cyrilzakka/clinical-trials huggingface dataset:
Parasternal Nerve Block in Cardiac Patients

Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.

This is a Phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (CABG) surgery.

78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal saline solution). The nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* non-emergent coronary artery bypass grafting surgery (on and off pump)
* median sternotomy

Exclusion Criteria:

* Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
* Redo sternotomy.
* \< 50 kg (Exparel® is currently only approved in patients \> 50 kg).
* Pregnant or nursing
* History of alcohol, narcotic or illicit drug abuse
* Participation in another study evaluating investigational medications within the past 30 days
* Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
* Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
* Pre-operative mild liver insufficiency as defined by liver function tests \[(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)\] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
* Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
* Allergy to amide-type anesthetics
* Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction \< 30% at time of pre-operative screening/evaluation.
* Unable to provide informed consent or unable to understand how to use pain rating scales.
* Inability to understand or operate the patient-controlled analgesia (PCA) machine.
Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis

This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.

First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first MTP joint. Osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first MTP joint and transferring the graft to the head of the first metatarsal. A new synthetic cartilage implant, Cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first MTP range of motion in the Cartiva group was maintained or even improved in some patients.

This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. The hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 80 years old
* Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification
* Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting
* Capable of consenting for self

Exclusion Criteria:

* Patients \<18 years of age
* Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification
* Active bacterial infection of the foot
* Previous bilateral total knee arthroplasty
* Previous fracture or significant trauma to the ipsilateral knee
* Inflammatory anthropathy
* Gout
* Inadequate bone stock
* Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP
A Patient-Directed Computerized Intervention to Address Reproductive Coercion

The goal of this clinical trial is to evaluate the feasibility and acceptability of "BRIDGES" (Building Reproductive Decision-Making, Empowerment, \& Support), a new patient-directed educational website (bridges4support.org). BRIDGES aims to improve family planning (FP) patients' understanding of reproductive coercion (RC) and harm-reduction strategies, as well as their ability to discuss RC-related issues with healthcare providers if they so choose. Designed to be integrated into routine FP clinical care and pre-visit materials, this brief (5-10 minute) educational website includes 1) education on reproductive coercion and (un)healthy relationships, 2) harm-reduction and safety planning strategies, and 3) patient activation messages to encourage patients to actively engage with their healthcare provider. Four study clinics were selected from Planned Parenthood of Michigan (PPMI) clinics based on patient volume and number of clinics. Two of the four chosen clinics will be randomly assigned to receive BRIDGES, with 40 participants per clinic, and the other two clinics will be randomly assigned to receive the standard of care, also with 40 participants per clinic. Control clinics will receive the standard of care, which includes the typical support and counseling provided at these centers for FP patients, and the intervention clinics will receive BRIDGES plus standard of care. Research staff will recruit FP patients ages 18-29 (N=160) through patient portal messages. Participants will complete online, self-directed Qualtrics surveys at three time points: pre-appointment, post-appointment, and 3-months. Survey data will be used to assess differences in patient knowledge, self-efficacy, and behavior between patients attending intervention clinics and patients attending control FP clinics (i.e., receiving standard-of-care FP services). Feasibility, implementation, and pilot outcome data will be used to further refine the intervention towards the goal of conducting a future larger-scale study of BRIDGES within FP clinics.


Eligibility Criteria:
Inclusion Criteria:

* Family planning patients at study clinics, including women, transgender men, non-binary, and other gender-diverse people
* Ages 18-29
* Able to participate in English
* Has an upcoming birth control appointment (telemedicine or in-clinic) scheduled at a study clinic during the enrollment period (November 2024-June 2025). Appointments must be scheduled for at least 24 hours after study enrollment.
* Has access to PPMI MyChart (i.e., study clinic patient portal)
* Participants who complete the Pre-Appointment Survey and attend the scheduled birth control appointment or a rescheduled (up to 3x) appointment are eligible for the Post-Appointment Survey
* Participants who complete the Pre-Appointment Survey are eligible for the 3-Month Survey, regardless of whether they complete the Post-Appointment Survey

Exclusion Criteria:

* Previously exposed to the intervention (e.g., participated in user testing during September and October 2024)
* Does not have a valid email address
Prognostic Factors and Mortality in Older Stroke Patients With Mechanical Thrombectomy

The study focus on the elderly patient (older than 80 years of age) who had acute ischemic stroke and received mechanical thrombectomy. The investigators analyze different factors in the stage of before, between, after procedure and trying to figure out if there is any difference between the 30-day-mortality group versus non-30-day-mortality group.

