cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)

Percutaneous coronary intervention (PCI) has become one of the main treatments for rapid recovery of revascularization in patients with coronary heart disease (CHD). PCI has some advantages, such as easy operation, small trauma and rapid recovery. It can significantly improve myocardial ischemic symptom and reduce the incidence of cardiovascular adverse events in CHD patients. However, many studies have found that the incidence of PCI-related myocardial injury is relatively high, and affect the efficacy of PCI and prognosis in patients with unstable angina pectoris (UAP). A meta-analysis of a total of 7578 patients with UAP from 15 studies who underwent PCI was found to have a 28.7% increase in myocardial biomarkers after PCI. The objective of this randomized control trial is to gain a clinical insight on the use of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients. The primary objective is assess efficacy and safety of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients.

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in levels of myocardial injury biomarkers (such as TNI and CK-MB) between low temperature contrast group and room temperature contrast group. Based on previous study, the incidence rate of PCI-related myocardial injury is 28.7% in UAP patients undergoing PCI. And in our study the expected incidence rate of PCI-related myocardial injury is up to 14.3% in UAP patients undergoing PCI after treatment with low temperature contrast. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 440 UAP patients were required, and with 220 patients per group as a ratio of 1:1 randomization.

Eligibility Criteria:
Inclusion Criteria:

* De novo lesions
* Those who meet the diagnostic criteria of unstable angina pectoris
* New generation drug eluting stent implantation
* Only single coronary artery treated at this time

Exclusion Criteria:

* Those who meet the diagnostic criteria of acute myocardial infarction
* Those who meet the diagnostic criteria of stable angina pectoris
* Patients with cardio-genic shock
* Patients with multiple organ failure
* Patients allergic to contrast
* Patients who can not tolerate dual antiplatelet therapy
* Patients who can't tolerate anticoagulation
* Recently infected patients
* Patients with hepatorenal dysfunction
* Thrombotic lesion of coronary artery
* Chronic total coronary occlusion lesion
* Patients with complex coronary bifurcation requiring two stent strategy
* Severe coronary calcified lesion
* Patients with percutaneous coronary angioplasty
* Patients with directional coronary atherectomy or rotational atherectomy
* Patients with drug coated balloon treatment
* Patients with bioabsorbable vascular scaffold implantation
* Previous percutaneous coronary intervention or coronary artery bypass graft
* Patients with active stage of autoimmune disease
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent

The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

The objective of this study is to demonstrate that Custodiol is not inferior to cold cardioplegic solution for myocardial protection by comparing standard cold blood cardioplegia to Custodiol solution with respect to myocardial injury as measured by Creatine phosphokinase MB isoenzyme (CK-MB),troponin-I at 7 hours post surgery and changes in ejection fraction by trans-thoracic echocardiogram (TTE)or trans-esophageal echocardiogram (TEE) at 24 hours post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes
* Patients age 18 and older

Exclusion Criteria:

* Pregnant women\*
* Urgent or emergent cases
* Repeat cardiovascular surgical procedures
* Patients on dialysis
* Any known allergies to components of either cardioplegia solution \*All women of child bearing potential must have a negative serum or urine pregnancy test.
Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).

The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Children with secondary scoliosis undergoing posterior spinal fusion

Exclusion Criteria:

1. Known bleeding disorder as this may increase the risk of bleeding
2. Current antifibrinolytic therapy as these patients may bleed less
3. Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
4. Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
5. Known allergy to TXA
6. History of renal insufficiency as TXA is renally excreted
7. Colour vision disturbance
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:

* Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
* Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.

Eligibility Criteria:
Key Inclusion Criteria:

* Completion of ARC001 study
* No change in the status of any longitudinally applicable ARC001 inclusion criteria

Key Exclusion Criteria:

* Early termination from ARC001
* Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
* A lapse in dosing of more than 10 days from completion of ARC001
* Change in the status of any longitudinally applicable ARC001 exclusion criteria
Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
* Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion Criteria:

* Patients that are not able to meet the extensive postoperative evaluation requirements
* Mentally retarded patients
* When the patient has no useful vision or vision potential in the fellow eye
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
* Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
* Patients with uncontrolled glaucoma
* High preoperative intraocular pressure, \>25 mmHg
* Chronic or recurrent uveitis or history of the same
* Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
* Patients with a retinal detachment or a family history of retinal detachment
* Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
* Diabetes mellitus
* Pregnant, lactating, or plans to become pregnant during the course of this study
Microneedle Patch for Psoriatic Plaques

The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.

As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.

