cyrilzakka/clinical-trials huggingface dataset:
PROphylactic Manual RotatIon in the Second stagE of Labor

This is a randomized controlled trial to determine whether prophylactic manual rotation for fetuses identified to have persistent occiput posterior or occiput transverse presentation (POP/OTP) at the initiation of the second stage of labor in nulliparous individuals reduces rates of operative delivery, second stage of labor duration, and resultant adverse clinical outcomes compared to standard management of the second stage of labor.

This is a randomized controlled trial in which nulliparous individuals with a term, singleton gestation who undergo a trial of labor with neuraxial anesthesia and have a fetus presenting with persistent occiput posterior or occiput transverse presentation (POP/OTP) confirmed by ultrasound at the initiation of the second stage of labor will be randomized to either prophylactic manual rotation or sham rotation. The study aims to evaluate whether prophylactic manual rotation reduces the incidence of operative delivery (a composite of cesarean and operative vaginal delivery), second stage of labor duration, and maternal and neonatal morbidity among nulliparous individuals with a fetus with POP/OTP at the initiation of the second stage of labor.

Individuals will be screened for eligibility upon admission to Labor and Delivery and approached for potential recruitment with informed consent obtained on enrollment. Once women achieve complete cervical dilation and within the first fifteen minutes of commencement of pushing, a bedside ultrasound will be performed to determine the fetal position. Those with POP/OTP will be randomized at that time point to either prophylactic manual rotation or sham rotation. The patient's primary obstetrician will be blinded to the randomization arm. The electronic health record will be reviewed and used to assess trial outcomes. The study will enroll 350 individuals, powered to detect a 15% reduction in operative delivery (instrumental vaginal delivery or cesarean section) with prophylactic manual rotation of POP/OTP, from a baseline risk of 50% without manual rotation to 35% with prophylactic rotation at initiation of the second stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Age 18 years or greater
* English-speaking
* Nulliparous
* Singleton gestation
* Planning a vaginal birth
* Have neuraxial anesthesia
* Term gestation (≥37 weeks' gestation)
* Ruptured membranes
* Complete cervical dilation
* Cephalic presenting fetus
* Fetus presenting with occiput posterior or occiput transverse position confirmed by ultrasound

Exclusion Criteria:

* Pregnancies with intrauterine fetal demise
* Pregnancies affected by major fetal anomaly
* Maternal or fetal contraindication to vaginal delivery, including operative vaginal delivery
* Fetal malpresentation, including brow or face presentation
* Category III fetal heart rate tracing at time of randomization
* Duration of pushing already exceeding 15 minutes in the second stage of labor
* Lack of other inclusion criteria as described above
Ketamine Versus Propofol as ICU Sedation

this study is to assess the hemodynamic profile of ketamine compared with propofol in critically ill, mechanically ventilated adult Patients study will be carried out on 100 mechanically ventilated patients who received one sedative agent propofol or ketamine The patients will be randomized into two equal groups to receive either ketamine or propofol Group 1 (Ketamine group): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation. Group 2 (Propofol group): Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6 mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve appropriate sedation.


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated, and receive sedation with continuous infusion propofol, or ketamine for at least 24 hours

Exclusion Criteria:

* Receiving propofol or ketamine concurrently.

  * Transferred from an outside hospital on sedation.
  * Receiving ketamine for an indication other than sedation.
  * Daily intake of opioids.
  * Contraindication to any drug used in the study.
Novel Therapy Target in Metastatic Prostate Cancer

The aim of this study is to use multiomics sequencing to explore the molecular characteristics of metastatic prostate cancer (mPCa), especially metastatic castration-resistant prostate cancer (mCRPC). At the same time, mCRPC models will be constructed, including organoids and animal models, serving as a basic and translational research platform to help identify novel drug targets for mPCa.

Although substantial progress in treatments for prostate cancer have been made in the past decades, distant metastasis and drug resistance remained a major cause of prostate cancer-related deaths. The five-year survival rate for men with mPCa was only 30% and all patients with mPCa would inevitably progress to the castration-resistant stage with limited therapeutic chance. In China, the current situation is more worrying, with rapidly increasing PCa incidence and higher proportion of mPCa diagnosed compared with the Western nations (\~30% vs \~5%).

Multiomics sequencing provides a promising strategy to discover the underlying molecular basis driving metastasis and resistance and identify the new treatment strategies for patients with mCRPC. The candidate drug target revealed by the multiomics sequencing could be further examined in the organoid and animal models, facilitating the clinical application from basic discovery.

This study can establish a mCRPC research system to find the molecular mechanism and potential intervention targets of mCRPC, thereby paving the way for the discovery of new treatments for mCRPC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed prostate cancer
2. metastatic disease confirmed by image examination
3. Patients who can undergo surgery or biopsy for prostate cancer
4. Able to provide informed consent

Exclusion Criteria:

1. Patients diagnosed with other types of cancer besides prostate cancer
2. Not accessible to surgery sample
3. Patients fail to provide informed consent
4. Other situation that researchers think are unsuitable for this study
Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.

