cyrilzakka/clinical-trials huggingface dataset:
Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The conservative treatment of diaphyseal fractures of the humerus has long been considered the only option and the surgical treatment was primarily reserved for displaced fractures with no contact of bone ends. However, for a few years there has been an upsurge of indications for the surgical treatment of diaphyseal fractures.

The purpose of this study is to compare the functional outcomes and the quality of life of surgically treated patients versus those who undergo a conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Fracture of the humeral diaphysis
* Recent fracture (14 days or less)
* Closed fracture
* Signing of consent form

Exclusion Criteria:

* Segmental fracture of the humerus
* Fracture with proximal or distal intra articular extension
* Open fracture
* Polytrauma
* Floating elbow or shoulder
* Pathological fracture
* Simultaneous fracture of both humerus
* Associated vascular disease
* Severe neuromuscular disorders such as Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...
* medical contraindication to surgery
* severe central neurological disease disabling patient to fill in questionnaires (senile dementia, Alzheimer's, etc ...
* Male or female unable to consent
* Any other condition which prevents the assessor from fully monitoring the patient during study
Prevention Interventions for Opioid Misuse

The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-30 years
* Seeking care in Michigan Medicine emergency department (ED)
* Ability to read/comprehend and communicate in English
* Medically \& cognitively able to provide consent or assent
* Prescription opioid use plus \>=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse \[prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)\]

Exclusion Criteria:

* Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment
* Current pregnancy at baseline
* History of injection drug use within last 12 months
* High risk for opioid use disorder
* Enrolled in Aim 1
Combined Hormonal Versus Progestin Only Contraception During Lactation

Objective: To determine and compare the effect of low dose estrogen combined hormonal contraceptives and progestin-only contraceptives on lactation.

The subjects will be drawn from a healthy obstetric population in each center, where possible preliminary contact during antenatal period. At the postpartum visit, subjects that express their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an informed consent the participants will be allocated according to their free wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to analysis.

Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12 weeks post - partum. Instruction will be given as to recording information on intercurrent disease, frequency of nursing and use of complementary formula supplements. Maternal BMI calculation ( weight/height2) will be obtained at first visit.

The objective is to compare the capacity of the breast to secrete milk under standard conditions and evaluate the influence of different hormonal contraception means. Thus samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding and multiplied by the number of feedings reported.

Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk analysis : lipid, casein and carbohydrate content


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* mothers to infants that their weight will be below the 10th percentile
* mothers to infants sensitive to milk
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.

Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).

To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).

Primary Effectiveness Objective

• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:

* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
* Calculating the invalid rate of tested samples.

Eligibility Criteria:
Group 1: Inclusion Criteria - General Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.

Group 2: Inclusion Criteria - Enriched Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. One or more of the below:

   * Prior diagnosis of hrHPV within previous 6 months and/or
   * Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
   * Presenting for colposcopy/LEEP/excisional intervention

Exclusion Criteria - All Groups

1. Participant has impaired decision-making capacity or is unable to provide informed consent.
2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy

Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated in normal volunteers and in patients with CNS diseases. This study will develop and evaluate new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to existing MR techniques.

Patients and volunteers age 18 and older are eligible for the study. A history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. Each subject will also be asked to fill out a questionnaire.

Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be placed on the head and participants may be asked to do simple or complex tasks. A catheter will be placed in an arm vein and a contrast agent will be administered. This agent will allow structures in the brain to show up more clearly.

Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) have provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both normal individuals and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. New MRI and MRS techniques specifically designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS will be evaluated at 1.5 and/or at 4.0 Tesla on normal volunteers and in patients with CNS pathology.

Eligibility Criteria:
INCLUSION CRITERIA:

Any normal volunteer age 18 and over who is capable of giving informed consent.

For the purposes of evaluating new techniques for fMRI, patients will be considered the same as volunteers.

EXCLUSION CRITERIA:

A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or Insulin pump.

Subjects who have a history of a reaction to MR contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. The contraindications to MRI at 1.5 Tesla and 4 Tesla are identical.
Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture

To compare the impact of ASAP protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome.

Retrospective double cohort analysis for ASA physical status 1, 2 and 3 elderly patients \>65 years old, scheduled to undergo surgery for hip fracture between January 1st 2017 and December 31st 2022.

The investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the ASAP protocol was applied, starting from 1 January 2020.

ASAP protocol follow the latest international guidelines about hip fracture in elderly patient. The investigator focuses the research about the impact of ASAP protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.

Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022

Exclusion Criteria:

* Fracture without indication for surgery
* Death before surgery
* Intensive care's or polytrauma patients (\> 2 fracture sites) or under pharmacological coma needed before and after surgery.
Workplace Violence, Hostility & Safety

Workplace violence has been documented as a global, epidemic healthcare- related problem. The American Nurses Association (ANA) describes customer/client violence as an assault from a member of the public with whom the nurse interacts during the course of their regular duties. According to the ANA's website, types of violence that contribute to unsafe work environments are varying. However the customer/client violence type is prevalently experienced in healthcare, and 1 in 4 nurses are abused and experience workplace violence.

