cyrilzakka/clinical-trials huggingface dataset:
Identification of the Clinical Specificities of Complex Posttraumatic Stress Disorder

Identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

In general, the current state of the literature in the field the lack of data on elements of characterization of PTSD compared to simple PTSD, which are which are essential for deciding on the discriminatory validity of discriminative validity of PTSD as a disorder in its own right disorder in its own right. The challenge of defining the nosographic scope of this disorder is twofold, since the links between diagnosis and treatment are decisive for developing treatments adapted to the treatments adapted to the psychopathology of the patients. These characterization elements are therefore crucial in order to improve the perspective of improving the effectiveness of future treatment which are currently lacking in TSPTC.

Eligibility Criteria:
Inclusion Criteria Patient :

* Age ≥ 18 years
* Free, informed and signed consent
* Affiliated to a social security scheme

Inclusion Criteria volonteer :

* Age ≥ 18 years
* Free, informed and signed consent
* Affiliated to a social security scheme

Exclusion Criteria (patient and volonteer):

* Under legal protection (curatorship, guardianship, safeguard of justice)
* Present a former or current psychotic disorder, a former or current neurological disease, a history of head trauma (loss of consciousness of more than 10 minutes)
Patient's Management Receiving Eplerenone Therapy

On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:

* To describe the characteristics of the population treated.
* To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations).
* To describe the follow-up methods of the treatment.
* To describe the possible interruptions of the treatment

A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.

Eligibility Criteria:
Inclusion Criteria:

The following patients may be selected to participate in the survey:

* Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
* Those likely to be followed by the same physician for a minimal period of twelve months.

Exclusion Criteria:

* Severe Kidney Disease
* Hyperkamiemia more than 5.5
Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers

The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females between the ages of 20-64 years
2. Body Mass Index (BMI) of 18.5 (inclusive) to 24 kg/m2; and a total body weight \>45 kg
3. Accessible vein for blood sampling
4. No significant abnormalities in electrocardiogram (ECG) recording as per sites' local practice
5. No significant abnormalities in general physical examination as per sites' local practice
6. No significantly abnormal findings in laboratory assessments including hematology, biochemistry and urinalysis as per site's local practice
7. A signed and dated written informed consent must be obtained from the subject prior to study participation
8. Capable of understanding and willing to comply with study procedures
9. A negative serum pregnancy test before the first dose of study drug must be available for women of childbearing potential

Exclusion Criteria:

1. Females who are pregnant, breast-feeding or have positive pregnancy test
2. History of hypersensitivity to granisetron or its analogs
3. Subjects with nasal ulcer, septal perforation, or other nasal conditions that may interfere with nasal administration and determined by the investigator to be ineligible
4. Subjects with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history
5. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or other significant disease or clinical findings at screening and determined by the investigator to be ineligible
6. Subjects with a history of drug and/or alcohol abuse within 12 months prior to dosing
7. Inability to read and/or sign the consent form
8. Treatment with any other investigational drug during the 4 weeks prior to the initial dosing for this study
9. Subjects who have donated or lost more than 250 ml blood within 2 months prior to the initial dosing for this study
10. Male and female subjects with reproductive potential who are not willing to use effective method of contraception. Use of hormonal contraceptive is not allowed during the study period
11. Clinical significant rhinitis or rhinorrhea at screening determined by the investigator to be ineligible
12. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing of study medication
13. For subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.), 2 weeks abstinence is required
14. Conditions upon screening which might contraindicate or require that caution be used in the administration of granisetron
Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound

The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.

In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 yrs
* Weight 40-100 kg
* Either sex
* Height \>150 cm
* American Society of Anesthesiologists physical status 1-3
* Scheduled for hand or elbow surgery under regional anesthesia

Exclusion Criteria:

* Inability to give informed consent
* Refusal of treatment randomization
* Language barrier
* Allergy to any medications being used in the study protocol
* Ongoing major medical or psychiatric problems
* Chronic pain or narcotic use/abuse
* Peripheral neuropathy or major neurological problems
* Scarring in area of blockade
* Inability to co-operate with post-operative evaluation
* Major coagulopathy
* Pregnancy and breast feeding
* Patients requiring anesthesia of other surgical sites
* Obese patients (i.e. BMI \>40)
* Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual protocol of care
Evaluation of FUSION™ Vascular Graft for Above Knee Targets

The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.

This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.

