cyrilzakka/clinical-trials huggingface dataset:
Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire

The diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. The primary aim of the study is to assess the sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. The second aim of the study is to assess the sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.

Patients who received follow-up during pregnancy as recommended. Age over 18

Exclusion Criteria:

Patients age under the age of 18 Patients who did not have follow-up during pregnancy as recommended Patients taking long-term anticoagulants and/or antiaggregants Patients with a language barrier
The Optical Coherence Tomography in Age-Related Macular Degeneration Study: The OCT in AMD Study

The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the retina by providing cross-sectional scans through the retina. Measurements of the retinal thickness based on automatically set border lines created by threshold algorithm provide information concerning the amount of intraretinal fluid and activity of the lesion. In this study the reproducibility of retinal thickness measurements in patients suffering from age-related macular degeneration performed by two independent examiners of two examinations of the same day but performed in a time interval of at least two hours should be evaluated. Using the macular thickness program of stratus OCT, 6 radial lines through the center of the foveal avascular zone are performed, Differences between the first and second measurement will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding regression analysis) and a random effect model with time, examiner and diagnosis as fixed factors. Although threshold algorithm failures and fixation problems are common in age-related macular degeneration evidence of reproducibility and repeatability of maximum retinal thickness is expected.


Eligibility Criteria:
Inclusion Criteria:

* Age over 50 years
* Age related macular degeneration

Exclusion Criteria:

* Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
* Not consented patients
Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang

Diarrhea irritable bowel syndrome(IBS-D）has seriously affected health and quality of life of patients.It may be important pathogenesis in development and recurrence of the process of IBS-D,excessive endoplasmic reticulum stress (ERS) activated PERK(proteinkinaseR-like ERkinase，PERK)-eIF2a(eukaryotic translation initiation factor 2 alpha,eIF2a) pathway and damaged intestinal mucosal epithelial Barrier. Tongxieyaofang(TXYF) had obtained satisfactory effect in treating IBS-D in clinic and previous study, but it is unknown that herbal formula how to work.This project applies metabolomics method to detect plasma,urine and stool metabolites for patients before and after treatment, to determine the effects of the"multiple ingredients"of TXYF in body.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the diagnostic criteria of Western medicine for IBS-D;
* aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
* voluntarily signed the informed consent;
* local resident who could ensure follow-ups, with basic reading ability

Exclusion Criteria:

* Patients with IBS-C, -M, and uncertain forms;
* accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
* gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renal insufficiency, and nervous system diseases);
* undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
* with history of abdominal surgery (e.g., cholecystectomy);
* with an allergy history of tested drugs or severe allergy history of food;
* pregnant and lactating female;
* with a history of neurological or psychiatric disorders;
* or participating in other clinical trial.
Validity and Reliability of the GPCOG -TR

The General Practitioner assessment of Cognition (GPCOG) was specifically developed as a brief cognitive screening tool to be used by general practitioners (GPs). It consists of a patient section testing cognition and an informant section asking historical questions. The aim of this study was to test the validity and reliability of the Turkish version of GPCOG-TR on Turkish older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age: least 55 years old
* Provide informed consent
* Diagnosed with dementia ( patient group)

Exclusion Criteria:

* Living in a nursing home
* Presence of psychiatric disorders requiring treatment
* Presence of other comorbidity interfering with cognitive performance such as severe chronic heart failure, chronic obstructive pulmonary disease, diabetes, anemia Impairment of auditory or visual perception
* Low education
* Known cognitive impairment (for control group only)
* Lack of a reliable informant.
Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face

To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 20 to 75 years of age
2. Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale

Exclusion Criteria:

1. Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
2. Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia.

The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.

This is a Phase 4 multi-center, randomized open-label study in 100 subjects aged ≥12 to 16 years who experience a decrease in blood pressure during a procedure requiring general or neuraxial anesthesia. At least 300 subjects will be enrolled in this study. It is anticipated that up to 33% of enrolled subjects will actually experience a decrease in blood pressure that requires treatment and so will receive Phenylephrine Hydrochloride Injection (PHI). There are 12 possible randomization assignments: one of six initial treatments PHI will be initially administered to approximately 50 subjects as an intravenous bolus (IV-B) at Low (1 μg/kg), Med (3 μg/kg), or High (5 μg/kg) level; PHI will be initially administered to approximately 50 subjects as a continuous intravenous infusion (IV-I) at Low (0.25 μg/kg/min), Med (0.75 μg/kg/min), or High (1.25 μg/kg/min) level\]; each initial treatment group will have two pharmacokinetics (PK) sampling schedules.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's age is between ≥12 and 16 years, inclusive
2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia
3. Subjects must have normal or clinically acceptable physical exam
4. Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
6. Subject's parent or legal guardian gives informed consent and subject gives assent.

Exclusion Criteria:

1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
6. Subjects taking antihypertensive medication
7. Subject is moribund (death is likely to occur in less than 48 hours)
8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.

