cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery

The purpose of this study is to better understand if either dalteparin or tinzaparin is a better drug to use in dialysis patients on blood thinners who are at high risk of developing blood clots and need surgery.

A prospective multicenter randomised trial involving 60 consecutive eligible and consenting patients from teaching hospitals in Canada. Patients will be randomised to either tinzaparin or dalteparin to investigate the pharmacokinetics of both low molecular weight heparins (LMWH) perioperatively in a special population, namely end stage renal disease (ESRD) dialysis patients.

To date although there exists evidence to suggest tinzaparin may be safe in patients on hemodialysis, LMWHs as a group have not been investigated in the perioperative setting in these patients. This protocol has been developed so that the pharmacokinetic behaviour of tinzaparin and dalteparin can be compared but also so that the duration off warfarin is minimised. Therapeutic doses of LMWH are administered pre-procedure during as much time of the period as possible that oral anticoagulation is sub-therapeutic.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients aged \>= 18 with end stage renal disease requiring chronic hemodialysis (HD) three times a week and clinically stable on HD for 4 weeks (x 4 wks)
* Patients requiring active oral anticoagulation for prosthetic heart valves, recent deep vein thrombosis \>= 1 month, or patients with atrial fibrillation and a major risk factor (previous transient ischemic attack \[TIA\] or stroke, high blood pressure, diabetes, aged \>= 75, moderate/severe left ventricle dysfunction) who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.

Exclusion Criteria:

* Evidence of active bleeding prior to stopping warfarin
* Hemoglobin \<= 90 or platelet count \<= 100x10\^9/L
* Uncontrolled hypertension or stroke within 6 months of study commencement
* Spinal or neurosurgery
* Eye surgery (excluding cataract surgery)
* Life expectancy less than 3 months
* Patients requiring cardiac surgery
* Presence of active duodenal ulcer
Turkish Version of the Worry About Pain Questionnaire

Pain is one of the main complaints that causes people to apply to health institutions. Pain is seen as a passive warning signal of an underlying disease process; When it becomes chronic, it is considered a disease on its own. Pain that persists longer than the expected recovery time is defined as chronic pain.

Pain is associated with a number of psychological, physical, and social factors. Clinical observations report that various psychological problems, especially anxiety, and depression, accompany chronic pain, and the long-term persistence of pain significantly impacts a patient's quality of life. Chronic musculoskeletal pain causes fatigue, sleep disruption, and activity and participation restrictions. Therefore, evaluation of pain originating from the musculoskeletal system and factors that cause and increase pain need to be addressed from a biopsychosocial perspective. Chronic pain is an ideal environment for anxiety to develop. If the person's chronic pain cannot be resolved, anxiety increases and the anxiety becomes excessive, the person may lose the ability to distinguish what is dangerous from what is not, as he cannot evaluate pain-related cues properly. Anxiety and depression scales are often used to assess the long-term psychosocial consequences of chronic musculoskeletal pain. However, these scales are inadequate to explain the relationship between pain and anxiety. The Worry About Pain Questionnaire is a self-report scale of 15 items specifically developed to assess pain-related pressure.

To our knowledge, there is no standard, valid, and reliable Turkish questionnaire in the literature that evaluates the pain-related concerns of individuals with musculoskeletal pain and takes into account the cultural differences of Turkish patients. For this reason, our study aims to translate and culturally adapt the Worry About Pain Questionnaire into Turkish in individuals with chronic musculoskeletal pain and to examine the psychometric properties of the Turkish Worry About Pain Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Being able to read and write in Turkish
* Not having any cognitive impairment
* Having chronic musculoskeletal pain
* Being over 18 years of age
* Being willing and volunteer to work

Exclusion Criteria:

* Having a complaint of pain in the musculoskeletal system due to cancer, fracture or surgery within the last 6 months.
* Having severe cognitive impairment
* Having a systemic disease such as rheumatoid arthritis, diabetes mellitus
* Having any neuromuscular disease (such as MS, myopathy)
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
* BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)

Exclusion Criteria:

* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
* Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study

Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc.

Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT.

The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
* Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion
* Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
* Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
* Patient capable of performing functional exploration during the year
* Affiliation to a social security system
* Patient who has given free and informed consent

Exclusion Criteria:

* Any other connectivity associated to systemic sleroderma
* Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
* All known fibrotic and/or obstructive respiratory pathologies.
* Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
* Diagnosis of left heart disease
* Cumulative smoking \> 10 packs.years
* Infectious pneumonia within 90 days prior to inclusion
* Acute respiratory illness requiring hospitalization within one year prior to inclusion
* Pregnant or breastfeeding woman
* Refusal to participate in the study
* Refusal to use the data
* Adults under legal protection (temporary protection measure, curatorship, guardianship)
A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the following criteria in order to be included in the research study:

