cyrilzakka/clinical-trials huggingface dataset:
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop

The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)


Eligibility Criteria:
Inclusion Criteria:

* neurogenic intermittent claudication due to lumbar spinal stenosis
* diagnosed on MRI in maximum two levels
* walking distance on 250 metres
* symptom relief on flexion of the lumbar spine
* duration of the symptoms more than 6 months
* non-operative treatment is tried or considered as not indicated

Exclusion Criteria:

* vascular claudicatio intermittens
* spinal stenosis on more than 2 levels
* cauda equina syndrome
* severe paresis
* clinical monoradiculopathy
* grave scoliosis
* previous lumbar surgery
* degenerative spondylolisthesis more than 25%
* spondylolysis with listhesis
* osteoporotic fracture in lumbal column
* clinical and radiological (both) arthritis in the hip joint
* ASA \>3
* verified polyneuropathy on neurophysiological test
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. Have a current diagnosis of schizophrenia.
2. Increase in symptoms over the past 2-4 weeks.
3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.
Transcultural Validation of Activities Scale for Kids (ASK)

The Activities Scale for Kids performance (ASKp) is one of the few self-assessment questionnaires in pediatric rehabilitation that measures child perception in performance of daily routine activities. ASKp is composed of 30 questions designed to explore activities and participation in children and teenagers with musculoskeletal disorders. Scores assess level of physical ability, identify appropriate treatment and monitor changes over time. We recently undertook the cross-cultural validation to achieve a culturally adapted Italian version of ASKp: the Italian version is now to be tested on Italian children.

The purpose of the study isto test the psychometric properties of the Italian version of the ASKp assessment scale, in a representative sample of individuals with PCI.

ASK p will be administered on a sample of individuals belonging to the population of children and / or adolescents with diplegia and hemiplegia as a consequence of PCI. We will perform comprehensive descriptive analysis of the data collected as well as the measurement of the degree of reliability of the Italian version of the scale. The aim is to obtain an estimate of ASKp reliability obtained through transcultural validation.

Additionally, we will submit the ASKp on a control group of typical development children in order to test its ability to discriminate between different skill levels.

Eligibility Criteria:
Inclusion Criteria:

* Italian nationality

Exclusion Criteria:

* moderate or severe cognitive impairment;
* linguistic barriers
Surgical Telemedicine in the COVID-19 Pandemic Era

The current COVID-19 pandemic has caused delays in initial or follow-up encounters between surgical patients and physicians. While this delay allows for resource allocation to those most severely affected by the pandemic, surgeons are faced with potential important delays in diagnosis and the expanding backlog of elective cases and initial evaluations.

This project will assess surgeon and patient telemedicine perspectives. Pre-pandemic views on telemedicine among a cohort of surgeons will be obtained and compared to views at 3 months from the peak of the pandemic. Patients will be surveyed following telemedicine appointments with an anonymous questionnaire to learn about patient receptiveness to telemedicine. Barriers to implementation will be addressed throughout the duration of the study.


Eligibility Criteria:
Inclusion Criteria

1. Surgical faculty at participating institutions will receive surveys regarding telemedicine early in the start of the study to assess baseline perceptions. These same group of surgeons will receive subsequent surveys 3 months after the peak of the pandemic to evaluate telemedicine perceptions following a rapid implementation and adoption of telemedicine.
2. Surgical patients evaluated from the start of the study through a 6-month period will be included in the study. They will have the option after each telemedicine encounter to complete an anonymous survey regarding perceptions to this technology.

Exclusion Criteria

1. No exclusions for surgical faculty are identified. Accrual of data from this group will be limited only by response rates to administered surveys.
2. Exclusions for surgical patients will include the inability to access the technology required for a telemedicine consultation (e.g.: absence of a camera enabled smartphone, absence of a required internet or cellular connection to perform a telemedicine encounter). The investigators will keep a list of reasons for the inability to perform a telemedicine encounter to identify the barriers to implementation among patients.
Analytical Evaluation of the Endotest® Diagnostic

This is an interventional with minimal risks and constraints (RIPH 2 in France), prospective, longitudinal, non-randomized, multicenter study.

The present study will allow us to evaluate multiple factors assessing the Endotest® Diagnostic accuracy and its possible limitations. To characterize the Endotest® Diagnostic, the following parameters will be evaluated:

* Repeatability: the verification of the invariability of its results without condition changes,
* Circadian cycle: whether the circadian cycle affects the determination of the signature,
* Intermediate fidelity: the verification of the invariability of its results with an operator change,
* Interferences: the impact of different interferences on its results,
* Stability: the possible modification of its results depending on the samples conditions of storage.

