cyrilzakka/clinical-trials huggingface dataset:
Treatment of Insomnia in Migraineurs

It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.

Eligibility Criteria:
Inclusion criteria:

1. Men and women, 18 to 64 years of age (inclusive) with International Headache Society (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV primary insomnia (sleep onset/sleep maintenance).
2. Migraine frequency is 4-12 times per month, with a maximum of 20 days with headache per month, for 1 month or longer prior to screening.
3. A usual, estimated total sleep time of 6½ hours per night or less, for 1 month or longer prior to screening, due to problems falling asleep, waking up during the night, or waking up early.

Exclusion criteria:

1. Abortive migraine treatment with schedule II-III opioids.
2. Use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month.
3. Preventive migraine treatment with tricyclics or anticonvulsants.
4. Treatment of insomnia with non-prescription medications, such as diphenhydramine, melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates, benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.
Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy

Graft nephrectomy is associated with massive allo-sensitization following this event. The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Investigators propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of serious infectious complications following graft nephrectomy, with a treatment by Tocilizumab. Secondary endpoints evaluated here are - to evaluate all complications after graft nephrectomy, - and the Tocilizumab effectiveness to reduce anti-HLA antibodies at one year post nephrectomy.

Background: graft nephrectomy is associated with massive allo-sensitization following this event The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Moreover, a systemic inflammatory response syndrome can occur which could lead to serious patient's complications, in case of early graft thrombosis. To date, no treatment or strategy is available to reduce these risks, after graft nephrectomy. IL-6 is a key cytokine in inflammation, but also in the development of T and B cells activation. This treatment previously demonstrated a major role in the occurrence of allo-antibodies. Tocilizumab is a monoclonal antibody blocking IL6 receptor, previously used with success in kidney transplantation to reduce anti-HLA antibodies mediated rejection.

Objectives: Investigators hypothesize that Tocilizumab is useful to prevent allo-sensitization post graft nephrectomy. They propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult recipients,
* affiliated to the social security
* requiring a graft nephrectomy, with a project to retransplantation

Exclusion Criteria:

* combined transplantations, PRA \>20%.
* Patient under protective measures,
* Rituximab used for immunosuppression induction
* Previous transplants not removed,
* Active infectious complications at graft nephrectomy, need for immunosuppressive treatments after graft nephrectomy,
* Participation to another interventional studies using Rituximab, polyclonal antibodies, Eculizumab, or Tocilizumab.
* adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision,
* pregnancy or breastfeeding.
An Extension Study of Maralixibat in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

The study will be conducted at multiple sites in North America, Europe, Asia, and South America.

Eligibility Criteria:
Key Inclusion Criteria:

1. Provide informed consent and assent (as applicable) per Institutional Review Board/Ethics Committee (IRB/EC)
2. Completion of study MRX-502

Exclusion Criteria:

1. Any female who is pregnant or lactating or who is planning to become pregnant
2. Administration of prohibited medication between the MRX-502 EOT visit and the MRX 503 Baseline Visit (Day 0)
3. History of non-compliance in study MRX-502, non-adherence to medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to non-adherence with the study protocol based on Investigator judgment
4. Experienced an adverse event (AE) or serious adverse event (SAE) related to maralixibat during the MRX-502 study that led to permanent discontinuation of the subject from maralixibat
5. Any other conditions or laboratory abnormalities that, in the opinion of the Investigator or Sponsor Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study
F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).

Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR\<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.

Eligibility Criteria:
Inclusion Criteria:

* juxtarenal abdominal aortic aneurysms
* pararenal abdominal aortic aneurysms
* suprarenal abdominal aortic aneurysms
* type IV thoracoabdominal aneurysms

Exclusion Criteria:

* extent I to III thoracoabdominal aneurysms
* ruptured o symptomatic aneurysms
* dissections or connective tissue disorder aneurysms.
Minimalist Shoes Walking for Children

This is a single-blind randomized control study that will investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. The children in the control group will wear traditional footwear with arch support. It is hypothesized that walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.

