cyrilzakka/clinical-trials huggingface dataset:
Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder

This study aims to test whether aerobic exercise improves the consolidation and subsequent recall of the learned safety memories among adult women with PTSD related to interpersonal violence exposure and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study sessions: Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and Exercise, and Day 4 of Recall of Emotional Learning.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
* English speaking
* Medically healthy

Exclusion Criteria:

* Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
* Major medical disorders (such as cancer, AIDS)
* Physical discomfort or difficulty with blood draws
* Psychotic disorders
* Intellectual disabilities
* Developmental disorders
* Active substance use disorders
* Pregnancy
* Due to safety concerns, participants with these conditions will be ineligible to participate:
* Major medical disorders (e.g., HIV, cancer)
* Daily cannabis use
* History of light headedness or fainting during blood draws or physical activity
* History of chest pain during physical activity
* Abnormal EKG finding at intake visit screening, without follow-up clearance from their physician
* Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD), diabetes, hypertension) that is not currently addressed via medication or lifestyle change.
* A positive pregnancy test
* A self-reported history of loss of consciousness (greater than 30 minutes)
* Physical disabilities that prohibit task performance (such as blindness or deafness)
* Psychotic disorders (e.g., schizophrenia)
* Any other condition that the investigator believes might put the participant at risk
Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial

This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week Tai Chi intervention for relieving aromatase inhibitor (AI)-induced arthralgia in women with breast cancer (BCa).

OUTLINE:

Patients attend Tai Chi exercise classes over 1 hour twice weekly (BIW) and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.

Eligibility Criteria:
Inclusion Criteria:

* Be able to speak and read English
* Been diagnosed with stage I-III breast cancer (BC)
* Had completed all active treatments
* Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months
* Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI
* Report worst pain in the past week \>= 4 on a 0-10 numeric rating scale
* Be willing to adhere to all study procedures

Exclusion Criteria:

* Has been diagnosed with another form of cancer in the past 5 years
* Uncontrolled cardiac, pulmonary, or infectious disease
* Body mass index (BMI) \> 40 kg/m\^2
* Currently attending any mind-body therapy classes (e.g. yoga)
* Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record \[EMR\] data)
* Had surgery or joint infection in the past 6 months
* Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months
Low Energy Ketogenic Diet in Obese Subjects - the Impact on Whole Organism

The study evaluates the timeline of changes of body composition, physical and psychological performance, and biochemical markers of metabolism and inflammation responses to low energy ketogenic diet for loosing weight in obese individuals. The participants will be monitored and guided by the interdisciplinary obesity team for 12 weeks.

Ketogenic diets have been shown to be an effective tool to fight obesity with reported good adherence due to their ability to suppress the drive to eat. They are also gaining popularity in public, despite some concerns regarding the quality and timeline of changes of body composition and the effects on health parameters of whole organism.

For effective weight loss, energy deficit is required. Very low energy (600 - 800 kcal) ketogenic diets have been extensively studied.

The proposed study combines low energy (800 - 1500 kcal) and ketogenic diet intervention. The aim of the study is a comprehensive determination of quality of body mass loss, metabolic states changes, physical and psychological performance changes, and inflammatory and hormones profile changes during and post a 12-week low energy ketogenic diet intervention.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* asymptomatic for any disease except obesity

Exclusion Criteria:

* presence of cardiovascular, endocrine, acute or chronic inflammatory diseases;
* taking medications for lipid metabolism, or psychiatric disorders;
* adherence to a prescribed diet;
* unstable weight in the past 3 months;
* BMI \< 30 kg/m2;
* unwilling or unable to eat the foods prescribed in the study;
* vigorous physical activity;
* pregnancy or lactation.
Fenofibrate in Patients with Primary Biliary Cholangitis (PBC)

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent (signed and dated)
* Participated in the PBC study with fenofibrate (NCT02823353)
* Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

* Treatment-related adverse event (AE) leading to fenofibrate discontinuation
* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
* Known history of other liver diseases
* For females, pregnancy or breast-feeding
* Long-term use of immunosuppressive agents
* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population

An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least one clinic visit record within the last 12 months from the date of data entry.
* Subjects with at least one hs-CRP level measured within the last 12 months from the date of data entry.

Exclusion Criteria:

* Use of statins or other lipid-lowering therapies including fibrates, niacin, and bile acid sequestrants in the past 3 months prior to hsCRP measurement
* Active inflammatory diseases documented during the period of CRP measurement
* Subjects taking immunosuppressants
* Findings of chronic inflammation: arthritis, lupus, or inflammatory bowel disease
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)

An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
* PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
* Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
* All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
* Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.

Exclusion Criteria:

* Subjects who require treatment with riociguat
* Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201
A Study of Monthly Risedronate for Osteoporosis

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Eligibility Criteria:
Inclusion Criteria:

* Female: 50 years of age or older
* \>5 years since last menses natural or surgical
* have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* BMI (body mass index) \>32 kg/m\^2
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair

The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

Eligibility Criteria:
Inclusion Criteria:

* Lower eyelid retraction, defined as inferior displacement of the lower eyelid margin with inferior scleral show, may be asymptomatic
* May have ocular irritation including foreign body sensation, burning, photophobia and tearing.
* May have aesthetically unsatisfactory eyelid appearance.

Exclusion Criteria:

* Have a condition that would be contraindicated to surgery
Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions.

