cyrilzakka/clinical-trials huggingface dataset:
PRogram In Support of Moms (PRISM): A Pilot Study

The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that aims to improve women's access to and participation in perinatal depression treatment and thereby improve depression outcomes

Major depressive disorder continues to be the leading cause of disability among women of reproductive age and major public health concern. Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, behavior and development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the majority of women are amenable to depression screening, screening alone does not improve treatment entry or outcome. Despite the availability of effective evidence-based treatments and frequent contact with obstetric providers, less than one-third of women who screen positive for depression receive treatment. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed a program called "PRogram In Support of Moms" (PRISM) that aims to leverage existing roles and resources to target patient, provider, and system level barriers to perinatal depression treatment. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. Four practices were randomly assigned to PRISM versus an active comparison group called MCPAP for Moms which is a state-wide telephonic perinatal psychiatry program. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 3 months postpartum among patients.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 18-55 years
3. English speaking
4. 4-36 weeks gestational age (GA) or 2-12 weeks postpartum
5. Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10
7. Able to communicate in written and spoken English; and
8. Cognitively able to participate in informed consent

Exclusion Criteria:

1. Lack of verbal and written English fluency
2. Under age 18 or over age 55
3. Current active substance use disorder
4. Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
5. Psychotic component to illness as determined by the M.I.N.I.
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain. The objectives of this project are to identify neonatal and young pediatric populations that are at increased risk of excessive brain Mn deposition and altered cognitive and motor development based on their dietary parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate Mn supplementation and monitoring of infants and young children receiving parenteral nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will have increased deposition of Mn in their brains and lower scores on neurodevelopmental, cognitive and psychophysiological assessments.

Specific Aims have been designed to test these hypotheses in three developmentally distinct populations:

1. preterm infants and
2. full term infants in the Neonatal Intensive Care Unit (NICU) requiring prolonged PN and
3. older infants and young children on home PN.

Mn neurotoxicity will be investigated by longitudinal assessments of cognitive (executive functioning battery), neurodevelopmental (Bayley III Scales of Infant Development), and psychophysiological (event-related potential) measures and will be correlated with brain deposition of Mn using the technique of magnetic resonance (MR) relaxometry in a vulnerable population of infants receiving Mn-supplemented PN and age-matched controls. This proposal addresses a clinically relevant and unexplored link between nutritional practices, brain Mn deposition and neurodevelopmental sequelae in an at-risk population of infants and young children utilizing state-of-the-art magnetic resonance imaging (MRI) technology and neurodevelopmental assessment techniques. The potential for increased brain Mn accumulation in infants, and by inference, the potential health risks associated with elevated brain Mn burden, represents crucial, unexplored issues of exposure and susceptibility. The potential contribution of Mn toxicity to the poor outcomes of infants dependent for an extended time on PN has not been fully acknowledged or studied. Improved understanding of the relationships between Mn exposure and developmental outcomes will undoubtedly lead to altered clinical practices and more careful monitoring of Mn intake and blood and/or brain Mn levels in high risk infants. Our studies will also contribute to an improved understanding of the value of non-invasive MR imaging in the monitoring of pediatric patients on PN.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than 30 days postnatal age
2. In the preceding four weeks, have received \>75% of their nutrition as Mn-supplemented PN
3. Clinically stable for transport to the MR facility
4. Signed parental consent.

Or healthy age-matched controls

Exclusion Criteria:

1. Any infant not expected to survive to the age of 3 months or
2. Not expected to achieve sufficient clinical stability to tolerate the MRI procedure.
Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome

The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Additionally, the patients' pain perception and emotional state will be evaluated, and the relationships between these factors and the treatment response will be analyzed.

