cyrilzakka/clinical-trials huggingface dataset:
Genetic Determinants of Hemodynamic Response to Esmolol

Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD and hypertension. However, there is large interindividual variability in the response to beta blockers.

The hypothesis underlying this study is that genetic differences between individuals will determine the individual response to esmolol, a betablocker that is administered intravenously. Esmolol will be administered intravenously to healthy volunteers, and the effects on heart rate and blood pressure will be monitored. In addition, we will measure plasma renin activity and plasma levels of norepinephrine.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and female
* able to understand and sign informed consent

Exclusion Criteria:

* consumption of any medication
* bradycardia \<50 BPM
* hypersensitivity to beta blockers
Clinical & Radiographical Evaluation of the Effect of Dycal & Biodentine in DPC in Primary Teeth

The purpose of this study was clinical and radiographical evaluation of the effect of calcium hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp capping in primary teeth.

The aim of the present study is to compare Calcium Hydroxide cement (Dycal) ® and Calcium Silicate cement (Biodentine)TM as pulp capping agents in primary molars. The objective of this study include the evaluation of clinical and radiographic efficacy of Calcium Hydroxide cement (Dycal) ® and Calcium Silicate cement (Biodentine)TM, and their response in direct pulp capping treatment on primary molars during a 6 months follow up. After following the proper standardized procedure for direct pulp cap. In the current study direct pulp capping was performed using calcium hydroxide cement (Dycal)® and Calcium Silicate cement (Biodentine)TM on 60 primary teeth of children equally divided between 2 study groups randomly of both the sexes aged 4-9 years old. Complete case history was recorded in detail and intraoral periapical radiograph was also taken for teeth indicated for direct pulp capping. Written consent was obtained from the parents of participants before starting the procedure. Strict standardized procedure had been followed and the pulp capping agent (Dycal®/BiodentineTM) were applied according to the manufacturer's instructions.Each patient was evaluated clinically and radiographically for any abnormal clinical signs and symptoms at 1,3 and 6 months postoperatively.Better results for the success of the study could be relatively enhanced by close attention to rigid criteria for case selection, standardization of direct pulp capping procedure and meticulous performance of the procedure appear to be prerequisites for successful treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Good health.
2. Cooperative behaviour.
3. Informed consent from parents.
4. Primary molars with clinically active caries.
5. No history of spontaneous pain in teeth.
6. Restorable tooth with at least one half of root length present.
7. Absence of pathological mobility.
8. Absence of tenderness to percussion.
9. Normal gingiva and periodontal condition without the sign of pathology such as redness and swelling of vestibule, draining sinus tract or sensitivity to palpate in the vestibule.

In addition, the teeth treated by direct pulp capping had only a pin point mechanical exposure (0.5 to 1mm), for which haemorrhage control could be achieved within two minutes before proceeding with direct pulp capping.

Radiographically, there was absence of internal resorption, external resorption, periapical or furcation radiolucencies and pathology of succedenous permanent tooth follicle.

Exclusion Criteria:

* Patients with a history of spontaneous pain, tooth tender to percussion, absence of underlying permanent teeth, internal/external root resorption, apical/furcal lesions, sinus tract, physiologic or pathologic luxation, and/or presence of abscess were excluded from the study.
RNA Sequencing of Individual Versus Wastewater - SARS-CoV2

The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.


Eligibility Criteria:
Inclusion Criteria:

* whole population tested in Nice during W43 of 2020

Exclusion Criteria:

* none
Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

To perform this, all patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center. Seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.

Will thus be measured, within the same ejaculate, the concordance between the presence of SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.

The investigators will also determine if the virus presence in the sperm is related with :

* (i) the presence of SARS-CoV-2 in the nasal swab;
* (ii) patient symptomatology;
* (iii) a specific serological profile;
* (iv) a particular oncological pathology and / or treatment. The investigators may also find out if the presence of the SARS-CoV-2 in semen affects sperm quality.

