cyrilzakka/clinical-trials huggingface dataset:
Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis

Aim of research is to investigates clinical, surgical and radiological outcome of vertebral pars intetarticularis repair by used smile face shape rod technique and bone grafting and comparing that with posteriolateral fusion with used traditional transpedical screw and rod fixation in management of isthmic spondylistheisis

Isthmic spondylolisthesis is considered to represent a fatigue fracture of the pars interarticularis of the neural arch, The clinical symptom is activity-related back pain in young and athletic patients . The cause of Isthmic spondylolisthesis in these patients is repetitive stress of the pars interarticularis with subsequent microfracture, which in turn may lead to a bony defect and cause progressive spondylolisthesis in up to 25% of cases. Surgical intervention is indicated for patients who are not responsive despite adequate period of conservative management such as activity modification , physical therapy, and occasionally bracing .

Techniques for repair of a pars defect include Scott wiring , a Buck screw , a pedicle screw and hook , multiple segment fixations or a U-rod . After repair, radiographic healing rates range from 67 percent to 90 percent; asymptomatic and return to sports rates range from 80 percent to 90 percent.

These methods have achieved variable success .In Buck screw fusion surgery,it is not effect on flexion and axial rotation of the spine but bone healing is compromised.

Stabilization with wiring and titanium cable had less success rate than other methods and requires the use of lumbar brace or prolonged immobilization.

The pedicle screw-vertebral plate hook system may complicated by injury to the dural sac or nerves ensues.

Multiple segment fixation with pedicle screws and rods has good success of stabilization but it is effect on flexion and axial rotation of the spine, and may cause degenerative change in adjacent normal segments.

Smiley face shaped rod technique is new method used for repair of isthmic spodylolisthesis using pedical screw on effected segment and smiley face rod revolve around spinal process to stabilization of pars interarticularis of the same segment so it preserve axial rotation and flexion of spin also avoid degenerative change in adjacent levels.

Eligibility Criteria:
Inclusion Criteria:

1. age above 18 years old
2. Both sex
3. failure of conservative treatment for 3months
4. fit for surgery

Exclusion Criteria:

1. age less than 18
2. Not fit for surgery
3. pathological fracture of pars
4. assosciated pathology like disc degeneration, spinal canal stenosis, spondylolisthesis grad 2,3and 4
Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?

The purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm.

Dipyridamole has been proven to reduce targeting of Annexin A5 in responses to ischemic exercise, indicating protection against ischemia-reperfusion injury in humans (pharmacological preconditioning). Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor protects against ischemia-reperfusion injury. We hypothesize that endogenous adenosine mediates the protective effect of dipyridamole against ischemia-reperfusion injury. Therefore the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm ischemia-reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18-50yr.

Exclusion Criteria:

* cardiovascular disease
* hypertension (systole \> 140 mmHg, diastole \> 90 mmHg)
* hypercholesterolemia (random total cholesterol \> 6.5 mmol/l)
* diabetes mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
* participation in any clinical trial during the last 60 days prior to this study.
* administration of two doses of Annexin A5 (0,1mg; 450MBq) during the last 5 years prior to this study.
Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France

An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local treatment practices and product label for the first time.
* Female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label.
* Participants must be willing and able to use an electronic device to complete the study PROs.
* Participant must sign and date the Informed Consent Form (ICF) before enrollment into the study.

Exclusion Criteria:

* Participation in any interventional or non-interventional study without prior approval from the Medical Lead. This does not preclude inclusion of participants enrolled to national registries.
* Female participant is pregnant or intending to become pregnant while taking filgotinib.
MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection

The goal of this observational study is to compare specific microRNA levels from the plasma of gastric cancer patients and healthy volunteers to see if there is an upregulated expression in gastric cancer patients.

The main question it aims to answer is:

- Can microRNAs be effectively used as diagnostic biomarkers for gastric cancer?

Participants will be asked for their consent to obtain 5 cc of blood.


Eligibility Criteria:
Inclusion Criteria for Gastric Cancer group:

* Recently diagnosed gastric cancer
* Never received any treatment for gastric cancer

Inclusion Criteria for Control group:

* Age 50 or above
* Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
* No prior history of gastric dysplasia or cancer

Exclusion Criteria:

* Patients who cannot give informed consent
* Pregnancy
* Lymphoma
Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations

The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. Up to three 18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.

Approximately 40% of cases of Frontotemporal lobar Degeneration (FTLD) are also associated with abnormal deposition of tau protein. The purpose of this study is to image MAPT mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in Frontotemporal Lobar Degeneration with tau deposition (FTLD-tau).

Eligibility Criteria:
Inclusion Criteria:

* Members of families with established MAPT mutations, who either have the capacity to consent to participate in the protocol, or else have designated a surrogate/proxy to consent to participate in this study

Exclusion Criteria:

* Unwillingness to participate
* Usage of medication which significantly prolongs QT interval
* Pregnancy or plans for pregnancy within 90 days after participating in study
Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer and Colorectal Cancer, screened in Amgen's clinical trial (Protocol No. 20170543).

This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples (either core needle (NSCLC only) or excisional biopsies), obtained from patients with Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), using the therascreen® KRAS RGQ PCR Kit, (hereafter referred to as KRAS Kit).

Up to 280 patient tissue samples (from approximately 100 clinical study sites), obtained in the Amgen Clinical Protocol 20170543 study, will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing site, NeoGenomics Laboratories, Inc., 7256 S. Sam Houston Pkwy W., Suite 300, Houston, Texas, 77085, USA.

The primary objective of the Amgen Clinical Study is to evaluate tumor objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Trial Assay, therascreen® KRAS RGQ PCR Kit to assess whether to treat patients with KRAS G12C mutated advanced tumors (NSCLC and CRC).

