cyrilzakka/clinical-trials huggingface dataset:
Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle

The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain.

Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.

Eligibility Criteria:
Inclusion Criteria:

1. patients with low back pain and/or radicular pain,
2. patients scheduled for lumbosacral TFESI.

Exclusion Criteria:

1. patients with contrast/local anesthetic allergy,
2. patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent,
3. vulnerable patient population including prisoners,
4. patients with severe anxiety,
5. patients with prior lumbar surgery,
6. age \<18 years old, and
7. Body Mass Index (BMI) \> 40.
His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.

Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree AV block are included. The study has a randomized double blinded crossover design. Patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is performed as to which pacing modality is used during the first 6 months. After 6 months the pacing modality is changed. Patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. Device nurse and physician are not blinded.

Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. Secondary endpoints include complications and safety of the device/electrode, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* AV block II or III with high expected pacing need
* Left ventricular ejection fraction between 40% and 55% (inclusive)
* Willing to participate and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Pregnant
* Hypertrophic cardiomyopathy
* Cardiac sarcoidosis
* Cardiac amyloidosis
* Previous myocardial infarction within last 3 months
* Ventricular septum defect or other other left ventricular corrective surgery
* Congenital heart disease surgically corrected
* Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)
Persistent Postoperative Pain After Major Emergency Abdominal Surgery

Perioperative pain is one of the most significant complaints and problems for patients undergoing major open surgery. Pain after surgery carry an abundance of consequences such as reduced mobilization, reduced nutrition intake, reduced pulmonary capacity and increased risk of complications and length of hospitalization. The literature does not supply much information on short- or longer-term outcomes of pain treatment for emergency surgery. The investigators know that for planned surgery in general around 10-50 percentage suffer from persistent postoperative pain. It is therefore important to follow-up on the longer-term outcomes after the standardized analgesic pain treatment. Based on a predefined patient group called OMEGA (Optimizing Major EMergency Abdominal surgery) the investigators hypothesize that OMEGA patients will present a significant incidence rate of patients with persistent postoperative pain and/or continued opioid/non-opioid usage. Therefore this study is to investigate the incidence of prolonged postoperative pain and opioid/non-opioid consumption in OMEGA patients at 3 month after major emergency abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* OMEGA patients (patients who have undergone major emergency abdominal surgery including the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction)
* Age 18 or more
* Surgery performed within 72 hours of an acute admission or as an acute re-operation

Exclusion Criteria:

* Elective laparoscopy
* Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed
* Non-elective hernia repair without bowel resection
* Admission or transfer to an intensive care unit
FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.

Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1 mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical cost for previous treatment is collected as well at pt perspective and QoL.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \< 90 years at the time of Screening.
2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (\> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other.
3. CDI infection under symptomatic control with \< 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
4. Those with ability to provide informed consent.

Exclusion Criteria:

1. Those with complicated CDI, defined as white blood cell\>35 or \<0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure \< 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission.
2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment.
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent


Eligibility Criteria:
Inclusion Criteria:

* Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae

Exclusion Criteria:

* Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma
Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students

80 participants studying in the physiotherapy technician department were included in this cross-sectional study. Participants' age, gender, year of being a student, the people they live with, the precautions they take regarding COVID-19, whether there is a history of COVID-19 in them or their immediate surroundings, and whether they have COVID-19 transmission and / or contagion fears during their vocational training, whether there are fears of achieving professional goals and competence because of COVID-19 and / or its consequences were recorded. Afterwards, the participants were asked to answer the questions on the coronavirus anxiety scale, the fear of COVID-19 scale and the cognitive and behavioral avoidance subscales of the Avoidance Attitudes from COVID-19 scale.


Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-65
2. Being a physiotherapy technician student

Exclusion Criteria:

1. Being under the age of 18, over the age of 65
Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder

In this study, the investigators test whether a 4-week 12-session attention bias modification treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the investigators also test whether a 2-week 4-session ABMT booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up

Attention Bias Modification Training was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. The placebo training procedure is a classic dot-probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month and 12-month follow-ups after training.

Eligibility Criteria:
Inclusion Criteria:

* The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses

Exclusion Criteria:

* a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).
Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

The primary aims of this research are three folds: (1) To identify more relatively effective interventions for improving pain symptoms in CP/CPPS patients. (2) To ascertain the correlation between PFM elastic modulus and tenderness symptoms. This may find a more objective method of assessing efficacy. (3) To determine the correlation between the intensity of the sympathetic response and the patient's symptoms and to explore other possible pathogenetic mechanisms.

Chronic prostatitis/chronic pelvic pain syndrome is a high prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve quality of life in patients with Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, a combined therapy with extracorporeal shockwave therapy and myofascial release therapy is likely to have significant advantages in treating CP/CPPS.

