cyrilzakka/clinical-trials huggingface dataset:
Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers

The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.

After the end of treatments, cancer patients face a difficult time because it is expected that they return to normal, but at the same time they still have to struggle with the aftermath of cancer and fear of recurrence. This is why there is room in this period for an intervention designed to help patients to cope with their emotions. . Patient emotional skills are patient abilities to identify, express and manage their emotions for the best possible psychological adjustment. In general population, emotional skills have been shown to be highly related to a better quality of life. In this randomized controlled study, bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end of treatments will undergo either the emotional skills intervention (intervention group) or the relaxation group (control group).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 ans,
* Oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the end of cancer treatments
* Patient of the CHRU (Regional Teaching Hospital) of Lille,
* Registered with a social security scheme
* Speak and understand French language
* Signature of the informed consent to participate in the study.

Exclusion Criteria:

* Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
* Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
* Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapy )
* Patients under judicial protection (guardianship or curators).
Asthma Control: Increased Physical Activity in Young Adults

Investigators want to study to see if patients who participate in a physical activity intervention involving increasing daily step counts will have better mini asthma quality of life questionnaire (Mini AQLQ) scores at the end of the study period compared to patients that are in the control group and do not increase daily step counts. Participants will be randomized into the two groups.

The Control group (usual care group) of 75 patients will not participate in the intervention but will take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.

The Intervention group of 75 patients who will participate in the intervention of step counts and take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.

Eligibility Criteria:
Inclusion Criteria:

* Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma

Exclusion Criteria:

* Patients with any medical history which would prohibit their ability to participate in increased exercise, and/or patients that are diagnosed or associated with severe asthma
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy

The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.

Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.

Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Age:18 to 60
* Weight: 60 to 80 Kg
* ASA Class: I,II
* Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
* Single level lumbar disk herniation unresponsive to medical treatment

Exclusion Criteria:

* Previous consumption of Gabapentin or Amitriptyline
* Known allergy to investigated drugs
* Reluctant to sign informed consent
* Previous history of intolerance to narcotics
* Simultaneous lumbar diskectomy and a fusion technique
* Known renal failure
* Pregnancy
* Contraindications to Amitriptyline or Gabapentin prescription
* Unable to use PCA
* Habitual use of alcohol or opium
* History of analgesic consumption during the last 24hours
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in borderline patients is still limited.

A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included borderline patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs.

Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients.

Eligibility Criteria:
Inclusion Criteria:

* Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
* Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
* Patient capable of understanding and/or singning the informed consent.
* Patient who understands the type of study and will comply with all follow-up tests throughout its duration

Exclusion Criteria:

* Pregnancy or lactation.
* Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
* Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
* Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
* Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
* Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
* Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
* Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
* Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
* Patients incapable of maintaining follow-up appointments (lack of adherence).
* Lack of informed consent.
Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction.

The occurrences of morbidity of the neck after cancer therapy were considerable and consisted of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave therapy (ESWT) is one of the treatment options used for patients with myofascial pain syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two major causes of trigger pathophysiology) and mechanical transduction as a cellular response to external stimulation. the aim of this study was to investigate efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Previous unilateral modified radical neck dissection.
2. Patients with myofascial pain of upper trapezius for at least 3 months.
3. Patients with palpable intramuscular taut band.
4. Restriction in cervical ROM of lateral flexion and rotation.
5. Provocation of the clinical symptoms by compression of the active trigger point

Exclusion Criteria:

1. Patient who received medication or other therapies for MPS within the previous 2 months.
2. Patients with pacemaker, pregnancy
3. Open wound at the treatment area.
4. Cervical myelopathy or radiculopathy, cervical spine fracture or spondylolisthesis.
5. Rheumatoid arthritis.
6. Coagulopathy.
7. Epilepsy or any psychological disorder.
Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults

In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.

After providing their written informed consent, participants were randomized to receive either a healthy Nordic diet or a control diet for 8 days. All meals were provided and minimal food preparation was required. Participants picked up their food outside the study kitchen every 3 days. Before and after the intervention, health-related self-rated questionnaires were completed. For every meal during the intervention, participants completed a questionnaire on their perceptions of the meal. Every evening a questionnaire was completed to assess dietary adherence. At the end of the study, a final evaluation questionnaire was completed to assess participants' perceptions of the diet and study as a whole.

