cyrilzakka/clinical-trials huggingface dataset:
Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.

Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* hypersensitivity or contraindications of use of tranexamic acid
* patient refuses to consent
Neuromuscular Electrical Stimulation in Critically Ill Patients.

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.

The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.

Eligibility Criteria:
Inclusion Criteria:

* All patients that will be admitted to the intensive care unit
* Hemodynamic stability
* Mechanical ventilation.

Exclusion Criteria:

1. In general:

   * a. Pregnant women
   * b. Brain death
   * c. Neuromuscular diseases
   * d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.
2. Contraindications for the use of NMES:

   * a. Fractures
   * b. Burns
   * c. Skin lesions
   * d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
   * e. Lower limb amputations
   * f. Cardiac pacemaker,
   * g. Thrombocytopenia less than 20,000/mm3
   * h. BMI greater than 35 kg/m2
   * i. Important lower extremity oedema
   * j. Agitation and/or signs of pain during the electrical stimulation.
3. Contraindications to begin or continue NMES procedure:

   * a. Mean arterial blood pressure less than 65 mmHg
   * b. Use of vasopressor \>50% of themaximum dose (dopamine \>12.5 μg/kg per minute; vasopressin \>0.02U/min and norepinephrine \>1 μg/kg per minute),
   * c. Heart rate \<50 or \>140bpm
   * d. Arrhythmias with hemodynamic consequences
   * e. Myocardial ischemia,
   * f. Temperature \<34 or \>39oC
   * g. Intracranial pressure \>20 cmH2O
   * h. Decrease in 10% of SpO2 baseline value or \<88% for more than one minute.
Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy

The primary objective of the study is to evaluate the safety and tolerability of 2 dosing regimens of pozelimab and cemdisiran combination therapy during the open-label treatment period (OLTP)

The secondary objectives of the study are:

* To evaluate the effect of the combination treatment on the following parameters of intravascular hemolysis: lactate dehydrogenase (LDH) control, breakthrough hemolysis, and inhibition of total complement hemolysis activity (CH50)
* To evaluate the effect of the combination treatment on hemoglobin levels
* To evaluate the effect of the combination treatment on red blood cell (RBC) transfusion requirements
* To evaluate the effect of the combination treatment on clinical outcome assessments (COAs) measuring fatigue and health related quality of life
* To assess the concentrations of total pozelimab in serum and total complement component (C) 5 and cemdisiran in plasma
* To assess immunogenicity to pozelimab and cemdisiran
* To evaluate the long-term safety and efficacy of pozelimab and cemdisiran in an optional open-label extension period (OLEP)
* To assess safety after treatment intensification with pozelimab and cemdisiran


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants with PNH who are receiving treatment with pozelimab monotherapy in the R3918- PNH-1868 study (NCT04162470)

Key Exclusion Criteria:

1. Documented, positive polymerase chain reaction (PCR) or equivalent test based on regional recommendations for COVID-19 or suspected SARS-CoV-2 infection as defined in the protocol
2. Participants with documented history of liver cirrhosis or participants with liver disease with evidence of currently impaired liver function; or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) as described in the protocol
3. Significant protocol deviation(s) in the parent study based on the investigator's judgment as described in the protocol
4. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the participant unsuitable for enrollment or would jeopardize the safety of the participant
5. Known hypersensitivity to cemdisiran or any component of cemdisiran formulation

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.

It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk.

Mask ventilation and tracheal intubation in morbidly obese patients can be difficult with the anatomical changes caused by obesity. Reduced functional residual capacity in morbidly obese patients makes it difficult to maintain peripheral oxygen saturation at normal limits. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.

The use of videolaryngoscope in patients with difficult intubation such as morbid obesity, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes.

