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.

Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).


Eligibility Criteria:
Inclusion Criteria:

* To be over 18.
* To be scheduled for VATS in the center of the study during the study period.
* Thoracic Epidural analgesia of Bi-block analgesia.

Exclusion Criteria:

* Chronic pain or opioid use before surgery (6 months).
* Postoperative hospitalization in ICU during the first two days.
* Postoperative surgical complication needing surgical revision during the first two days.
* Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.
Understanding Changes in Heart Function After Exercise in People With Stroke

Little is known about how exercise can affect heart function in stroke survivors.

This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation.

This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk.

Purpose

To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends.

Methods

A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):

1. BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
2. AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.

Participants will be evaluated at 3 time points - baseline (0 months), post-intervention (6 months) and follow up (8 months) - for stroke risk factors, cardiorespiratory fitness, arterial stiffness, echocardiography measures, inflammatory biomarkers, ambulatory capacity and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 years old
* Has experienced a stroke
* At least 12 months post-stroke
* Able to stand independently
* Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)

Exclusion Criteria:

* Stroke of non-cardiogenic origin (aneurysm, tumour)
* Actively engaged in other stroke rehabilitation services
* Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
* Resting blood pressure \> 160/100 mmHg
* Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
* Has a pacemaker
* Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
* Behavioural issues that would limit participation in exercise
Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones

The management of coexisting intrahepatic bile duct (IBD) and extrahepatic bile duct (EBD) stones is complicated and requires a multidisciplinary approach. The long-term clinical outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography (ERCP) EBD stone extraction remain unclear. Investigators conducted a retrospective study of patients with coexisting IBD and EBD to investigate the long-term impact of ERCP on the incidence of recurrent EBD stones and to identify risk factors of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* non-gastrointestinal tract reconstruction patients with coexisting IBD and EBD stones who underwent ERCP between July 2008 and December 2020 at Xijing Hospital in China

Exclusion Criteria:

* patients with benign or malignant EBD strictures
* sclerosing cholangitis
* suspected choledochal cysts
* liver cirrhosis
* parasitic liver diseases
* long-term biliary drainage with biliary stents or percutaneous tubes
* without a definitive IBD stone or with a diagnosis of liver calcification as determined by imaging review
* medical records or follow-up information was unavailable
A Comparison of PRK and LASIK for Correction of Myopia

The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.


Eligibility Criteria:
Inclusion Criteria:

* spherical equivalent subjective refraction between -6.00 and -8.00 diopters
* age between 18 and 49 years
* desire for having laser refractive surgery

Exclusion Criteria:

* present or past eye disease excluding myopia
* pregnant or lactating woman
(PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Overdenture

The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

1. Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
2. Patients have completely edentulous upper and lower arches.
3. Patients have healthy mucosa free from any ulceration, inflammation or infections.
4. All patients are free from neuromuscular and temporomandibular joint disorders.
5. Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

Exclusion Criteria:

1. Patients with limited manual dexterity.
2. Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia...etc.)
3. Pregnant females.
4. Un co-operative patients.
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with schizophrenia
* Be in stable medical condition (DSM-V)
* report smoking ≥10 tobacco cigarettes/day
* present a breath CO ≥10 ppm
* report wanting to reduce their cigarette smoking
* be fluent in English
* have a stable living situation

Exclusion Criteria:

* be currently pregnant or breastfeeding
* report wanting to quit smoking in the immediate future
* test positive for illicit drugs except THC
* have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study