cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of CATS Tonometer Prism

Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT). Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based on standard of care vision examination at the clinical investigation sites. All subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted. The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Male and female patients, at least 18 years of age

Exclusion Criteria:

* Subject has undergone ocular surgery within the last 3 months
* Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
* Pregnant or nursing women
* Subjects with only one functional eye
* Those with one eye having poor or eccentric fixation
* Eyes displaying an oval contact image
* Those with corneal scarring or who have had corneal surgery including corneal laser surgery
* Microphthalmos
* Buphthalmos
* Contact lens wearers
* Severe Dry eyes
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection.
* Central corneal thickness between 0.600 mm and 0.500 mm (more than 2 standard deviations about the human mean)
Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants

This a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.


Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants who have received chloroprocaine for epidural anesthesia.

Exclusion Criteria:

* None
Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria

The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.

Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Eligibility Criteria:
Inclusion Criteria:

1. SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
2. Urine protein≥3.0g/24h, Alb\<30g/L and Scr\<1.5mg/dL.
3. All cases are type IV, confirmed by renal biopsy.
4. All patients sign the informed consent and be willing to follow-up on time

Exclusion Criteria:

1. Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
2. Scr level above 1.5mg/dL, lasts more than 3 months.
3. Heart, lung or central nervous systems involved or combined with severe infection.
4. With liver function abnormal, ALT or AST being two times above the normal.
5. Pregnant women or patients still in lactation.
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy

The purpose of this study was to determine whether disconnecting pulmonary vagus nerve branch can abatement chronic cough in patients undergoing unilateral thoracoscopic lobectomy,compared with preserving pulmonary vagus nerve branch.

After screening for the Inclusion criteria and the exclusion criteria, 116 patients undergoing unilateral thoracoscopic lobectomy are randomly assigned to two groups, disconnecting pulmonary vague nerve branches and preserving pulmonary vague nerve branches. The incidence of chronic cough after surgery is compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with preoperative imaging of bronchial lung cancer below the secondary bronchus ,the maximum diameter of the tumor ≤ 5cm (T ≤ 2) and staging check not suggesting distant and mediastinal lymph node metastasis (N ≤ 1, M = 0) schedule to receive elective unilateral thoracoscopic lobectomy from 2019 to 2021 will be included in the trial.
* ASAⅠ-Ⅲ

Exclusion Criteria:

* Chronic cough (\>8 weeks), its causes including chronic bronchitis, asthma, gastroesophageal reflux disease, history of postnasal drip syndrome, and the use of ACEI drugs and so on;
* other history of lung surgery;
* patients with severe arrhythmia;
* there are contraindications for anesthesia and surgery;
* pregnancy and lactation.
Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa

This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.

In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare the effectiveness of family-based therapy versus ego-oriented individual psychotherapy for the treatment of adolescent anorexia nervosa. Simultaneously, it will examine potential predictors, mediators, and moderators of weight gain, psychological concerns about weight and shape, and changes in family functioning.

Participants in this open-label study will be randomly assigned to receive one of two types of therapy: family-based therapy or ego-oriented individual psychotherapy. Both types of therapy will be given for a total of 24 hours over the course of 12 months. Physical and psychological assessments will be completed during study visits at baseline, immediately post-treatment, six months post-treatment, and one year post-treatment. Amount of weight gain will be evaluated, along with changes in weight and body shape concerns, as measured by the Eating Disorder Examination.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for anorexia nervosa
* Lives with at least one parent who is willing to participate
* Medically stable
* Adequate transportation to clinic
* Proficient at speaking, reading, and writing English

Exclusion Criteria:

* Currently undergoing treatment or taking medication that may affect eating or weight
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.

The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy.

Eligibility Criteria:
Inclusion Criteria:

* stage II or greater anterior vaginal prolapse requiring surgical correction
* age 21 years and older

Exclusion Criteria:

* less than Stage II anterior vaginal prolapse
* decline participation
* pregnant or contemplating future pregnancy
* prior anterior vaginal prolapse repair with biologic or synthetic graft
* active or latent systemic infection
* compromised immune system
* previous pelvic irradiation or cancer
* known hypersensitivity to polypropylene
* uncontrolled diabetes mellitus
* unable or unwilling to give valid informed consent
* unable or unwilling to comply with the protocol
* scheduled to undergo concomitant Burch colposuspension or pubovaginal sling
Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.

A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.