This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer patients. This will guarantee the safety of fertility preservation procedures during the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Man above 18 years of age, of reproductive age, needing oncofertility preservation through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during the COVID-19 pandemic.
* Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic if he presents one or several of the following clinical signs: fever, cough, cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.
* A sufficient number of remaining spermatozoa straws to perform at least six ART attempts

Exclusion Criteria:

* Azoospermia
* Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
* Semen collection failure
* Non-emergency fertility preservation or treatment with low gonadotoxic risk
A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment

Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year old
* Patient is receiving kidney from live or death donor
* Kidney donor younger than 65 years old
* PRA ≤ 30%
* Negative pregnancy test for women
* Patient agreement to practice birth control
* Patient has been fully informed and has given written informed consent

Exclusion Criteria:

* HLA identical
* Patient multi-organ transplant recipient
* Any pathology or past medical condition that can interfere with this protocol
* Allergy or intolerance of any study medication
A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Eligibility Criteria:
Inclusion Criteria:

1. unresectable or recurrent histologically proved gastric cancer
2. adequate oral intake
3. age 20 or older and 75 or younger
4. Performance Status (ECOG):0, 1, 2
5. measurable or unmeasurable lesions
6. preserved organ functions
7. no severe medical condition
8. no prior chemotherapy for gastric cancer
9. written informed consent

Exclusion Criteria:

1. patient with marked infection or inflammation
2. patient with severe peritoneal metastasis
3. patient with massive pleural effusion
4. patient with metastasis to CNS
5. patient with diarrhea 4 or more times per day
6. patient severe medical condition
7. patient with other concurrent malignancy affecting on survival or adverse events
8. pregnant or nursing patient or with intent to bear baby
9. patient evaluated to be inadequate by a attending doctor
10. patient requiring nutritional support
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors

A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.

This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.

Eligibility Criteria:
Key Inclusion Criteria:

* Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy
* Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing.
* ECOG performance status of 0 or 1
* Demonstrate adequate organ function
* Additional inclusion criteria exist

Key Exclusion Criteria:

* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive
* Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV)
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable
* Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association \[NYHA\]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are \> 60 years of age must undergo cardiology clearance exam and cardiac stress test.
* Prior cell therapy or organ transplant
* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
* LVEF ≤ 45%
* FEV1 ≤ 60% of predicted value and DLCO (corrected) \< 60% of predicted value
* Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
* Additional exclusion criteria exist
A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

The primary objective of this study is to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD)

Tolvaptan has been demonstrated to delay the decline of kidney function in adults with rapidly progressing ADPKD (CKD stages 1 to 3), a closely related indication to ARPKD, as measured by estimated glomerular filtration rate (eGFR) and Total Kidney Volume (TKV).

The trial will be the first trial of tolvaptan in a pediatric ARPKD population.

Participants in this study will be assigned to tolvaptan for 24 months and closely monitored over the course of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 28 days and \< 12 weeks of age, inclusive at the time of enrollment.
2. Must have clinical and imaging features that are consistent with a diagnosis of ARPKD with all the following characteristics:

   * Nephromegaly (\> 2 standard deviations from age appropriate standard via ultrasound)
   * Multiple renal cysts
   * History of oligohydramnios or anhydramnios
3. Ability for parent or guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

Exclusion Criteria:

1. Premature birth (≤ 32 weeks gestational age)
2. Anuria or RRT, defined as intermittent or continuous hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or history of kidney transplantation
3. Evidence of syndromic conditions associated with renal cysts (other than ARPKD)
4. Abnormal liver function tests including ALT and AST, \> 1.2 × ULN
5. Parents with renal cystic disease
6. Need for chronic diuretic use
7. Cannot be monitored for fluid balance
8. Has or at risk of having sodium and potassium electrolyte imbalances
9. Has or at risk of having significant hypovolemia as determined by investigator
10. Clinically significant anemia, as determined by investigator
11. Severe systolic dysfunction defined as ejection fraction \< 14%
12. Serum sodium levels \< 130 mmol/L or \>145 mmol/L
13. Taking any other experimental medications
14. Require ventilator support
15. Taking medications known to induce CYP3A4
16. Having an infection including viral that would require therapy disruptive to IMP dosing
17. Platelet count \<50,000 µL
18. Significant Portal Hypertension
19. Bladder dysfunction or difficulty voiding
20. Taking vasopressin agonist
21. Having concomitant illness or taking medications that are likely to confound endpoint assessments.
22. History of cholangitis
23. Received or scheduled to receive a liver transplant
Antero-posterior Versus Antero-lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter

The aim of this study is to identify the one electrode position out of two most commonly used for external electrical cardioversion of typical atrial flutter, which needs less delivered energy and less needed number of shocks for successful cardioversion.

