cyrilzakka/clinical-trials huggingface dataset:
Online Group Psychological Intervention for People With Emotional Disorders

Participants will receive an online synchronous group therapy based on the Unified Protocol (UP) model for 11 subsequent weeks, with 90-minute meetings. After every session, they will be sent the chapter with the notions addressed in the session from the UP's patient manual (Barlow et al., 2011) and the scales to work with during the week.

Participants in the waiting list will complete the evaluation scales at the same time as people in the intervention group (before the intervention, in the middle, after the intervention, three months after and six months after). After this period they will receive the group therapy based on the UP.

The group admission criteria are: 1) being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

The group exclusion criteria are: 1) comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment. All candidates who are not included in the group will be informed of this decision and will be given information on places to seek treatment. Evaluations will be carried out via video calls on the Google Meet platform, using the MINI (Ferrando et al., 2000) and SCID-II (Grilo, Anez \& McGlashan, 2003) diagnostic interviews.


Eligibility Criteria:
Inclusion Criteria:

* 1) being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

Exclusion Criteria:

* 1) comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment.
Bioresorbable Intramedullary Nailing of Forearm Fractures

The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

Residual risk related to re-fracture rate will be addressed by this PMCF study. The research question is, if the re-fracture risk with Activa IM-nail is in line with the other treatment methods, namely ESIN.

Primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by X-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, BMI, surgical technique, immobilization time and bony union formation.

Eligibility Criteria:
Inclusion Criteria:

* Diaphyseal forearm fractures (radius or ulna or both)
* Patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition

Exclusion Criteria:

* multifragmentary fractures, metaphyseal and epiphyseal fractures
* Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.
Study of GW685698X In Patients With Seasonal Allergic Rhinitis

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility Criteria:
Inclusion criteria:

* Informed consent
* Outpatient
* Diagnosis of seasonal allergic rhinitis with symptoms
* Able to comply with study procedures

Exclusion Criteria:

* Significant concomitant medical condition
* Use of corticosteroids/allergy medications
* Laboratory abnormality
* Positive pregnancy test
* Allergy to any component of investigational product
PENG Block vs. ESP Block for Pediatric Hip Surgery

The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.

The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.

Eligibility Criteria:
Inclusion Criteria:

- pediatric patients aged between 0-12 years who will undergo hip surgery

Exclusion Criteria:

* a history of chronic pain use of gabapentin/pregabalin for \> 3 months opioid use \> 1 repeated opioid prescription in the last three months
* morbid obesity (BMI \> 99th percentile)
* Infection at block application area
* coagulopathy
Coronary Aspiration Catheter Clinical Trial

To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria:

- General inclusion criteria

1. Age 18-80 years old (inclusive);
2. Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
3. Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
4. DSA image showed that the target lesion was in situ coronary artery lesion;
5. Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;

Exclusion Criteria:

- General exclusion criteria

1. previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
2. Comorbid cardiogenic shock;
3. severe renal failure or ongoing dialysis;
4. severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
5. Failure of preoperative thrombolysis requiring remedial PCI;
6. Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
7. Ischemic stroke within 3 months prior to surgery;
8. Known allergy to anticoagulant and antiplatelet agents or contrast media;
9. female subjects who are known to be pregnant or lactating;
10. Participation or planned participation in other clinical studies of drugs or devices;
11. other conditions that the investigator evaluates to be unsuitable for participation in this trial.

    Imaging exclusion criteria
12. Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
13. severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
14. the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
15. the presence of severe triple coronary artery lesions requiring revascularization.
Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and provide written informed consent
* Male and female adults aged \> 18 years and less than 65 years
* Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening
* Must have fatigue-predominant PASC
* Other than PASC, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions

Exclusion Criteria:

* Other than PASC, have an explanation for fatigue
* Other than PASC, a history or presence of an uncontrolled, clinically significant disease
* Medical history that includes of Non-invasive or invasive ventilatory support for COVID 19, Intensive care unit or other high dependency unit admission for COVID-19, Hospitalization for \>1 week for COVID-19 without intubation
Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization

This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.

Patients in the study were hospitalized following a characterized depressive episode. The study is based on a review of these patients' medical records and data from the three-month assessment. No additional assessments are planned.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older, having been informed of the research
* Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)
* Discharged from hospitalization
* Considered in remission (total or partial) and with a MADRS score \< 20

Exclusion Criteria:

* Patient hospitalized for \< 15 days
* Patient with bipolar depression
* Patient with a psychotic disorder
* Patient using narcotics with a "moderate to severe" severity
* Patient previously included in this study
* Patient under court protection, guardianship or curatorship
* Patient unablé to respond correctly to a depression self-assessment questionnaire
Potentially Avoidable Hospitalisation in France

Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In The Lack Of Data On Actual Primary Care Utilization.

The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially Avoidable Hospitalizations At the Zip Code Level, In The French Region Languedoc-Roussillon-Midi-Pyrénées.

The investigator will implement An Ecological Approach In Which The Geographic Variation In The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.