Based on anecdotal reports at MRMC, and as a follow up to a 2020 research study, evidence-based practice research council (EBPRC) members and staff asked colleagues about stress-producing events in their scope of work. It was reported that individuals were unclear about available resources and preparation to handle unsafe environments when client/visitor behaviors escalated to aggressive or unsafe situations. The EBPRC members reviewed the MRMC policies related to violence/assault/injury towards MRMC personnel. What remains unclear is if staff are aware of existing policies and are adhering to reporting guidelines pertaining to employee and stakeholder safety. Additionally, based on literature review, the problem of workplace violence perpetrated by patients and visitors is excessive and escalating nationally and internationally. Additionally, at MRMC, the EBPRC acquired documentation of the number of reported assaults, aggressive behavior or violence of stakeholders (patients and visitors) towards healthcare providers that were documented and referred to the MRMC employee health services. From the local hospital's tally, there were 28 cases from January, 10, 2020 to February 4, 2021. Of the 28 cases, seven occurred between February 2, 2021 and February 4, 2021. Hence, it is essential to conduct a study targeting healthcare workers at MRMC to identify opportunities for further intervention that creates a safety-focused, supportive culture.

The Occupational Safety and Health Act and the Occupational Safety and Health Administration require that employees and employers work together to prevent or abate recognized hazardous and cited workplace areas for concerns and develop a successful safety and health management system especially for Healthcare and Social Services workers.

Eligibility Criteria:
Inclusion Criteria:

* must be a full-time, part-time or PRN \[per diem\] employee of MRMC
* who cares for or has contact with patients and visitors
* able to read and understand English

Exclusion Criteria:

* Individuals who are not full-time, part-time or PRN employees of MRMC who cares for or has contact with patient s and visitors
Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest

Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall prognosis after ROSC has not improved much and the in-hospital mortality is still reported to be 50 to 70 %. The "post-resuscitation disease" is now called the "post-cardiac arrest syndrome" (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic ischemia and reperfusion.

Treatment of patients after cardiac arrest has often followed guidelines that were primarily developed for treatment of septic shock. It is still uncertain whether this is the optimal way to deliver circulatory support after cardiac arrest.

There is a lack of studies assessing the relationship between the inflammatory response measured by inflammatory biomarkers and circulatory failure in PCAS.

In this study a detailed description will be given of the clinical trajectory of the circulation and the inflammatory response during the first 5 days after cardiac arrest, and it will be investigated whether patterns of circulatory and inflammatory response may be predictive of deterioration of clinical state.

This study will obtain longitudinally advanced hemodynamic observations with high resolution during the acute phase of post cardiac arrest syndrome (PCAS), and analyze the details in clinical transitions related to circulatory failure. The study will also analyze the relationship between inflammatory biomarkers and circulatory failure in PCAS and kinetics of hemodynamics associated with standard interventions in the intensive care unit (ICU).

Eligibility Criteria:
Inclusion Criteria:

* Return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA)
* Admitted to Coronary Care Unit (CCU) or Intensive Care Unit (ICU), St. Olav's University Hospital

Exclusion Criteria:

* Sepsis within 24 hours before cardiac arrest
* Pregnancy
* Decision of withdrawal or withholding of life prolonging therapy (i.e. due to advanced malignancy)
Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

This study will evaluate the safety and efficacy of PF 03187207.


Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria:

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.


Eligibility Criteria:
Inclusion Criteria:

* Have completed all other formal physical therapy
* Are between the ages of 18 and 35
* Underwent an ACLR between 6 and 24 months prior to enrollment.
* Demonstrate underloading during gait (vGRF- impact peak \<1.09 x BW)
* Demonstrate clinically relevant-knee symptoms (KOOS-QOL \<72)
* Have undergone ACLR surgery

Exclusion Criteria:

* ACLR revision surgery
* A multiple ligament surgery
* A lower extremity fracture
* Knee osteoarthritis
* The participant has a BMI ≥ 36.
Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.


Eligibility Criteria:
Inclusion Criteria:

* Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
* Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
* Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
* CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
* World Health Organization (WHO) performance status ≤ 2

Exclusion Criteria:

* Cytopathologically confirmed central nervous system (CNS) infiltration
* Impaired cardiac function
* Use of therapeutic coumarin derivatives
* Acute chronic liver or renal disease unrelated to tumor
* Other uncontrolled medical conditions
* Treatment with hematopoeitic colony stimulating factors
* Treatment with medications that have potential to prolong the QT interval
* Another malignancy currently clinically significant or requires active intervention

Other protocol-defined inclusion/exclusion criteria may apply.
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.


Eligibility Criteria:
Inclusion Criteria:

* children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
* aged 12-35 months
* youngest eligible child in each household

Exclusion Criteria:Unable to drink 20 mL of sugar water

* Demonstrating evidence of severe acute malnutrition, WHZ \< or = -3, presence of bi-pedal pitting edema
* Apparent need for acute medical treatment for an illness or injury
* Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients

This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.

In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.

Eligibility Criteria:
Inclusion Criteria:

* patient request for a labor epidural
* BMI≥35

Exclusion Criteria:

* BMI\<35
* patient refusal of a labor epidural
* coagulopathy
* platelets\<80,000
* prior spine procedure or instrumentation
* a diagnosis of scoliosis
* an intracranial or spinal mass
Topical Tacrolimus for Breast Cancer-related Lymphedema

The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:

* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* BCRL ISL stage I or II
* Pitting edema
* Postmenopausal or use of Contraceptive drugs
* Healthy opposite arm
* L-Dex score over 10

Exclusion Criteria:

* Pregnant, breast-feeding, or aiming to conceive within the next year
* Bilateral breast cancer
* Contralateral lymphadenectomy
* Allergy to tacrolimus, macrolides, or iodine
* Pacemaker
* Known kidney or liver disease