cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.

This study consisted of a randomized, double-blind, placebo-controlled, 26-week treatment period, sequentially followed by an open-label, single-arm, 12-week treatment period, and an additional 4-week safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old;
* Diagnosed primary ITP for at least 12 months;
* Had received at least one first-line ITP treatment with no response or recurrence after treatment;
* Had a platelet count \<30×10\^9/L within 48 hours before the first dose;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
* Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.

Exclusion Criteria:

* Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.
* Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.
* Underwent splenectomy within 12 weeks before the first dose;
* Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;
* Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;
* Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator;
* Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin \>1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) \>3 ULN, hemoglobin \< 100g/L, absolute neutrophil count \<1.5x10\^9/L;
* Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)

Ilioinguinal and iliohypogastric (ILIH) nerve blocks are frequently performed for analgesia in inguinal surgery.

The investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ILIH) nerve blocks will produce better intraoperative analgesia and less analgesic requirement postoperatively in comparison to commonly used preoperative local infiltration anaesthesia for patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).

It is a prospective, randomized trial.

The patients will be randomized to one of the 2 groups:

Group 1 - NERVE BLOCK. Ultrasound-guided ILIH nerve block will be performed by attending anaesthesiologist.

Group 2 - LOCAL INFILTRATION. Local anaesthetic infiltration of the operative area will be performed by operator.

During surgery patients will receive low-dose propofol infusion in order to achieve conscious sedation level, when indicated.

An extra dose of local anaesthetic drug for infiltration of the surgical field or intravenous fentanyl or/and intravenous paracetamol will be given as rescue analgesics in patients reporting pain sensation.

The patients will be observed for 24 hours. The pain at rest will be assessed using numeric rating scale (NRS 0 -10; 0 = no pain: 10 = max pain imaginable).

On the first postoperative day intravenous analgesics will be given on demand (paracetamol 1 g iv (if NRS \<5) and oxycodone 2,5 mg iv (if NRS \> or = 5)).

Eligibility Criteria:
Inclusion Criteria:

* patients with aortic valve stenosis referred for TF-TAVI
* using a minimalist approach of local anesthesia or nerve block with conscious sedation

Exclusion Criteria:

* patient's refusal to participate
* allergy to local anaesthetic
* TF-TAVI requiring general anesthesia or surgical cut-down
* patients with major cognitive impairment and inability to assess their pain level in Numerical Rating Scale (NRS).
Renal Denervation for Resistant Hypertension

This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

Eligibility Criteria:
Inclusion Criteria:

* systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
* concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
* female participants of childbearing potential must have negative pregnancy test prior to treatment
Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 30 years or older.
2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

   1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
   2. glaucomatous optic disc cupping
   3. agreement between two baseline exams for reliability
3. Best corrected visual acuity at least 20/60 in at least one eye.
4. Prior Humphrey visual fields demonstrate acceptable reliability standards.

Exclusion Criteria:

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse \< 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Study of the Effect of Differing Platelet Transfusion Times in Neonates

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

1. It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion.
2. We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.

Eligibility Criteria:
Inclusion Criteria:

* Infants with significant thrombocytopenia requiring a transfusion of platelets.

Exclusion Criteria:

* Infants requiring extracorporeal membranous oxygenation.
* Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).
* Babies diagnosed with neonatal alloimmune thrombocytopenia.
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up

This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Ability to give feedback on hearing impressions
* Aged 18 years of age or older
* Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side

  * Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side
  * Group 2 - Bilateral: implanted on both sides
  * Group 3 - Bimodal: hearing aid on the contralateral side
* Minimum of six months of cochlear implant experience
* Minimum of one month experience with a Naída CI M or Sky CI M sound processor
* Fluent in French language
* Ability to be tested via speech perception test in noise
* Smartphone user

Exclusion Criteria:

* Clinical presentation indicative of potential implanted device malfunction
* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator

Pregnancy and breast-feeding are not exclusion criteria.
Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne

This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.

A study on the effects and side effects of ProOxy facial spray was done. Sixty people were selected and approved to participate in this study. Pictures of the face (frontal,left side and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks intervals.

Eligibility Criteria:
Inclusion Criteria:

* patients with acne on their faces only
* patients who are at least 18 years of age
* patients who have normal and disease free skin at the dorsal surface of the upper arm.
* patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits.

Exclusion Criteria

* patients with systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
* patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to post=inflammatory hyperpigmentation.
* patients with intake of oral medications including glucocorticoids or any immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2 weeks prior to the patch test.
* patients with history of contact dermatitis, dermatographism or anaphylaxis.
* patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis.
Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring

Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.


Eligibility Criteria:
Inclusion Criteria:

* Standard of care placement of arterial line
* 18 years of age or older

Exclusion Criteria:

* Pregnant females
* Nursing mothers
* Prisoners
Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study

The study hypothesis is that dilations of idiopathic bronchi are particularly common in French Polynesia, and that there are arguments in favour of an underlying genetic factor.

The study will retrieve retrospective data in the history of bronchial dilation, patients' personal and family history, microbiological and scannographic data, and the latest cardio respiratory checkup.


Eligibility Criteria:
Inclusion Criteria:

* Polynesian patient
* Patient with bronchial dilation followed by Centre hospitalier de Polynesie Francaise or patient with bonchial dilation no longer consulting in the hospital over the study period Jan 1, 2010 to Dec 31, 2020

Exclusion Criteria:

* Expressed refusal to participate in the study for patients undergoing follow-up
Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers

The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken.

