cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.

This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement will be used to publish and promote recruitment.

The study will include 3 visits: Screening visit and two consecutive visits each one after monthly menstrual period. Treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.


Eligibility Criteria:
Inclusion Criteria:

1. Women between the age 18 to 45 years
2. Women reporting painful menstruation during the last 3 menstrual cycles.
3. Pain VAS score of at least 60 based on previous menstrual cycle
4. Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.
5. Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral).

Exclusion Criteria:

1. Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
2. Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk.
3. Pregnant woman
4. A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
5. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
The Role of Cytokines in Apparently Normal Pregnancies

To provide rigorous, detailed normative data for diagnostics and comparative studies, to determine relationships between cytokine levels (and other biomarkers) and clinical data, and gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester amniotic fluid.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Pregnancies between 15-25 weeks gestation.
* Able to provide informed consent.
* No apparent major sonographic abnormality.

Exclusion Criteria:

* Any major fetal anomaly
Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)

The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.


Eligibility Criteria:
Inclusion Criteria:

* Children between 0 and 18 years old
* Intra-abdominal infection with and indication for surgery or radiologically guided drainage.
* No opposition from the child or his parents

Exclusion Criteria:

* No microbiological sampling.
* Primitive peritonitis (Spontaneous bacterial peritonitis, peritonitis during peritoneal dialysis)
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain

Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.

The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. Eligible patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. A follow-up assessment will take place 2-3 days after the completion of the treatment phase.

Eligibility Criteria:
Inclusion Criteria include:

* Moderate to severe acute pain for which parenteral opioid therapy is warranted
* Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Exclusion Criteria include:

* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study.
* Hemodynamic instability or respiratory insufficiency.
* Advanced cancer in palliative or end-of-life care.
* Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study.
* Clinically significant, immune-mediated hypersensitivity reaction to opioids.
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.

2-hydroxyglutarate (2HG) imaging will identify glioma, tumor progression and response to therapy noninvasively at an earlier time point than currently detectable with standard MR imaging. This utility of 2HG can be used for improving the patient care in a more effective manner when the 2HG imaging is incorporated in regular clinical MR scans in brain tumor patients. We aim to translate the 2HG MRS protocol into two clinical MR centers at UTSouthwestern Medical Center: The Mary Nell and Ralph B. Rogers Magnetic Resonance Center with Philips 1.5Tesla and 3Tesla scanners and The Algur H. Meadows Diagnostic Imaging Center with a GE 3Tesla scanner. In addition, we will perform Magnetic Resonance (MR) scans in patients with neurological diseases that can mimic gliomas, including stroke, epilepsy, encephalitis, and brain metastases in order to establish the specificity of 2HG to malignant gliomas.

Eligibility Criteria:
Inclusion Criteria:

(120 Brain Tumor Patients)

* All races and ethnicities
* Must meet at least one of the 3 following criteria regarding diagnosis:

  * Histological diagnosis of a brain tumor
  * Pre-operative MR imaging suggestive of a brain tumor
  * Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)
* Pretreatment evaluations required for eligibility include a medical history, physical examination, and neurological exam within 30 days prior to study entry.
* Patient must be able to provide study-specific consent prior to study entry and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
* Karnofsky performance status \>70%
* Life expectancy greater than 3 months.

  (50 Non-Tumor Neurological Disorders)
* All races and ethnicities
* Patients with clinically-proven multiple sclerosis, temporal lobe epilepsy, stroke, or encephalitis.

  (5 Health Volunteers)
* 18-40 years of age
* All races and ethnicities
* Excellent general health

Exclusion Criteria:

* Under age 18
* Cardiac pacemaker
* Intracranial clips, metal implants, or external clips within 50 cm from the head
* Metal in eye
* Pregnancy
* Claustrophobia
* Obesity or any other factors that provide difficulty with supine pose in the magnet
* Patients who are unable to provide informed consent
* Patients who are pregnant or nursing
* Patients with severe kidney dysfunction or uncontrolled cardiac dysfunction
* Patients who are claustrophobic or have other contraindication to MRI, such as implanted pacemaker device, vascular clips, surgical clips, prosthetic valves, pace¬makers, otologic implants
* Patients with uncontrolled psychiatric manifestations of their brain tumor
* Patients for 7 Tesla scans can have no metal in the body
Bioavailability Study of BIA 5-453

The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.

This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 45 years, inclusive.
* had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
* had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
* were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
* was able and willing to give written informed consent.

