cyrilzakka/clinical-trials huggingface dataset:
A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.

This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen).

In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires.

Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.

Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.

The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

The recruitment period for the first stage is comprised between March 2008 and August 2008.

The recruitment period for the second stage started in September 2008.

Eligibility Criteria:
Inclusion Criteria:

* To be more than 18 years old (the legal age to gamble in France)

Exclusion Criteria:

* None
Registry of AngioJet Use in the Peripheral Vascular System

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
* Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Exclusion Criteria:

* Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars.

The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical and dental history was obtained from all participants in this trial and clinical and radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or without apical periodontitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (irrigation using 1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment was performed with a week interval in between visits. Each patient received a 7-day diary to record postoperative pain and rescue medication intake. Post-operative pain was measured at the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and postobturation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 25-45 year old.
2. Medically free.
3. Non-vital mandibular teeth (first or second molar) with or without apical periodontitis
4. No sex predilection

Exclusion Criteria:

1. Pregnant females.
2. History of allergy to any medication used in the study.
3. Preoperative premedication 12 hours before procedure.
4. Acute abscess cases.
5. Badly-decayed crown.
6. Retreatment cases
Me & You-Tech: A Socio-Ecological Solution to Teen Dating Violence for the Digital Age

The purpose of this study is to develop and evaluate a multi-level (youth, parent, school) Internet-based dating violence prevention program, 'Me \& You-Tech' (MYT) for 6th-grade middle school students.

The purpose of this three year study is to develop and evaluate Me \& You - Tech, a computer-based healthy relationships and dating violence prevention curriculum for 6th grade students. The curriculum will be developed and adapted from an existing effective healthy relationship curriculum, Me \& You: Building Healthy Relationships. A randomized two-arm design will be conducted among 6th grade students, where students receiving the curriculum were compared to students receiving usual care. Four middle schools participated in the study, 2 schools were randomly assigned to receive the curriculum and two to receive usual care. Outcomes were assessed at baseline, 3 months following completion of the intervention, and 9 months after baseline. Parental permission and student assent were obtained prior to administration of the surveys. The primary hypothesis is that students who receive the curriculum will have significantly lower teen dating violence perpetration than those who do not receive the curriculum.

Eligibility Criteria:
Inclusion Criteria:

* 6th grade student
* Currently attending a middle school

Exclusion Criteria:

* Previous participation in usability and feasibility testing
* Inability to complete activities
* Inability to read English
* Lack of home internet connectivity
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms.

The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms. The total length of the program will be 8 weeks. The sessions will be held 3 hours per week with 1.5 hours of group cognitive behavioral therapy and 1.5 hours of yoga. Changes in PTSD symptoms and sleep quality will be measured at baseline, immediately following the program, and at 2 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed posttraumatic stress disorder (PTSD) or subthreshold PTSD symptoms

Exclusion Criteria:

* current uncontrolled psychotic or bipolar disorder, significant cognitive impairment, substance dependence, non-English speaking, or a significant medical condition that would interfere with participation in the yoga portion of the program
HFNC and Acute Hypercapnic Respiratory Failure

High-flow nasal cannula (HFNC) enables delivering humidified gas at high-flow rates controlling the oxygen inspired fraction (FiO2). Its efficacy has been demonstrated in hypoxemic acute respiratory failure. However, little is known about its use in hypercapnic acute respiratory failure (ARF). Therefore, we aimed to evaluate the effect of using HFNC through "Precision Flow" equipment as first line of ventilatory support for COPD patients with hypercapnic acute respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to very severe COPD patients (GOLD 2 to 4) over 18 years old admitted to the ICU with hypercapnic ARF (PaCO2\> 45 mmHg and respiratory acidosis \[pH ≥7.30\], with or without hypoxemia + one of the following: Respiratory Rate ≥25 cycles per minute, intercostal and / or supraclavicular recruitment, or thoraco-abdominal synchrony, no prior use of NIV)

Exclusion Criteria:

* Patients less than 18 years old
* Mild COPD patients
* Absence of hypercapnia
* Kelly M Score \> 3
* Haemodynamic instability (despite fluid resuscitation)
* NIV or Invasive Mechanical Ventilation (IMV) (Need to use previously to HFNC)
* Contraindications to implement high-flow oxygen therapy.
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Psychophysiologic insomnia
* Severity: mild to moderate
* Duration: subacute to chronic
* Subjects age \> 18 and \< 65, men or women
* Subject had to give written informed consent

Exclusion Criteria:

* Regular use of psycho-active drugs
* Work in shifts
* Use of psychoactive drugs during the past 30 days
* Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
* known hypersensitivity to any of the ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential not using an established contraceptive
* Drug and alcohol abuse
* Participation in another trial within the past 30 days
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS).