Intrinsic foot muscles(IFM) are the prime stabilizers of the foot. When the IFM become weakened and unstable, the foot and lower limb become more vulnerable to injury. IFM develop across early childhood and evidence suggests that the critical time window for foot arch development is the first 6 years of life (i.e., preschool age). Human's feet and arches developed naturally due to the daily loads imposed on them, while evidence for using protective footwear to promote arch development is very weak. Moreover, the investigation suggested that local children may have a danger in insufficient daily physical activity. Thus the children may be at high risk for having weak feet.

Minimalist shoes are defined as footwear with little to no cushioning, highly flexible soles, and no arch support devices. Minimalist shoes are shaped with a wide toe box, allowing the foot to move more naturally than when confined in conventional footwear. Both running and walking studies have shown that the use of minimalist shoes increases IFM strength by increasing the mechanical load to the foot. Measuring the strength of individual IFM is challenging at best. However, muscle strength has been directly correlated with muscle size. As a result, studies have used imaging techniques such as MRI and ultrasound to measure foot muscle size. A very recent study suggests that walking with minimalist shoes increased the cross-sectional area (CSA), thickness and strength of IFM in adults. Similar findings have been reported by another study adopting a 12-week program.

This study aims to investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness.

In view of the treatment effectiveness and user-friendliness, walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.

Eligibility Criteria:
Inclusion Criteria:

* no history of known neurological or orthopedic conditions
* presentation of flexible flatfeet with the Chippaux-Smirak Index \>0.6

Exclusion Criteria:

* having previous experience using minimalist footwear
* presenting with any symptoms in the lower limbs within the last three months
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
* Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
* One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
* Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
* Adult (18 years of age or older) patients
* Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
* Serum creatinine less than 2.0 mg/dL
* Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
* ECOG performance status of 0 - 2
* Bidimensional measurable disease
* Patients who have signed an IRB / Ethics Committee approved informed consent
* Life expectancy at least 12 weeks
* Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
* Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

* Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
* Patients with intracranial metastases
* Females who are pregnant or lactating
* Patients with peripheral neuropathy NCI-CTC grade 2 or greater
* Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
* Patients who have had an investigational agent within 4 weeks of study entry
* Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
Effect of Remimazolam on the Recovery Quality After Day Surgery

The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:

• The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.


Eligibility Criteria:
Inclusion Criteria:

* undergoing day surgery under laryngeal mask anesthesia
* American society of anesthesiologists (ASA) grade 1-3
* BMI\<30kg/m2

Exclusion Criteria:

* have benzodiazepines drugs in the latest month cognitive dysfunction
* Cognitive dysfunction and neuropsychiatric disorders
* It was estimated as a difficult airway
* There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy
* There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components
Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T)

DTFI is a single-center, prospective cohort study aimed at evaluating the hemodynamics of in-stent stenosis after flow diverter implantation, seeking to identify the threshold effect of blood flow in stenosis.

DTFI study investigates the hemodynamic changes in patients with intracranial aneurysms who have undergone flow diverter implantation, using a combination of three-dimensional digital subtraction angiography (3D-DSA) and transcranial color-coded duplex (TCCD) sonography. The aim is to understand the development of in-stent stenosis and its impact on blood flow.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18, male or non-pregnant female. Diagnosis of intracranial aneurysm confirmed by DSA (Digital Subtraction Angiography).

Intracranial aneurysms treated with flow diverter (FD). DSA follow-up of at least 1 month.

Exclusion Criteria:

Secondary intracranial aneurysm cases: traumatic aneurysms, infectious aneurysms, or aneurysms associated with arteriovenous malformations (AVM) or vasculitis.

Previously treated recurrent aneurysm or target aneurysm with craniotomy clipping surgery or other endovascular interventions.

Aneurysms located at the distal end of the circle of Willis where TCCD (Transcranial Color-Coded Doppler) cannot be detected.

Known familial clustering history. Expected survival less than 1 year. Preoperative clinical assessment with mRS (Modified Rankin Scale) score ≥ 3. Known allergy or contraindication to antiplatelet drugs, anticoagulants, contrast agents, anesthetics, nitinol memory alloy, platinum-tungsten alloy, or platinum-iridium alloy.

