cyrilzakka/clinical-trials huggingface dataset:
Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease

Aortic valve disease (AVD) is the most common and age-related mortality in elderly patients with valvular heart disease (VHD). Although transcatheter aortic valve replacement (TAVR) has been recommended at a higher level in foreign guidelines, there are still many high-risk and severe elderly patients with VHD who have not received effective treatment because of many complications and untimely medical treatment. Different from Europe and the United States, the majority of patients with bicuspid aortic valve are in China, and the calcification is more serious. The current clinical evaluation system and treatment guidelines can not be effectively applied to the high-risk and complex elderly patients. Therefore, the investigators should train and set up a valvular heart disease team, explore the technical difficulties of TAVR treatment in such patients, establish emergency TAVR operation mechanism, build a clinical evaluation system for high-risk and complex elderly patients with aortic valve disease in China, evaluate the curative effect periodically and further optimize the treatment strategy, so as to improve the quality of life and the meaning of life cycle of elderly patients with VHD in China Great significance.


Eligibility Criteria:
Inclusion Criteria:

* • patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography:

  1. aortic stenosis, moderate or above, or valve area ≤1.0cm2, or maximal jet velocity ≥4.0m/sec, or mean pressure gradient ≥40mmHg,
  2. aortic regurgitation, moderate or above, or jet width ≥65% of left ventricular outflow tract, or regurgitant volume≥60ml/beat, or regurgitant fraction ≥50%,

Exclusion Criteria:

* • Patients cannot be followed up for any reasons.
* •Patients have been enrolled in this study
Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study

Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with \<b\>distal\</b\> elective bowel anastomosis. Summary Background Data. Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in children and adults, to hasten bowel function, prevent post operative complications and shorten hospital stay. However, there is no former study that states in a scientific manner its benefit in children. Methods. The investigators performed a clinical controlled, randomized trial, comprising 60 children that underwent distal elective bowel anastomoses comparing post operative complications between a group with nasogastric tube in place (n=29) and one without it (n=31). \<b\>As an equivalence study the investigators expected that the two techniques were equivalent.\</b\> Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and chi square test for qualitative variables. Considering statistically significant a p-value less than 0.05. \<b\>Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups.\</b\> Results: Demographic data and diagnosis were comparable in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any patient. The investigators demonstrated equivalency since each confidence interval is entirely contained within delta, except for one variable (beginning deambulation), in which equivalency is suggested. There were no significant differences between groups in abdominal distention, infection, or hospital stay variables. Only one patient in the experimental group required placement of the nasogastric tube due to persistent abdominal distension (3.2%). Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective intestinal surgery in children. It's use should be individualized.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 1 month to 18 years old that required elective laparotomy with an intestinal anastomosis (jejunum, ileum and colon).

Exclusion Criteria:

* Non elective anastomosis and high risk groups:

  * newborns
  * upper gastrointestinal tract anastomoses (esophagus, gastric, duodenal or jejunal)
  * bilious-digestive or rectal anastomoses
  * immunosuppressed patients
  * gastrostomy or any pre anastomotic derivation
  * multiple anastomoses
  * chronic intestinal obstruction
  * intraoperative fluids-electrolyte disorders
  * reductive enteroplasty (tapering)
  * emergency operations and patients who did not complete the minimum POP follow up of one month.
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
* Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
* Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and \<30 mmHg
* No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
* Age \> 18 years and \< 90 years
* Patient able and willing to complete postoperative follow-up requirements

Exclusion Criteria:

* Patient who has been diagnosed for normal tension glaucoma
* Ocular or retrobulbar tumor
* Ocular infection within 14 days prior to the HIFU procedure
* Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema...)
Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

Patients benefit as part of the care:

* A clinical cochleo-vestibular examination
* Functional otoneurological explorations: audiogram, caloric tests, vHIT, otolithic evoked potentials
* From an uninjected brain MRI

Participation in this research entails the addition of an MRI sequence and an injection of contrast product (Gadovist®):

- 3D FLAIR MRI sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 6 months old
* With a history of confirmed congenital CMV infection
* Suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold\> 20dB in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level)
* For adult patients, having received informed information about the study and having signed a consent to participate in the study
* For minor patients written consent of the two holders of the exercise of parental authority
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Contraindication to MRI (implanted electrical device, metallic foreign body, claustrophobia)
* Patient with a proven allergy to gadolinium
* Injection of gadolinium in the previous 7 days
* Known impairment of renal function ((estimated GFR \<60 mL / min / 1.73 m²)
Social Functioning in Schizophrenia

There are two research purposes of this study. One is to explore which psychosocial issue or biological issue would affect the social function among people with schizophrenia. The other one is to explore which social function would affect the job tenure among people with schizophrenia. There are 60 participants diagnosed with schizophrenia and divided into two groups, employment and unemployment. we will use several social function tests to collect social function, PANSS to evaluate their psychotic symptoms. And then we will compare and analysis the data through statistic software. Finally, we will have he answer about how social skills affect the social function and which social skill would affect the job tenure among people with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia

Exclusion Criteria:

* substance abuse
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)

The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of erectile dysfunction (ED)
* lower urinary tract symptoms (LUTS)

Exclusion Criteria:

* previous prostate surgery or invasive intervention for BPH
* active urinary tract disease
NovoTTF Treatment Signatures in Glioblastoma Patients At Autopsy

This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.