Seventy-two patients aged 18-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with shoulder impingement syndrome based on magnetic resonance imaging (MRI), and who received ultrasound-guided corticosteroid injection, will be included in the study. No additional interventions or procedures will be performed for the research. These patients, who were previously assessed and treated in the outpatient clinic, will be invited for a follow-up examination at the 4th week after the injection. During the follow-up, their response to the treatment will be evaluated using the Visual Analog Scale (VAS). A reduction of less than 50% on the VAS by the end of the 4th week will be considered an inadequate response. Patients with inadequate and good responses will be divided into two groups and assessed for central sensitization, pain perception, and emotional state. Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), and hyperalgesia will be assessed using an algometer to measure pressure-pain threshold. Additionally, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale will be used to determine the patients' emotional state and pain perception.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65.
* Diagnosed with shoulder impingement syndrome.
* Received ultrasound-guided subacromial corticosteroid injection.
* Experienced shoulder pain for at least 6 months.

Exclusion Criteria:

* History of surgery or fracture in the shoulder or related areas.
* Presence of an active infection.
* Received shoulder injection within the last 6 months.
* Underwent physical therapy for the shoulder in the last 6 months.
* Presence of other musculoskeletal or neurological conditions that could cause shoulder pain (e.g., cervical disc herniation, stenosis, moderate to severe osteoarthritis, adhesive capsulitis, rheumatologic pathologies, infectious joint diseases).
Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

Some patients, specifically those with a diagnosed genetic mutation, will have their ovaries and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian and fallopian tube cancer from developing.

Anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries. The fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm of the uterine muscle wall.

The purpose of this study is to determine if the technique used to remove fallopian tubes only (without removal of the uterus) adequately removes or destroys all the fallopian tube cells that remain in the uterine muscle wall.

Currently, during the operation an instrument is used that burns the fallopian tube and allows it to be cut away from the uterus. The investigators do not know if this procedure successfully destroys all the fallopian tube cells within the uterus. Therefore, we will compare this single step procedure to a two step procedure. The two step procedure is to burn and cut the fallopian tube followed by an additional burning step, called cauterization at the top of the uterus. The investigators will assess if either or both of these procedures destroy the fallopian tube cells that may remain inside the uterine wall. This is important to determine since the goal is to remove the ovaries and all of the fallopian tubes in order to prevent future development of ovarian or fallopian tube cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a non-emergent total hysterectomy with removal of the tubes and ovaries by the gynecologic service for benign or malignant conditions uterine, cervical or early ovarian cancer.
* Patients will undergo either a laparotomy, total laparoscopy or laparoscopically assisted vaginal hysterectomy
* Patients will be 21 years and older.

Exclusion Criteria:

* Patients with abnormal fallopian tubes seen preoperatively by radiologic exam or intraoperatively by visual inspection.
* Patients who are suspected to have fallopian tube cancer prior to their surgery
* Patients who have had prior pelvic radiation therapy
* Patients who are undergoing a Robotically Assisted procedure
* Patients who have had any type of prior tubal surgery
Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors

This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023.

Plan for conducting study:

* The investigator consults and gets consensus form of the patient with periampullary cancer.
* The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking.
* The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion.
* The investor follows post-operative period.
* If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology.
* The investigator analysis the risk factors of pancreatic fistula.

Data analysis:

* To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used.
* To determine the risk factors of pancreatic fistula, logistic regression will be used.

Sample size:

* The investigator plans to collect 145 patients in the research period.

Plan for missing data:

* Any case that miss information will be removed from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
* Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.

Exclusion Criteria:

* The patient does not consent to participate in the study
The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis

This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis.
* Inıtial curve magnitude between 55-75°
* Patients who followed up at least 6 months
* Patients who wearing CAD-CAM (Computer-Aided Design\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more

Exclusion Criteria:

* History of spinal surgery or trauma
* Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes
* Ankylosing spondylitis and other spondyloarthropathies.
* The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment.
Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* at least one coronary lesion of more than 50% stenosis shown by angiography
* history of acute myocardial infarction(at least one month before)
* history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)
* typical angina episodes with evidence of myocardial ischemia
* Signed informed consent

Exclusion Criteria:

* Obvious aortic insufficiency, aortic aneurysm, aortic dissection
* Coronary fistula or severe coronary aneurysm
* Symptomatic Congestive heart failure
* Valvular heart disease, congenital heart diseases, cardiomyopathies
* Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;
* Lower limb infection, phlebitis, varicosity, deep venous thrombosis;
* Progressive malignancies or diseases with poor prognosis;
* uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg
Perceptual Distortions in Acute Neck Pain

Research has shown that chronic pain is related to variety of perceptual distortions. Little is known on how acute pain experience influences perception, especially precision of touch. This project is aiming to test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity.