The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms consistent with acute STEMI lasting at least 30 minutes
* STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads
* Patient eligible for PCI

Exclusion Criteria:

* Cardiac arrest with return of spontaneous circulation
* Known prior history of MI
* Known history of severe COPD requiring supplemental home oxygen
* Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device
* Known severe anemia or abnormal platelet count
* Known significant renal insufficiency
* Known contraindication for MRI
* Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
* Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
* Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
* Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
* Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
* Written informed consent obtained prior to study

Exclusion Criteria:

* Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
* Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
* Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
* Ascites
* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
* Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
* Renal insufficiency (serum creatinine and potassium must be within normal limits)
* Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
* Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
* Hypersensitivity to active ingredients
As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient comparing with standard maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled corticosteroid.

The study will measure the efficacy of as-needed low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed as asthma at least 6 months.
2. Patients who have well controlled asthma by ACT \> 23 and ACQ-7 \< 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
3. Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid.
4. Patients who able to do spirometry without contraindication.

Exclusion Criteria:

1. History of using systemic steroid previous 12 week and respiratory infection History of pulmonary tuberculosis with residual lung lesion by chest radiograph recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.
2. History smoking less than 10 pack-years or be smoking
3. History of asthma exacabation previous 12 week
Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

The purpose of this study is to examine the dose-response relationship of esketamine in combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.

Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. They have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the colonoscopic procedure in autism children. Propofol sedation for endoscopic procedures is safe and acceptable for children, especially those who express significant anxiety. Propofol-based sedation turned out to be the most effective dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain dose ketamine to propofol may increase the effectiveness without creating more adverse events.

Eligibility Criteria:
Inclusion Criteria:

* （1) aged 2-12 years;
* (2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
* (3) evaluated as American Society of Anesthesiologists (ASA) physical status I-II;
* (4) scheduled for colonic procedure.

Exclusion Criteria:

* (1) oral sedation (premedication) before intravenous catheter placement;
* (2) any contraindication to study medications;
* (3) other circumstances in which the investigator determined that a patient was not suitable for participation in the clinical trial.
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.


Eligibility Criteria:
Inclusion criteria:

* Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
* Participants are permitted to be receiving a therapeutic dose of select UC therapies

Exclusion criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.

This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
* Any form of glaucoma other than open-angle glaucoma.
* Severe central vision loss in either eye.
* Chronic, recurrent, or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
* Ocular surgery within the preceding 6 months.
* Ocular laser surgery within the preceding 3 months.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.
* Other protocol-specified exclusion criteria may apply.
Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms

This is a randomized controlled trial that will randomize 40 surgical skill naive medical students to practice on a robotic simulator or laparoscopic simulator after first completing a baseline evaluation on both surgical simulation platforms. Medical students will be evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess transferability of skills between the surgical simulation platforms.

This is a randomized controlled trial that will randomize medical students to practice on a robotic simulator or a laparoscopic simulator. The investigators will first obtain baseline data by having the study participants perform one task (peg transfer exercise) on a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA), and a similar task on a robotic trainer (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA). Participants will then be randomized to practice on the robotic simulator or practice on the laparoscopic trainer for at least 10 repetitions. After the participants complete 10 repetitions, they will be evaluated again on both the laparoscopic and robotic simulator using time to task completion and Mimi DV trainer motion metrics. Two expert laparoscopic and robotic surgeons will also evaluate participant performance using previously validated global rating scales for robotic and laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Medical students with no prior laparoscopic or robotic experience in clinical or practice setting

Exclusion Criteria:

* Prior laparoscopic or robotic experience in clinical setting or in practice setting
AI Chatbot-Based Learning on Dry Eye and Eye Strain Knowledge

The aim of this project is to evaluate the effectiveness of using chatbots for patient education about dry eye disease. The study will examine how the chatbot affects patients' levels of information, managing symptoms, and overall satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* to be actively enrolled in the nursing program
* to demonstrate baseline digital literacy.

Exclusion Criteria:

* diagnosed visual impairments,
* those with prior specialized ophthalmological training,
* individuals with limited digital technology proficiency
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management

This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.

We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* none
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers

According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criteria will only be assessed at the screening visit.
* Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: male, or non-pregnant non lactating female, or females must be at least 90 days post-partum or nulliparous.
* Satisfactory medical assessment with no clinically or relevant abnormalities in medical history, physical examination, vital signs, ECG, and clinical laboratory evaluation as assessed by the investigator.

Exclusion Criteria:

* Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.

  a- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
* Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Primary Hypothesis:

1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction

Secondary hypotheses:

1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
2. Compare the complication rates between the two types of acellular dermal matrix
3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation


Eligibility Criteria:
Inclusion Criteria:

* Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
* Female gender
* Age between 18 and 80
* Consent to participate in the study

Exclusion Criteria:

* Patients not undergoing breast reconstruction following mastectomy
* Patients undergoing delayed breast reconstruction following mastectomy
* Patients undergoing immediate definitive breast reconstruction after mastectomy
* Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
* Medical debility precluding surgical treatment
* Prior breast or chest wall irradiation
* Pregnant patients
* Male gender