Eligibility Criteria:
Inclusion Criteria:

* If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression

Exclusion Criteria:

* A score of 8 or higher (out of a maximum of 12 points) on a brief diet survey (the retired version of the Swedish Food Agency's online Matvanekollen, conducted via phone interview), indicating a relatively healthy habitual diet
* Presence of food allergies, intolerances or sensitivities
* Consuming any form of special diet that excludes certain foods, for example a vegetarian or gluten-free diet
* Suicidality, indicated by a score of 4 or higher on the MADRS-S suicidality question.
Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam

Vietnam is currently decentralizing its methadone maintenance therapy (MMT) dispensing network to its local commune health centers (CHC), which provides a window of opportunity to study decentralization of harm reduction and HIV-related healthcare services into community-based healthcare settings. Commune health workers (CHW) in Vietnam have widespread misconceptions about harm reduction and perceived significant challenges associated with treating people who use drugs. Intervention effort is needed to address these issues to ensure a smooth implementation of the decentralized service model. This study is to pilot testing an intervention with a primary focus on process optimization in six CHC-based MMT distribution sites with 30 CHW and 90 MMT patients. The six CHC in Thai Nguyen Province of Vietnam will be randomized to either an intervention condition or a control condition. The intervention will be executed through a combination of in-person training and mobile phone application utilization. The intervention outcomes on CHW and MMT clients will be evaluated at baseline, 3-, and 6-months.

The intervention pilot will be conducted in six commune health center (CHC)-based methadone maintenance therapy (MMT) distribution sites in Thai Nguyen Province of Vietnam. Five commune health workers (CHW) and 15 MMT clients will be recruited from each of the CHC (total n = 30 CHW and 90 MMT clients). The six CHC will be matched into pairs based on the current number of CHW and MMT patient load; and within each pair, the two CHC will be randomized into either a control condition or an intervention condition. The intervention contents will include the promotion of streamlined procedure, skill training, problem solving, knowledge acquisition, networking and support, and information sharing. The intervention will be delivered through a combination of service provider in-person training and mobile phone application utilization. Provider-level outcomes (e.g., CHW's MMT/HIV service provision) and client-level outcomes (e.g., treatment progress) will be measured at baseline, 3-, and 6-month follow-ups.

Eligibility Criteria:
MMT patients (n=90):

Inclusion criteria:

* Age 18 or over
* Currently seeking MMT services in one of the participating commune health centers
* Voluntary informed consent

Exclusion criteria:

* Having psychosis or neurological damage, or cannot understand the study purposes as judged by the recruiter in consultation with a clinic supervisor.
* Inability to give informed consent

CHW (n=30):

Inclusion criteria:

* Age 18 or over
* Currently working in one of the participating commune health centers and have direct contact with MMT clients
* Providing informed consent

Exclusion criteria:

• Inability to provide informed consent
Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques

The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.

Patients with Abdominal Aortic Aneurysm, (AAA), will be identified within the vascular surgery practice. Those patients who meet standard indications for surgery including symptomatic AAA, size \>5.0-5.5 cm, or rapidly enlarging \>0.5 cm per 6 months will have standard pre-operative work-up which includes magnetic resonance angiogram (MRA) and Echocardiogram (ECHO). These pre-operative studies will be modified for the study patients to include electrocardiogram(ECG)-gating (coupled with MR angiogram) and 2-Dimensional speckle-tracking ultrasound of the abdominal aorta. Patients in the study will be followed for 1 year. Measurements will be analyzed for any relationship between aortic wall properties and clinical outcomes such as aneurysm growth, rupture risk or aortic dissection. This study will be comparing 3 groups of patients: no surgery (surveillance), open surgery, and endovascular aneurysm repair (EVAR).

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age with ability to provide informed consent.
* Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter.
* Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason.