Eligibility Criteria:
Inclusion Criteria:

* No known malignant disease
* Patient was willing and able to have follow-up visits and examinations
* Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery
* Patient was not participating in other clinical trials that would conflict with this protocol
* Patient agreed to the study provisions and provided written informed consent

Exclusion Criteria:

* Urgent or emergent surgery of any kind
* Documented acute or suspected systemic infection
* Life expectancy of less than one year
* Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke
* Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris
* Severe chronic renal insufficiency or undergoing hemodialysis
* Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment
* Medical conditions requiring oral anticoagulation
* Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin
* International normalized ratio (INR) \> 2.0
* Known hypersensitivity to heparin
* Patient not tolerating aspirin
* Previous history of bypass surgery in the target limb
* Patient with category 6 ischemia (tissue loss)
* Acute limb ischemia of any grade (0-3)
* Patient with no outflow beyond the popliteal artery
* Pregnant or may become pregnant during the course of the study
* Uncontrolled arterial hypertension (BP \> 200 mmHg) at 2 successive readings
* Anaemia (hemoglobin \< 8 g/ml)
* Thrombocytopenia \< 50 g/L
* Active bleeding according to clinical judgment
* Infected wet gangrene of any size and location at the target limb
* Compromised arterial flow
* Patient unwilling or unable to comply with follow-up requirements
Internet-delivered Cognitive Behaviour Therapy for Students: Duration Preference Trial

There is growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (ICBT) for post-secondary students with symptoms of depression and anxiety. In ICBT, clients review structured online content over several weeks to learn strategies and skills to manage their symptoms. Low treatment completion rates remain a concern for post-secondary students, so it is possible that existing treatment protocols do not offer enough flexibility for students' needs and preferences.

This trial will examine students' preferences for different course options (fast-track, 5-week, and 8-week) and compare enrollment, adherence, and outcomes of students who pick each of the three options. In all three options, students will receive optional therapist support, in which the assigned therapist only contacts the student on weeks where the student sends the therapist a message. This trial will help inform the delivery of flexible treatment options for post-secondary students in a routine care setting.


Eligibility Criteria:
Inclusion Criteria:

* registered as a student at a post-secondary institution in Saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the PHQ-9) and/or anxiety (score of 5 or greater on the GAD-7); and be able to access computers and the Internet and be comfortable using them

Exclusion Criteria:

* high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years old and older
* Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
* Radiologically confirmed relapse after \>6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
* The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study

Exclusion Criteria:

* FIGO I,II epithelial ovarian cancer
* FIGO III, IV clear cells epithelial ovarian cancer
* Non-epithelial ovarian cancer
* Borderline tumors (tumors of low malignant potential)
* Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\] except first line Platinum-based chemotherapy (with or without bevacizumab)
* Previous radiotherapy to the abdomen and pelvis
* Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
Comparing Health Services Interventions for the Prevention of HPV-related Cancer

The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.

Safety data and HPV vaccine compliance will be assessed.

A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.

Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.

Eligibility Criteria:
Inclusion Criteria:

* women within the age range of 25-45
* attending cervical cancer screening

Exclusion Criteria:

* previous history of HPV vaccine administration
Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas

The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.

The overall objective is to determine the impact of daily consumption of processed pulse-based food products on metabolic health, specifically the physiological responses related to energy metabolism. The primary hypothesis is that consuming a serving of pulses daily for 12 weeks will improve metabolic responses related to energy metabolism, particularly fat oxidation and molecular adaptations related to fat and glucose metabolism, compared to current Dietary Guidelines for Americans (DGA) recommendations. Furthermore, we hypothesize that the degree of processing will influence these metabolic adaptations such that the daily consumption of 100% pulse flour food products will result in the greatest effect on fat oxidation and molecular adaptations related to fat and glucose metabolism followed by the pulse purée which will have a greater effect than the whole cooked pulse (100% pulse flour \> purée \> whole).

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy adults
* BMI \>18.5 or \<35 kg/m2 (healthy body weight - class I obesity)
* ability to understand and sign the consent form
* availability of transportation (i.e., participants must provide their own transportation to the Center)
* non-smoking or do not use other tobacco products, including e-cigarettes
* not taking steroid-based medications
* not planning to or currently attempting to gain or lose weight
* not allergic to study foods
* willing to comply with study demands

Exclusion Criteria:

* usual pulse consumption greater than DGA recommendation
* inability or unwillingness to consume any of the provided foods
* more than a 10% change in body weight within the past 2 months
* actively trying to lose weight
* pregnancy or actively trying to get pregnant
* lactation
* uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg)
* diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
* HbA1c ≥ 5.7%
* complete blood count (CBC) outside of the normal range for a healthy adult
* history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
* using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
* cannot read or understand English
SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

In this study, a single non-invasive tool, spleen stiffness measurement (SSM), was used to monitor the disease regression of inpatients with chronic liver disease (CLD) and acute liver injury. The present study aimed to establish an early diagnosis warning model for acute-on-chronic liver failure (ACLF) by SSM and investigate the effect of dynamic changes in SSM on the short-term prognosis (28-day, 90-day morbidity and mortality) of inpatients with CLD and acute liver injury.

