cyrilzakka/clinical-trials huggingface dataset:
Maternal High Blood Pressure and Newborn's Blood Profile

Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.

Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.

Eligibility Criteria:
Inclusion Criteria:

* Age: 0-28 days
* Newborns of healthy mothers;
* Newborns of mothers with Pregnancy Induced Hypertension;
* Inborn Patients;
* Written Informed Consent signed by legal guardian.

Exclusion Criteria:

* Maternal disease other than PIH;
* Syndromal, chromosomal or infectious diseases of the newborns;
* Causes other then PIH for perinatal asphyxia.
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy patients with rosacea
* Males and females ≥18 years of age
* 10 to 40 papules and pustules and ≤2 nodules
* Score of 2 to 4 on the IGA
* Presence of telangiectasia
* Moderate to severe erythema

Main Exclusion Criteria:

* Use of topical acne treatments or topical or systemic antibiotics
* Use of systemic retinoids within 90 days of baseline
* Use of an investigational drug within 90 days of baseline
* Pregnant or nursing women
* Women of childbearing potential not using an adequate form of contraception
* Change in method of contraception within 4 months of baseline
* Known hypersensitivity to tetracyclines
* Surgeries that bypass or exclude the duodenum or achlorhydria
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.

Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.

Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.

Clinical, randomized, controlled, multicenter, parallel and open trial.

Eligibility Criteria:
Inclusion Criteria:

* Men and women.
* Age from 18 to 75 years.
* Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
* Maddrey score\> = 32.
* Acceptance of participation through written informed consent.

Exclusion Criteria:

* Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
* Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
* Hepatocarcinoma.
* Portal cavernomatosis.
* Portal cavernomatosis.
* Any disease whose life expectancy is less than 12 months.
* Patients with nitroglycerin and / or carbamazepine-based treatments.
* Patients with uncontrolled active infection.
* Acute kidney disease with creatinine\> 2.5 mg / dL.
* Uncontrolled upper gastrointestinal bleeding.
* Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
* Multiple organ failure or shock.
Beta2-adrenergic System and Training

This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Trained individuals with a maximal oxygen uptake above 55 ml/min/kg
* Body mass index lower than 26

Exclusion Criteria:

* Allergy towards study drug
* Unacceptable side effects to the study drug
* Chronic disease deemed by the MD to interfere with the study
* Smoking
* Use of prescription medicine
Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation

A case series study on ten patients with lack of keratinization in the non-esthetic area .the purpose of the study is the evaluation of using the titanium tacks in free gingival graft fixation as an alternative to the conventional suturing techniques or the tissue adhesives.

A case series study conducted on 10 patients with lack of keratinization in the non- esthetic areas for clinical evaluation of the effeciancy of the titanium tacks in free gingival graft fixation in terms of the amount of the graft shrinkage through out a six months follow up period . the records will be taken through imagej software for comparing the graft surface area at 1 , 3 and six months .

Eligibility Criteria:
Inclusion Criteria:

* patient with lack of keratinization in the non-esthetic areas

Exclusion Criteria:

* patients on chemotherapy
* patients on radiotherapy
* smokers
* patients with bad oral hygiene
Role of Bumetanide in Treatment of Autism

Role of bumetanide in Autism

Role of Bumetanide in Treatment of Autism spectrum disorder in children

Eligibility Criteria:
Inclusion Criteria:

1. All patients with ASD diagnosed by CARS rating Scale⩾30.
2. Age of patients range between (3-12) years.

Exclusion Criteria:

* Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult

This study was conducted to determine the effectiveness of digital manipulation of thyroid cartilage for the management of stuttering in adult.There were three groups,Group A received Digital Manipulation of Thyroid cartilage (DMT),Group B received Fluency shaping Therapy(FST),Group C received combination of DMT,FST.

The purpose of speech therapy is to stop progression of stuttering while teaching the method to client how to cope efficiently his or her stuttering disorder.

The goal of fluency shaping therapy to eliminate the severity of stuttering by adopting the specific pattern of speech production and also reduce negative reaction to stuttering by default).

Digital manipulation of thyroid cartilage decreases tension in vocal fold and reduces severity of stuttering and improves production of speech. DMT reduces unnecessary amount of tension in vocal tract and participant speaks with relax respiration,phonation, articulation and facilitate more fluent.in DMT subject speaks in natural way rather than in specific method in every situation.