In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of morbidly obese patients undergoing bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology score III,
* 18-65 years,
* BMI\> 40

Exclusion Criteria:

* American Society of Anesthesiology IV,
* Under 18 years,
* Over 65 years,
* Under BMI\<40
* Obstetric patients,
* Uncontrolled cerebrovascular disease,
* Patients who refused written informed consent forms
Cerebrospinal Fluid Proteome in Hydrocephalus

PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

CSF proteome is the real time protein content that may reveal useful biomarkers for diagnosis and therapeutic decision-making. But the low protein concentration in CSF and the low volumes typically obtained after lumbar puncture precludes the conventional use of proteomic analysis. We miniaturized the method to be compatible with low-volume samples by combination of nanoLC-MS/MS analysis and combinatorial peptide ligand library technology to reduce the dynamic range of protein concentration in CSF and unmask previously undetected proteins. We demonstrated that this deep proteomic analysis allows profiling the CSF proteome with a reasonable depth, in short analytical times and good accuracy. We settled a clinically-compatible proteomics strategy targeting the deep CSF proteome discovery.

The PROLIPHYC study is a prospective study that aims at analysing CSF proteome with our new strategy in a cohort of patients suspected of normal pressure hydrocephalus and/or related neurodegenerative diseases. The PROLIPHYC project combines detailed clinical and neuropsychological evaluation, gait analysis, MRI brain imaging, lumbar CSF dynamics and deep proteome. We hypothesize in the PROLIPHYC study that a specific cluster of polypeptides can be associated with Alzheimer disease, vascular dementia and normal pressure hydrocephalus profiles. Validating this hypothesis might be a significant step towards a proteomic lexicon of aging brain, neurodegenerative diseases and dementia.

Neurosciences department and Alzheimer disease centre from the Toulouse University Hospital are both involved in this project. The deep proteomic study is performed in Toulouse by the Institute of Pharmacology and Structural Biology with the academic support of the Institute of Mathematics of Toulouse.

Eligibility Criteria:
Inclusion Criteria:

* Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging

Exclusion Criteria:

* Psychiatric disorders
* Lumbar punction contraindication
* RMI contraindication
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia

Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.

Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.

Eligibility Criteria:
Inclusion Criteria:

* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

- Subjects who are unwilling or unable to provide informed consent.
Mutation Detection for VRL

Vitreoretinal lymphoma (VRL) is a rare but aggressive masquerade syndrome, which would be easily confused with uveitis. The diagnostic gold standard remains the pathologic examination of ocular specimen with invasiveness and low sensitivity. To improve the safety and accuracy of VRL diagnosis, alternative techniques using intraocular fluid (IOF) samples are emerging. In this study, we aimed to test the diagnostic value of mutation analysis for VRL

chest CT, urinalysis, kidney, and liver function were routinely checked.

IL-10/IL-6 ratio, genetic mutation analysis and samples were IGH gene rearrangements were reviewed and analyzed retrospectively.

The diagnoses were identified after careful evaluation of treatment effects in follow-up. The diagnostic value including sensitivity, specificity, positive and negative predictive values, and test efficiency of genetic mutation analysis in diagnosing VRL were analyzed.

Furthermore, a validation group of patients including VRL and uveitis was selected to validate the diagnostic value of mutation analysis in the diagnosis of VRL. All the patients signed an informed consent and institutional review board approval was obtained. The study was performed in accordance with the tenets of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* suspected VRL patients who had intraocular fluid for mutation test. And got a clear diagnose of VRL or uveitis afther having dianostic tests and follow-up treatment

Exclusion Criteria:

* suspected VRL patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-65 years, inclusive
* Written informed consent
* Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting
* Complex skin defects of 3-49% TBSA requiring excision and autografting
* Total burn may consist of more than one wound area
* Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting
* First excision and grafting of treatment sites

Exclusion Criteria:

* Pregnant women and prisoners
* Patients receiving systemic immunosuppressive therapy
* Patients with a known history of malignancy
* Preadmission insulin-dependent diabetic patients
* Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
* Expected survival of less than three months
* Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment
* Full-thickness burns will be excluded as treatment sites
* Chronic wounds will be excluded as treatment sites
* The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites
* Treatment sites adjacent to unexcised eschar
* Clinical suspicion of burn wound infection at the anticipated treatment sites
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).

Ripasudil eye drops will be administrated to all enrolled preterm infants with zone I/II stage 1 or greater ROP （except for aggressive posterior ROP, Type1 ROP ）.

The safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control.

Eligibility Criteria:
Inclusion Criteria:

* 1. Informed consent signed by parents or legal guardians of the patient
* 2. Patients born with less than or equal to 32 weeks of gestational age and/or less than or equal to 1,500 grams of birth weight
* 3. Patients with the following types of ROP in both eyes

  1. Zone I ROP with stage greater than or equal to 1
  2. Zone II ROP with stage greater than or equal to 1

Exclusion Criteria:

* 1. Patients with aggressive posterior ROP in one or both eyes
* 2. Patients with type 1 ROP in one or both eyes
* 3. Patients with a confirmed or suspected chromosomal abnormality or genetic disorder
* 4. History of hypersensitivity to ripasudil (including drugs with similar chemical structure) in patients or their mothers
* 5. Patients or their mothers have participated in another intervention study and have used the study drug of another intervention study within 30 days prior to enrollment in this study or within 5 times the half-life of the study drug
* 6. Patients with an ocular structural abnormality that can affect the evaluation of this clinical study by investigators
* 7. Patients with a clinically significant neurological disease (e.g., intraventricular hemorrhage grade 3 or higher, severe hydrocephalus with significantly increased intracranial pressure)
* 8. Patients with inadequate blood access
* 9. Patients with complications, allergies, or worsening systemic conditions that make it difficult to conduct this trial
* 10. Patients judged unsuitable by investigators
Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada

Swimming and other recreational water activities at public beaches are increasingly popular leisure activities among Canadians. However, harmful algal blooms caused by blue-green algae (i.e., cyanobacteria) have also been increasing reported at Canadian public beaches in recent years. These algal blooms can cause various acute illnesses among recreational water users through ingestion, inhalation of aerosols, or skin contact with contaminated water. In addition, blue-green algae blooms and their toxins can cause illnesses in pets and wildlife. Currently, baseline data are lacking on the risk of recreational water illness from exposure to blue-green algae blooms in Canada. This study will identify the burden of recreational water illness among recreational water users at four targeted beach sites in Ontario, Manitoba and Nova Scotia, over a two-year period. A prospective cohort study design will be used. The investigators will determine the risk of acquiring acute illness outcomes in recreational water users, as well as their pet dogs, that engage in different levels of water contact at beaches at risk of blue-green algae blooms. The investigators will examine differences in illness risks by gender, age, and location. Relationships between cyanobacterial cell counts, toxin levels, and environmental conditions with the risk of acute illness among participants will be determined. Overall, results will provide important data on the risk of recreational water illness from exposure to blue-green algae and their toxins in Canadian beach settings.

This study will investigate the incidence of recreational water illness due to exposure to cyanobacterial blooms and their toxins in four targeted and popular freshwater beaches in Ontario, Manitoba, and Nova Scotia, Canada. A prospective cohort design and One Health approach will be used. On-site recruitment of recreational water users will be conducted at two beaches per year during the summers of 2024 and 2025. The population of interest includes recreational water users of any age and their pet dogs. After enrollment, an in-person survey will determine beach exposures and confounding factors, and a three-day follow-up survey will ascertain any acute illness outcomes experienced by participants or their dogs. The target sample size is 2500 recreational water users. Water samples will be taken each recruitment day and analyzed for cyanobacterial indicators (pigments), cell counts, and toxin levels. Regression analysis will be conducted to estimate the association with water contact, cyanobacterial levels, and risks of different acute illness outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ability to provide informed consent
* ability to complete the surveys in English or French
* must not have participated in the study in the past 21 days
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 35 years old, married female and infertile.
* BMI≥25kg/m2.
* Diagnosed as PCOS.
* No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
* Subjects do not take part in other clinical trial study within 3 months.
* The subjects sign the informed consent form.

Exclusion Criteria:

* BMI\<25kg/m2.
* Hyperprolactinemia and congenital adrenal cortical hyperplasia.
* Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
* Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
* Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
* Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
* Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma\>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
* Allergic to E. coli. expression product and its excipients.
* Being involved in other drug clinical researchers.
* The researchers consider who is not suitable for the group.