cyrilzakka/clinical-trials huggingface dataset:
Endogenous Pain Modulation Study

Rationale: Although most patients experience significant pain relief after total shoulder arthroplasty (TSA), pain persists for some patients even after surgery. The endogenous pain system may be involved in persisting postoperative pain in total knee arthroplasty (TKA) and total hip arthroplasty (THA) patients, but this has never been studies for TSA patients. Furthermore, psychological factors and coping strategies may also be of interest but have not yet been extensively studied in TSA patients.

Objective: The primary objective is to explore whether central sensitization and/or abnormal CPM responses are present in (a subgroup of) patients who will receive shoulder arthroplasty for osteoarthritis, and whether shoulder arthroplasty produces change in these measures of the endogenous pain modulatory system.

The secondary objective, in case patients with altered endogenous pain modulation are found, is to explore if change in pain over time, psychological factors and coping strategies differ between patients with and without altered pain modulation.

Study design: An exploratory prospective observational cohort study.

Study population: Patients (age 18 years or older) who are scheduled to undergo shoulder arthroplasty for osteoarthritis, at the Reinier Haga Orthopaedic Centre.

Intervention (if applicable): Not applicable.

Main study parameters/endpoints: The main study parameters are CPM and TS values at baseline and at 3 and 6 months after surgery, as well as the absence/presence of allodynia at baseline and at 3 and 6 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation will consist of completing questionnaires at baseline and at three and six months after surgery. In addition, subjects will undergo psychophysical testing at 3 moments, which can lead to redness or a burning sensation of the skin during the first 24 hours after testing. The investigators do not expect any additional risks associated with participation. There is no direct benefit for the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yrs
* Scheduled to undergo primary total shoulder arthroplasty (TSA) or reversed shoulder arthroplasty (RSA) for primary shoulder osteoarthritis or cuff tear arthropathy
* American Society of Anesthesiologists score 1, 2 or 3
* Able to provide written informed consent

Exclusion Criteria:

* Regular use of anti-depressants or anti-epileptics for any purpose, including SNRIs and gabapentinoids
* The presence of any chronic pain disorder other than osteoarthritis
* Osteoarthritis in joints other than the affected shoulder, for which arthroplasty is/will be planned in the near future
* Difficulty with or inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders)
* Difficulty with or inability to communicate with the investigators (eg. difficulty with the Dutch language, cognitive/memory disorders)
Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

The purpose of this study is to estimate the prevalence of post-traumatic stress disorder (PTSD) at one month in women who have given birth at the University Hospital of Angers over a period of 1 year.

Childbirth is a natural process expected, prepared and imagined by all future parents.

A traumatic experience of childbirth and its consequences is a major problem that is often underestimated for women's health. Some women may develop Post Traumatic Stress Disorder (PTSD) after delivery. The literature reports a prevalence of PTSD in relation to childbirth of 1.3 to 6%.

Symptoms of post-traumatic stress can be triggered by any event, perceived as threatening to the life or physical integrity of the person or a third party and causing intense fear, helplessness and horror.

It may be thought that childbirth, by its psychological and physiological characteristics, can be described as an extreme experience and its experience depends on multiple factors. Thus, an innocent childbirth for caregivers can be traumatically experienced by the woman.

The symptoms described are symptoms of avoidance (inability to return to the scene of trauma, denial of trauma), symptoms of intrusion (nightmares, reviviscences) and symptoms of neuro-vegetative hyper activation (sleep disorders, anger, emotional indifference ).

The development of PTSD following childbirth is a known phenomenon, but minimized and very little diagnosed by obstetric teams.

Therefore, it seems interesting to assess the prevalence of PTSD during childbirth in order to optimize our management, that is to identify patients at risk of PTSD and offer them adapted psychological follow-up.

This study also aims to describe the kinetics of the development of post-traumatic postpartum symptoms and to study the risk factors for the development of PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Major and francophone patient,
* Giving birth (≥ 37 weeks of amenorrhea) to the maternity hospital of Angers University Hospital,
* Agree to participate in the study (signature of consent).

Exclusion Criteria:

* Personal antecedent (s) of psychiatric pathology (s),
* Birth of a child born lifeless,
* Patient deprived of liberty by judicial or administrative decision,
* Patient subject to a legal protection measure,
* Patient unable to express her consent.
Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia

Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.

Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>20 y/o)
* ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
* Treatment with endotracheal Intubation

Exclusion Criteria:

* Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
* Nosocomial infection
The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury

Objective: to verify the effect of solution-focused group therapy (SFBT) on pain management as well as physiological, psychological and social adaptation in patients with spinal cord injury.

Setting: for matters of convenience, the samples were collected at medical and rehabilitation centers in Taiwan. Twenty-six patients with spinal cord injuries and neuropathic pain were invited to join the four pain management groups.

Method: In the case of patients with spinal cord injury affected by neuropathic pain, a solution-focused pain management group therapy was conducted once a week for 6 weeks, 90 minutes each time; fear avoidance theory and acceptance and commitment therapy was used for pain management, using solution-focus group counseling strategies to guide group members to achieve pain management goals by accepting pain and establishing goals.The group effectiveness was assessed before and after the group intervention in terms of pain intensity (0-10 numeric rating scale), brief pain inventory-pain inference, chronic pain self-efficacy scale, pain fear (0-10 numeric rating scale), depression (patient health questionnaire-9), demoralization (demoralization scale), post-traumatic growth inventory and life quality (WHOQOL-BREF). Then we analyzed the correlation between the difference values of the variables before and after the test in order to understand the clinical application of the pain management group therapy for patients with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with spinal cord injury as being in compliance with the Taiwan National Health Insurance's definition

Exclusion Criteria:

* Psychiatric disabilities
* Intellectual disabilities
* Unconscious patients
* Patients in critical condition
* Bedridden patients
Satiety Effects of Protein and Fiber Added to Pasta

The combination of fiber and protein added to pasta will enhance satiety.