This project has following goals:

1. To test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity
2. To investigate intra-rater reliability of tests measuring perceptual distortions in pain
3. To investigate validity of novel tests measuring perceptual distortions in pain
4. To explore the influence of acute neck pain on left/right recognition task
5. To explore the effect of acute neck pain on body perception

Eligibility Criteria:
Inclusion Criteria:

* Only participants without tactile dysfunction will be included.
* Participants reporting availability during the days in which the research will be performed.

Exclusion Criteria:

* current pain experience
* episodes of neck
* thoracic or lumbar pain lasting more than 24 hours within previous month
* history of chronic pain, i.e. pain lasting more than three-month period
* comorbidities affecting nervous system
* cardio-vascular diseases
* psychiatric illnesses
* any disease requiring systematic drug consumption
* diagnosed scoliosis.
Quick Start of Highly Effective Contraception

This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).

Women seeking emergency contraception (EC) frequently report multiple recent episodes of unprotected sex. Although high sensitivity urine pregnancy tests effectively rule-out pregnancy resulting from sex that occurred more than 14 days ago, clinicians are frequently concerned that pregnancy may result from unprotected sex that occurred \<14 days prior to IUD placement. Placement of a copper IUD within 5 days of unprotected sex is a highly effective form of EC. Among 52 Chinese women who reported unprotected intercourse 5-7 days prior to copper IUD insertion, no pregnancies occurred. However, the effectiveness of the copper IUD when unprotected sex occurs 7-14 days prior to IUD placement is unknown. Intrauterine pregnancies rarely occur with a copper IUD in place. As some clinicians are concerned about injuring a pregnancy that occurs with an IUD in place, women who have had unprotected sex 7-14 days prior to requesting IUD placement are typically told they must use another, less effective, contraceptive for 2+ weeks and then return to obtain an IUD. To remove this barrier to emergency placement of a copper IUD, we propose to study rates of pregnancy when a copper IUD is placed "any time a urine pregnancy test is negative." We believe that simplifying guidance regarding the recommended timing of copper IUD placement has the potential to significantly increase the number of women offered "same-day" IUD service.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse.

Exclusion Criteria:

* History of tubal ligation or hysterectomy.
* Positive urine pregnancy test
Comparing Rezum and Urolift

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or prostatic urethral lift (UroLift) arm.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml

Exclusion Criteria:

* History or high suspicion of prostate cancer
* Current urinary tract infection
* Refractory urinary retention or post-void residual (PVR) ≥250 mL
* Intravesical prostatic protrusion (IPP)\>10mm
* Prior prostate surgery
* Known or suspected allergy to nickel, titanium, or polyester/polypropylene
* Urethral stricture, meatal stenosis, bladder neck contracture
* Neurogenic bladder and/or sphincter abnormalities
Skin Irritation Test of Ten Products

Evaluation of cutaneous tolerance of ten products by primary irritant patch test

The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 70 years old, healthy male and female (sex ratio 1:1)
* No acute or chronic diseases including skin diseases.
* No current medications.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
* Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
* Current dermatology medication which might affect skin condition evaluation.
* Current irritated reaction on test site.
* Participating in other clinical trial(s) within 7 days.
Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study

This study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine whether it is feasible for veterans who don't live close to a VA to perform this cognitive training at home.

Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment.

This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.

Eligibility Criteria:
Inclusion Criteria:

* Rural residence
* Willingness to commit to the time requirements of the study
* Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
* Native English speaker
* 20-40 years
* Normal or corrected to normal vision and hearing.

Exclusion Criteria:

* Substance dependence
* Major depression with suicidal ideation
* Psychotic disorder
* History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
* History of known or suspected learning disorder.