cyrilzakka/clinical-trials huggingface dataset:
17-OHPC in Pregnancy: IM vs SC Routes

This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).

17-hydroxyprogesterone caproate (17-OHPC) is used in women with a prior preterm birth (PTB) as it reduces recurrences by a third. The drug is administered intramuscularly (IM) but that creates discomfort and in many instances requires repeated office visits as the drug is administered weekly from 16-20 weeks until 36 weeks or delivery. AMAG Pharmaceuticals obtained FDA approval to administer the drug subcutaneously (SC) based on demonstration of bioequivalence of a dose of 275 mg SC to a dose of 250 mg IM. That bioequivalence study was performed in postmenopausal women who received a single dose. This study will be performed in pregnant women with repeated injections both to demonstrate that equivalent exposure is seen and to assess the side effects and acceptance of each route of administration.

A pharmacokinetic (PK) study will be performed after participants have reached steady state (after 9 injections). Participants will receive their injections from research personnel up until the time of completion of the PK study. Home injections will be an option for all participants after the PK study is completed.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant female with documented prior birth between 16 0/7- 36 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes
2. Gestational age (GA) \< 22 weeks, based on study determined GA (as treatment must start between 16 0/7 and 21 6/7 weeks)
3. Singleton gestation
4. Age between 18 - 45 years
5. Able to give informed consent and undergo all study procedures including a single seven day pharmacokinetic study which requires daily venipunctures and willingness to answer questions about side effects and discomfort at each study visit.

Exclusion Criteria:

1. Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery
2. Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus)
3. Medical or obstetrical complication that might affect gestational age at delivery, such as active ulcerative colitis, liver tumors, liver disease/failure, renal disease/failure, undiagnosed vaginal bleeding unrelated to pregnancy, or hypertension requiring 2 or more agents
4. Current or history of thrombosis or thromboembolic disorders
5. Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions
6. Moderately severe depression (Patient Health Questionnaire-9 (PHQ-9) score ≥15, Edinburgh Postnatal Depression Scale (EPDS) score of \>13, or suicidal ideation)
Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

The goal of this clinical trial is to compare the effects of changes in autonomic nervous activity on changes in blood pressure after anesthesia induction between propofol and remimazolam in patients undergoing low-risk surgery. The main questions it aims to answer are:

* Does remimazolam shift sympathovagal balance toward parasympathetic predominance less than propofol?
* Does the less shift in sympathovagal balance toward parasympathetic predominance attenuate the reduction in blood pressure? Participants will be administered either propofol or remimazolam for anesthesia induction, after which the autonomic nervous activity and blood pressure will be measured.

Researchers will compare the propofol and remimazolam groups to see if remimazolam causes less shift in sympathovagal balance toward parasympathetic predominance and subsequently attenuates the reduction in blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years
* American Society of Anesthesiologists physical status of 1
* Elective low-risk surgery requiring general anesthesia, the duration of which is shorter than 2 hours and 30 minutes (e.g., Laparoscopic cholecystectomy, Functional endoscopic sinus surgery, etc.)
* Body mass index less than 30 kg/m2

Exclusion Criteria:

* Arrhythmias or cardiac conduction disorders
* Disease or medical conditions affecting autonomic nervous activity (hypertension, diabetes mellitus, ischemic heart disease, congestive heart failure, cerebrovascular accident, chronic kidney disease, thyroid dysfunction, etc.)
* Valvular heart disease
* Use of medications affecting autonomic nervous activity or cardiac conduction (e.g., beta blocker)
* Limited mouth opening, limited head and upper neck extension, history of obstructive sleep apnea, or Modified Mallampati class 3 or 4
* Serum electrolyte abnormalities
* Severe hypovolemia
* Psychiatric diseases
Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients performing chronic hemodialysis for more than 3 months
* Adult aged \> or = 18 years old
* Information letter delivered to subjects
* Written free informed consent
* Clinically stable patients
* Voluntary patients to perform 30 minutes cycling per dialysis session
* Social French Security Affiliated subjects

Exclusion Criteria:

* Subjects without inclusion criteria
* Pregnant women
* Subjects protected by the law
* Physical impossibility to achieve exercise
* Medical contraindication to perform physical exercise
Nabilone in Cannabis Users With PTSD

Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.

This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.

Eligibility Criteria:
Inclusion Criteria:

* Current cannabis use
* PTSD symptoms
* Able to give informed consent and comply with study procedures
* Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives

Exclusion Criteria:

* Meeting criteria for certain current psychiatric disorders
* Clinical laboratory tests outside of normal limits
* History of clinically significant cardiac or respiratory diagnoses
* Current parole or probation
* Women who are currently pregnant or breastfeeding
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.

The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease harm for both the patients and their families.

Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Primary school degree or above
* Normal vision and hearing
* Dextromanual
* Less than one month before last drug use

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease
A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age
* Diagnosis of NSCLC with locally advanced or metastatic disease
* Positive for KRAS mutation or Squamous cell histology
* Previously treated with one platinum-based chemotherapy
* Disease status must be that of measurable and/or evaluable disease
* Performance status of 0 to 1 on the ECOG Scale
* Prior chemotherapy completed at least 3 weeks prior to study enrollment
* Prior radiation therapy allowed to \< 25% of the bone marrow
* Patient compliance and geographic proximity that allow adequate follow-up
* Adequate organ function
* Patients with reproductive potential must use contraceptive methods
* Signed informed consent from patient

Exclusion Criteria:

* Active infection
* Pregnancy or planning to become pregnant
* Breast feeding
* Serious concomitant systemic disorders
* Second primary malignancy
* Patients who are symptomatic from brain metastasis
* Presence of detectable (by physical exam) third-space fluid collections
* More than 1 prior cytotoxic chemotherapy regimen for advanced disease
* Prior treatment with docetaxel
* History of severe hypersensitivity reaction to polysorbate 80
* Peripheral neuropathy at study entry
* Patients known to be HIV positive
* Patients known to be seropositive for hepatitis C hepatitis B
* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy

It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these informations, is to help prevent those consequences. Information tools have been known to enhance retention of information given orally. The objective of this study is to assess the knowledge and satisfaction of women after an episode of preeclampsia after reading an explanatory pamphlet on preeclampsia. The investigators also want to change their perception on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term consequences and the ways to prevent them.

This is a randomised-controlled trial. Women recruted will first answer a questionnaire assessing demographic data, knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected.

Then, women in the intervention group will receive the pamphlet. One month after, women in both groups will receive a questionnaire similar to the first one assessing knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected, including the pamphlet for the intervention group.

The pamphlet was validated by a multidisciplany team including patients, doctors, nurses, education specialists and communication specialists.

The questionnaire was also validated by the same multidisciplinary team. Section on knowledge and anxiety were remodeled from previously validated questionnaires Section on perception of cardiovascular risk was reproduced and translated with permission from its author.

Section on satisfaction was reproduced from the investigators' previous study where it was validated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* followed at the CHUS obstetrical clinic for a 4 weeks to 18 months postpartum follow up
* had hypertension in her last pregnancy

Exclusion criteria:

* Not able to read and write in French.
What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood?

The purpose of this study is to investigate whether early life exposures such as premature birth or exposure to preeclampsia before you are born results in long-term alterations in the cardiovascular system that increase risk of cardiovascular disease development.

While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.

We have thus designed the Early Vascular Study to investigate the long-term impact of early life exposures, with a particular focus on the impact of preterm birth, in the presence or absence of pregnancy-induced hypertension in the mother, on the cardiovascular system in young adulthood. This study also allows investigation of the long term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype. This is combined with blood sample collection to study changes in molecular and metabolic markers and pathways.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Preterm-born Cohort: Born premature (\<37 weeks completed gestation), originally recruited as part of a randomised feeding trial at birth from one of five United Kingdom centres between 1982 and 1985.
* Term-born Cohort: Born at term (\>37 weeks completed gestation) with normal birth weight for gestational age.
* Able (in the Investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

-The participant may not enter the study if ANY of the following apply:

* Unwilling or unable to give informed consent for participation in the study.
* Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
* Contraindication to Cardiovascular Magnetic Resonance Imaging.
Postpartum Pelvic Floor Workshop

After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four weeks after delivery can improve pelvic floor disorders compared to those that did not have a workshop.

There is compelling evidence for the need for perineal education and care, especially in women who have recognized risk factors. For example, 30-50% of women who have a clinically recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal pain. Despite this, a study found that less than 50% of women with anal incontinence voice those symptoms unless directly asked about them.

Some authors discuss how women may not share these symptoms with their care providers out of the belief that it is a "normal" effect of childbirth. A review of the literature shows that antenatal educational workshops can be an effective means to provide pregnant women with information regarding pelvic floor health, including how modes of delivery impact pelvic floor function. Similarly, antenatal pelvic floor workshops have been found to improve patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises and their confidence with these exercises.

To our knowledge, there is no literature exploring the role of a postpartum pelvic floor workshop, on managing perineal and pelvic floor symptoms in women who are identified as being at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such a workshop.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum (ie no more than 4 weeks postpartum at time of group allocation)
* Vaginal delivery
* Sustained one or more of the following insults to perineum/pelvic floor

  * Third or fourth degree laceration
  * Vacuum or forceps assisted vaginal delivery
  * Delivery of macrosomic infant ≥4000g)

Exclusion Criteria:

* Prior pelvic floor physiotherapy treatment
* Prior surgical management for pelvic organ prolapse or incontinence
* Unable to understand English
* Caesarean delivery
* Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc
The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia

The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.

The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patients who undergo surgery under spinal anesthesia
* American Society of Anesthesiologists (ASA) physical status classification I-III

Exclusion Criteria:

* patients undergo urgent operations
* patients have psychiatric disorders
Pre-pectoral Breast Reconstruction PART 2

The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.

This phase III randomized clinical trial will be investigating the Two-stage, using Tissue Expander (TE) pre-pectoral reconstructions.

The trial will comprise two arms:

PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic.

Included patients baseline characteristics will be:

* age 18-80 years old
* BMI between 18.5 and 35.
* Former smokers (up until 3 weeks before surgery)
* hypertension at oral medications
* diabetes
* previous breast surgery
* previous breast and chest wall radiation therapy will be allowed.

Exclusion Criteria:

* T4 and metastatic breast cancers
* obese patients (BMI over 35)
* currently smoking patients (within 3 weeks before surgery)
* refusal to sign the consent
* severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).