The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Eligibility Criteria:
Inclusion Criteria:

* 35 years of age or older
* While male patients will not be explicitly excluded, it is expected that all patients in this study will be women
* Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5
* Scheduled for ultrasound or stereotactic core biopsy
* Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.
* Ability to understand risks, procedures, and benefits involved

Exclusion Criteria:

* Recent breast biopsy
* History of breast augmentation implant
* Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding
* History of moderate or severe adverse reaction to iodinated contrast injection
* Recent serum creatinine ≥ 1.5 mg/dL
* History of Diabetes Mellitus
* Currently taking Glucophage or Glucovance (Metformin)
* History of chronic asthma
* History of allergy to iodine
* Multiple food and/or drug allergy
* Renal disease
* History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold
Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.

The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy or neck dissection surgery.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 16 years of age.
* Planning to undergo surgery in the Head and Neck.
* Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.
* Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Sexually active patients must be willing to use an acceptable method of contraception while participating in the study and for 30 days after receiving bevonescein.
* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.

Exclusion Criteria:

* Patient has a history of prior surgery and/or radiation to the intended surgical site.
* Patient has abnormal cardiac rhythm not controlled with medication.
* Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \< 60 mL/min.
* Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.
* Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy \<= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.
* Patient has a history of fluorescein allergy.
* Patient has a history of drug-related anaphylactic or severe allergic reactions.
* Presense or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the Investigator, places the patient at increased risk for adverse effects.
* Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction, or cerebrovascular accident.
* Presence or history of any condition, that in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
* Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study.
* Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
Finite Element and z Shap Mini Plate With Lingual Extension

* A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of parasympheseal mandibular fracture
* 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which plate is the best


Eligibility Criteria:
Inclusion Criteria:

- parasymhyseal fracture

Exclusion Criteria:

• absence of other facial trauma, mandibular condylar fracture
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years of age)
* Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation \[\> 1L within 12 h of screening\]) and need for vasopressors at the time of screening.

Exclusion Criteria:

* Confirmed or suspected pregnancy
* Previous inclusion in the trial
* Screened more than 12 hours after ICU admission
Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults

The goal of this intervention study is to analyse the microbiota composition after the water kefir consumption. The main questions are to evaluate the potential probiotic drink can have beneficial effect on the gut microbiota. Participants will consume the water kefir for two weeks and microbiota will be analysed. Researchers will compare the microbiota composition before and after consumption.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* must be able to complete the form digitally.

Exclusion Criteria:

* must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV.
* must not take antibiotics during the study period.
Phase II Dose Ranging Study of Artesunate

The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy.

To compare the efficacy and tolerability of intravenous artesunate for the initial treatment of uncomplicated Plasmodium falciparum malaria at doses that bracket anticipated clinical doses (2.4 mg/kg once daily for 3 days; or 2.4 mg/kg initially, at 12 hours on Day 0, and then daily on Day 1 and 2) and thereby establish the safest, highly efficacious dosing regimen for use in future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Acute symptomatic Plasmodium falciparum malaria infection as determined by malaria smear with a parasite density of ≥ 5000 asexual parasites/mL
2. Age: 5-65 year old males and females.
3. Written informed consent must be obtained from adults age \> 18 years. Parental consent will be obtained from children and adolescents, and subject assent will also be obtained from adolescents (age 12-17 years).
4. Willing to stay hospitalized for 4 days for treatment and for 3 scheduled follow-up outpatient visits at Day 7, 14 and 28.

Exclusion Criteria:

1. Pregnant women (clinically or by positive urine β-HCG) and nursing mothers
2. Clinical evidence of severe malaria (see Appendix B)
3. Mixed malaria infection on admission by malaria smear
4. A previous history of intolerance or hypersensitivity to the study drug artesunate or other artemisinin derivatives or Malarone.
5. Efficacious malaria drug therapy administered in the past 30 days by history (i.e. quinine, mefloquine, lumefantrine and artemisinin derivatives)
6. Previous participation in this trial or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
7. Laboratory evidence or a history of significant liver or renal functional abnormality.
8. Anyone who has received a transfusion or any blood product within 30 days
9. Unable and/or unlikely to comprehend and/or follow the protocol.
10. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.
* The reported duration of the PTSD is at least 3 months.

Exclusion Criteria:

* The index traumatic event that led to development of PTSD took place more than 15 years before screening.
* The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study.
* The patient is at significant suicidal risk.

Other inclusion and exclusion criteria may apply.
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients

Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has been demonstrated to be effective in controlling these symptoms, but trials identifying their efficacy in the outpatient surgery population are lacking. This study integrates conventional pharmacotherapy with alternative medicine in prevention of PONV.

Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an outpatient surgery center were randomized to two treatment arms. The first arm was standardized pharmacologic PONV prevention typical for patients undergoing outpatient surgery, while the second arm employed the use of ReliefBand, an FDA-approved electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms, emetic events, the need for rescue medications and the time to discharge.


Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery at the University of Wisconsin outpatient surgery center

Exclusion Criteria:

* pregnancy
* currently experiencing menstrual symptoms
* cardiac pacemaker
* previous experience with acupuncture therapy
* pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery