cyrilzakka/clinical-trials huggingface dataset:
Biobehavioral Correlates of Acute Phobic Fear

This study seeks to measure the time course of circulating proinflammatory markers (interleukin-1 beta \[IL-1β\], interleukin-6 \[IL-6\], tumor necrosis factor alpha \[TNF-α\], and C-reactive protein \[CRP\]) and salivary alpha amylase (sAA) following laboratory fear arousal. Further, this study seeks to implement neurocognitive, physiological, and self-report measures to explore the role of threat sensitivity as a predictor of this response. The broad research question seeks to better understand the relationship between neurocognitive fear and subsequent stress responding elicited by both the immune system (i.e., proinflammatory markers) and autonomic nervous system (i.e., sAA). In light of these aims, the primary outcomes of the current study are the proinflammatory markers (IL-1β, IL-6, TNF-α, CRP), while secondary outcomes consist of sAA, neurocognitive measures (i.e., dot-probe task), physiological correlates (i.e., heart rate, galvanic skin response), and self-report measures.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old
* Phobic or nonphobic fear of spiders.
* Willing to proceed through 5-stimulus fear hierarchy or maintain 7 or higher subjective units of distress through fear task (see Procedures section).

Exclusion Criteria:

* Lifetime history of serious mental illness
* Lifetime history of intellectual or developmental delays
* Lifetime history of chronic physical or medical illness including blood clotting disorders
* Lifetime history of allergies to latex
* Lifetime history of hormonal replacement therapy
* Lifetime history of blindness
* Lifetime history of blood/injection phobia or aversion to needles/injection (based on IPS-Anx and MQ)
* Substance abuse in the past 2 years
* Cigarette/tobacco use in the past 2 years
* Major depression within the past 12 months
* Traumatic stress within the past 12 months
* Pregnancy within the past 12 months
* Anesthesia within the past 3 months
* Night shift work within the past month
* Use of medication within the past month (except for oral contraception)
* Acute illness or infection within the past month
* Average sleep outside of 6 - 10 hours per night within the past month
* Average intake of 4 or more alcoholic beverages per week
* Average intake of 6 or more cups caffeine per day
* Use of marijuana within the week before the laboratory session
* Use of alcohol within the week before the laboratory session
* Body mass index outside of 18.5 - 24.9 range
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.


Eligibility Criteria:
Inclusion Criteria:

* existing diagnosis of ADPKD by modified-Ravine criteria
* Total kidney volume \>= 300 cc/m height by ultrasound or \>= 250 cc/m height by MRI

Exclusion Criteria:

* Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

The objective of this study is to evaluate the safety and performance post last embolization with Onyx


Eligibility Criteria:
Inclusion Criteria:

* The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products.
* The patient is at least 18 years of age.

Exclusion Criteria:

* The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment)
* The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication.
* The patient refuses to give consent to the collection and processing of data required for centralized monitoring.
* A condition which could jeopardize follow-up of the patient.
Post COVID-19 Functional Status in Egypt

Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed


Eligibility Criteria:
Inclusion Criteria:

* All confirmed cases with COVID-19

Exclusion Criteria:

* Non COVID-19 cases
Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers

assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

Juvenile-onset systemic lupus erythematosus (jSLE) is a rare but severe multisystem autoimmune disease which may cause significant damage, disability, and death . Juvenile SLE patients constitute 15-20% of all SLE cases . Compared to the adult SLE, jSLE patients have higher morbidity and mortality rates. Renal, cardiovascular, and neuropsychiatric (NP) involvements are the most important reasons for morbidity and mortality .

Therefore, knowledge of common mental illnesses such as major depressive disorder (MDD) and anxiety disorders in cSLE may be limited. Establishing the prevalence of MDD and anxiety in cSLE is important , as comorbidity rates of these disorders may be increased in cSLE for several reasons. First, the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness, helplessness, stress, and worry about the future.9 For some individuals, such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance, requiring therapeutic intervention. SLE carries a patient-treatment burden similar to other chronic diseases. Such treatment burden places susceptible individuals at risk of psychiatric disorder. Second, although depressed mood may present in the absence of active CNS disease, it may also occur as a symptom of neuropsychiatric c SLE (NPSLE), yielding clinically significant treatment implications. Third, treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD. Moreover, among patients with depressed mood as a manifestation of NPSLE, the initiation of steroid treatment may worsen depressive symptoms. It is unclear whether such risks are observed in the cSLE population.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 11 to 18 years
2. Both sex
3. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
4. Met the New ACR and EULAR criteria for classification of SLE .

Inclusion criteria of the control healthy group : 1- no history of psychiatric and medical disease 2-Intelligence quotation more than 70.

Exclusion Criteria:

1. No history of psychiatric illness prior to the diagnosis of lupus.
2. Intelligence quotation more than 70.
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent before any study-specific evaluation is performed
* At screening, have a mean fasting TG level of ≥180 mg/dL and \<550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and \<500 mg/dL
* Able to meet all inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

* Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study
* Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
* Meet any other exclusion criteria outlined in clinical study protocol
Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations

The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.

The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke
* Patients with fire-heat syndrome
* Stoke onset within 48 hours
* NIHSS scores range from 5 points to 25 points
* Age from forty to seventy-five,gender not limited
* Informed and signed the consent

Exclusion Criteria:

* Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained
* Patients suitable for thrombolytic therapy(rt-PA, urokinase)
* Patients have received thrombolytic therapy
* Patients with serious diseases of heart,lungs,liver,kidneys
* Patients with bleeding or bleeding tendency recently
* Pregnant or lactating women
* Pre-existing neurological or psychiatric diseases that could confound the study results
* Patients be allergic to alcohol,Ixeris of sonchifolia Hance components (KDZ injection) or Panax notoginseng saponins components (Xueshuantong injection)
* Patients have participated in other clinical trials within 3 months
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery

All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve block administered in pediatric patients undergoing cardiac surgery will reduce the requirement of Opioids and other pain medications as well as decrease postoperative pain scores. This is a prospective, double-blind, randomized controlled trial. Subjects are randomized to receive either 0.25% Bupivacaine or normal saline following their cardiothoracic surgery.

One of the most challenging struggles in clinical practices in pediatric cardiac intensive care units is the provision of optimal and safe postoperative analgesia and sedation. All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. Bupivacaine is a local anesthetic that can be injected into the intercostal spaces on each side of a sternotomy to induce nerve block.

The purpose of this study is to evaluate whether the use of Bupivacaine as a nerve block in children undergoing cardiothoracic surgery will reduce postoperative pain medication use and decrease postoperative pain scores. The investigators hypothesize that the administration of Bupivacaine bilaterally into the posterior intercostal spaces on each side of a sternotomy following cardiothoracic surgery will reduce the requirement of pain medications as well as decrease postoperative pain scores.

This is a prospective, randomized, double-blind, control study. Subjects are randomized into two arms: those who receive 0.25% Bupivacaine and those who receive placebo (normal saline). Subjects receive 1 milliliter per kilogram up to 20 kilograms, then 0.5 milliliters per kilogram up to 50 kilograms of study drug.

Subjects are followed for 5 days postoperatively, then on day of discharge. Pain medication administered and Face, Legs, Activity, Cry, and Consolability (FLACC) scores are recorded daily for 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-17 years old at time of surgery
* Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT) mortality categories 1-3
* Surgical intervention requiring median sternotomy
* Expected extubation within 24 hours of surgery

Exclusion Criteria:

* Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic agent of the amide type
* Delayed sternum closure
Under- and Overdiagnosis in BreastScreen Norway

This PhD project will describe tumour characteristics and survival associated with of under- and overdiagnosed breast cancers, the rate of overdiagnosis in BreastScreen Norway, and whether women and family doctors are aware of, and knowledgeable about, under- and overdiagnosis in breast cancer screening.

Mammographic screening among women aged 50-69 reduces breast cancer mortality but also carries some risk. This PhD project will study under- and overdiagnosis, two risks associated with mammographic screening, in BreastScreen Norway. Underdiagnosis can occur when a tumour is present but not detected as a result of screening, while overdiagnosis can occur when a woman is diagnosed with a slow growing cancer that would not become symptomatic during her lifetime.

This project will address the following topics and research questions using observational study methods.

Study 1: To determine whether tumour histopathology and survival differentially associated with potentially under- or overdiagnosed interval and screen-detected breast cancers.

* Do women with potentially underdiagnosed interval cancers have different tumour histopathology and survival than those whose interval cancers showed no signs at the prior screen?
* Do women with potentially overdiagnosed screen-detected cancer have different tumour histopathology and survival than those whose screen-detected cancer showed no signs at the prior screen?

Study 2: To estimate overdiagnosis in the screening program using individual-level data:

* What was the rate of overdiagnosis for women screened in the program during 1996-2003?
* How does adjusting for sociodemographic factors affect estimates of overdiagnosis?

Study 3: To describe awareness and knowledge about under- and overdiagnosis and breast screening in general:

* Are women aware of and knowledgeable about under- and overdiagnosis in breast screening?
* Are family doctors aware of and knowledgeable about breast screening, and under- and overdiagnosis? Are they confident in their ability to relay this information to their patients?

Study 1 is a quality improvement study and has approval from Personvernombudet (PVO 2016-4696). Study 2 has research ethics board (REK) approval (REK 2013/795), while REK approval will be sought for Study 3.