The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

The main objective of this study will be to estimate the negative predictive value of the combination of cutaneous tests and provocation test by intravenous reintroduction in the IHS to iodinated contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Having suffered single-blind reintroduction
* Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS

Exclusion Criteria:

* Patient with delayed hypersensitivity
* Opposed to use data
Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
* Able to complete three blood draws during study
* At least 3.5 kg at enrollment

Exclusion Criteria:

* Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
* Immune deficiency, bleeding disorder or significant chronic medical condition
Assessment of Executive Functions After Covid-19

As it is evident that Covid-19 may have some impacts on cognition, the primary aim of this study is to investigate -if any- deficits of attention, working memory and executive functions after Covid-19.

Since Covid-19 (Coronavirus Disease-2019) was declared as a pandemic by the World Health Organization (WHO) on December 31, 2019, it is still widespread and deadly. As an ongoing pandemic, it has led to a panic and then a controlled fear in societies. In many studies, neuropsychological deficits were observed in Covid-19 patients both during the illness and after recovery. A recent study found that impairment in cognitive functions continued after recovery of Covid-19, and it was associated with peripherical inflammatory markers, such as C-Reactive Protein (CRP). CRP, as a peripherical inflammatory marker, has been proven to be inversely related to serum levels of the brain-derived neurotrophic factor (BDNF), an important neurotrophin in the growth and differentiation of neurons. In this study, attention, working memory and executive functions of Covid-19 patients at post-covid period and its relation with the severity of the disease will be investigated.

Eligibility Criteria:
Inclusion Criteria:

Covid-19 patients:

* Diagnosed as Covid-19 by RT-PCR at least 60 days but not more than 90 days ago
* Asymptomatic at the moment
* Not having any other general medical, neurological or psychiatric conditions except Covid-19 at the time of acute infection

Healthy subjects:

* Not having any of Covid-19 symptoms at the testing time point
* Not having any general medical, neurological or psychiatric condition

Exclusion Criteria:

Covid-19 patients:

* Diagnosed as Covid-19 by RT-PCR less than 60 days or more than 90 days ago
* Having any symptom of acute phase of Covid-19
* Having any other general medical, neurlogical or psychiatric contidions

Healthy subjects:

* Having any of Covid-19 symptoms at the testing time point
* Having any general medical, neurological or psychiatric condition
A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture

The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following surgical repair, there are a variety of protocols, ranging from complete immobilization to immediate postoperative mobilization with early weightbearing. However, no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization, with a trend toward a reduction in lost work days and an earlier return to sport. However, these trials define early postoperative mobilization differently (i.e. use different combinations of weightbearing and range of motion). This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery. An important component of early rehabilitation is weightbearing.

Comparison: Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair. With the exception of weightbearing status, both groups performed the same rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* closed and complete Achilles tendon rupture
* seen within 14 days of injury in hospital

Exclusion Criteria:

* unwilling to follow the study's rehabilitation protocol
* unable to speak or read English
* co-morbid conditions such as diabetes and neurological or collagen disease
* pregnancy
* recent immunosuppressant or fluoroquinolone therapy
* previous Achilles tendon symptoms
* previous ipsilateral rupture
* sustained an additional injury not allowing weightbearing
* an Achilles tendon avulsion injury
* unfit for surgery
Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies

The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects.

The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets using flow cytometry and turbidimetric and impedance aggregometry for use in the differential diagnosis of thrombocytopenia and platelet defects

Eligibility Criteria:
Inclusion Criteria:

* Pediatric participants with hemorrhagic syndrome (hemorrhagic rash, bruising, bleeding, increased bleeding of the skin and mucous membranes, spontaneous hemorrhages in soft tissues and joints)
* Pediatric participants with acute leukemia
* Parameters of the plasma level of blood coagulation correspond to the age normal levels

Exclusion Criteria:

* Anticoagulation drug therapy
* Antiaggregation drug therapy
* Biologically active additives
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle accidents. In most cases it is life threatening and the standard treatment is surgery. Many times when a person has a BTAI they also have other injuries that can affect the results of the surgery.

Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in the aorta to help seal the injury and keep it from bleeding.


Eligibility Criteria:
Inclusion Criteria

* Subject had a blunt thoracic aortic injury which:
* was confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) and/or contrast-enhanced magnetic resonance angiogram (MRA)
* occurred no more than 30 days prior to the stent implant procedure
* Subject was ≥ 18 years of age
* Subject or subject's legally authorized representative signed an IRB approved informed consent
* Subject was hemodynamically stable
* Subject's anatomy met all of the following anatomical criteria:
* Aortic diameter (adventitia to adventitia) of the proximal and distal landing zones between 18 mm and 44 mm
* Subject had patent iliac or femoral arteries or could tolerate an iliac conduit that allowed endovascular access to the injury site with the delivery system of the appropriate sized device
* The centerline distance from the distal margin of left common carotid artery (LCC) to the injury was ≥ 20 mm

Exclusion Criteria

* Planned placement of the COVERED portion of the stent graft over the celiac axis or the LCC, or in cases of bovine anatomy, innominate artery
* Subject had systemic infection
* Subject was pregnant
* Subject had received a previous stent or stent graft or previous surgical repair in the DTA
* Subject had a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
* Subject was participating in an investigational drug or device clinical trial which would interfere with the endpoints and/or follow-ups of this study
* Subject had a known allergy or intolerance to the device components
* Subject had a known hypersensitivity or contraindication to anticoagulants or contrast media, which was not amenable to pre-treatment
* Subject was in extremis, defined as subject that had non-survivable injury/condition
* Subject had a Cerebral Vascular Accident (CVA) within two (2) months prior to implant procedure