cyrilzakka/clinical-trials huggingface dataset:
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline.


Eligibility Criteria:
Inclusion Criteria:

1. written informed consent duly read, signed and dated by the subject;
2. aged ≥18 and ≤65 years;
3. history of hypothyroidism due to total thyroidectomy;
4. on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily);
5. TSH at screening ≥0.3 and ≤4.0 mIU/L;
6. history of gastroesophageal reflux disease or associated gastrointestinal issues on prescription PPIs (i.e. omeprazole ≥20 mg daily, or esomeprazole ≥ 20 mg daily, or lansoprazole ≥ 15 mg daily, or pantoprazole ≥ 40 mg daily) for at least 8 weeks before screening visit and for whom chronic therapy with PPIs for the next 5 months has been prescribed;
7. for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause;
8. reasonable assumption of understanding the study and willingness to take part to the study and to comply with protocol requirements.

Exclusion Criteria:

1. suspected or ascertained non-compliance with LT4 or PPI therapy;
2. subject requiring changes of levothyroxine dose;
3. use of over-the-counter (OTC) PPIs;
4. history of malabsorption or history of gastric bypass surgery, short-gut syndrome, inflammatory bowel disease and other conditions of the gastrointestinal tract that may affect drug absorption (e.g. celiac disease)3;
5. multiple co-morbidities (e.g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);
6. neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology);
7. terminal condition;
8. parenteral or assisted enteral feeding;
9. presence of any medical condition or other circumstances which would significantly affect the safety of the subject or decrease the chance of obtaining reliable data, achieving study objectives or completing the study;
10. history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements;
11. pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;
12. known hypersensitivity to the ingredients of the preparation involved in the study3;
13. use of forbidden concomitant medications;
14. regular consumption of soy and soy derivatives, cotton seed meals, walnuts, and dietary fibres;
15. participation in other clinical studies during the 3 months prior to screening;
16. presumption of poor reliability/cooperation;
17. any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using alloderm versus connective tissue graft both with xenogenic bone membrane in immediate implants of anterior aesthetic zone.

Twenty surgical sites will be divided into two groups; each of which has 10 surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE)

The groups will be treated as follow:

* Group I: Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
* Group II: Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft Each group will be subjected to intraoral scanning at baseline, 6 months and 12 months. The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.

The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software Each group will be subjected to Cone Beam Computed Tomography (CBCT) at baseline, 6 months and 12months to asses both thickness and height of labial (facial) plate of bone and implant survival.

Eligibility Criteria:
Inclusion Criteria:

* Adults (20-50) years old.
* Class II socket according to Elian et al, (7)described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
* Thin gingival phenotype.
* Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
* Presence of at least 3 mm of keratinized gingiva.
* Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
* Smokers, diabetics, pregnant or lactating women.
* History of chemotherapy, radiotherapy in head and/or neck region.
* Bisphosphonate therapy.
Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B

The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.

Hemophilia B is a genetic X-linked bleeding disorder caused by a deficiency in blood-clotting Factor IX (FIX) activity. FIX is synthesized in the liver and circulates in the blood as a proenzyme. Current treatment for hemophilia B is based on replacement of the deficient FIX with IV injections of recombinant FIX protein prophylactically or as needed to treat bleeding episodes. This clinical program will test a gene transfer approach involving the use of a gene delivery vector carrying a FIX gene. This first-in-humans study is intended to evaluate the safety, kinetics, and if possible, the dose of AskBio009 required to achieve stable plasma FIX activity between 10% and 40% of normal activity.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18-75 years, inclusive
* Established hemophilia B with ≥3 hemorrhages per year requiring treatment with exogenous FIX OR use of FIX prophylaxis because of history of frequent bleeding episodes
* Plasma FIX activity ≤2% (\<1% for first cohort; then per protocol)
* Negative for active Hepatitis C virus (HCV), defined as Hepatitis C virus antibody negative and negative (undetectable) PCR test for plasma Hepatitis C virus ribonucleic acid (RNA) OR if Hepatitis C virus antibody positive must have ≥2 consecutive negative (undetectable) PCR tests for plasma HCV RNA at least 3 months apart, and negative at screening

Exclusion Criteria:

* Family history of inhibitor to FIX protein or personal laboratory evidence of having developed inhibitors to FIX protein at any time (\>0.6 Bethesda Units on any single test)
* Documented prior allergic reaction to any FIX product
* Detectable AAV8 neutralizing antibodies
* Markers of hepatic inflammation or overt or occult cirrhosis as evidenced by one or more of the following:

  * Platelet count \<175,000/μL
  * Albumin ≤3.5 g/dL
  * Total bilirubin \>1.5 x ULN and direct bilirubin ≥0.5 mg/dL
  * Alkaline phosphatase \>2.0 x ULN
  * ALT or AST \>2.0 x ULN (except for subjects who are HIV infected)
  * Liver biopsy in the past indicating moderate or severe fibrosis (Metavir staging of 2 or greater)
  * History of ascites, varices, variceal hemorrhage or hepatic encephalopathy
Emotion-Diet Interactions in Pregnancy

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).

Maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. Although maternal diet is a key regulator of this process, its effects vary widely across individuals. Maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. This project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* English and/or Spanish speaking
* 18-22 week's gestation
* Pre-pregnancy BMI 25.0-39.9 kg/m2
* Singleton, intrauterine pregnancy
* Non-smoker
* Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (\<200 mg/dl)

Exclusion Criteria:

* Non-fluency in English or Spanish
* BMI \<25.0 or ≥40.0 kg/m2
* \>22 week's gestation
* multiple pregnancy
* current smoker
* present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)
* presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
* current psychiatric disorders or undergoing treatment/taking psychiatric medications
* use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
* gestational diabetes mellitus or raised glucose result detected on the screening visit
* unwilling to eat the standard breakfast meal at each laboratory visit
Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD

This is a prospective, single-arm, multi-center, international, open-label, clinical study.

The aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
3. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
4. Subject has an infrainguinal target lesion(s) with any type of stenosis (naïve recurrent, or in-stent) estimated to be ≥70% based on CT angiogram or any other imaging modality.
5. Subject is capable and willing to comply with the scheduled follow up
6. Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

1. Target lesion has a stenosis estimated to be ≥70%.
2. In ATK subjects - at least one patent tibial run-off vessel into the foot

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Exclusion Criteria:

1. Target lesion is in a vessel graft or synthetic graft.
2. Target lesion length \<1cm and \>15 cm (in ISR cases could be \>25cm).
3. Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure.
4. Intent to use other atherectomy device in the same procedure.
5. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
6. Evidence or history of aneurysm in the target vessel within the past 2 months.
7. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
8. History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
9. Subjects requiring dialysis.
10. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
11. Serious illness that may affect subject compliance to protocol and 30-day follow-up.
12. Participating in another clinical study
13. Subject is pregnant or planning to become pregnant during the study period.
14. Life expectancy \< 12 months
15. Any planned amputation above the ankle.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

1. Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
2. Target lesion length \<1cm and \>15 cm (in ISR cases \>25cm).
3. Reference vessel lumen diameter proximal to target lesion is \<150% of the outer diameter of the B-LaserTM.
4. Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.

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Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors

Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation

Secondary Endpoints:

* To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation
* To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation
* To assess the incidence and duration of renal replacement therapy
* To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12
* To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation
* To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation

Definition of ECD

* Brain-dead donor \> 60 years old or
* Donor age \> 50 years old with two of the following criteria;
* History of HT
* Terminal SCr. ≥ 1.5 mg/dL
* Death from cerebrovascular accident Definition of AKI donor
* Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Recipients of first DDKT from ECD or AKI donors
* Patient willing to participate in the study

Exclusion Criteria:

* Multi-organ recipients

  * Organ donation after Cardiac Death (DCD).
  * PRA \> 20 % or with historical peak PRA \> 50%
  * Patients who lost first graft due to immunological reason within the first year post-transplantation.
  * ABO incompatible transplants or positive cross-match
  * Patients with chronic inflammatory bowel disease.
  * Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin
  * Thrombocytopenia (platelet \< 75,000/mm3), ANC \< 1,500 /mm3 or leucopenia (leucocytes \< 2,500/mm3), or Hb \< 6 g/dL
  * Chronic active HCV, HIV, or HBsAg positive
  * History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.
  * Ongoing infection requiring treatment with a systemic antibiotic.
  * Patient with severe hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 600 mg/dL) that cannot be controlled
  * Evidence of severe liver disease.
  * Severe restrictive or obstructive pulmonary disorders.
  * Pregnant or nursing (lactating) women.
  * Patient who refuse to participate into the study or would like to withdraw from the study.
Overactive Bladder Syndrome

Purpose:

A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB.

Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.

A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.

Eligibility Criteria:
Inclusion Criteria:

* overactive bladder syndrome
* enuresis nocturna

Exclusion Criteria:

* diabetes mellitus,
* neurological diseases
* bladder outlet obstruction,
* active urinary system infection
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects

The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric intraocular lens in the bag in high myopic subjects.

According to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (D) of refractive astigmatism. New toric IOL designs (Acrysof © toric IOL; Alcon), approved by the US Food and Drug Administration (FDA) at the end of 2005, have been found to be more stable and safety in the capsular bag in subjects with normal axis length of eye. Then,this study aims at the confirmation of the stability of The AcrySof Toric intraocular lens in the bag in high myopic subjects.Then we may find a more effective treatment for the high myopic patients with complicated cataract and sever cornea astigmatism .

Eligibility Criteria:
Inclusion Criteria:

1. Sphere more than -6.0D;
2. Cornea astigmatism from -1.0 D to -4.0D;
3. Clinical diagnosis of complicated cataract;
4. Ask for and accept refractive lens exchange surgery;
5. Accept AcrySof Toric intraocular lens .

Exclusion Criteria:

1. Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
2. Previous corneal or intraocular surgery;
3. Refuse surgery;
4. Refuse to use AcrySof Toric intraocular lens .
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.

The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 10 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.

Eligibility Criteria:
Inclusion criteria:

* Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
* Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at \>1 L/kg/min of flow
* Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
* Onset of RSV-related symptoms must be less than 5 days
* Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.

Exclusion criteria:

* AZM use within 7 days of ICU admission;
* Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
* Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
* Intensive respiratory support greater than 48 hours prior to ICU admission;
* Chronic ventilation or supplemental oxygen need at home;
* Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
* History of pyloric stenosis;
* AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).
Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response

Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
* Patient to be managed by surgery (laparoscopy and / or laparotomy).

Exclusion Criteria:

* Pregnant woman
* Persons deprived of liberty or guardianship (including curatorship)
* History of any other clinically active malignancy in the last 5 years prior to inclusion