cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary signed informed consent
* have histologically documented prostate cancer
* have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
* expected to continue LHRHa therapy uninterrupted for the next 12 months
* have total testosterone levels less than 50 ng/dL
* Have BMD of lumbar spine or femoral neck at or below the BMD thresholds
* have a Zubrod performance status \<or equal to 1
* subject weight \<300 lbs(\<136 kg)
* agree to complete a daily diary of medication intake
* agree not to take excluded medications throughout the trial
* agree to use an effective method of contraception
* have adequate bone marrow, liver and renal functions

Exclusion Criteria:

* Currently or previously exposed
* within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
* for more than 3 years to oral bisphosphonates
* within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
* have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
* have \<8 evaluable vertebrae
* have a BMD T score \<-4 at the lumbar spine or total hip or femoral neck
* have any history of other carcinomas within the last 5 years
* Serum PSA \> 5ng/mL at baseline under ADT
* have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis
* have active uncontrolled systemic viral, bacterial or fungal infections
* have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance
* received treatment with other investigational agents within 30 days
* taking finasteride, dutasteride, danazol or testosterone like substances
* taking herbal medicines or dietary supplements
* have a history of thromboembolic disease including DVT or pulmonary embolus
* have a QTcF of \> or equal to 450 msec or congenital or acquired QTc prolongation
* have HIV
* calcicum urolithiasis prohibiting the use of vitamin D
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the patient
* Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
* Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy

Exclusion Criteria:

* Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
* known or suspected hypersensitivity to the medication used in the study
Tympanic Thermometers Accuracy

The aim of the present study is to evaluate the measurement precision and accuracy of the third-generation tympanic thermometer in relation to the measurement modalities considered gold standard. The evaluation of the instrument will be conducted in relation to the different calibration times of the tympanic thermometer, the level of re-training of healthcare personnel in the use of the instrument and the adult and paediatric population subjected to the measurement. Finally, the diagnostic capacity of the instrument in correctly identifying states of hypothermia and febrile elevations will be assessed.

The temperature measurement will be taken on each patient enrolled at a single time by the caregiver for that patient. As the measurements do not depend on which side they are taken, the most convenient side will be chosen. Each patient will only be included once

The research nurse will record the core temperature from the monitor on the CRF and, within the next 5 minutes, take the peripheral temperature with the tympanic thermometer three times in a row, recording all three values on the CRF. Subsequently a second operator will always take the temperature 3 times within 5 minutes of the gold standard measurement. The gold standard (reference tests), as indicated in the literature, can be either the thermometer inserted in the probe placed in the pulmonary artery, or the thermometer inserted in the bladder catheter or oesophageal probe, or directly a rectal thermometer.

Only the first tympanic measurement will then be used to assess accuracy against the gold standard. The other measurements above will only be evaluated for inter and intra reliability. The unit under study is therefore the individual patient at a precise point in time

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients over the age of 4 months
* adults admitted to intensive care and resuscitation
* undergoing surgery who by current practice undergo invasive core temperature measurement

Exclusion Criteria:

* Patients with bilateral auricular inflammatory problems,
* patients who will not use the gold standard for clinical reasons,
* patients or legal guardians who do not consent to participate in the study.
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy


Eligibility Criteria:
Inclusion Criteria:

* Completion of parent clinical trial for treatment of partial seizures

Exclusion Criteria:

* Receiving any study drug or experimental device other than lacosamide
* Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
Life Without Diabetes

The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes

A total of 125 individuals with pre-diabetes will be included and randomized into four different groups (N=25, each group): 1) Increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 25 kg/m2
* Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol)
* Weekly training status \<150 minutes

Exclusion Criteria:

* BMI \<25 kg/m2
* Diabetes
* Pregnancy and breastfeeding
* Treatment with medicine, there influence glucose metabolism
* Decreased liver function (liver transaminases \> 3 times of limit of normal)
Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial

Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in pregnant patients with sleep-disordered breathing and gestational diabetes

Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.

General Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.

Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over \~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre
* \>20 weeks and \<34 weeks gestational age at time of recruitment
* Gestational diabetes
* Sleep-disordered breathing (SDB)

Exclusion Criteria:

* Pre-gestational type 1 or type 2 diabetes
* Multiple pregnancy
* Conception by IVF
* Prior treatment for SDB
* severe medical illness
* Severe SDB (AHI \>30) and Epworth Sleepiness Scale \>15 or oxygen desaturation index \>30 or sustained hypoxia \< 80%
* Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)
* Cigarette smoking, alcohol consumption or illicit drug use
Gynecologists' Feedback on ART-Birth Rates

The investigators will examine the hypothesis that women who are given their personalized IVF-prognosis are less likely to overestimate their IVF-live birth rate, as compared to women who do not receive a personalized IVF-prognosis.

Control group: At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos.

Intervention group: At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos, calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model).

Primary outcome:

The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.