A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age: older than 19
* A patient with psoriasis
* A patient with symmetrical psoriatic lesions
* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
* A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria:

* Age: lower than 20
* A pregnant or lactating patient
* A patient who cannot understand the study or who does not sign the informed consent
Comorbid Painful TMD Among Trigeminal Neuralgia

An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients visited the three clinical sites for facial pain
* Patients diagnosed with trigeminal neuralgia
* Has active pain symptoms in the past 30 days

Exclusion Criteria:

* Non-English speakers
* Patients with psychiatric disorders that might alter pain perception
* Adults lack the capacity to provide informed consent.
* Persons under the age of 18.
* All vulnerable populations.
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
* A verified previous manic, hypomanic, or mixed episode
* Score of 20 or higher on the HAMD-17
* Score of 2 or higher on Item 1 of the HAMD

Exclusion Criteria:

* Score greater than 12 on the Young Mania Rating Scale
* Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
* Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)
Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

* According to the local drug information
Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* males or females, 50 to 89 years of age
* must have GA from AMD in one or both eyes

Exclusion Criteria:

* GA due to any disease other than AMD (eg, drug-induced)
ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients +18 years
* Patients with visceral fat quantification by BIA at baseline and week twelve
* Patients with body mass index \>25
* Patients can swallow tablets

Exclusion Criteria:

* Patients treated with other oral antidiabetic agents or insulin
* Glomerular filtration rate less than 30 mL/min
* Transaminemia greater than 2 times the upper reference value
* Pregnancy
* Malnutrition
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Main Study:

Primary Objective:

Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).

Secondary Objective:

Assess the long term efficacy of sarilumab in participants with RA.

Sub-Study:

This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

The maximum duration of the study was up to 523 weeks:

* Up to 1-week of screening, if any.
* At least 264 weeks of open label treatment phase and up to 516 weeks as maximum.
* 6-week post-treatment follow-up as required per protocol.

Eligibility Criteria:
Inclusion criteria :

Main study:

Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.

Sub-study:

Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.

Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.

Exclusion criteria:

Main study:

Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.

Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.

Sub-study: There are no additional exclusion criteria to those defined in main study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Resistance Training to Optimize Health in Pre-frail Older Adults

Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life. This study will examine the safety and feasibility of a novel, higher intensity resistance training program in older adults, and compare the effects with standard care, lower intensity training. It is anticipated that both programs will be safe and feasible, but higher-intensity training will lead to greater improvements in quality of life, mobility and strength, which are part of the physical phenotype definition of frailty and markers of mobility disability.

It is critically important to identify effective strategies to reduce the risk and impact of mobility disability and frailty in older adults. Exercise, particularly resistance training (RT), has the potential to influence a person's ability to navigate around their environment and impact the components of the frailty phenotype which include weakness, physical inactivity, and slowness. Higher training intensities have been used with athletes and younger adults to achieve greater gains in strength, but the feasibility and effectiveness is less established in older persons who exhibit preclinical disability, or are at-risk for mobility decline where conservative protocols are typically employed. Higher intensity RT may be an innovative and effective strategy in preclinical disability pre-frailty to reduce the risk and impact of future frailty and mobility decline.

This study aims to examine: 1) the safety and feasibility of a 12-week higher intensity RT protocol in community dwelling older adults at risk for mobility disability, and 2) the effects of this protocol on walking, balance, muscle strength, quality of life compared to lower intensity RT

It is hypothesized that the higher intensity RT: 1) is safe and feasible for at-risk community-dwelling older adults, 2) more effective in improving walking, balance, muscle strength, and quality of life than lower intensity RT

Eligibility Criteria:
Inclusion Criteria:

* self-reported mobility limitations
* living in the community
* not currently engaged in regular resistance training
* able to follow instructions

Exclusion Criteria:

* contraindications for intensive resistance training (e.g. recent cardiovascular event, fracture within the past 12 months)
* musculoskeletal injuries for which intervention participants are receiving concomitant rehabilitation treatments
Target Behaviours to Identify Minimally Conscious State Patients

To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery Scale-Revised assessment of minimally conscious state diagnosis and evidence for the simplification of Coma Recovery Scale-Revised in the future.

Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome patients were distinguished.

Eligibility Criteria:
Inclusion Criteria:

* Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.

Exclusion Criteria:

* Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment were excluded.
Deep Venous Thrombosis After Hepatobiliopancreatic Surgery

To investigate the incidence of pre- and early postoperative deep venous thrombosis in patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk factors with special attention to circulating tumor cells.

Thromboembolic events are a common cause of morbidity and mortality in oncological patients. Up to 20% of cancer patients suffer from venous thromboembolism (VTE) induced by the underlying malignancy itself. Oncologic gastrointestinal surgery is a well-known risk factor for VTE. About 4-6% of patients undergoing elective hepatobiliopanreatic surgery develop a deep venous thrombosis (DVT) or pulmonary embolism. However, there are no data referring to the incidence of DVT shortly ahead of the surgical event, implementing that a certain percentage of postoperative DVT might have already been acquired before the operation. Furthermore, most studies only evaluate the rate of symptomatic VTE. In this study, all patients undergoing hepatobiliopancreatic surgery will be screened for deep venous thrombosis the day before surgery, on the third postoperative day (primary endpoint) and 90 days after the operation with a 2-point compression sonography of the lower extremities. The development of a symptomatic VTE (DVT or pulmonary embolism) will be recorded as secondary endpoint. Risk factors, perioperative morbidity / mortality and presence of circulating tumor cells will be analyzed with regard to VTE incidence.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective oncological liver or pancreatic resection
* Age equal or greater than 18 years
* Written informed consent

Exclusion Criteria:

* Preexistent coagulopathy
* History of previous VTE
* benign disease