cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent

PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after implantation.


Eligibility Criteria:
Inclusion Criteria:

* age \>50 years
* de novo lesion
* lesion length \<24 mm
* reference vessel diameter 3 mm

Exclusion Criteria:

* low compliance to dual antiplatelet therapy
* life expectancy \<1 year
* allergy to any drug or substance use prior, during or after percutaneous coronary intervention
* chronic renal insufficiency
* low left ventricle ejection fraction (\<35%)
* recent acute myocardial infarction
* previous coronary intervention
* off-label indication to stenting
* participation in another investigation
* refusal to participate to the study
Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the PCT ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation
* abdominal sepsis according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definition

Exclusion Criteria:

* pregnancy
* immunosuppressive medication
HealthySteps: Exercise for Older Adults With Mobility Limitation

This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.


Eligibility Criteria:
Inclusion Criteria:

* Men and women who live in the lower mainland (greater Vancouver) area of British Columbia
* Aged 65 years or older
* Living independently in their own home
* Report mobility limitation, defined as any difficulty walking one-quarter mile (about 2-3 blocks) outside on level ground or climbing one flight of stairs (about 10 steps) without resting because of a health or physical problem

Exclusion Criteria:

* Have a current medical condition for which exercise is contraindicated
* Have participated in an exercise intervention study in the past 6 months
* Do not have adequate cognitive function to provide informed consent and participate fully in the study
* Do not speak and understand English fluently
Neonatal Microbiome Validity Study

This is a validation study to compare proposed field collection methods with a gold standard collection technique for microbiome analysis of stool and breast milk samples.

In order to conduct a future study of the gut microbiome in a population living in a rural, low income setting, this validation study will be conducted to verify the validity of our proposed field collection methods for stool and breast milk samples. We will compare the microbial diversity and abundance in the biologic samples using various proposed field collection methods to an immediately frozen sample. The proposed field collection methods are feasible for use in a community-based study in a low income setting with limited access to cold storage.

Eligibility Criteria:
Inclusion Criteria:

* Lactating women (for breast milk sample)

Exclusion Criteria:

* None
Recovery of Respiratory System in COVID-19 Patients

The purpose of this study is to determine the effects of the clinical course of treatment as well as long-term symptoms of COVID-19 on respiratory function, exercise capacity, and quality of life.

This study will be completed over 4 sessions at the Mayo Clinic at either the Scottsdale Arizona or Rochester Minnesota locations. You will be asked to complete a series of questionnaires, lung function tests, and exercise tests at two time points: ≥ 28 days post diagnosis and 4-6 months after the first laboratory visit. All visits will take approximately 2 hours. During visits 1 and 3 a series of questionnaires as well as breathing tests, and an exercise test will be completed on a stationary bike. You will also be asked to breathe a gas mixture out of a bag to obtain measures of gas movement and sensitivity. During visits 2 and 4 you will complete an exercise test on a stationary bike to measure changes from the previous exercise test and a chest scan.

Eligibility Criteria:
Inclusion Criteria:

* Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis
* At least 18 years of age.
* Female subjects must not be pregnant or trying to become pregnant during the duration of study participation.
* No known plans to move out of the state, or become unable to return to one of the Mayo Clinic sites for follow-up testing.
* Must be able to provide clear informed written consent.

Exclusion Criteria:

* Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
* Individuals with major limitations to exercise.
Transversalis Fascia Plane Block in Caesarean Section Patients

Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cesarean section under general anesthesia ASA I-II

Exclusion Criteria:

* patients undergoing cesarean section under neuraxial anesthesia morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs
Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser

Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.

Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.

Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up.

Grid laser and ranibizumab therapy is expected to be effective in DME management during long-term follow-up. Immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. Intraretinal hyperreflective material in SD-OCT will likely negatively related to BCVA.

Eligibility Criteria:
Inclusion criteria:

* DME that will be detected clinically and on FA as well as on SD-OCT \[diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area\]
* Patients will be included into the present study following informed consent
* Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR).

Exclusion criteria:

* Eyes with other retinal diseases \[i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies\]
ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis

This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).

Eligible patients who enroll in this study will receive a one-time subretinal injection of ATSN-201 in one eye. Safety and tolerability will be evaluated for 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 for Cohorts 1 through 3, and age ≥ 6 years and \< 18 years for Cohort 4.
2. Male patients with clinical diagnosis of XLRS caused by mutations in RS1.
3. Best corrected visual acuity (BCVA) in study eye of 34 to 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (corresponding to a Snellen acuity of 20/200 to 20/40).

Exclusion Criteria:

1. Pre-existing eye conditions in the study eye that would contribute significantly to an increased risk of visual loss from a subretinal injection.
2. Any intraocular surgery (including laser treatment) in the study eye within 6 months prior or any intraocular surgery anticipated in the study eye during the first 12 months of the study.
3. Treatment in a prior ocular gene or cell therapy study.
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components.

  2. Has not receiving systemic therapy for local advanced/metastatic disease. 3. At least has one measurable lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  5. Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection.

  7. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.

  8. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.

  2. Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy.

  3. Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders.

  4. Has participated in other clinical trials within 30 days before randomization.

  5. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.