The acts and procedures performed in this research will be divided into three visits:

* Inclusion visit: performance of 4 Endotest® Diagnostics (3 at the visit and 1 at home) by the 60 included subjects,
* "Circadian cycle" visit: performance of 17 Endotest® Diagnostics (14 at the visit and 3 post-visit at home) by 6 subjects selected after evaluation of the results of the inclusion visit,
* "Repeatability-intermediate fidelity-interference-stability" visit: realization of 17 Endotest® Diagnostic by 10 or 16 subjects, depending on the results of the impact of the circadian cycle on the saliva signature. These subjects will be selected according to the results of the inclusion visit, excluding those who participated in the circadian cycle visit.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 years to 43 years,
* Subject having dated and signed the consent form,
* Subject affiliated to the French health system,
* Subject able to return for a full day for the rest of the study,
* Subject whose diagnosis of endometriosis has been established with certainty or definitively ruled out.

Non-Inclusion criteria:

* Pregnant subject,
* Subject with an acute or chronic infection (viral hepatitis, HIV...),
* Subject with history of hypersensitivity or allergy,
* Subject with a personal history of cancer,
* Subjects with significant difficulties in reading or writing the French language,
* Subject unable to comply with the study and/or follow-up procedures,
* Subject who has objected to the collection of her data,
* Subject participating in an interventional study or in the exclusion period of an interventional study.

Exclusion Criteria:

* Pregnant subject,
* Subject with acute or chronic infection (viral hepatitis, HIV...),
* Subject unable to comply with study and/or follow-up procedures (including absence of outside salivary sample after the inclusion visit),
* Subject participating in an interventional study or in the exclusion period of an interventional study.
NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

Primary Objective:

To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.

Secondary Objectives:

To evaluate:

* The radiological response after chemotherapy and radiotherapy
* The pathological response after chemotherapy by cavum biopsy

To estimate:

* The duration of overall response
* The time to progression (T.T.P)

To analyze:

* The overall survival
* The safety profile


Eligibility Criteria:
Inclusion criteria:

* Written or witnessed oral informed consent prior to beginning specific protocol procedures \>Histologically proven undifferentiated carcinoma of nasopharyngeal type (UCNT- stage II-III OMS) at first diagnosis
* Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T, N2 - N3 UCNT, without metastasis
* Adenopathy \> 3 cm
* Patients are required to have an unidimensionally measurable disease with RECIST method
* Performance status 1 or karnofsky index 3
* Previous therapy: Chemotherapy :none Radiation therapy: none Surgery: none
* Laboratory requirements

Exclusion criteria:

* Prior chemotherapy or / and radiotherapy
* Metastatic disease (M as per the UCCI/AJC classification)
* Past or current history of neoplasm other than UCNT, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years
* Pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation
* Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI criteria
* Others serious illness or medical condition:

  1.Congestive heart failure or unstable angina pectoris even if it is medically controlled 2.Previous history of myocardial infraction within 1 year from study entry 3.Uncontrolled hypertension or high risk uncontrolled arrhythmias 4.Uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate any use of corticoids 5.Concomitant treatment with corticoids initiated \> 6 months prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg 6.Definite contraindications for the use of Corticoids 7.Concurrent treatment with other experimental drugs 8.Participation in another clinical with any investigational drug within 30 days prior to study entry 9.Performance status = 2,3,4 or karnofsky index \< 80 10. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Safety and Effectiveness of Different Doses of Vitamin C in HIV-Infected Patients

This is a study to evaluate the tolerance and antiviral effect of oral vitamin C in HIV-infected.


Eligibility Criteria:
Not applicable - Study withdrawn since 04/23/1996
A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects

An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Male or female subject aged at least 18 years at Screening.
* Women of non-childbearing potential (e.g. post-menopausal)

Additional inclusion criteria for subjects with severe renal impairment (Group A).

- Severe renal function impairment as confirmed at Screening based on an estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula of \< 30 mL/min (not on dialysis).

Additional inclusion criteria for control subjects (Group B):

* Normal renal function as confirmed at Screening based on eGFR.
* Each control subject must be matched to the values of one subject with severe renal impairment based on age (±10 years difference allowed), BMI (±15% difference allowed), and sex, determined by results at Screening.

Exclusion Criteria:

- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

This is a parallel Randomized Controlled Trial comparing two different delivery modes of post hip fracture management-a specialized Fracture Follow-up Clinic versus Usual Care alone. The Fracture Follow-up Clinic will focus on bone health and fall risk factors. The investigators will evaluate the effect of the clinic and exercise program on mobility and falls. The investigators primary hypothesis is that within the first year following a hip fracture, older adults who are assessed in the B4 Clinic and prescribed an exercise program will have significantly improved Short Physical Performance Battery (SPPB) scores compared with participants who receive usual care alone.


