cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement

Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement

The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, III
* Planning to undergo unilateral THA
* In good health and capable of undergoing THA with spinal block and sedation anesthesia
* No additional planned surgeries during the course of the trial
* Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English

Key Exclusion Criteria:

* A body mass index greater than 40
* Known bleeding disorder or is taking agents affecting coagulation preoperatively
* A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
* Diabetes mellitus with a known HbA1C\>9.5 or a history of prolonged uncontrolled diabetes
* Previous hip arthroplasty of the same hip
* Participated in another clinical trial within 30 days of the planned hip surgery
Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)

The aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used to determine the exact locations for stimulation.

Central post stroke pain is often very resistant to treatment. TMS has been shown to be a promising tool in treating difficult pain conditions. The best sites for stimulation are still not known and navigation has been used only in few studies.

The aim is to evaluate the analgesic effects of Navigated Repetitive Transcranial Magnetic Stimulation ( nrTMS ) on pain in a three armed crossover study. The navigation is done by using magnetic resonance imaging and stereotactic camera system. The three arms include stimulation to M1, S2 and sham stimulation to M1. 10 Hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. A months washout period is kept between each arm of the study.

Pain and other variables are followed before, during and after the study for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* MRI defined brain infarction or hemorrhage before or at the age of 65 years
* CPSP diagnostic criteria is met (definite), verified by a neurologist
* Stable analgesic medication
* Average pain NRS 4 or more

Exclusion Criteria:

* Epilepsy
* Difficult aphasia
* Dementia
* Contraindication for TMS or MRI
* Alcohol and/or drug abuse
Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids.

Hypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients.

Hypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented.

The aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.

In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* Individuals who have received glucocorticoid treatment for RA, SLE or vasculitis in the last 2 years or at current admission.
* Patients approved by the physician to participate in the study
* Patients giving written consent

Exclusion Criteria:

* Younger than 18
* Patients with communication disabilities
* Patients involved in another clinical and/or drug trial
Laparoscopy-Assisted Transgastric ERCP

We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The presentation of the case is presented as well a review of the literature.

The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the biliary tree very challenging for the surgeon or the endoscopist. There are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. The patient evolved favorably and was discharged on his second postoperative day without complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient with altered Roux en Y Gastric Bypass anatomy

Exclusion Criteria:

* Patients without Roux en Y Gastric Bypass anatomy
Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury

The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.

In 2015, our team launched the Trauma Resilience and Recovery Program (TRRP) at the Medical University of South Carolina's Level I trauma center. TRRP is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education via our automated text messaging system (Step 2), screen for PTSD and depression by chatbot or telephone 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4). The purpose of the proposed study is to examine the clinical and functional impact of TRRP over a period of 12 months. We will conduct a randomized controlled trial (RCT) with one-year follow up of TRRP vs. enhanced usual care (EUC) with 350 patients at The George Washington University (GWU) hospital, which serves a diverse population of \~2000 trauma center patients per year (15% penetrating mechanism). Trained, supervised interviewers blind to study condition will assess clinical and functional outcomes 3-, 6-, and 12-months post-baseline (Aim 1). Qualitative interviews will be conducted with ≥ 30 patients from underrepresented minority groups (i.e., African American, Latinx) as well as ≥ 20 victims of violent trauma (penetrating mechanism) to identify opportunities to strengthen the model to meet the diverse needs of these patients (Aim 2). GWU does not currently have an embedded mental health program in place, which will enable us to explore implementation determinants systematically (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included.

Exclusion Criteria:

* Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (\~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (\>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER

The present study aims to assess and compare the effectiveness of distraction technique using virtual reality glasses and white noise with basic behavior guidance techniques on dental anxiety in children with Attention Deficit/ Hyperactivity Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
* All children should be on stimulant medication.
* No previous dental experience.
* Written consent of the legal guardian.

Exclusion Criteria:

* Children with physical disabilities or other psychiatric disorders.
* Children with visual or hearing disabilities.
* Patients requiring emergency treatment
Validation of COMPAT-SF Spanish Translation

Prospective translation validation pilot study that will collect data from Spanish-speaking CP patients seen at Methodist Dallas Medical Center (MDMC) beginning June 2024 through July 2027, in order to validate a Spanish-translated COMPAT-SF instrument.

Prospective translation validation pilot study that will collect data from Spanish-speaking CP patients seen at Methodist Dallas Medical Center (MDMC) beginning June 2024 through July 2027, in order to validate a Spanish-translated COMPAT-SF instrument.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older in age
* Have a definite CP diagnosis and a stable pain pattern with no new interventions or medications in the last three months
* Able to read and understand the study information in Spanish
* Personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study
* Subject is willing and able to comply with the scheduled questionnaires

Exclusion Criteria:

* Subjects who do not meet the criteria in section 4.1
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers

24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures.