The "all-comers" study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* willing to give informed consent
* hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries
* adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
* sinus rhythm

Exclusion Criteria:

* inability to give consent;
* younger than 18 years of age
* atrial fibrillation rhythm at the time of inclusion
* with significant valve disease
* in cardiogenic shock
* with reduced kidney function - eGFR \< 30 (mL/min/1.73m2);
* with congenital heart defects
* with acute pulmonary artery embolism;
* with isolated left main ostial stenosis;
* on active oncologic treatment or toxic cardiomyopathy;
* revascularization by PCI is not possible due to other comorbidities or patient denial of treatment.
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age 4 -6 years
* Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
* Use of inhaled beta-2-agonists \< 1/week (max 3 puff /d)
* Exacerbation-free interval \> 4 weeks prior to visit 1
* The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present

Exclusion Criteria:

* Asthma severity ≥ Step 2
* Severe concomitant diseases
* Suspected non-compliance
* age below 4 and age above 7 years
* last study participation \< 30 days
Effect of Avastin in Juxtafoveal Telangiectasias

Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal Telangiectasias

After diagnose Yuxtafoveal telangiectasias secondary to Branch Retinal Vein Occlusion and with Idiopathic Ethiology by clinical signs and Fluorescein angiogram (FA)findings we treated patients with Intravitreal Injection of Bevacizumab (2.5mg/0.1ml). We performed a complete ophthalmological evaluation and at baseline and follow-up (1 and 3 months) we evaluate ETDRS Best Corrected visual acuity (BCVA), fluorescein angiogram (FA) and Optical Coherence Tomography (OCT)findings. We found an improvement in visual acuity and reduction of FA leakage and decrease retinal thickness in OCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Telangiectasias secondary to Branch Retinal Vein Occlusion
* Patients with Idiopathic Juxtafoveal Retinal Telangiectasias

Exclusion Criteria:

* Diabetic Retinopathy and Diabetic Macular Edema
* Hypertensive Retinopathy
* Choroidal Neovascularization
Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder

This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.

This is a randomised-intervention, parallel, multicentre study which will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with silodosin.

Eligibility Criteria:
Inclusion criteria:

• willing to provide written informed consent

* men over 50 years with lower urinary tract symptoms and overactive bladder and benign prostatic hyperplasia
* persistence of overactive bladder despite 4 weeks of silodosin treatment
* symptoms of overactive bladder (urinary frequency and urgency with or without urinary incontinence) for ≥3 months prior to visit 1.
* willing and able to complete the 3-day voiding diary and questionnaires
* International Prostate Symptom Score (IPSS) score ≥8.
* experience an average of 8 or more micturition's per day over the 3-day diary period.
* experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period

Exclusion criteria:

* post-void residual volume (PVR) \>200 mL
* evidence of Urinary Tract Infection and haematuria
* use anticholinergics, beta 3 mimetics within 4 weeks prior to Visit 1 and during the study
* oncological diseases of the lower urinary tract and prostate
* neurogenic bladder
* urethral strictures and bladder neck stenosis
* urolithiasis
* diabetes mellitus
* previous surgery of lower urinary tract
* stress urinary incontinence
* intermittent catheterisation
* chronic urinary tract infection
* previous botox treatment in the last 12 months
* chronic electrostimulation treatment of OAB in the last 12 months
* patient began or has changed a bladder training program or pelvic floor exercises less than 90 days before 1 visit
* cognitive deficits and dementia
* man has participated in an interventional trial within 30 days prior to Visit 1
* total daily urine production over 2500 mL according to voiding diary
Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. These patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.

Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. As a multi-center prospective observational clinical study, the study intends to enroll 2000 suspected neonatal sepsis cases from multiple centers. Culture, classical PCR and mNGS were performed simultaneously. This study is one of the few multi-center studies in China to evaluate the value of mNGS in the diagnosis and treatment of neonatal sepsis, and will provide representative data for the distribution characteristics of pathogen spectrum of children in the real world and the clinical diagnosis and treatment value of mNGS.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with suspected early-onset sepsis or late-onset sepsis;
* Neonates diagnosed with clinical sepsis.

Exclusion Criteria:

* Died before the results of conventional methods test or metagenomics test were obtained;
* Suffering from diseases of the blood system;
* Suffering from malignant tumor;
* Birth defects, congenital heart disease or autoimmune disease.
Ovulation Induction With Clomiphene Citrate and Dexamethasone

The purpose of this study is to determine if the addition of dexamethasone to clomiphene citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.

