cyrilzakka/clinical-trials huggingface dataset:
Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA

The aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.

Primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention.

Twelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. The training sessions will last between 15 and 20 minutes. During each training session, the participant will note on his/her own "Tracking sheet" how long they listened to the audio and their comments. The "Tracking sheet" will document whether or not the patient has participated in each of the twelve sessions.

In parallel, a control group will follow a placebo programme according to the same formalities.

Twenty-three participants (min.) will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* men and women of legal age
* to be capable of discernment
* to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs.
* to have had an ACL surgery performed by the Doctor Siegrist within the last three days using the Hamstrings Tendon Graft or the Kenneth Jones method.

Exclusion Criteria:

* not having a good spoken knowledge of the French language
* recurrence of ACL injury in the same knee
* meniscal sutures
* associated fractures
* pre-existing balance problems (tested at recruitment)
* pre-existing neurological problems diagnosed by a doctor.
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are:

Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?

Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?

Investigators also seek to understand and explore:

How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes.

How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes.

How factors like craving and opioid withdrawal symptoms influence treatment outcomes.

Participants will:

Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine.

Provide blood and urine samples while on the inpatient unit and at follow up.

Complete in-person follow up visits at 1-,2-,3-,4-, 8- and 12-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65
* Voluntarily seeking treatment for opioid use disorder (OUD)
* Consistent use of fentanyl or other high potency synthetic opioids
* Meets DSM-5 criteria for OUD with at least moderate severity
* Able to provide written informed consent in English and willing to comply with study procedures

Exclusion Criteria:

* Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
* Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
* Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
* Buprenorphine or methadone treatment in the past 30 days
* Known allergy, hypersensitivity or intolerance to buprenorphine
* Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
* Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
* Liver function tests \> 2x the upper limit of normal
* Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 60
* Patient is documented to be HBsAg positive for \> 6 months.
* Patient with compensated hepatic function.
* Nucleoside treatment-naÃ-ve subjects of either gender
* Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels â‰¥ 1 x 10(5) copies/mL within 30 days of baseline.
* Patient has ALT levels which are in the range of 2 x ULN and \< 10 X ULN
* Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.

Exclusion Criteria

* Patient is currently receiving antiviral or corticosteroid therapy.
* Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, famciclovir or any other investigational nucleoside for HBV infection.
* Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
* Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
* Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
* Patient is coinfected with HCV, HDV or HIV.
* Patient with following clinical evidence

  * Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
  * Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
* Previous organ transplantation
* Patient has a clinically relevant history of abuse of alcohol or drugs.
* Patient is pregnant or breast-feeding.
* Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
* Patient has Î±-Fetoprotein more than 100ng/mL
* Patient has Hemoglobin \<11g/dL (Male), 10g/dL (Female) or WBC count \< 3,500/mm3 (PMN\<1,500/mm3) or Platelet count \<50,000/mm3
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.

Prednisone is a potent anti-inflammatory drug that has large variability in its response. The large inter individual variability in the response to prednisone has a genetic component, but the genetic determinants of this variability remain unknown. We propose to use two relevant phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in vivo administration of prednisone, to characterize gene expression patterns and identify variants that are involved in the in vivo response to prednisone.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old (to exclude the effect of age on glucose tolerance);
* BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired insulin response);
* Normal fasting glucose;
* Stable weight for three months before participation

Exclusion Criteria:

* BMI \>25kg/m2;
* Fasting glucose ≥126 mg/dl
* Shift work or disordered sleep (to exclude individuals with alterations in the hypothalamus-adrenergic axis);
* Any diseases;
* Use of any medication regularly (including over-the-counter);
* Previous exposure to glucocorticoids (within the last year);
* Pregnancy
A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin

Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and tobramycin (0.3%)


Eligibility Criteria:
Inclusion Criteria:

* Any patient who experienced an IOP spike while using Lotemax or Zylet will be included

Exclusion Criteria:

* N/A
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. Caregivers randomly assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers randomly assigned to the control group will receive care as usual with psychoeducation materials provided during the study period. Outcomes regarding caregivers' mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 3-month follow-up) and compared between groups over time. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling adults (age 18 or over) who are currently taking the primary responsibility for the care of a relative with dementia living in the community
* having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
* having a computer or a smartphone with the internet access at home and
* being able to provide informed consent

Exclusion Criteria:

* having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
* having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
* taking antipsychotic or anticonvulsant medication at the time of recruitment
* considering or planning to place family members of PwD in a nursing home within 6 months or
* having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)
Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).

Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)

Eligibility Criteria:
Inclusion Criteria:

Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal).

Elective open-heart surgery via median sternotomy and under CPB (cardiopulmonary bypass).

Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation.

Exclusion Criteria:

Previous, urgent, or emergent cardiac surgery. Children with cyanotic congenital heart disease. local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension.
Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock

In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.

Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet all criteria (A+B+C):
* A) Identified infection source under adequate treatment
* B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
* C) Severe septic shock (serum lactate \> 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is \> 0.2 mcg/kg/min for more than 1 hour or \>0.1 mcg/kg/min for more than 3 hours )

Exclusion Criteria:

* Onset of severe septic shock more than 24 hours
* Received continuous renal replacement therapy within 24 hours before enrollment
* Serum white blood cell count count \< 1000 cells/μL or Platelet count \< 50000 cells/μL
* History of allergy to heparin
* Received cardiopulmonary resuscitation within 4 weeks before enrollment
* ICU admission due to severe septic shock within 2 months
* Patients or Family had chosen palliative care and signed an agreement to deny aggressive treatment
* Pregnancy
* APACHE II Score \> 30 at enrollment
* Non-native speakers
Fertility After Uterine Artery Embolization

Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility.

Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020).

In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes.

The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years, ≤ 45 years at the time of their embolisation
* Uterine pathology responsible for disabling symptoms: uterine leiomyomas with no limitations in size, number or location, adenomyosis
* Having had a uterine artery embolisation between 2007 and September 2020
* Minimum delay of one year after embolisation
* Information and no opposition from patients

Exclusion Criteria:

* Women \< 18 years and \> 45 years at the time of embolisation
* Uterine artery embolisation for delivery haemorrhage
* Patients under court protection, guardianship or curatorship
* Refusal to participate in this research
A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:

  1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
  2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
  3. treatment of participants with relapsed or refractory MCL
* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
* Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification

Exclusion Criteria:

* Currently participating in another investigational study, clinical study, or any expanded access program at study entry
* Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.

Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.

An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary

Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.

Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
* ASA score 3, 2 or 1

Exclusion Criteria:

* Allergy for tranexamic acid
* Clinical signs of acute thromboembolic event
* Renal function impairment (S-creatinin\>120micromol/l)
* Active thrombotic disease or DIC
* K-vitamin antagonist treatment
* Malignancy
* Pathological fracture
* Previously operated in same hip
* BW \> 100kg