1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
4. Subjects with life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. History (≤3 years) of cancer that is histologically distinct from the cancer under study.
2. Known serious allergy to investigational drug or excipients
3. Active brain or spinal metastases
4. History of pericarditis or Grade ≥2 pericardial effusion
5. History of interstitial lung disease.
6. History of Grade ≥2 active infections within 2 weeks
7. Known human immunodeficiency virus (HIV) infection
8. Seropositive for hepatitis B virus (HBV)
9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
10. Any severe and/or uncontrolled medical conditions
11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
12. Impaired cardiac function or clinically significant cardiac diseases
13. QTcF \>470 msec at screening
14. History of medically significant thromboembolic events or bleeding diathesis
15. Unresolved Grade \>1 toxicity
16. History of malignant biliary obstruction
17. Pregnant or breast-feeding
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan


Eligibility Criteria:
Inclusion Criteria:

* patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
* treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after washout epoch and after 4 weeks run-in epoch
* untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and \< 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after 4 weeks run-in epoch
* patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria:

* Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
* History of angioedema, drug-related or otherwise
* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
* Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment
Effects of Leader Sleep Improvement on Leadership

The purpose of the study is to investigate the effects of sleep improvement in leaders on leader outcomes.

The investigators seek to extend the findings of a recent research which demonstrated that treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, \& Bostock, in press). In the present study, the investigators propose that the treatment of leader insomnia would beneficially influence leadership, specifically abusive supervision, charismatic leadership, and laissez-faire leadership.

Eligibility Criteria:
Inclusion criteria:

* Working adults who have at least one direct report (i.e., subordinate).

Exclusion criteria:

* Non-working adults/ adults who do not have at least one direct report (i.e., subordinate).
A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death

Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.


Eligibility Criteria:
Inclusion Criteria:

1. Study on prevention of MSC to rejection after transplantation

   * Age between 18-60 years
   * having the indication of renal transplantation
   * having no absolute contraindication
   * renal transplantation by donation after citizen death
   * the first time to receive renal transplantation
   * signed informed consent
2. Study on treatment of MSC to rejection after transplantation

   * renal transplantation by donation after citizen death
   * BPAR
   * having no contraindication of renal biopsy
   * signed informed consent

Exclusion Criteria:

* loss to follow-up
* serious adverse events
Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.

Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
* Glaucoma stable with current medication assessed by a glaucoma specialist
* Clinically significant cataract

Exclusion Criteria:

* Secondary Glaucoma e.g. due to previous injury or uveitis
* Exfoliation syndrome
* Pigment dispersion syndrome
* Previous transscleral or endoscopic cyclophotocoagulation
* Previous other glaucoma surgery
* Cataract due to eye injury or congenital cataract
* Zonular weakness due to Marfan syndrome or other
* Previous retinal detachment
* Previous intraocular surgery like vitrectomy and other retinal surgery
* Wet age-related macular degeneration
* Diabetic retonopathy
* Previous corneal transplant or previous refractive surgery
* Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
* The patient does not want to participate in the study
* The glaucoma progresses on current IOP
* The patient does not speak Finnish, Swedish or English
* Dementia
* Only eye with vision worse than 20/200 or loss of central visual field
A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility Criteria:
Inclusion Criteria

* Stage IIIB or IV breast cancer.
* Recurrent tumor after or while on taxane therapy (taxol or taxotere).
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.
Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism

The purpose of this research study is to look at how trauma affects the ability of blood to clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years of age or older
* Blunt trauma patients including those with closed head injury
* Penetrating trauma patients

Exclusion Criteria:

* Are on therapeutic anticoagulation
* Have preexisting coagulopathy
* Patients greater than 12 hours from time of injury
* Have history of malignancy or preexisting diagnosis of sepsis or renal failure
* Patients with burn injuries
* Male and female patients younger than 18 years of age
* Pregnant patients
Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.

Eligibility Criteria:
Inclusion Criteria:

* Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
* Diagnosed with CIPN
* Age 18 years or above
* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
* Dutch-speaking
* Signed informed consent

Exclusion Criteria:

* Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
* Severe or unstable cardio- respiratory or musculoskeletal disease
* Interruption of more than two consecutive laser treatments
* Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
Plyometric Exercise Training in Athletes With Chronic Low Back Pain

The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study.

Visual Analog Scale (VAS) for pain assessment and Oswestry Disability Index for disability level will be used. Sit and Reach Test, Vertical Jump, Flamingo balance test and Shuttle Running test (20 min.) will be used to measure the physical functioning of the participants. Manual Muscle testing will also be used to measure the participants' lower and upper muscles. The participants were divided into two groups. The interventional program will be finished after 6 weeks (3 days a week). The program includes; physical therapy session (Hot packed, vacuum interferential current therapy, therapeutic ultrasound, exercises) and plyometric exercises.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being a licensed athlete (male of famele)
* Low back pain is chronic and lasts at least 3 months

Exclusion Criteria:

* Having had back pain or any surgery that caused it in the last year.
* Having cardiovaskular disease
* Doping and using banned substances.