cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery

Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning.

Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified.A nomogram is a pictorial representation of a scoring model that possesses a simple user interface and shows favorable predictive performance. By integrating a patient's diverse determinant variables, a nomogram can provide a personalized probability for quantitative predictions of the incidence of an outcome of interest.Therefore, we conducted a retrospective study to assess the incidence, risk factors and outcomes associated with major complications patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

Age more than 18 years Undergoing Cardiovascular surgery

Exclusion Criteria:

Missing primary outcomes or variables
Suicide in Urban Natives: Detection and Networks to Combat Events

This study compares the effectiveness of a program to detect and manage suicide risk among American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase engagement, social connectedness, and resilience in at-risk youth. The other half will receive usual care that does not include the caring text messages.

The study, "Suicide in Urban Natives: Detection and Networks to Combat Events," builds on Screening, Brief Intervention and Referral to treatment (SBIRT), carried out through the primary care setting, to detect and manage suicide risk. This approach is multilevel, targeting both the healthcare system and the individual, and links screening to existing mobile phone technologies shown to promote resilience and to tap the protective benefits of social connectedness. This Collaborative Hub will conduct a randomized control trial that compares the effectiveness of enhancing these SBIRT programs by sending caring text messages to reduce suicidal ideation, attempts, and hospitalizations, and to increase engagement, social connectedness, and resilience. The Investigators' long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN youth and young adults.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as American Indian or Alaska Native;
* Screen positive for mild, moderate, or severe risk of suicidality (referred by a clinical provider);
* Have a text-enabled mobile phone;
* Willing to be contacted by text;
* Able to participate voluntarily;
* Speak and read English;
* Cognitively able to independently provide written informed consent

Exclusion Criteria:

* Under age 18
* In danger of imminent self-harm;
* Hospitalized
Perceptions of Physiotherapy and Rehabilitation Professions

In this study, it is aimed to determine the perspectives and satisfaction of the students of the Physiotherapy and Rehabilitation Department about the physiotherapist profession, and to compare these results according to the class periods.

Our secondary aim is to determine the perspectives and satisfaction of graduate physiotherapists towards the physiotherapist profession and to compare these results according to their graduation years.


Eligibility Criteria:
Inclusion Criteria:

* Students in the physiotherapy and rehabilitation department or become a graduate physiotherapist

Exclusion Criteria:

* Students or a graduate physiotherapist with serious mental illness
Cost Effect of Erector Spina Plane Block

Use of erector spina plane (ESP) block for postoperative analgesia is continuously increasing. However, few studies have investigated intraoperative effects of ESP block. The investigators aim to study the effects of ESP block in terms of cost-effectiveness, consumption of inhalation agents and opioids in perioperative and postoperative period.

Erector spina plane (ESP) block has analgesic efficiency and its popularity is growing steadily. ESP block forms a sensorial block by local anesthetic infiltration between the musculus erector spina and facia. ESP block given to participants undergoing laparoscopic cholecystectomy for postoperative opioid analgesia resulted in a decrease of postoperative pain scores in the first 24 h. Due to increases in health expenditure, cost control is becoming more and more important. Cost-effective studies are important in healthcare economics. Inhaled anesthetics used in anesthesia departments account for about 20% of total anesthetic agents. Local anesthetic agents decrease the minimum alveolar concentration (MAC) value of inhaled agents. And also in perioperative and post operative period, the anesthetic management often need to be supported with opioid drugs. The investigators think that ESP block has analgesic effects and decreases the consumption of inhalation agents. The investigators aim to investigate the cost-effectiveness of ESP block in anesthetic applications in laparoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologist (ASA) physical status I-II,
2. ages 18-75 years,
3. undergoing laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients with cardiac, endocrinological, neurological diseases,
2. patients with coagulation disorders
3. allergy to local anesthetics
4. Operations that started as laparoscopy but transitioned to open surgery for a surgical reason
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.


Eligibility Criteria:
Inclusion Criteria

* ≥ 18 years of age
* Moderate-to-severe OSA
* Available to attend study visits and sessions
* Reliable access to a phone

Exclusion Criteria

* Prior or current use of PAP therapy or other treatment (e.g., oral appliance) for OSA
* History of upper airway surgery for OSA
* Moderate to severe insomnia
* Commercial drivers
* Use of non-standard PAP including adaptive servo-ventilation or bi-level positive airway pressure
* Report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep apnea test
* Resting awake oxygen saturation (SpO2) \< 90%
* Participation in another clinical trial
Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth.

A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.


Eligibility Criteria:
Inclusion Criteria:

* Determination of being likely or possibly nausea-prone.
* Male or non-pregnant and non-lactating female.
* Surgical extraction of at least 2 impacted third molar teeth
* A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control.
* Surgical extraction of at least 2 impacted third molar teeth.
* Presence of at least moderate post-operative pain.