Eligibility Criteria:
Inclusion Criteria:

* ① According to the National Institutes of Health classification of prostatitis\[27\], all male patients meet the diagnostic criteria for chronic prostatitis type IIIB/chronic pelvic pain syndrome (pain in the bladder, groin, perineal area, genitalia or lower abdomen with no significant abnormalities on urological examination);

  * Patients are aged 20-40 years;

    * Patients with Chronic pelvic pain lasting over 6 months； ④ Patients sign the informed consent form.

Exclusion Criteria:

* ① Patients with significant coagulation disorders, perineal anatomical abnormalities, hormonal abnormalities and neurological abnormalities;

  * Patients with a clear cause of pelvic pain, such as a history of previous surgery, chronic infection, trauma, prostatitis and epididymitis;

    * Patients receiving other treatments during the study; ④ Patients with any urethral pathology;

      * Patients who have had closed lumbar injections and previous lumbar surgery within six months;

        * Patients with other conditions causing pelvic pain; ⑦ Patients with contraindications to physiotherapy; ⑧ BMI\>22.9
Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.

Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.

Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.

All imaging results and histopathology results will be pooled and compared.

Eligibility Criteria:
Inclusion Criteria:

* age \<= 85 years
* Karnofsky \>= 80%
* patient with indication ofr carotid endarterectomy
* signed consent form

Exclusion Criteria:

* indication for surgery other than endarterectomy \<14 days
* contraindication to surgery
* contraindication to MRI
* contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR\<30ml/min/1.73m2)
* pregnancy, breastfeeding
* lack of discernment
Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease

Due to different study designs, the sponsor separated Part C into this separate registration (NCT04958642), leaving Parts A/B in NCT02534844. The trial's final results for the primary outcome measure of Adverse Events (AE) will be reported here.

This study is to evaluate how safe and effective adrabetadex is for participants with Niemann-Pick Type C1 (NPC1) disease who experience neurologic symptoms (listed under Keywords).

In Parts A/B (NCT02534844), two out of every 3 participants will receive the study drug. The third participant will receive 1 to 2 small needle pricks at the location where the IT injection is normally made (sham control).

In Part C, all participants will receive study drug.

Participants in Part C will receive adrabetadex until the investigator considers adrabetadex to no longer be beneficial to the participant, or the development program is discontinued.

Eligibility Criteria:
Inclusion criteria:

One of the following is required for inclusion into VTS301 Part C:

* Has agreed to convert from the monthly dosing regimen used in the NIH phase 1/2a protocol to an every 2 weeks dosing regimen
* The investigator has received prior written authorization from the sponsor for the participant to enter VTS301 Part C on an amended dose and/or regimen
* Has received prior written authorization from Vtesse to enroll directly into Part C

Exclusion criteria:

* None of the inclusion criteria are applicable
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Stable fiber therapy
* Normal colonoscopy/sigmoidoscopy
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Experiences abdominal discomfort/pain associated with bowel movements
* Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria:

* Diarrhea-predominant or alternating (diarrhea \& constipation cycling) IBS, or constipation other than that associated with IBS
* Open gastrointestinal or abdominal surgery prior to IBS onset
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Female Sexual Function After Cystectomy

Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments.

This surgery has both the objective of preventing urological complications and improving quality of life.

We know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. Patients are often young and sexually active before the surgery.

Despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients.

Indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer.

Data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. We can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life.

Thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged from 18 to 75 years
* With Partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital.
* Surgery was performed for urological disorders caused by a non-malignant disease
* Patients currently more than 6 months away from the last urological cystectomy/ urinary diversion/ urinary stoma repair surgery

Exclusion Criteria:

* Patients deceased
* Patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement
* Patients unable to complete the questionnaires
Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care

This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19

An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust.

Eligibility Criteria:
Inclusion Criteria:

* having a confirmed diagnosis of COVID-19
* being mechanically ventilated for at least 24 hours
* surviving to critical care discharge.

Exclusion Criteria:

* none
Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery

This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.


Eligibility Criteria:
Inclusion Criteria:

1. the patient can consent for themselves;
2. age 18+ years old;
3. at least 7 days since diagnosis "stroke".
4. Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field

Exclusion Criteria:

1. Diminished capacity to consent;
2. Pregnancy
3. Known or suspected non-compliance, drug or alcohol abuse
4. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
5. Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.
6. Previous enrolment into the current study
7. Exclusion criteria of MRI, tACS, TMS
8. Use of psychoactive medication
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* female patients, 18-70years of age;
* histologically-proven invasive breast cancer;
* no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
* no distant disease/secondary cancer.

Exclusion Criteria:

* pregnant or lactating women;
* pre-operative local treatment for breast cancer;
* prior or concurrent systemic antitumor therapy;
* clinically significant cardiac disease.