Portal hypertension is a major complication of cirrhosis and can lead to serious clinical manifestations such as ascites, hepatic encephalopathy, variceal bleeding, etc. Colecchia et al. proposed the use of spleen stiffness measurement (SSM) to dynamically monitor portal pressure and to predict the risk of oesophageal varices. Studies have now demonstrated the utility of SSM in assessing portal hypertension, ruling out high-risk varices, and predicting clinical complications in cirrhotic patients. Furthermore, the Baveno VII consensus of portal hypertension has included SSM in its recommendations for non-invasive screening. Pathogenic triggers, important clinical events (ascites, encephalopathy, etc.), and short-term prognosis in compensated advanced chronic liver disease are associated with portal pressure. Exploring the relationship between portal hypertension and liver failure development would be of great clinical and scientific value. The present study is mainly based on a single non-invasive tool, SSM, to monitor the disease regression of chronic liver disease (CLD) inpatients with acute liver injury, to establish an early warning model for early diagnosis of acute-on-chronic liver failure, and to investigate the effect of dynamic changes in SSM on the short-term prognosis of inpatients with CLD and acute liver injury.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years and 80 years
2. Chronic liver diseases regardless of etiology
3. Acute liver injury with total bilirubin ≥ 3 mg/dl regardless of inducement

Exclusion Criteria:

1. Prior surgery of liver diseases before enrollment such as liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy and partial splenic embolization
2. Severe extrahepatic diseases such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission
3. Receiving Immunosuppressive drugs for reasons rather than chronic liver diseases
4. Diagnosis of hepatocellular carcinoma or other non-liver malignancies during screening period
5. Serious mental illnesses such as anxiety, depressive disorders to obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD)
6. The pregnant
7. Jaundice due to biliary obstruction or cholestasis
8. Unsuitable to participate in this study judging by investigators
The Stockholm III Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer

Preoperative radiotherapy (RT) is recommended to many patients with localised rectal cancer, not previously treated with pelvic RT. However, the optimum fractionation, the timing of surgery and the best use of concomitant chemotherapy remains controversial. There are theoretical reasons to believe that radiotherapy given in larger fractions during a shorter period of time might result in more late side effects than giving a conventional, more protracted RT in patients with rectal cancer. In addition, the optimum timing of surgery after RT, with respect to postoperative morbidity, mortality and potential downsizing of the tumour is not known.

To address these questions, a prospective randomized multicenter trial was initiated, the Stockholm III trial, in which patients with primarily resectable rectal cancer were randomized to short-course preoperative RT (5x5 Gy) followed by surgery within one week or after 4-8 weeks or long-course preoperative RT(25x2 Gy) followed by surgery after 4-8 weeks.

840 participants (men and women) with a biopsy verified adenocarcinoma of the rectum scheduled for an open abdominal procedure were enrolled at 18 Swedish Hospitals during 1998-2013.

In the initial protocol patients were randomly assigned (1:1:1) between three different RT courses; 5x5 Gy with surgery within 1 week (SRT), 5x5 Gy with surgery after 4-8 weeks (SRT-delay) or 25x2 Gy during 5 weeks without concomitant chemotherapy and surgery after 4-8weeks (LRT-delay). After a protocol amendment on May 21, 1999, participating hospitals could choose to randomise patients to just the short-course radiotherapy arms (1:1) or to all three arms.

Randomisation was done by telephone by the Regional Cancer Centre in Stockholm, Sweden, after assessing inclusion and exclusion criteria. Computer generated randomisation lists were constructed by use of permuted block technique (block size of six for the three- arm randomisation, block size of four for the two-arm randomisation) and stratified by participating center. Investigators and patients were not masked to treatment.

Follow-up was recommended at 3-, 6- and 12 months after surgery, and yearly thereafter. Although follow-up according to national guidelines with a minimum follow-up at 1 and 3 years was allowed. Patient data was also collected from the Swedish ColoRectal Cancer Register (SCRCR) and medical records.

Primary outcome:

1. Time to local recurrence.

Secondary outcomes:

1. Recurrence-free survival
2. Frequency of postoperative complications
3. Frequency of tumour regression

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed clinically resectable rectal adenocarcinoma within 15 cm from the anal verge
* Planned for bowel resection with an abdominal procedure.
* Informed consent.

Exclusion Criteria:

* Distant metastases
* Locally advanced unresectable tumors
* Planned for local excision
* Previous radiotherapy to the abdominal or pelvic region
* Severe ischemic heart disease or symptoms of severe arteriosclerosis