In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose to test will be done after the safety of the previous dose has been ensured.

For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. The global length of the study will be approximately 15 months.

RUTI is a therapeutic vaccine made from virulent M.tuberculosis bacteria, grown in stressful conditions, fragmented, detoxified, heat inactivated (FCMtb) and liposomed. RUTI provides a strong humoral and cellular immune response against antigens from active growing and latent bacilli but also against structural antigens, as it has been proved in animal models of latent tuberculosis infection. The vaccine has been designed to be used against Latent Tuberculosis Infection as a therapeutic vaccine after 1-month of chemotheraputic treatment, instead the current treatment based on 6-9 months of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy, based on medical examination at inclusion
* Male Caucasian subjects, aged between 18 and 40 years
* Willing and likely to be able to comply with the trial procedures

Exclusion Criteria:

* Evidence of previous, current or latent tuberculosis, as radiological findings on chest X ray compatible with previous or current infection with tuberculosis
* Positive T-SPOT TB result
* BCG-vaccinated subjects
* History of severe organ-system diseases, including
* History of allergic disorders or known hypersensitivity to any drug or vaccine, or to any of the vaccine to be studied components
* Personal or familiar history of autoimmune diseases, or Positive Antinuclear Antibodies
* HIV, HBV and HCV sero-positive
* Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of \> 50 g a day
* Lost of more than 400 mL of blood within 12 weeks, or more than 250 mL within 4 weeks, before the recruitment
* Laboratory parameters outside of normal ranges considered clinically significant
* Intake of trial medication in other clinical trials within 1 month of the first vaccination
* Intake of any other drugs that could not be eliminated of the body before the first vaccination, especially anti-inflammatory nonsteroid and corticosteroid drugs
* Acute disease with \> 37ºC temperature within 72 hours before the first vaccination
Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery

This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.

This is a simple pragmatic systematic quality improvement study aimed at real-world evaluation of a device claimed to reduce pressure ulcers in patients undergoing cardiac surgery.

Data acquisition will be based on systematic sampling of cardiac surgery operations based on odd and even calendar dates. On odd dates the Dabir micropressure overlay will be functional on the operating room tables. On even dates the Dabir micropressure overlay will not be functional on the operating room tables. Data on baseline characteristics, operative parameters, and primary and secondary endpoints will be gathered from STS and wound care sources, which are routinely collected for all patients. There will be no additional patient information and data collected specifically for this study.

Eligibility Criteria:
Inclusion Criteria:

* All cases scheduled in the cardiac surgery OR suites at the CCF main campus.

Exclusion Criteria:

* Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.
Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).

Comparing real to sham treatment.


Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis per DSM IV

Exclusion Criteria:

* Schizophrenia
* Bipolar I
* severe Axis II diagnosis
* risk factors to convulsions
* drug / alcohol abuse
A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial

This clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). These rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, Pap, and colorectal screening recommendations. This study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as "Screen to Save (S2S)" and a fecal immunochemical test (FIT) kit distribution are acceptable and accessible to patients. FIT kits may help doctors find colorectal cancer sooner, when it may be easier to treat.

OUTLINE:

Participants receive S2S online screening education and FIT kit for sample collection.

After completion of study intervention, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 years or older or \< 45 years old with family history of CRC
* Speak and read English or Spanish
* Current resident in Clallam county
* Currently non-adherent to CRC screening recommendations

Exclusion Criteria:

* Age \< 18 years old
Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers

This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers.

Corneal ulceration is one of the leading causes of corneal blindness. Multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions.

Amniotic membrane (AM) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, A variety of matrix proteins, in addition to anti-microbial effect. Inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely.

Researchers found that amniotic membrane extract eye drops (AMEED) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 80 years.
* Both sexes.
* Patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention.

Exclusion Criteria:

* Severe corneal melting.
* Perforated corneal ulcer.
* Corneal ulcers with significant thinning with or without descemetocele.
* Patients who were unable to adhere to the treatment plan properly.
Complications of Endocrine Surgery: Data From the United HealthSystem Consortium

The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. This study will do a database review from all University HealthSystem Consortium (UHC).


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure.
* Parathyroid patients will also be studied.

Exclusion Criteria:

* Non endocrine surgery patients
Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients

The purpose of this study is to determine the usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients in emergency room

We prospectively enrolled the patients with acute chest pain who visited ED. Exclusion criteria were myocardial infarction (MI) with ST elevation, unstable vital sign, uncontrolled arrhythmia, renal dysfunction, hypersensitivity to contrast media and pregnancy. Patients were allocated into 3 categories based on history, physical exam, and electrocardiogram: 1) definite angina with uncertainty of regarding MI (high risk), 2) probable angina (intermediate risk), 3) low likelihood of angina (low risk), and then randomized to either receive MDCT immediately (MDCT group), or not (control). We compared diagnostic accuracy, length of stay in ER, admission rate, and major adverse cardiac events (MACE) and clinical diagnosis in 1 month after discharge from ED.

Eligibility Criteria:
Inclusion Criteria:

* Acute chest pain patient visiting emergency room

Exclusion Criteria:

* unstable vital sign
* renal failure
* ST elevation myocardial infarction
* uncontrolled arrhythmia
* hypersensitivity to contrast dye
* clinically no possibility of angina