Exclusion Criteria:

* had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* had a clinically relevant surgical history.
* had a clinically relevant family history.
* had a history of relevant atopy or drug hypersensitivity.
* had a history of alcoholism or drug abuse.
* consumed more than 14 units of alcohol a week.
* had a significant infection or known inflammatory process at screening or admission to the first treatment period.
* had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
* used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
* used any investigational drug or participated in any clinical trial within 3 months prior to screening.
* participated in more than 2 clinical trials within the 12 months prior to screening.
* donated or received any blood or blood products within the 3 months prior to screening.
* was a vegetarian, vegan or with medical dietary restrictions.
* could not communicate reliably with the investigator.
* was unlikely to co-operate with the requirements of the study.
* was unwilling or unable to give written informed consent.
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

Primary Objective:

To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose

Secondary Objectives:

* To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
* To assess the safety and tolerability of the test and the reference formulation of insulin lispro

Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

Eligibility Criteria:
Inclusion criteria :

* Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
* Total insulin dose of \<1.0 U/kg/day
* Fasting serum C-peptide \<0.30 nmol/L at screening
* Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening
* Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
* Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L
* Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
* More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month).
* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* If female, pregnancy (defined as positive β-HCG blood test), breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely.

OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (\>10 MIPDs per year, total \>20 PDs per year).

METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Indication for open or minimally invasive pancreatoduodenectomy
* Pancreatic head, bile duct, or duodenal cancer or cysts

Exclusion Criteria:

* Chronic pancreatitis without suspected solid tumor.
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)

The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).


Eligibility Criteria:
Inclusion Criteria:

* Both Sexes, Aged 20 Years Or Older
* Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA
* Written Informed Consent

Exclusion Criteria:

* Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
* Participants With Pneumonia
TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear quality have suggested that TXA may reduce blood loss and maternal morbidity, while a Cochrane Collaboration review has concluded, that "TXA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. Further investigations are needed on efficacy and safety of this regimen for preventing PPH.

Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery.

The follow-up visit will take place in the postpartum ward of the maternity unit, on D2 postpartum. This stage will include a venous blood sample to measure plasma concentrations of Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events.

At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. At 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.

Eligibility Criteria:
Inclusion Criteria:

* : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
* hemoglobin level at the last blood sample \>9g/dl,
* available blood test for Hb and Ht within one week before caesarean delivery,
* informed signed consent

Exclusion Criteria:

* previous thrombotic event or preexisting pro-thrombotic disease,
* epileptic state or history of seizures,
* presence of any chronic or active cardiovascular disease outside hypertension,
* any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,
* sickle cell disease,
* placenta praevia,
* placenta accreta/increta/percreta,
* abruption placentae,
* eclampsia,
* HELLP syndrome,
* significant hemorrhage before cesarean section
* in utero fetal death,
* administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
* planned general anesthesia,
* hypersensitivity to tranexamic acid or concentrated hydrochloric acid,
* instrumental extraction failure,
* multiple pregnancy with vaginal delivery of the first child,
* poor understanding of the French language.
Breast Augmentation Rehabilitation Program

The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.


Eligibility Criteria:
Inclusion Criteria:

* women who undergo endoscopic transaxillary subpectoral breast augmentation
* women above the age of 18 years
* women with a BMI 18-27

Exclusion Criteria:

* women who underwent previous breast reconstruction (cosmetic or therapeutic)
* women who underwent previous chest surgery
* women with previous chest trauma
* women who underwent previous shoulder/arm surgery
* women with previous shoulder/arm injury
* women who smoke
* women who are Immunocompromised
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI can be used to identify patients who would respond positively and safely to tissue plasminogen activator (tPA) beyond 3 hours post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present:
* with acute hemispheric stroke within 3-6 hours of onset,
* have at least moderate limb weakness,
* a National Institute of Health Stroke Scale (NIHSS) score \> 4,
* had a pre-stroke modified Rankin Scale (MRS) score of 0 - 2
* and who are able to undergo CT and MRI, are eligible for this study.

Exclusion Criteria:

* Females who are pregnant or breast-feeding,
* persons who have CT-verified hemorrhagic stroke, major ischemia ( \> 33% of the middle cerebral artery (MCA) territory infarcted), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, intracranial neoplasm that is terminal or poses a risk of hemorrhage ,
* are comatose or severely obtunded with fixed eye deviation and complete hemiplegia,
* have had another stroke within the past 6 weeks,
* have had a seizure prior to the administration of the study drug,
* have active peptic ulceration, bleeding diatheses, previous intracerebral hemorrhage,
* blood pressure \> 185/110,
* major surgery or trauma within the past 30 days, or any other contraindications to tPA
* have a presumed septic embolus or a myocardial infarction within the past 30 days
* blood glucose values are \< 2.8 or \> 22.0 mmol/L,
* pacemakers, aneurysm clips, implanted devices, claustrophobia, or any other contraindications to MRI,
* decreased consciousness,
* rapid clinical improvement,
* confounding neurological condition (e.g. dementia),
* any other life-threatening illness, or who are participating in another clinical trial, will be excluded from this study.