The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Eligibility Criteria:
Inclusion Criteria:

* All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.

Exclusion Criteria:

* Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.
Peritoneal Dialysis in Congestive Heart Failure

Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.

Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..

Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF \< 30%, older than 18 years).

Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).

Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Refractory Left Ventricular Congestive Heart Failure: LVEF \< 30%
* Diminished renal function: eGFR \< 60 ml/min
* Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
* Hospitalization for CHF during the last 6 months
* Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks
* Suitable for PD

Exclusion Criteria:

* Hypotension (SBP \< 100 mmHg / MAP \< 70) mmHg
* Instable AP or recent (\< 6 months) myocardial infarction.
* Contraindications for PD (e.g. visual handicap, social)
* Liver failure
* COPD Gold class IV
* Malignancy with life expectancy \< 2 years
* Non compliance
* No informed consent
* Poor mental health
Medication Abortion Via Pharmacy Dispensing

This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.

Improving access to and efficiency of abortion provision is important for patients and providers. The Risk Evaluation and Mitigation Strategy (REMS) requires that Mifeprex ® ( mifepristone) be dispensed only from a doctor's office, clinic or hospital (not from a pharmacy by prescription) by a certified health care provider and the health care provider must obtained a signed Patient Agreement Form before dispensing mifepristone. Data are needed to investigate the feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. In order to address the study question, a mixed methods study design is appropriate. To assess feasibility, the study will collect data on pharmacists' satisfaction with dispensing mifepristone. To assess acceptability, qualitative data will be collected from pharmacists about their perspectives on dispensing Mifeprex before and after the study, as well as measure patient satisfaction through open-ended and close-ended survey questions. To assess effectiveness of the pharmacy dispensing model, the study will evaluate clinical outcomes from electronic health records. The proposed feasibility study would take place at sites in California and Washington states.

Eligibility Criteria:
Patient Inclusion Criteria:

* Women seeking medication abortion through 70 days gestation
* Eligible for Mifeprex® at a study clinical site
* English or Spanish speaking
* Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone

Patient Exclusion Criteria:

* Not pregnant
* Not seeking medication abortion
* Under the age of 15
* Contraindications for medication abortion

  * All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy

This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene abeparvovec and experience a plateau or decline in function. Participants to be enrolled are children \<2 years of age genetically diagnosed with SMA.


Eligibility Criteria:
Inclusion Criteria:

* \<2 years of age at the time of informed consent
* Confirmed diagnosis of 5q-autosomal recessive SMA
* Confirmed presence of two SMN2 gene copies
* Administration of onasemnogene abeparvovec pre-symptomatically or post-symptomatically
* Has received onasemnogene abeparvovec for SMA no less than 3 months prior to enrollment
* In the opinion of the investigator, has demonstrated a plateau or decline in function post-gene therapy (with a duration of 6 months or less) documented by 2 individual time points in the functions as follows: swallowing AND one additional function/ability (respiratory, motor function, other) per appropriate expectation.

Exclusion Criteria:

* Treatment with investigational therapy prior to initiation of study treatment
* Any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information
* Concomitant or previous administration of a SMN2-targeting antisense oligonucleotide or SMN2 splicing modifier either in a clinical study or as part of medical care
* Requiring invasive ventilation or tracheostomy
* Presence of feeding tube and an OrSAT score of 0
* Hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening
* Any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.
The Effect of Calorie Deprivation on Adipose Tissue Distribution

In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast) on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will increase after an acute fast.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 21-45 years
* 101-130% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
* Normal thyroid function
* Regular menses (women)
* Normal liver transaminases

Exclusion Criteria:

* Any disease known to affect bone metabolism, including untreated thyroid dysfunction, Cushing's syndrome, or renal failure
* Any medication known to affect bone metabolism -- including systemic steroids or immunosuppressants -- within three months of the study, excluding estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for six months after their last injections. Bisphosphonates must have been discontinued for at least one year before participation
* Serum potassium \<3.0 meq/L
* Pregnant and/or breastfeeding (women)
* Diabetes mellitus
* Active substance abuse, including alcohol
* Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility for PCI due to angina
* Anatomical evidence of significant multi-vessel coronary stenosis defined by either:

  1. ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)
  2. Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA
* Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:

  * dobutamine stress echocardiogram
  * cardiac MRI
  * myocardial perfusion study
  * invasive metrics of coronary physiology

Exclusion Criteria:

* Recent acute coronary syndrome
* Previous coronary artery by-pass graft surgery (CABG)
* Significant left main stem disease
* Chronic total occlusion in the target artery(s)
* Moderate to severe valvular disease
* Moderate to severe left ventricular impairment
* Contraindication to PCI or a drug-eluting stents
* Contraindication to antiplatelet therapy
* Contraindication to adenosine
* Pregnant
* Inability to consent
Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy

Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).

Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.

Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.

Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent pancreaticoduodenectomy (PD) for periampullary neoplasms
* Patients underwent PD with pancreaticojejunostomy reconstruction.
* Patient with data of blood count in first postoperative day

Exclusion Criteria:

* None of the above criteria
Sildenafil Effect After Ovulation Induction

100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Folliculometry was assessed by:

* Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.

When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.

Pregnancy was assessed by:

* Beta HCG test: (Radioimmunoassay)

Eligibility Criteria:
Inclusion Criteria:

1. Infertile women whether it's primary or secondary infertility
2. Woman's age: (18-35 years old)
3. Menstrual cycle from (24-35 days)
4. Normal semen analysis

Exclusion Criteria:

1. Age more than 35 years old
2. Ovarian cysts
3. Abnormal hormonal profile (e.g hyperprolactinaemia)
4. Significant cardiovascular disease
5. Serious liver disease or renal failure
6. Poorly controlled diabetes mellitus