Eligibility Criteria:
Study 1

Inclusion Criteria:

* Breast cancer diagnosed within BreastScreen Norway using digital mammography
* Prior screening images available for review

Study 2

Inclusion Criteria:

* Women born between 1927 and 1934 (inclusive)
* Legal resident in Norway at any time between 1996 and 2003 (inclusive)

Study 3

Inclusion Criteria:

* Women residing in Norway, aged 50-69 (inclusive)
* Practising family doctors in Norway, aged 25-75 (inclusive)
* Provide informed consent
Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study

The purpose of this study is to develop an effective telephone mediated follow-up system to reduce the number of unplanned readmissions and emergency department visits after total joint arthroplasty. This will help reduce costs related to unnecessary visits to the hospital as well as catch complications earlier on. The investigators plan to accomplish this by performing a pilot study that will compare the outcomes of using an Interactive Voice Response system through phone call in addition to the standard follow-up protocol. The outcomes of this group will be compared to those receiving the standard of care follow-up protocol.

Upon patient education and consent to participate in this study, patients will be randomized via online randomizer during their baseline visit into either Treatment As Usual (TAU) or Integrated Voice Response (IVR) cohorts. During this baseline visit, the patients in the IVR group will be given specific information on the nature of the calls and what to expect. Both groups will fill out a form for assessing their baseline pain and functionality. Both groups will receive standard total joint arthroplasty. After this, the TAU group will receive the standard of care which involves appropriate pain management and scheduled clinic follow-ups lasting approximately 60 minutes at 2 weeks, 6 weeks, and 12 weeks along with additional visits if required. Clinic visits will assess pain via VAS scale, joint functionality via HOOS and KOOS scale, and quality of life via SF-36.

In addition to the standard of care follow-up visits as in the TAU group, the IVR group will also receive automated phone calls lasting up to 3 minutes, which will be the focus of this research study. These phone calls will be daily for the first week, every other day the second week, twice a week for weeks 3-6, and weekly for weeks 7-12. The content of these calls will assess pain management, wound healing and screen for potential complications through a series of questions (questionnaire script attached). At the completion of each call, the patient will be instructed to either continue standard treatment or visit the emergency department based on the content of their response. If there is reason for concern, the PI will automatically be informed.

Survey questions pertaining to the patients outcomes and satisfaction will be completed in clinic and collected by the PI. The responses and data relating to IVR calls will made available through computer software designed by our team on the secure REDcap network.

Eligibility Criteria:
Inclusion Criteria:

* Participants eligible to undergo the TJA surgical procedure

Exclusion Criteria:

* Participants who are not eligible to undergo the TJA surgical procedure
Prospective Evaluation of Femoral Tripod Eversion Technique

Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. The major advantage of the eversion technique is the absence of prosthetic material to be performed. However, its use has been scarcely evaluated in the literature to date. This work aims at evaluating the long term safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly described and participants were followed up for two years by serial clinical and doppler US examination.

Femoral bifurcation lesions is one of the most frequent lesion encountered in lower limb atheromatous occlusive disease. Current treatment options consists in femoral endarteriectomy or bypass. More recently, endovascular treatment of femoral tripod lesions has been reported. Inguinal area is prone to postoperative infection in up to 20% of the cases. Hence, the use of synthetic graft puts the participants at risk of dramatic consequences in case of postoperative infection. Besides, long term data are still required to validate the use of endovascular device in this very "surgical" area. The use of the eversion technique is possible in the majority of the lesions and offer the major advantage of open surgery in terms of durability, without the use of synthetic material in case of postoperative infection.

The investigators herein report the detailed technique, tips and variations of the eversion technique as well as the clinical follow up in terms of clinical benefit according to Rutherford classification and restenosis evaluated by serial doppler US.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Lower limb atheromatous occlusive disease.
* Stage 2 to 4 according to Rutherford's classification

Exclusion Criteria:

* Age\< 18
* Previous surgery or endovascular treatment of the ipsilateral limb
* Non atheromatous disease
* Pregnancy
* Life-expectancy estimated to be less than one year
Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients

The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that receive high dose melphalan for bone marrow transplantation commonly develop significant mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal of this study is to scientifically determine (using randomization and a larger sample size) if a short-term schedule is as effective as the standard long-term schedule in preventing, or minimizing the symptoms involved with oral mucositis. The study is also trying to determine the best dose of melphalan and how patient's body breaks down melphalan and will obtain blood through central venous catheter to measure the amount of melphalan in patient's blood at specific times after the melphalan is infused

PRIMARY OBJECTIVES:

I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic stem cell transplantation at Ohio State Medical Center.

SECONDARY OBJECTIVES:

I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area under the concentration-time curve (AUC).

II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute cryotherapy regimens.

III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 120 minutes.

ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 360 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with multiple myeloma be admitted for autologous stem cell transplantation
* Age \> 18 years
* Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial

Exclusion Criteria:

* Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Iron Status in Autism Spectrum Disorders

to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group


Eligibility Criteria:
Inclusion Criteria:

* children who are diagnosed with autism spectrum disorder according to DSM -V
* not having infection inflammatory conditions chronic physical illness
* children who are not receiving iron supplementation

Exclusion Criteria:

* age below 2 years and above 12 years
* having an infection or inflammatory conditions chronic physical illness
* receiving iron supplementation