Eligibility Criteria:
Inclusion criteria:

* year 2014
* LRMP region
* Hospital admission in any public or private hospital

Exclusion criteria:

* none
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

* to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
* to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
* To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years, at date of signing informed consent, males or females
* Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
* Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
* Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
* Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
* Further inclusion criteria apply

Exclusion Criteria:

* Evidence of abdominal abscess at screening
* Evidence of fulminant colitis or toxic megacolon at screening
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Further exclusion criteria apply
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old, Hunt-hess scale \< 3

Exclusion Criteria:

* Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.
Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients

The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.

Heparin-induced thrombocytopenia (HIT) is of concern in critically ill patients, given the high prevalence of heparin use. The diagnosis of HIT in surgical intensive care unit (ICU) is problematic due to the lack of reliable diagnostic method. No gold standard currently exists and the definitive diagnosis is mainly based on the detection of heparin-dependent platelet-activating antibodies by ELISA method, on the platelet serotonin release assay (SRA) and on the changes of the blood platelet count after the discontinuation of heparin therapy. As a result, no early definitive diagnosis could be done. This could expose patients to thrombotic complications related to the HIT or hemorrhagic complications related to the alternative anticoagulant prescribed. This complications can threaten the prognosis of these patients. Particle gel immunoassay and automated immunoassay has been proposed for the early diagnosis of HIT in medical critically ill and non-critically ill patients. Many authors suggest that the accuracy of these immunological methods for the diagnosis of HIT could be altered in surgical patients, but these tests has never been specifically evaluated in this population. The 4Ts and the HIT Expert Probability (HEP) score systems sound interesting for the diagnosis of HIT. These clinicobiological scores can be easily used by non-expert clinicians, but have also never been evaluated in the surgical ICU.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Diagnosis of HIT suspected
* Admitted in our surgical intensive care unit during the study period

Exclusion Criteria:

* Age \< 18 years old
* Pregnancy and/or breast feeding
* Fondaparinux anticoagulation
* Withdrawal of consent
The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Diabetes is a growing epidemic within the United States that disproportionately affects economically disadvantaged communities like East Harlem. As diabetic patients are at very high risk for heart disease, experts recommend an aggressive approach towards using statins in people with diabetes. However, statins and other helpful drugs are only effective if patients decide to take them. Adherence to this medication is notoriously poor and is aggravated by its required life-long use. This study is designed to test the effectiveness of a new decision aid in helping diverse, inner-city patients with diabetes understand the risks and benefits in taking statins and whether this enhanced decision making process improves their adherence to the medication.

To compare the efficacy of usual consultations with or without the decision aid STATIN CHOICE in type 2 diabetic patients using or considering using statins to lower CV risk in terms of statin use, adherence, knowledge, beliefs and decisional conflict. The study team's primary hypothesis is that 3 months after the index discussion, significantly more patients randomized to STATIN CHOICE are using statins, are adherent to statins, are knowledgeable about the statin choice, and are satisfied with their decision than patients randomized to usual care consultation, and that these benefits will be achieved without deterioration in quality of life.

Eligibility Criteria:
Inclusion Criteria:

Eligible providers are

* Internists and nurse practitioners
* Provide care for patients with type 2 diabetes
* Do not plan to relocate outside the practice in the next 6 months.

Eligible patients

* Have a diagnosis of type 2 diabetes mellitus \> 1 month confirmed by provider or the medical chart
* Do not take statins, but their providers identify them as eligible for this medication
* Are currently taking statins

Exclusion Criteria:

Ineligible patients

* Have, in the providers' judgment, major barriers such as hearing impairment or dementia that would compromise their participation in shared decisionmaking;
* are not available for follow-up 3 months after randomization
* are pregnant
* are under age 21
Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg.

Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as "transient neurologic symptoms" - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours.

Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II women
* 18-45 yrs old
* Singleton pregnancy
* Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia
* Height 150 - 180 cm
* BMI ≤ 40 kg/m2.

Exclusion Criteria:

* Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy)
* Pre-existing/chronic back pain
* Ester local anesthetic allergy, PABA allergy
* History of atypical cholinesterase (CP is metabolized by cholinesterase)
Tourniquet-Test in HHT

The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT.

The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT.

Eligibility Criteria:
Inclusion Criteria:

* In patients with confirmed HHT diagnosis (≥ 3 Curaçao criteria or positive molecular genetics)
* aged over 18 years

Exclusion Criteria:

* if inclusion criteria does not apply
Mother-infant Connection Strategy Program

This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women

The aim of this study was to test the efficacy of an online mindfulness program in reducing women's perceived stress, anxiety, depression, and in enhancing mindfulness and mother-infant bonding compared to a control group. The investigators hypothesize that the use of an online mindfulness program or an eight-week mindfulness program by the two experimental groups will lead to improved mood symptoms and mother-infant bonding compared with the control group.

A randomized controlled trial comparing three groups of healthy, singleton pregnant women was conducted using the Random Allocation Software (Saghaei, 2004). We used G-Power 3.1.9 for Windows to analyze the minimum effect size that would be statistically significant with an 80% probability, using an alpha error probability of 0.05 in the "ANOVA: Repeated measures, between factors" option. We inputted 3 for the number of groups, 4 for the number of measurements, 0.5 for the correlation between repeated measures, and factored in a 20% attrition rate. There are 41 women in each group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were at the age over 18
* Could speak and read Chinese fluently
* Willing and be ale to attend the education program

Exclusion Criteria:

* Taking medication for diagnosing mental illness
* With complicated or high-risk pregnancies