Exclusion Criteria:

* Medial Condition, presence of a serious medical condition.
* Active local infection.
* Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
* Caffeine use since midnight before the operation.
* Use of an IND Drug within past 30 days.
* Previous participation in this study.
* Pregnant or lactating.
* Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.
Therapy of Pragmatic Disorders in Brain-damaged Individuals

This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives.

This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.


Eligibility Criteria:
Inclusion Criteria:

* Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months.
* Be of French mother tongue or have an excellent mastery of French.
* Be between 20 and 65 years old.
* Be right-handed
* Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination.

Exclusion Criteria:

* Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia).
* Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria).
* Have significant uncorrected vision and/or hearing problems.
* Have aphasia and/or significant reading and comprehension problems.
* Present significant spatial neglect.
* Present an impaired capacity for judgment and discernment, objectified by a neuropsychological evaluation.
* Have been the victim of several TBI or stroke
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition.

The main question it aims to answer is:

* If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles.
* If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles.

Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or above
* Flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking
* Foot postural index ranging from 6 to 12
* No neurological or physical disabilities

Exclusion Criteria:

* Below 18 years of age
* Inability to understand or answer questions
* Any lower limb surgery within the past two years
* Any lower limb injury within the past six months
* Any neurological disorder affecting gait
Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.

The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60 kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women with a body weight \> 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is administered for COH. These two protocols are comparable in safety and efficacy of follicular stimulation.

On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa in obese women (BMI\>30 kg/m2) is lacking.

Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC is necessary for the development of mature and quality oocytes. It has been proposed, that analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2 (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2), glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte maturity and developmental potential.

The effect of Corifollitropin alfa on expression of these genes however, is unknown.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* BMI 18.5-24.9 kg/m2

Exclusion Criteria:

* polycystic ovary syndrome, severely abnormal sperm parameters, and age \> 38 years
Foley's Catheter Balloon for Induction of Mid Trimester Abortion in Nulliparous Women With or Without Tension Applied

Induction of abortion is a hot subject that has complex and emotional controversy. The most common time of abortion is the second trimester which represent about 10-15% of all induced abortions over the world. As well as, two-thirds of all serious abortion-related complications are related to induced second trimester abortion.

There are many causes for induction of abortion in the second trimester such as missed abortion, serious fetal abnormalities such as central nervous system or skeletal malformation and lastly some women do not wish to continue a pregnancy and will often seek out termination of pregnancy.

Termination of second trimester is more risky than the first trimester. So many lines have been emerged to achieve safe and effective method of termination of second trimester.

Pharmacologic management seems to be an appealing method for induction of abortion. The combing between mifepristone and misoprostol is the effective regimen for termination of second trimester abortion with success rate reaching about 97-99% within 24 hours.

However, mifepristone is not available or affordable in many countries worldwide so misoprostol have been used alone but it needs higher total dose with lower effectiveness and higher percentage of side effects rate than the combined regimens.

The optimal method for inducing second trimester nulliparous women with an unfavorable cervix is not known. Several studies in literature have described the effectiveness of Foley's catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices . It may act in addition to its mechanical effect by increasing the release of prostaglandin and/or oxytocin release secondary to localized inflammation.

In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying tension in trial to shorten the time between the insertion and expulsion of the fetus, however; this tension adds more pain for the pregnant women with higher rate of vaginal bleeding and dissatisfaction.

Gary et al in 2016 concluded that the application of tension did not result in faster delivery times, but did result in faster times to catheter expulsion.


Eligibility Criteria:
Inclusion Criteria:

* Singleton second trimester (12-28 weeks) pregnancy.
* Nulliparous woman.
* Bishop score ≤ 6.
* BMI 18-22.5 kg/m2

Exclusion Criteria:

* Multiple gestations.
* Premature rupture of membranes before induction.
* Pregnancy complicated by antepartum hemorrhage (placenta previa or abruptio placenta).
* Low amniotic fluid volume (\< 5cm).
* Scarred uterus including hysterotomy or myomectomy.
* Uterine infection.
* Unexplained bleeding.
* Latex allergy
Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis

Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

LESS trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up. Both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire. In addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand. At 24 months, we will repeat the interview and the outcomes assessment. We will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions. In addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?). We hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

Eligibility Criteria:
Inclusion Criteria:

Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial

Exclusion Criteria:

none
Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline

There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari \& Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson´s disease, Hoehn \& Yahr stage ≤ III
* aged 18-64 yrs
* hyposmia/functional anosmia defined as TDI\<30
* written consent

Exclusion Criteria:

* congenital olfactory loss
* significant infections of the nose and nasal sinuses
* diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc.
* dementia, psychiatric illness, addictive behaviour
* smoker
* severe liver disease
* pregnant or breastfeeding women
* any contraindication for the treatment with Rasagiline
* women without reliable contraception