Exclusion Criteria:

* Subjects with a supine BP \>140 mm Hg systolic or \>90 mm Hg diastolic or \<100 mm Hg systolic or \<60 mm Hg diastolic based on the average of the triplicate
* Serum potassium \>=5.1 mmol/L or \<3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
* Estimated GFR \<60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.
Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes

This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.

Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
* On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation.
* Clinical history consistent with hypoglycemia
* Hba1c \<9.0%

Exclusion Criteria:

* Patients with type 2 diabetes mellitus
* Patients on insulin pump
* Poor control of diabetes (HbA1c \> 9.0%)
* Pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). Insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed.
* Serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation

The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.

This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.

Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.

Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.

Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.

Eligibility Criteria:
Inclusion Criteria Aim 1:

* 18 years of age or older
* Currently smoking 3 or more cigarettes per day for the past year.
* Carbon monoxide level \>/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be \>/ level 3
* Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days
* If male, consume \>/= 5 drinks and if female consume \>/= 4 drinks on at least 1 occasion in the past month
* Willing and able to attend the 8 weekly group sessions
* Valid home address in the Tampa Bay area
* Functioning telephone number
* Can speak, read and write in English

Inclusion Criteria Aim 2:

* 18 years of age or older
* Currently smoking 3 or more cigarettes per day for the past year.
* Motivated to quit smoking and decrease alcohol use within the next 60 days
* If male, consumes \>/= 5 drinks and if female consumes \>/= 4 drinks on at least 1 occasion in the past month
* Willingness and ability to attend 8 weekly video group sessions
* Willingness and ability to use an email account for study materials
* Valid address
* Functioning telephone number
* Can speak, read and write in English

Exclusion Criteria:

* Unable to wear nicotine patch
* Participants who have an active substance use disorder other than an alcohol use disorder
* Participants who have an active psychotic disorder
* Current use of tobacco cessation medications
* Pregnant or nursing
* Participants who have a household member already enrolled in the study.
* In rare cases, study staff might exclude a participant for a reason not specified here
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.

MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.

Eligibility Criteria:
Inclusion Criteria:

For MTF youth (cases):

* Identify as MTF
* Age 11-20 years at the time of enrollment
* Plan to start estrogen clinically in \&lt; 6 months

For cisgender male youth (controls):

* Identify as cisgender male
* Age 9-20 years at the time of enrollment
* No diagnosis of Klinefelter Syndrome (XXY)

Exclusion Criteria:

* Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety
* Known history of stroke, multiple sclerosis, or other serious neurologic condition

  * MRI-specific exclusion criteria (Weight \&gt; 500 lbs, claustrophobia, metal in body)
Effects of Antenatal Education on Maternal Childbirth

In prenatal education, pregnant women's knowledge is a crucial issue for protecting pregnant women and newborns healthy. Therefore, prenatal education has become a basic and essential program for each pregnant woman. However, most of the current prenatal education courses are taught via a group teaching approach, which makes it difficult for pregnant women to think deeply about relevant birth issues due to the lack of interaction and context. This may in turn have an impact on childbirth choice and clinical judgment.

My study Purpose wants to see doseThe mobile chatbot approach improve prenatal education shared decision-making. In order to verify the effectiveness of such a learning design, an experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants.

Eligibility Criteria:
Inclusion Criteria:

* Parturients who have come to the hospital for obstetrics

Exclusion Criteria:

* Parturients who have ever to the hospital for obstetrics
Ketamine-midazolam As a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?

Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:

1. 20-45% failure of sedation during ERCP
2. Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%

Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years old which able to give valid consent
* Patient planned for ERCP (either emergency or elective)
* American Society of Anaesthesiologist (ASA) score of I-III

Exclusion Criteria:

* Known hypersensitivity towards Ketamine or Midazolam
* Increased intracranial pressure, acute stroke (\<3 months), intracranial haemorrhage (\<3 months)
* Severe hypertension (BP\>170/110) and tachycardia (Heart rate \>110)
* Acute myocardial infarction, acute coronary syndrome (\< 6 months)
* Tachyarrhythmia
* Pregnancy
* Intravenous drug user (IVDU) or substance abuse patient
* History of hallucination
* Child's Pugh class C
Effectiveness of Virtual Reality Vision Therapy - VERVE

The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.


Eligibility Criteria:
Inclusion Criteria:

* Age 9 years and older
* CISS score ≥ 16
* Best-corrected distance visual acuity of 20/25 or better in each eye
* Random dot stereopsis appreciation of 500 seconds of arc or better
* Parent or subject understands the protocol and is willing to enroll in the study

Exclusion Criteria:

* Constant strabismus at distance or near
* Vertical heterophoria ≥ 2 ∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \> 20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain
* Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease
* Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
* Inability to comprehend and/or perform any study-related test or procedure