For decades clomiphene citrate (CC) has been the first line therapy for ovulation induction in anovulatory or oligoovulatory women, and for superovulation in women with unexplained infertility or partners with mild sperm abnormalities. While approximately 80% of patients achieve ovulation with CC, less than half conceive. Pregnancy is achieved in approximately 10% of ovulatory cycles.

Addition of dexamethasone to CC has been shown to result in pregnancy rates of 21-40% in CC-resistant women (defined as patients failing to ovulate on CC alone). A subsequent randomized controlled trial demonstrated higher pregnancy rates in patients with unexplained infertility undergoing intrauterine insemination (IUI) with CC + dexamethasone compared to those taking CC alone.

In light of the relatively high pregnancy rates achieved in previous trials, we hypothesize that dexamethasone as an adjunct to CC will increase the ovulation rate and pregnancy rate for all appropriate candidates for IU with a standard CC regimen.

Our study is designed to randomize patients undergoing ovulation induction with IUI into two groups: one consisting of a standard CC regimen, and the other consisting of the same CC regimen with the addition of daily dexamethasone. The primary outcome measure is pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military members or dependents seeking infertility treatment at Brooke Army Medical Center
* primary or secondary infertility
* candidate for intrauterine insemination (IUI)

Exclusion Criteria:

* Severe male factor infertility (total motile sperm count \<10 million/mL)
* Bilateral fallopian tube obstruction
* Diminished ovarian reserve (baseline follicle stimulating hormone \> 20)
* History of clomiphene resistance as determined by a Clomid challenge test or prior non-ovulatory cycles while taking clomiphene
* Known or suspected hypopituitarism or hypothalamic amenorrhea
* Six or more prior therapeutic CC cycles without a pregnancy
* Diabetes
* Renal impairment, hepatitis, hepatic cirrhosis, or myasthenia gravis
* Osteoporosis
* Cataracts or glaucoma
* Congenital Adrenal Hyperplasia, Cushing's disease, or any condition requiring chronic corticosteroid use
Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome

The aim of this study is to compare the efficacy of fluoroscopy guided lumbar facet joint injection versus ultrasound guided injection in patients with low back pain due to facet syndrome.

All patients will be randomly classified into two equal groups (40 patients each) by using closed envelops, a computer generated random allocation codes.

Group 1(Fluoroscopy guided group) (n =40 patients):

The patient will be placed in the prone position with a pillow under the abdomen to correct the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then slowly rotated till the joint appear in profile as two parallel lines. After cleaning and drapping and administration of local anesthesia a22-g spinal needle is inserted in line with x-ray beam till bony contact is felt. All procedures will be performed under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.

Group2 (Ultrasound guided group) (n=40 patients):

Patients will be placed in a prone position. Posterior paravertebral parasagittal sonograms will be obtained to identify of the different spinal levels. The spinous process and adjacent structures (lamina of the vertebral arch, facet joint, accessory process, and mammillary process) will be delineated by transverse sonograms at the target level, and the midpoint of the facet joint space will be established. After cleaning and drapping and administration of local anesthesia. If the joint is clearly or partially visible, a spinal needle is advanced under US guidance into the joint space of each lumbar facet joint. The needle is inserted 1-2 cm laterally from the midline at the lateral end of the transducer and precisely positioned in the US plane at an angle of approximately 45owith respect to the axial plane until the needle tip reached the target and bony contact is felt. This enables visualization of the needle, which appears as a bright line-shaped echo pattern on the transverse sonogram. If the needle placement is correct, a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was encountered) and injected around the posterior facet joint capsule.

Eligibility Criteria:
Inclusion Criteria:

* Patients, more than 18 years old, with pain associated with lumbar hyper-extension, lateral flexion, and tenderness on paravertebral regions corresponding to facet joints but normal findings on the straight leg raise test and neurologic examination.

Exclusion Criteria:

* Patient refusal and lack of consent.
* Local or systemic infection.
* allergy to steroids or local anesthetics
* Patients with coagulopathies.
* Evidence of nerve root compression at the expected level on MRI.
* Pregnant patients
RESIPI for Reducing Perioperative Major Adverse Cardiac Events

This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Eligibility Criteria:
Inclusion Criteria:

* Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
* Surgery type: Major Abdominal Oncologic Surgery
* Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days

Exclusion Criteria:

* Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
* Patients with Chronic Kidney Disease Stage IV or V
* Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
* No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30