cyrilzakka/clinical-trials huggingface dataset:
4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief.

The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Patient who underwent a transcatheter aortic valve implantation
* Patient who provided informed, written consent to participate to FRANCE TAVI study
* Patient for whom a CT-Scan performed before TAVI procedure is available.

Exclusion Criteria:

* none
Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery

One of the most common post-operative complications of gynaecological surgery, and in particular endometriosis surgery, is the formation of peritoneal adhesions. After laparotomy, it affects up to 90% of patients. Minimally invasive techniques (such as laparoscopy) reduce the risk of adhesion formation, but cannot totally prevent it. Adhesions can lead to chronic pelvic pain, dyspareunia, digestive disorders and infertility. Various strategies and devices have been developed to try and limit adhesion formation, but their effectiveness has not been fully proven in the literature. The only real treatment for adhesions is adhesiolysis, although adhesions often reform. The quality of surgery remains the best means of preventing adhesion formation. To reduce the morbidity associated with pelvic adhesions, it is essential to develop alternative, non-invasive, anti-adhesive methods such as manual osteopathic visceral mobilization.


Eligibility Criteria:
Inclusion Criteria:

* Woman of legal age
* Indication for surgery for infiltrating endometriosis
* Able to give informed consent to participate in research
* Patient included in NO ENDO (national endometriosis observatory promoted by Clermont-Ferrand University Hospital)

Exclusion Criteria:

* Indication for surgery for superficial endometriosis
* Patient of legal age, under guardianship or trusteeship
* Pregnant or breast-feeding patient
* Patients not affiliated to the social security system
* Patients who do not speak French
* Patients under court protection
* Simultaneous participation in another study
* Refusal to participate.
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.

This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have or are:

  1. Orthopedics service patients having shoulder surgery
  2. ASA(American Society of Anesthesiologists) class I, II, or III.
  3. Patients at least 18 years old but less than 71 years old.
  4. Patients giving informed consent.
  5. Non-Emergency Surgery

     Exclusion Criteria:
* Patients who have or are:

  1. An inability to cooperate during the block placement.
  2. Neuropathy of the planned extremity to block
  3. Diabetes
  4. Documented Kidney Disease
  5. Documented Liver Disease
  6. A lack of or inability to give informed consent.
  7. Currently incarcerated.
  8. Pregnant
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
* Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
* Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Prior allogenic stem cell or solid organ transplantation
* Untreated symptomatic central nervous system (CNS) metastases
* Clinically significant ascites as defined by:

  i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment

Other protocol-defined inclusion/exclusion criteria apply
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.

In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. In the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. In this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Preterm babies born weighing less than 1500 grams

Exclusion Criteria:

* Babies with congenital anomalies
* Infants who develop necrotizing enterocolitis or spontaneous intestinal perforation before starting a breast milk fortifier
* Babies lost before reaching 50 cc/kg enteral nutrition
* Babies who are not breastfed
A Predictive Score System for AKI Following Pediatric Cardiac Surgery

Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. However, how to precisely identify those who have greater hazard to encounter postoperative AKI seems ambiguous.

The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.

Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.

At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.

This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.

Eligibility Criteria:
Inclusion Criteria:

1. \< 18 years old
2. Pediatric patients undergoing cardiac surgery in Fuwai Hospital

Exclusion Criteria:

1. Supported by dialysis for renal failure prior to cardiac procedure
2. Previously received a renal transplant
3. Lack of preoperative or postoperative serum creatinine measurements
4. Guardians' refusal on informed consent sign
The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms of COVID-19

This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.

Subjects who contracted COVID-19 and present remission of symptoms will be studied, with different age groups, illiterate or literate, of both genders and with different socio-demographic characteristics. The volunteers will be submitted to the application of MentalPlus® to assess cognitive functions and SF-8® to assess Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by COVID-19 with or without comorbidity for cardiovascular diseases, diabetes mellitus, hypertension, cancer, asthma between the ages of 8 and 88 years of both sexes and illiterate or literate.

Exclusion Criteria:

* Disability for the instrument's use: limitation for the mobility of the upper limbs, presence of significant mental retardation that compromises the understanding of the instructions for the use of MentalPlus®, significant lowering of visual acuity.
Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis

The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images.

The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Schroth exercises will be administered to both groups twice a week for 12 weeks. Kinesiological taping will be applied twice a week to the group receiving both Schroth exercises and kinesiological taping. Pre-treatment evaluations will include assessments of Cobb angles, trunk rotation, serum markers, quality of life and perception of deformity. Post treatment evaluations will include assessments of trunk rotation, cobb angles, serum markers, quality of life and perception of deformity.