Eligibility Criteria:
Inclusion Criteria:

* 65 years +
* community-dwelling
* residents of Metro Vancouver
* recent history (within 12 months) of femoral fracture

Exclusion Criteria:

* unable to ambulate 10 meters prior to the femoral fracture were(with/without a walking aid)
* discharged to a residential care facility
* and/or diagnosed with any type of dementia (Alzheimer's, vascular etc.)
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study

Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters


Eligibility Criteria:
Inclusion Criteria:

* EF \< 35%
* CHD or dilate cardiomyopathy
* sinus rhythm
* NYHA III (or IV but stable recompenstated)
* QRS \< 120 ms 2-3 of the following:
* LV-fillingtime \< 40% of the cyclelength
* TDI septal-lateral (LV basal) \> 60ms
* 2D-Strain-Score \> 9 points

Exclusion Criteria:

* tricuspid or artificial valve
* AV block II or III or PQ time \> 250ms
* revasculisation or condition after cardiac surgery \< 3 months
* myocardial infarction or bypass OP \< 3 months
* hytertrphic obstructive cardiomyopathy, constrictive pericarditis
* intravenous catecholamines because of HF
* manifeste hyperthyreoses
* kidney failure (creatine \>2,5 mg/dl)
* no written informed consent
* no compliance
* participation in another study
* life expectancy \< 1 year
* patients \< 18 years
* pragnancy or no safe contraception
Imipenem/Cilastatin/Relebactam PK in ECMO

Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.

This is a single center, open-label study to determine imipenem-cilastatin-relebactam pharmacokinetics in critically ill patients receiving ECMO. Eight patients with suspected suspected sepsis and who are receiving ECMO will be enrolled. Each participant will receive four to six doses of imipenem-cilastatin-relebactam according to current approved prescribing information, followed by ten blood samples to determine concentrations. Non-compartmental and population pharmacokinetic analyses will be determined to assess the effects of ECMO on imipenem and relebactam pharmacokinetic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* On support with Veno-venous- or Veno-arterial-ECMO;
* Documented infection or presumed infection as confirmed by the presence of at least one of the following criteria within the past 72 hours:

  * Documented fever (oral, rectal, tympanic, or core temperature \> 38.5° C)
  * Hypothermia (oral, rectal, tympanic, or core temperature \< 35.0° C)
  * An elevated white blood cell (WBC) count ≥ 12,000 cells/mm3

Exclusion Criteria:

* If female, currently pregnant or breast feeding;
* History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam agent (a history of mild rash to a β-lactam followed by uneventful re-exposure is not a contraindication);
* Severe renal dysfunction defined as a creatinine clearance \< 15 mL/min (calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis;
* Hemoglobin less than 8 mg/dL at baseline;
* Use of probenecid, valproic acid, or imipenem within 3 days before study drug infusion;
* Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal;
* Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator);
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data;
* Planned or prior participation in any other interventional drug study within 30 days.
Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve pregnancy and live birth. Many reasons have been proposed to explain these results. Among them, the factor Embryo Transfer Procedure gained less of the attention since few papers have been published and most of them had a lot of biases. In order to eliminate possible biases, we wanted to analyze our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth rate.

Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard catheter to pass through the cervix and the orifice, the site of the uterine cavity that the embryo was released, single or double transfer due to blocked embryo in the catheter.

In addition for each embryo transfer variables that may influence the pregnancy rates will be collected: age of the woman, number of oocytes harvested, sperm characteristics, fertilization rate, stage and grade of the embryos the day of transfer

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing embryo transfer after IVF

Exclusion Criteria:

* Women with known embryo implantation issues
Quantification of Inspiratory Effort Through Nasal Pressure in Patients Undergoing Weaning From Invasive Mechanical Ventilation and Correlation With Clinical Outcomes

Weaning from invasive mechanical ventilation (MV) constitutes a fundamental procedure in intensive care, covering up to 50% of time spent on ventilation (1). Endotracheal tube (ETT) removal might be an important but delicate step in intensive care setting. Failure and subsequent need for re-intubation can occur in up to 20% of cases leading to a significant increase in mortality rates (24%), longer hospital stay and prolonged need for ventilation. Comorbidities such as obesity, COPD and cardiac related diseases might further increase this risk reaching up to 60% of failure in extubation. In this scenario, accurate predictors of weaning failure are far welcomed. The recurrence of respiratory failure after extubation might considerably raise rates of failure, probably due to increased work of breathing in patients after ETT removal. Most recent guidelines on the use of non-invasive ventilation (NIV) suggest using NIV after ETT removal in subjects with high risk of failure. NIV could contribute to reduce work of breathing hence preventing the onset of respiratory failure after extubation. Therefore, measuring inspiratory effort and its variation in weaned patients might help in identifying patients with significant risk of failing extubation. Esophageal pressure swings (DeltaPES) can be measured through a nasogastric tube with a pressure transducer located in the inferior part of the esophagus. DeltaPES is an extremely precise and accurate method to quantify inspiratory effort, however its use in daily clinical practice is limited due to the invasive nature of the maneuver, elevated costs and need for considerable clinical training of operators. Physiological studies have shown a correlation between nasal pressure measured at nostril entrance and esophageal pressure (which in turn is a measure of respiratory effort .

Therefore, measuring nasal pressure could represent a method to quantify inspiratory effort non-invasively, proving to be useful in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

- candidates for endotracheal tube removal.

Exclusion Criteria:

* Age under 18
* Pregnancy
* Patient unable or unwilling to sign informed consent
* Neuromuscular diseases
* Patient with compromised neurological state (Glasgow Coma Scale (GCS) under 14/15)