  6. Pregnant or lactating women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
The Effect of Scapular Stabilization Exercises on the Upper Extremity in Patients With Chronic Stroke

There is still no approved exact treatment for stroke, one of the leading causes of disability. Neurorehabilitation is an important treatment option for stroke patients with anatomical and functional impairments in their interhemispheric connections. However, special techniques with high effectiveness are being investigated to increase the success of general rehabilitation. In this context, scapula-focused stabilization techniques have been used in stroke patients recently. In this randomized controlled study, investigators aimed to examine the effect of scapular stabilization exercises on upper extremity spasticity and motor function in addition to neurorehabilitation in patients with chronic stroke. 22 chronic stroke patients will be included in the study. The patients will be divided into two groups as scapular exercise group and control group using the simple randomization method. Scapular stabilization exercises will be applied in combination with neurorehabilitation to the first group, while only neurorehabilitation will be applied to the control group. A 6-week (30 sessions) neurorehabilitation program will be applied to all groups, specially planned for the patient. Spasticity of the patients participating in the study Modified Ashworth Scale, upper extremity recovery levels Brunnstrom Recovery Stage, upper extremity functions Fugl Meyer Upper Extremity Scale and Wolf Motor Function Test, independence levels Functional Independence Scale , activities of daily living will be evaluated with the Modified Barthel Index and quality of life will be evaluated with the Stroke Specific Quality of Life Scale. The first evaluation of the patients will be made before the treatment, and each patient will be evaluated after the 6-week exercise program. After all data are collected, in-group and intergroup comparisons will be made.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* 3 months past the stroke history
* No previous history of stroke
* Mini mental test score ≥ 24
* Upper extremity (elbow, wrist and finger) spasticity level to be 1-3 according to Modified Ashworth Scale (MAS)
* Upper extremity Brunnstrom recovery stage 2-5
* No botulinum toxin injection for the affected upper extremity in the last 6 months
* If he is using antispastic medication, his dose has not been changed in the last 1 month.
* Consent to participate in the study

Exclusion Criteria:

* Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke
* being pregnant
* Having upper extremity contractures
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight \>60 kg (132 lbs).
* Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)

This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.

* The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation.
* Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed \<5 days before the study
* Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
* The primary endpoint will be a reduction of the burden of clinical arrhythmia \>50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
* The study will include 80 patients over 4 years.

Eligibility Criteria:
Inclusion Criteria:

1. arrhythmic storm \<24 hours before inclusion:

   * 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
   * or incessant VT lasting \>30 minutes,
   * or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
2. clinical indication for LBGS based on the judgment of the physician, independent of the study

Exclusion Criteria:

1. known allergy to bupivacaine
2. prior LBGS performed \<7 days before the study
3. known reversible provoking trigger of the arrhythmias
4. ventricular arrhythmias triggered by premature ectopic beats during bradycardia
5. hemodynamically tolerated idiopathic VT in patients without structural heart disease
Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.

Eligibility Criteria:
Inclusion Criteria:

* adults (from 18 to 75 years old)
* suffering from a gall bladder disease
* with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
* accepted to participate in the study.

Exclusion Criteria:

* Patients with history of previous biliary surgery
* Patients with abdominal malignancy
* Patients with advanced chronic liver disease
* pregnant women
Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya

There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.

Rheumatic heart disease (RHD) in pregnancy can be associated with severe maternal and neonatal morbidity and mortality. Early identification of these women and referral to specialized, multi-disciplinary care is essential. Overall, studies on RHD prevalence are lacking in sub-Saharan countries and a significant gap in the literature exists for the prospective assessment of disease in the context of pregnancy. At Moi Teaching and Referral Hospital, there are an estimated 3-4 cases per month of women presenting with acute exacerbations of either known or newly diagnosed cardiac disease. These women are often the most challenging clinically and emotionally for the reproductive health team to manage, and contribute to a significant number of the 2-3 maternal deaths per month at MTRH. There is currently no routine screening for cardiac disease in the MTRH antenatal clinics. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to: 1. Use focused echocardiography as a screening tool to evaluate cardiac structure and function; 2. Use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.; 3. Determine the proportion of pregnant women with cardiac disease who endorse clinical symptoms as a potential means to develop a screening tool; 4. Promote a case-finding culture for cardiac disease in pregnancy

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at any gestational age
* capable to give informed consent

Exclusion Criteria:

* medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process
Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection

This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Current Helicobacter pylori infection.
* Age ≥ 60 years.
* Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
* Signed the informed consent document.

Exclusion Criteria:

* History of Helicobacter pylori treatment.
* History of gastric surgery.
* Allergic to any medications involved in the intervention.
* Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR\<60ml/min'1.73m2) , malignant tumor，mental disorder.
* Taking medications that may be conflict to the intervention drugs.
* Failing to express symptoms, unwilling to cooperate.
* Taking any antibiotics within a month.
Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression

The purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.

The suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. Retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function.

This study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. Patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. They will be randomized into two arms: In one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. Post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.

Eligibility Criteria:
Inclusion Criteria:

* Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction

Exclusion Criteria:

* Patients less than 18 years of age
* Irreparable rotator cuff tears