Exclusion Criteria:

* Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction.
* Patients who do not require contrast imaging or echocardiogram as part of their care plan.
* Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months.
* Patients unable to tolerate magnetic resonance imaging.
Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.

Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (\<1%) of localized prostatic cancer treatment but hard to manage. Different types of treatment exist: conservatory, trans-sphinteric (York-Masson), transanal, perineal, with or without muscle flap interposition. Gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce.

The aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male over 18 years old
* Treated for a localized prostatic cancer (Prostatectomy, cryotherapy, HIFU, radiotherapy)
* Affected with a treatment induced Rectourethral fistula

Exclusion Criteria:

* Rectourethral fistula caused by other pelvic diseases (gynecological or digestif cancer, inflammatory bowel disease, other urogenital issues)
* Rectourethral fistula treated by cysto-prostatectomy with urinary tract derivation
* Patient under guardianship
* Non comprehension of written or spoken French
Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma

The clinical and derived data from the preoperative computed axial tomography (CT) and Positron Emission Tomography (PET) of patients with pathological stage I pulmonary adenocarcinoma will be analyzed retrospectively, classified according to the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma, subjected to surgical treatment in our Operating Unit between August 2006 and July 2011. A follow-up will be performed on the patients enrolled in the study up to the date of death, and in any case no later than October 31, 2019


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from pulmonary adenocarcinoma in stage I underwent CT, PET and surgical treatment with radical intent, at San Raffale Hospital (thoracic surgery) between August 2006 and July 2011

Exclusion Criteria:

* primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.
Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 18-38.
* infertility.
* patients undergoing IUI treatment.
* at least one failed IUI cycle.

Exclusion Criteria:

* indication for IVF treatment.
* Known Pelvic inflammatory disease(PID).
Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

The impact of telemonitoring on patients' adherence to post trauma pain treatment , their satisfaction and pain relief after discharge from the ED.

This is a prospective, multicenter, randomized trial . Participants are recruited from the emergency departement of Fattouma Bourguiba Monastir.

This study is a seven day three-arm parallel group trial . Participants inculded are aged more than 16 years old who presented to the ED for minor trauma and discharged with analgesic treatment. They are randomized to one of two trial TM intervention groups (SMS and TM) or usual care group (control) in a 1 :1 :1 allocation ratio.

For all inculded patients, demographic characteristics were collected as well as clinical examination findings. The interventional care provided at the ED was mentioned. At ED discharge the pain Visual Analogue Scale (VAS) was evaluated and the analgesic treatment prescribed was noted.

Eligibility Criteria:
Inclusion Criteria:

* Age \>16 years old with minor trauma and discharged with an analgesic treatment.
* Included patients should have regular access to a mobile phone ,were able to interact with SMS or could do so with help of a relative.
* Patients who accepted to participate to the study.
* No contraindication to analgesic medication

Exclusion Criteria:

* Swallowing disorder or inability to swallow.
* Unsuitable for follow-up.
Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure

The investigators intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction

Sepsis is one of the common critical diseases in ICU with high mortality. Septic shock patients are often accompanied by multiple organ dysfunction (MODS), of which more than 50% of patients with varying degrees of myocardial injury.The investigators hope to find a drug with a protective effect on cardiac function and kidney function, so as to treat sepsis more effectively in the treatment of sepsis.

Recombinant human brain natriuretic peptide (rhBNP) was approved by FDA in 2001 for the treatment of acute decompensated heart failure.These effects play a role in the protection of cardiac and kidney function, and have achieved good results in patients with cardiac insufficiency and AKI caused by cardiac surgery.

The investigators are going to carry out related research from the following aspects: 1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.

Eligibility Criteria:
Inclusion Criteria:

* sepsis complicated with heart failure（Diagnosed by sepsis 3.0）
* Heart failure: BNP rises by 600 pg/ml
* Age\>=18 years old

Exclusion Criteria:

* Hemodynamically unstable
* Pregnant
* Disagree with comprehensive and active life support treatment
* coronary heart disease, myocardial infarction, and cardiac insufficiency
* chronic renal insufficiency