Eligibility Criteria:
Inclusion Criteria:

* The individuals who agree to the study conditions and will continue with the treatment protocol.
* 18-21 years
* Individuals with scoliosis

Exclusion Criteria:

* Individuals with metabolic problems such as diabetes, thyroid issues, kidney problems, etc.
* Individuals with joint diseases such as septic arthritis, viral arthritis, rheumatoid arthritis, etc.
Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment

this study was conducted to clarify the effect of two different attachments on patient satisfaction and marginal bone loss. The primary and secondary objectives are to determine patient satisfaction and the marginal bone loss around implant when using CM LOC compared to conventional ball attachment. all the patients will receive a single median implant to which the denture will be loaded upon using the two different attachment systems


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous male or female patients between the ages of 50 to 69.
* No contraindications for implantation.
* Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
* Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
* Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al.22This will be confirmed by the CBCT.
* Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
* Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
* Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
* All patients should have adapted to their dentures for at least six weeks before being included in the trial.
* Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.

Exclusion Criteria:

* Patients with a systemic or local contra-indication for implant placement.
* Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
* Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
* Incompliant and not cooperative patients.
* Patients smoking more than 10 cigarettes per day
the Pulmonary Safety of Antihepatitis C Treatment

pulmonary side effects of the new regimen of antihepatitis C

Hepatitis C is a liver disease caused by the hepatitis C virus.The hepatitis C virus is a blood borne virus The most common modes of infection are through exposure to small quantities of blood, through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.

An estimated 71 million people have chronic hepatitis C infection. A significant number of those who are chronically infected will develop cirrhosis and or liver cancer. the treatment of hepatitis C virus (HCV) infection has been difficult, particularly in patients with HCV genotype 1. Reasons for the difficulty include the inherent toxicity and limited efficacy of interferon-based therapy, which has been the cornerstone of anti-HCV efforts during the past 2 decades.

Newly available direct-acting antiviral agents (DAAs) have the potential to dramatically improve HCV eradication rates. Despite these new drugs has been characterized by a very low adverse events rate in the published clinical trials Few data are available on pulmonary adverse events based real life studies

Eligibility Criteria:
Inclusion Criteria:

1. HCV RNA positivity .

Exclusion Criteria:

* Child C cirrhosis.
* Clinically manifest liver decompensation :ascites ,encephalopathy, wasting, hepatorenal syndrome.
* Serum albumin less than 2.8 g/dl,total serum bilirubin more than 3 mg/dl ,INR1.7 or more .
* absolute neutrophil counts \< 1500\\mm3 and\\or platelet less than 50,000/mm3.
* HCC except 6 months after concluding intervention aiming at cure with no evidence of activity by dynamic CT or MRI.
* Extrahepatic malignancy except after two years of disease\\disease free interval
* In lymphomas and chronic lymphatic leukemia can be initiated immediately after remission based on the treating oncologist's report
* Pregnancy or inability to use effective contraception
* Inadequately controlled diabetes mellitus (HbA1c\>9%)
* sever renal impairment in which creatinine clearance \< 30 ml\\min
* chronic lung diseases .
Database for the Assessment of Efficacy and Safety of BPH Treatment

This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).

This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).

Clinical, patient reported and imaging data that are assessed in clinical routine will be prospectively collected. All patients that are treated for BPE / BPH-LUTS at our institution will be included if they provide written informed consent.

This registry enables us to compare novel treatment option (e.g. prostatic artery embolization; PAE) to established interventions (e.g., TURP, HoLEP, open prostatectomy, ThuLEP, Thulium laser vaporization, TUIP) regarding safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
* Patient age ≥ 18 years
* Informed consent provided

Exclusion Criteria:

-Cognitive impairment not allowing Informed Consent or adequate data assessment.
Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects

The increasing intake of fructose has been associated with an increase in obesity among US children and adolescents, but its "dose dependent" effects on insulin sensitivity and lipid metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will be included in this study. They will be randomly allocated into a low, moderate or high fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and with 4 week wash out intervals each subject will receive all six different diets. Three day food records will be used to measure total fructose and glucose intake. During the low fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at consumption of less than 1g fructose/d. During the moderate fructose diet subjects will receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the form of three daily soft drinks taken together with the three main meals.

75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index will be calculated The presence of phosphorylated fructose metabolites in plasma will be measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects an euglycemic hyperinsulinemic clamp will be performed using \[6,6- 2H2\]glucose.

Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts of glucose. Particularly, the question whether lipogenic effects are continuously dose dependent or whether there is a lipogenic shunting and if yes, at what level of ingested fructose will be addressed.


Eligibility Criteria:
Inclusion criteria:

* Healthy male volunteers aged 20-50y with a BMI between 19 and 25 kg/m2

Exclusion criteria:

* Acute infection, malignant disease, renal (abnormal creatinine), hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or major psychiatric diseases, manifested atherosclerosis
* Fasting plasma glucose \> 5.6 mmol/l
* Known alcohol or drug abuse
* HIV-antibody positive
* Subjects likely to fail to comply with the study protocol
* Smoking (\>1 cigarette/month)
* Subjects who do not give informed consent

Additional exclusion criteria after baseline measurements:

* Subjects with high baseline consumption of soft drinks (\>60g of carbohydrates daily)