Secondary outcomes:

The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.

Women's and men's anxiety will be assessed with the reliable 'State-Anxiety Inventory, (STAI-state)' questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.

Patient's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, within two days of the conclusive pregnancy test after the transfer of the last (fresh or cryopreserved) embryo of the studied IVF-cycle.

Eligibility Criteria:
Inclusion Criteria:

* Couples treated with a 2nd-6th fresh cycle of IVF (every couple can only participate ones in this study).

Exclusion Criteria:

* Couples treated with:

  * Pre-implantation Genetic Testing (PGT)
  * donated oocytes, sperm or embryos
  * Spermatozoa obtained by testicular extraction
  * HIV-positive diagnosis
  * Embryo transfer on day 2
Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial

The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.

Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients received percutaneous coronary intervention
* Patients older than 20 years old
* Patients who will not scheduled any staged percutaneous coronary intervention
A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit

The purpose of this study is to assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

Introduction: Effective communication with physicians is an important factor for families at intensive care unit. Although physicians should have adequate communication skills, training programs are not available that would enable them to enhance this competence. Formal training using a semi-structured interview to improve skills and quality of communication was provided to physicians in charge of supplying information to families at the intensive care unit (ICU).

Objective: To assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

Methods: A pre- and post- intervention study was designed for a university hospital mixed ICU (medical and surgical). Training was provided to 34 resident physicians in charge of giving information to families at the ICU using interview PACIENTE. The interview was done conjointly with participation in simulated difficult clinical cases with actors posing as family members.

Patient registries: Family satisfaction was assessed with a validated survey, FS-ICU 24, in 122 and 123 family members pre- and post-intervention training, respectively, on the fourth day after patient admission to the ICU. The surveys were identified with consecutive numbers and not collected data that would allow subsequent identification of patients or their families. After the intervention, structures of interviews were monitored with checklists designed for this purpose. The meetings were always in the same place for this activity.

The surveys were answered on paper and the data included in an SPSS database by one of the researchers. Single questions in the 24-FS-ICU survey were analyzed according to the author's suggestions with minor modifications. Scores from items 1-6 in the published survey were transformed to scores from 0 to 100. The Mann-Whitney U test was used to determine any score differences between pre- and post-interventions. Differences of P\<0.05 were considered statistically significant.

The sample size was calculated to be 122 participants for pre-intervention and 122 participants for post-intervention to detect α coefficient of 0.05 and with a power of 0.90. The survey was performed in the waiting room and questionnaires were collected immediately; thus, there were no missing questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* That consented to participate in the satisfaction survey
* That whom had been in the ICU for 72 h.

Exclusion Criteria:

* Family members with language barriers (requiring assistance to answer a question in writing)
* Previous ICU admission within the study period
* Patient's death by the fourth day of admission
* Proved reasons for risk of judicial proceedings.
Neurophysiological Diagnosis for ICU Septic Shock Patients

Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors.

ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness.

The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.


Eligibility Criteria:
Inclusion Criteria:

• Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

Exclusion Criteria:

* Hospitalization for more than 7 days before intubation.
* Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale.
* Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs.
* Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease.
* Burn patients admitted to ICU.
* Patient requesting withdrawal of therapies.
Post Market Registry Study of the AeriSeal System

* Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
* Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Emphysema
* AeriSeal System treatment

Exclusion Criteria:

* have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
* have had frequent COPD exacerbations within the past year
* require mechanical ventilatory support
* have a pretreatment DLCO \< 20% predicted or \> 60% predicted
* have a pretreatment FEV1 \< 20% predicted AND homogeneous emphysema
* have giant bullae
* have undergone lung transplantation, lung volume reduction surgery, or lobectomy
* are intolerant of corticosteroids or antibiotics
* are pregnant or breast-feeding
Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit

More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.

A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.

A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients.

Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes.

The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care.

Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.


Eligibility Criteria:
Inclusion Criteria:

* adults (\>=18 y.o.)
* hospitalized in the ICU for at least 48 hours
* with SARS-Cov2 infection confirmed by Polymerase Chain Reaction (PCR)/serology and/or a suggestive chest Computed Tomography scan
* during the first wave of COVID 19 from March to December 2020 at three investigator sites (2 in Paris and 1 in Lyon)
* discharged alive from the ICU
* at least 6 months after discharge

Exclusion Criteria:

* patient refusal
* inability to communicate or to have in-person appointment
* death in the period from ICU discharge to the first phone call for interview
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida

In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.


Eligibility Criteria:
Inclusion Criteria:

* 8 to 16 year.
* Male and female both are included.
* Lower extremity weakness (less than 2).
* Knee and hip flexion contractures

Exclusion Criteria:

* Bowel and bladder dysfunction.
* Children having absent tone.
* Children having bone fracture
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.

This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.

Eligibility Criteria:
Inclusion Criteria:

* Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding

Exclusion Criteria:

* None