With the constant improvements in health care, standard of living and the decrease birth rate, the percentage of the elderly population ( above 80 years old) is expected to double in Taiwan by the year 2044, according to data from the National Development Council. Consequently with the increase in the proportion of senior citizens, there will be an surge number of patient suffering from cardiovascular and cerebrovascular diseases, most importantly acute ischemic stroke. In recent years, mechanical thrombectomy has become the gold standard in the treatment for acute stroke patients, however, many studies have excluded the patients above the age of 80 years old as the benefits of the procedure have been very controversial and there is no clear evidence proving favorable a outcome. There are a few studies which state that though elderly patients had higher risk of complications when receiving mechanical thrombectomy as compared to younger patients, the prognosis was still superior to those didn't receive any intervention. Previous studies put more emphasis on the overall prognosis, morbidity and mortality rate, they didn't focused on the cause of mortality.

The study focuses on analyzing of the cause of mortality and whether there is a significant difference between 30-day-mortality group versus non-30-day-mortality group.

Eligibility Criteria:
Inclusion criteria:

1. elderly (older than 80 years old)
2. acute ischemic stroke in anterior circulation
3. NIHSS more than 8

Exclusion Criteria:

1. posterior infarction
2. ASPECT score less than 3
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet

The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers

This is a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers

Eligibility Criteria:
Inclusion Criteria:

* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
* A Healthy female volunteers, aged 19-45 years
* BMI 18 \~ 27(kg/m2)

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* History of gastrointestinal disease and resection
* History of clinically significant hypersensitivity to study drug, any other drug
* A subject with clinically significant genital bleeding
* Participation in any other study within 3 months
* Positive results for urine β-hCG in screening or lactating women
* A subject is using a method of hormone contraception and a Progesterone intrauterine device
Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms:

1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
2. Control arm: conventional intravenous sedation (propofol)

The study will be divided into three stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. In the second stage, accrual will be halted when about 90 patients have been randomized. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
* Provision of written informed consent

Exclusion Criteria:

* Scheduled dilation
* Active Crohn Disease
* Low auditory acuity that precludes use of the device
* Low visual acuity that precludes use of the device
* Head or face wounds precluding use of the device
* Schizophrenia
* Dizziness
* Water/sea phobia
* Non-proficiency in French or Dutch (research language)
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors

The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors;
* subjects must be able and willing to comply with study procedures.

Exclusion Criteria:

* Subjects with history of renal insufficiency (serum creatinine level \> 3.0 mg/dL \[265 µmol/L\]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;
* Subjects unable to tolerate lying supine;
* Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.
Clinical Test Report for Blood Pressure Meter of CH-658

Blood pressure meter model CH-658 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility Criteria:
Inclusion Criteria:

* 96 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Incisional Wound Vac in Obese Patients

It is the belief of the investigators that the current trends in complication rates associated with fixation of pelvic ring injuries and acetabular fractures in the obese are unacceptable. The overwhelming majority of these complications can be attributed to problems with surgical wound healing. The investigators feel that if a cost effective and easily performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma population in order to control a potentially devastating complication, then efforts in discovering such an intervention may prove valuable. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.

Obesity has been shown to be an independent risk factor for postoperative surgical infections in a variety of obesity related and non-obesity related surgeries. With the risk of an increasingly more obese society, complication rates that significantly differ based on patients' relative obesity may become increasingly unacceptable. The purpose of the proposed prospective study is to evaluate the role that vacuum assisted closure (VAC) may play in reducing these complication rates. Negative pressure or vacuum assisted closure was first introduced in 1997 as a way to control and potentially treat chronic wounds. Since that time, the indications have exploded to include a variety of chronic and acute wound healing problems. We have anecdotally been using VAC therapy (V.A.C.;KCI, San Antonio, Texas) in an effort to control the postoperative draining that is nearly ubiquitous in our morbidly obese orthopaedic trauma patients. The V.A.C. dressing is applied to the acute postoperative wound and maintained during the immediate postoperative period. Although a novel approach to the use of the V.A.C., this use has been previously reported in the orthopaedic literature as a case series. To our knowledge, there has not been a prospective study evaluating the efficacy of the immediate placement of a V.A.C. dressing on postoperative wound infection rates in the setting of the morbidly obese orthopaedic trauma patient. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 - 64
* Patients with a BMI greater than or equal to 30
* Patients with acetabular, pelvic ring, or proximal femur fractures with a degree of displacement that would require an open reduction for treatment under normal circumstances

Exclusion Criteria:

* Patients not within variables defined by the inclusion criteria
* Abdominal or urological surgery during the same hospital admission
* Ipsilateral soft tissue injuries that can be classified as internal degloving injuries
Role of the Central Nervous System in Allergic Rhinitis

In order to evaluate the effects a nasal provocation on the activation of different brain regions, the investigators want to set up a clinical trial investigating the short-term effects of a nasal histamine provocation in healthy volunteers and allergic patients while in supine position under the functional MRI device in order to visualize different brain regions.