Severe respiratory, hepatic, or renal disease (e.g., creatinine ≥ 3.0 mg/dL excluding dialysis) or coagulation disorders.

Undergoing major surgery (e.g., limb fracture fixation, tumor resection, major organ surgery, etc.) within 30 days prior to signing informed consent or planned within 60 days after signing informed consent.

Pregnant or lactating women, or women with a positive pregnancy test.
Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.


Eligibility Criteria:
Inclusion criteria:

* Adult (\>18 years-old)
* Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.

Exclusion criteria:

* Patients with any past medical history of disease that would put them at risk of receiving one of the four proposed medications. This includes, but it's not limited to, allergies, advanced stage kidney disease, congestive heart failure and non-controlled hypertension.
* With a known/documented history of opioid abuse at any point during life.
* PO2\< 60 mmHg or SO2 \<85% on room air during any of the encounters with physicians between the moment of initial screening and the procedure itself.
* PaCO2 \>60 mmHg
* Planned additional procedure(s) requiring general anesthesia after the dynamic bronchoscopy.
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of cystic fibrosis
* Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
* Be able to reproducibly perform spirometry
* Be clinically stable for at least 4 weeks before screening

Exclusion Criteria:

* Have abnormal renal or liver function
* Have lung transplant
* Unable to discontinue use of hypertonic saline
* Participated in Inspire trial 08-108
Immune Monitoring of Hepatitis C Under DAA Therapy

Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.


Eligibility Criteria:
Inclusion Criteria:

* written consent, age, HCV-RNA positive, DAA therapy

Exclusion Criteria:

-
Evaluation of Continuous Symptom Treatment of ADHD

The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised
* Males or females who are at least 6 years old and no more than 12 years old prior to visit 2
* Patients must be able to swallow capsules
* Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 70 or more if formal IQ testing were administered.
* Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)

Exclusion Criteria:

* Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)
* Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis
* Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.
* Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient
* Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.
The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial

The investigators are comparing the combination of a stainless steel repair and aggressive early active range of motion rehabilitation protocol for flexor tendon lacerations in the hand with a current, accepted treatment offered at our institution. Outcomes to be assessed will be time to return to work, joint range of motion in the injured fingers, and any potential complications that may arise (ex: surgical infections or repair rupture). All proposed treatments included in this study are currently being offered at our institution, but not in a randomized fashion.

This study will serve as a pilot-study for a future randomized controlled trial. Adult patients with zone 2 flexor tendon lacerations of the hand (anatomically from the A1 pulley of the hand to the insertion of the flexor digitorum superficialis) who have presented to the emergency room acutely (within 1 week of injury) at the Health Sciences Center in Winnipeg will be asked for their participation in this study. Consent will be obtained by a plastic surgery resident either in the emergency room or in the plastic surgency emergency decanting clinic. The investigators will include twenty-four patients in the study, randomized into one of two treatment groups (groups A and B) by block randomization. Randomization will be done once patients agree to participate in the study. All patients will be booked for surgery on the emergency slate. Each treatment group will be treated by a single surgeon who is an expert at treatment of these injuries. Group A patients will have their laceration(s) repaired using a modified Becker repair technique using stainless steel suture in the operating room, and then will proceed to undergo an aggressive early active range of motion rehabilitation administered by the hand therapists at HSC. Group B patients will undergo a double-locking loop suture repair using polypropylene. They will then undergo a less aggressive active range of motion rehabilitation protocol which is currently offered to patients at our center. Follow-up will occur in plastic surgery outpatient clinic at post-operative weeks 1, 2, 4, 6 and 12. Follow-up with hand therapy will be at the discretion of the therapists. At each visit with hand therapy, joint range of motion will be assessed at the PIP and DIP joints in the affected fingers. Final range of motion will be assessed using the Strickland system for evaluating flexor tendon surgery outcomes, and will be done by a blinded hand therapist.

Eligibility Criteria:
Inclusion Criteria:

* adults
* living in Winnipeg, Manitoba
* zone II flexor tendon lacerations in a single finger
* able to consent to and comply with surgery

Exclusion Criteria:

* crush injuries
* vascular injuries requiring re-vascularization
* fractures
* infection
* prior hand injury requiring surgery