This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.


Eligibility Criteria:
Main Inclusion Criteria:

* For male or female with reproductive potential, use of reliable means of contraception;
* RRMS according to the 2010 revised McDonald criteria;
* Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
* EDSS score \< 6.0.

Main Exclusion Criteria:

* Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
* Pregnant and nursing women.
Medical Thoracoscopy in Treatment Outcomes of Empyema Management

To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone.

To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods.

To asses resolution of pleural infection and rates of fluid re-accumulation over follow-up.

To compare safety profiles and complication rates of thoracoscopy versus tube drainage alone

Empyema is a serious infection characterized by pus accumulation in the pleural space. Effective drainage and treatment is necessary for resolution. Traditionally, intercostal tube placement was standard initial management. However, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (VATS).

Thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. Also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management.

Additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. Overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of empyema via Imaging tests (e.g. chest x-ray/CT scan)
* Age 18 years or older
* Clinical signs/symptoms consistent with Empyema such as fever, chest pain, coughs
* Pleural fluid loculations/septations seen on Imaging requiring drainage
* No previous drainage procedures done for Current empyema

Exclusion Criteria:

* Age less than 18 years
* Immunocompromised state or other conditions Contraindications to thoracoscopy
* Previous drainage procedure for current Empyema
* Residual pleural fluid not amenable to drain
IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC

This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years;
2. ECOG 0 \~ 1;
3. Histologically/cytologically confirmed R/M NPC;
4. Failed to prior Anti-PD-1 resistance;
5. Adequate organ and bone marrow function;
6. Expected survival ≥12 weeks;
7. Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
8. Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
9. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria:

1. Had tumors other than NPC within the past 5 years.
2. Had allogeneic organ or stem cell transplantation.
3. The presence of uncontrolled life-threatening illness
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
6. HIV positive.
7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
8. Severe, uncontrolled medical conditions and infections.
9. At the same time using other test drugs or in other clinical trials.
10. Refusal or inability to sign informed consent to participate in the trial.
11. Other treatment contraindications.
12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

Previous studies have indicated that Schisandra chinensis extract (SCE) may have the ability to prevent skeletal muscle atrophy. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 4 and 12 weeks of intervention. Fifty-four healthy adults were administered either 1,000 mg of SCE or a placebo each day for 12 weeks;

Eligibility Criteria:
Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer InBody 720)
* Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of fracture during the previous year
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
* Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer InBody 720)
Comparison of CABG Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel

In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a P2Y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect. In particular, in patients with acute myocardial infarction, who receive coronary angiography as an emergency, the dual antiplatelet is used immediately before the test to prevent and test further clot formation, regardless of whether or not the patient had previously taken dual antiplatelet.

Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS. Compared to its predecessor clopidogrel, the pharmacokinetic proﬁl of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days.

Most patients who receive emergency coronary heart surgery after undergoing coronary angiography as an emergency due to an acute myocardial infarction, it take approximately 24-48 hours to undergo surgery after examination. In fact, there have been reports of large-scale cross-country studies that do not increase bleeding risk compared to 5 days until 3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to September 2019.


Eligibility Criteria:
Inclusion Criteria:

* The patient with acute myocardial infarction received loading dose of clopidogrel or ticagrelor for coronary angiography within 2 days prior to emergency OPCAB or CABG.

Exclusion Criteria:

* heart surgery combined with other operation (valve surgery, aorta surgery, trauma surgery)
* History of coagulopathy
* History of liver cirrhosis
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.

Eligibility Criteria:
Key Inclusion Criteria:

* Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score \> 10 at baseline.
* Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline.

Key Exclusion Criteria:

* Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes).
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start.
* Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study.
* Pregnancy, breast feeding or inadequate contraception (if necessary)
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk

This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight
* Healthy
* Normal sleep times

Exclusion Criteria:

* Sleep disorders
* Overweight
* Diabetes
* Other health conditions
* Excessive caffeine and alcohol intake
* Smoking
Ultrasound-guided In-plane Puncture of the Femoral Artery

In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful.

In the "Ultrasound guided puncture of the femoral artery"-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").


Eligibility Criteria:
Inclusion Criteria:

* transfemoral catheterization

Exclusion Criteria:

* acute myocardial infarction