Subjects will consume 3 different pasta lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* nonsmoking
* body mass index from 19 - 29

Exclusion Criteria:

* Antibiotic use
* any disease
* weight loss
* food allergies
* high fiber intake
* restrained eater
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumour tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy ≥ 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.

Exclusion Criteria:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Current or History of ILD.
4. Clinical symptoms or diseases of the heart that are not well controlled.
5. Arterial/venous thrombosis events occurred before the first dose.
6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.
7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
8. Patients with intestinal obstruction or parenteral nutrition before the first dose.
9. Serious infection before the first dose.
10. Active hepatitis B or active hepatitis C.
11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
15. Other inappropriate situation considered by the investigator.
Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)

The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.

Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering \>100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients ≥ 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is a randomized, controlled, multi-center clinical trial of such an intervention. Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients; and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated ≥ 7 days
* Mechanically ventilated without \> 96 hour interruption
* Age ≥ 21 years
* ICU MD does not expect patient will die within 72 hours
* ICU MD does not expect patient will be liberated from the ventilator within 72 hours.

Exclusion Criteria:

* Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for \> 7 days before transfer
* Chronic Neuromuscular (NM) Disease
* Trauma
* Burn
* Previous palliative care consultation in this hospitalization
* No family or other surrogate decision-maker
* Family not available
* Surrogate lacks English proficiency
* Physician refused permission for research staff to approach the family
Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of Gougerot-Sjögren disease.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Patients with primary Sjögren's syndrome according to the AECG criteria

Exclusion Criteria:

* The subject is participating in a category I interventional study, or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Pregnant, parturient or breastfeeding patients
* Patients with secondary Sjögren's syndrome
Atrial Flutter Ablation in the iCMR

The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.


Eligibility Criteria:
Inclusion Criteria:

* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
* Patient 18 years and older

Exclusion Criteria:

* Contraindications for MRI procedures
* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
* Previous CTI ablation procedures
* Myocardial infarction within 60 days of enrollment
* Current unstable angina
* Cardiac surgery within 90 days of enrollment
* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
* Thrombocytosis or thrombocytopenia
* Contraindication to anticoagulation therapy
* Currently documented intracardiac thrombus or myxoma
* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment
* Prosthetic valve through which the catheter must pass
* Interatrial baffle or patch through which the catheter must pass
* Moderate or severe tricuspid valve regurgitation or stenosis
* Uncompensated congestive heart failure
* Active systemic infection
* Pregnancy or if subject plans to become pregnant during the trial
* Uncontrolled hyperthyroidism
* Any other significant uncontrolled or unstable medical condition
* Enrollment in any concurrent study without Imricor written approval
* Life expectancy of less than or equal to 2 years (730 days) per physician opinion
Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters

Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia \[Eljezi et al.. Reg Anesth Pain Med 2012; 37:166\]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy.
* Patients will be at risk of noncardiac postoperative complications, i.e. age over 75, BMI over 30, pulmonary disease, or active smoking habit

Exclusion Criteria:

* surgery in emergency
* thoracotomy
* cardiac graft
* redo
* aortic dissection
* age over 85
* pregnancy
* patient's refusal
* minor or adult under legal protection
* psychiatric ongoing disease
* addiction to opiates
* ongoing opiate treatment
* inability to use a PCA device
* respiratory insufficiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP \> 50 mmHg)
* cardiac failure or EF \< 40% or intra-aortic balloon use
* pulmonary hypertension over 50 mmHg
* severe renal insufficiency
* history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.
Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.

Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject with a minimum age of 22 years
* Planned natural lens replacement with posterior chamber IOL implantation
* Clear intraocular media other than cataract
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
* Ability to consent to the participation in study
* Signed informed consent

Exclusion Criteria:

* Corneal pathology/ectasia
* Prior ophthalmic surgery
* Zonular-defects, unstable bag
* Macular pathologies
* Expected Visual acuity of less than 0.63 (decimal)
* Glaucoma
* Use of systemic or ocular medication that might affect vision
* Patient is pregnant, plans to become pregnant, is lactating
* Concurrent participation in any other clinical trial with an investigation product
The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients

This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive rheumatoid arthritis (RA), who had not previously received any Disease modifying antirheumatic drug (DMARD) or biologic treatment.

Patients will be randomly assigned to either adalimumab q2w plus oral MTX qw combination therapy or oral MTX qw monotherapy plus placebo subcutaneous (SC) q2w in a ration 2:1. To maintain blinding, matching placebo SC injections will be dispensed q2w to the MTX monotherapy group. All subjects will receive open-label MTX 15 mg qw as oral tablets. All subjects will take approximately 5 mg weekly dietary supplement of oral folate throughout the study on any day beginning 48 hours after ingestion of their oral study medication. Defined as standard therapy oral folate supplementation will be taken in a single dose 24-48 h after MTX therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of early RA (ERA) fulfilling the 2010 American college of rheumatology (ACR) criteria for classification of RA
* Disease duration less than 12 months from symptoms onset.

Exclusion Criteria:

* Subject has previous exposure to any systemic biologic therapy (e.g. abatacept, tocilizumab) including anti-Tumor necrosis factor (TNF therapy) (e.g., infliximab, golimumab, certolizumab pegol, etanercept) including adalimumab.