Typical atrial flutter is the second-most prevalent atrial tachyarrhythmia. No guidelines for treatment exist and few studies investigate treatment of atrial flutter. Mostly, guidelines for atrial fibrillation are followed for treatment of atrial flutter. Atrial flutter has a different pathomechanism as atrial fibrillation, therefore special guidelines for treatment are needed. Among drug treatment and ablation procedures, external electrical cardioversion is commonly used, especially for treatment of acute symptomatic patients. This study may help to further define safe and successful procedures for electrical cardioversion of atrial flutter.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of typical atrial flutter
* signed written informed consent
* eligibility for sedation and external electrical cardioversion

Exclusion Criteria:

* clinical diagnosis of arrhythmia other than typical atrial flutter
* implanted ICD or pacemaker
* proof of atrial thrombi
Effects of Different Exercise Training on Atrial Function in Hypertension

The study aim is to compare the effects produced by two different exercise training modalities on atrial function evaluated by speckle-tracking echocardiography on hypertensive patients with coronary artery disease. 50 males patients will be randomized to interval training or combined training the latter including both aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols.

This is a prospective randomized two- arms, single-blinded, parallel trial evaluating the effects of two different exercise training modalities on atrial function, assessed by speckle-tracking echocardiography, on hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of exercise-induced changes on peak atrial longitudinal strain (PALS). Secondary endpoints will be: exercise-induced changes on diastolic function and left ventricular strain. We will include 50 patient with hypertension and underlying coronary artery disease, evaluated for entering a cardiac rehabilitation program. Patients that will be judged suitable for the study will be randomized, with a 1:1 ratio, to interval training (IT) or combined training (CT) the latter including both aerobic and resistance exercises. Each patient will undergo three visits. At visit 1 in which patients will perform a first echocardiography with evaluation of the acoustic window and an ergometric test (for excluding myocardial ischemia and for establishing the training intensity); visit 2- acute evaluation- :patients will undergo an echocardiographic assessment before and within 30 minutes after a single exercise session (alternatively interval or combined training according to the randomization code). Visit 3: at 12 weeks all patient will perform a final echocardiography evaluation and a second ergometric test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 45 minutes

Eligibility Criteria:
Inclusion Criteria:

* Hypertension;
* Coronary artery disease;
* Age over 45 years;
* Male gender

Exclusion Criteria:

* Secondary hypertension;
* Significant heart valve diseases;
* Hypertrophic cardiomyopathy;
* Signs and/or symptoms of myocardial ischemia during an ergometric test;
* Uncontrolled arrhythmia;
* Neurological and or orthopedic conditions contraindicating or limiting exercises;
* Significant chronic obstructive pulmonary disease (FEV1 \<50%),
* Symptomatic peripheral arterial disease
Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis \& Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Good general health.
* No contraindications for periodontal surgery.
* Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
* The cemento-enamel junction (CEJ) is visible in the defective teeth.
* All patients demonstrating good plaque control.
* No previous periodontal surgery in the targeted area.

Exclusion Criteria:

* Smokers.
* pregnant or nursing patients.
* history of malignancy, radiotherapy, or chemotherapy.
* Patients taking medications that affect mucosal healing.
* Patients with allergy to collagen.
* Previous participation in a clinical trial.
* Type-1 diabetes patients.
* Patient who have diseases that affect connective tissue metabolism.
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents

Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.


Eligibility Criteria:
Inclusion Criteria:

1. female residents;
2. long term residents
3. English speaking; and
4. age ≥ 65 years.

Exclusion Criteria:

1. residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal \[life expectancy \< 1 month\]);
2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
3. residents with end stage renal disease on dialysis (they do not regularly produce urine);
4. residents unable to produce a baseline clean catch urine specimen for collection;
5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
7. have an indwelling bladder catheter in place;
8. have an allergy to cranberry products;
9. are being treated with cranberry products;
10. residence \<4 weeks.