RATIONALE:

Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.

STUDY:

All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
* Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.

Exclusion Criteria:

* TTField compliance \< 75%.
* Any contraindication to Optune TTField treatment.
* Initial brain tumor diagnosis \< WHO grade IV.
* Duration of TTField therapy \< 3 months.
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection

This study targets patients undergoing laparoscopic gastric cancer surgery.

The investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement.

First factor is intraperitoneal pressure.

Second factor is epidural pressure.

The investigators divided the patients into three groups.

Group A is patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.

Group B is patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.

Group C is patients with open gastric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Gastric surgery due to cancer

Exclusion Criteria:

* Coagulopathy
* Infection
* Previous history of thoracic spine surgery
* Ophthalmic diseases
* History of increased Intracranial Pressure
Support C Post-Market Registry

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.

This multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.

A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.

Note:

1. In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule.
2. If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.

Exclusion Criteria:

* Patients are excluded if ANY of the following additional conditions apply:

  * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
  * A life expectancy of \<1year
  * Explicit refusal of participation in the registry
Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"

The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.

Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare priority. Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies. The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting , improving treatment efficacy and tolerance.

In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM (French national research institute) units and new biotechnology companies.

The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas.

Biological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:

* circulating cell polymorphism profile
* proteomic profile
* genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.

The main judgment criteria will be response to chemotherapy correlated with patient's biological profile.

Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.

The second purpose of this study is to validate less invasive methods of sampling using blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the current reference (frozen tumor), which is out of reach in clinical examination.

This will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.

Two previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.

For this study, 600 patients will be included over 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma
* Patient treated by chemotherapy with platinum salt
* Every stage TNM classification
* No previous chemotherapy
* One measurable lesion out of nervous central system at least
* Performance status from 0 to 2 on ECOG scale
* Life expectancy \> 12 weeks

Exclusion Criteria:

* Previous or Concomitant carcinoma over 5 last years
* Concomitant radiotherapy
* Cardiac disease
Effects of Grade III Traction-mobilization in End-range Joint Position in Patients With Hip Osteoarthritis

Lower limb osteoarthritis is a major health problem in the westernized countries. The current gold standard treatment is joint replacement. However clinical guidelines recommend physical therapy as first option for these patients. Manual therapy has reported good reports in function, range of motion and pain in patients with hip osteoarthritis. The main aim of this study is to test the effects of a manual therapy protocol based on manual traction mobilization of the hip joint in an end range position and compare them with the effects achieve with the same protocol based on manual traction mobilization of the hip joint in a resting position. The investigators will use the caudal traction mobilization described by Kaltenborn. The study will test the effects of both treatments in passive range of motion, function and pain after three weeks of treatment, three weeks after finalizing the treatment and six weeks after.


Eligibility Criteria:
Inclusion Criteria:

* Hip osteoarthritis diagnosis
* Diminished range of motion
* Sign the informed consent

Exclusion Criteria:

* Contraindications to Manual Therapy.
* Sensitivity impairments in low back, pelvis, knee or foot regions.
* Being involved in other physical therapy treatments
* To change medication use during the study
The Association of SERPINA1 Gene Disturbance in Patients With Lung and Gum Disorders

Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis.

periodontitis is a polymicrobial inflammatory disease caused by various modifiable and non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms like the gene coding for alpha-1-antitrypsinase

COPD is a chronic inflammatory disease characterized by deterioration of lung function due to loss of elasticity of the lungs.

SERPINA1 gene product has a protective role on the connective tissue components of both lungs and gums.

Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor for developing periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged between 30-70yrs diagnosed with COPD and chronic periodontitis who are willing to participate in the study.

Exclusion Criteria:

* Pateints with other systemic disorders
* patients not willing to participate in the study
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.


Eligibility Criteria:
Inclusion Criteria:

1. \> 48 hours and \<120 days of age at the time of daptomycin administration
2. Sufficient venous access to permit administration of study medication
3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

1. History of anaphylaxis attributed to daptomycin
2. Previous participation in the study
3. Exposure to daptomycin in the month prior to the study
4. Serum creatinine \>1.0 mg/dL
5. Concomitant administration of tobramycin
Differences in Radial Artery Occlusion From Two Different Compressive Methods Used in Patients in Order to Achieve Homeostasis After Transradial Catheterization and Their Repercussion in Artery Functionality and Hand Mobility

The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.

Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
* Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
* Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Patients that will be able to do the follow up visits at 1 week and 3 month.
* Signature of informed consent

Exclusion Criteria:

* Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
* Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
* Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Inability to visit at 1 week and 3 month.
* Impossibility to obtain informed consent form