Evaluate the effects a nasal provocation on the activation of different brain regions

Eligibility Criteria:
Inclusion Criteria:

* Patients with a positive skin prick test to grass pollen and with pollen allergic symptoms during the pollen season OR patients with a negative skin prick test and with no allergic symptoms during the pollen season.
* Age \> 18 and \< 50 years
* Written informed consent
* Willingness to adhere to visit schedules
* Adequate contraceptive precautions in female patients with childbearing potential

Exclusion Criteria:

* Current or recent (finished less than 2 years) immunotherapy against grass pollen.
* Systemic steroid treatment less than 6 weeks before the inclusion in the study.
* Nasal steroid spray, oral leukotriene antagonists or long-acting antihistamines less than 4 weeks before the inclusion.
* Presence of purulent secretions in nasal cavity.
* Severe septal deviation (septum reaching concha inferior or lateral nasal wall).
* Patient is pregnant or breastfeeding.
* Patient has any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study.
* Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
* No independent medication management in daily life or disability to perform fine motoric handling of medication
* Patients with asthma will be excluded.
* Patients suffering from claustrophobia
PRP and PBD-VSEL Stem Cell Therapy for Parkinson's Disease

An experimental study will be conducted at Iffat Anwar medical complex conducted to evaluate the effectiveness of PRP and stem Cell therapy in the treatment of PD. After the initial cognitive and laboratory testing, the first infusion appointment will be planned within 2 weeks.

* The treatment began with the administration of three PRP sessions, where the patients received intravenous injections at four acupuncture points (stomach 36 and GB 34 on both sides) at the 1st, 2nd, and 3rd month.
* After three months of treatment, patients were sent back to the neurophysician for evaluation. They will be given a booster dose of PRP during the 1-year follow-up, and then monitored every six months for the next two years.

The primary outcomes of the study will beto see the improvement in The Unified Parkinson's Disease Rating Scale (UPDRS), Hospital Anxiety and Depression Scale (HADS) and self-report Parkinson's Disease Questionnaire-39 (PDQ-39).

Parkinson's disease the second most common neurological disease worldwide is a progressive disorder that affects movement and can cause tremors, stiffness, and difficulty with coordination and balance caused by dopamine deficiency and progressive degeneration of dopaminergic neurons (DAn). Autologous Platelet Rich Plasma (PRP) and Stem cell therapy is new and practical treatment option that aims to decrease neuroinflammation, modulate immune system and stimulate, replace or repair lost or damaged dopamine-producing cells in the brain lost in Parkinson's disease.

Methods:

Total 30 patients aged 30 - 50 years will enrolled in the study. After the initial cognitive and laboratory testing, the patients will be infused PRP in the autologous blood, once a month for 2 months. After three monthly sessions of PRP treatments, peripheral blood derived very small embryonic like (PBD-VSEL) stem cells therapy will be done on the 90th day. All the patients will be sent to neuro physicians for evaluation and improvement after 3 months, 6 months and 12 months.

The primary outcomes of the study will be to see the improvement in The Unified Parkinson's Disease Rating Scale (UPDRS), Hospital Anxiety and Depression Scale (HADS) and self-report Parkinson's Disease Questionnaire-39 (PDQ-39). All the data will be entered and analyzed by SPSS 25.0. Before and after difference outcome variables will compared before and after difference will be observed by paired sample t test. P-value \<0.05 will be considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of clinically established PD for at least 1-3 years,
* Both genders aged between 30 to 50 years
* On stable therapy (dopaminergic medication and/or deep brain stimulation parameters)

Exclusion Criteria:

* Gout, congestive heart failure, renal failure
* Uncontrolled atrial fibrillation, stroke, anaphylaxis, blood clotting problem,
* Clinical suspicion or diagnosis of atypical forms of parkinsonism or essential tremor