Eligibility Criteria:
Inclusion Criteria:

* Developmental stuttering
* Between age of 18 to 30 years
* Only male

Exclusion Criteria:

* Language disorders
* Cluttering
* Neurological stuttering
Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

1. To compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors.
2. To validate a pharmacokinetic model which has been established in a formal paper.
3. To create a safe and effective RCA-CRRT protocol.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals, none-pregnant
* diagnosed with acute renal failure according to RIFLE criteria
* ARF with hepatic insufficiency
* ARF with MODS or sepsis
* within informed consent

Exclusion Criteria:

* used drugs with citrate within one week
* infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours
* serious alkalosis with PH\>7.55
* serious lactic acidosis
* not in resuscitation state
Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells

The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) \[containing Adipose Derived Stem Cells (ADSCs)\] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.


Eligibility Criteria:
Inclusion Criteria:

1. Female or Male, Age 18 years or older
2. Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
3. Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
4. BMI between and including 23 and 28
5. Able to understand and provide written and verbal informed consent

Exclusion Criteria:

1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening
2. Diagnosis of any of the following medical conditions:

   * Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
   * Active infection
   * Type I or Type II Diabetes
3. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
5. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
6. Subjects with elevated kidney and/or liver functions
7. Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase risk for subjects.
8. Subjects with life-expectancies less than 9 months
9. Subjects with known collagenase allergies
10. Subjects with idiopathic or drug-induced coagulopathy
11. Pregnant females
12. On radiotherapy or chemotherapy agents
13. Taking strong CYP450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
14. Subjects with a history of keloids or hypertrophic scar formations
EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions

The aim of this study is to evaluate the diagnostic accuracy, safety and tolerability, predictors of success of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions.

The Investigators will also evaluated the adequacy of samples obtained for molecular analysis in patients with Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is by far the leading cause of cancer death among both men and women worldwide. Non-Small Cell Lung Cancer (NSCLC) represents about 80-90% of all lung cancers. Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is a safe and accurate technique that has been mostly described for the diagnosis and the mediastinal nodal staging of NSCLC, as a complementary technique to endobronchial ultrasound trans-bronchial needle aspiration (EBUS-TBNA) or when EBUS-TBNA may be difficult and/or contraindicated for clinical reasons (e.g. excessive cough, respiratory failure etc).

Few retrospective studies evaluated the sensitivity and the safety of this technique in the diagnosis of parenchymal pulmonary lesions suspected for lung cancer, in contact or adjacent to the esophagus. Few data are available on the adequacy of the samples obtained by EUS-B-FNA for molecular analysis in NSCLC. The main predictors of success are still unclear.

The primary aim of this prospective study is to evaluate the diagnostic accuracy of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluate the safety and tolerability of the technique, the main predictors of success and the adequacy of samples obtained for molecular analysis in patients with NSCLC

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a lung parenchymal lesion suspected for malignancy, in contact or adjacent to the esophagus at the CT scan (with or without mediastinal lymph adenopathies), requiring a pathological diagnosis:

  * which can not be sample by bronchoscopy/EBUS-TBNA or
  * with a previous not diagnostic bronchoscopy/EBUS-TBNA or
  * with clinical/anesthesiological contraindications to bronchoscopy/EBUS-TBNA or
  * with a previous nodal EUS-B-FNA not diagnostic/not adequate at the ROSE
* Patients with lung parenchymal lesions who are able to sign the informed consent for the study participation

Exclusion Criteria:

* Patients with lung parenchymal lesions of known etiology;
* Patients with lung parenchymal lesions in whom bronchoscopic ultrasound-guided trans- esophageal needle aspiration is contraindicated;
* Patients with lung parenchymal lesions who refuse/are not able to sign the informed consent for the study participation
Evaluation of Neuroinflamation of SAH

The investigators are planning that can these markers be used a predictive marker at SAH and for this aim we will study both patiens' blood sample and their CT image.

An ideal marker which could be used clinically should meet numerous criteria, such as high sensitivity or the possibility of easy and quick assessment of its concentration in blood or blood plasma.The Fisher's scale presents an alternative for evaluating patients with subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and fishers scale at SAH.

Eligibility Criteria:
Inclusion Criteria:

* Ruptured Subarachnoid Aneursym

Exclusion Criteria:

* without aneursymal sah
* Patient's positive for rheumatoid factor and anti-CCP or with chronic inflammatory diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction, stroke, peripheral artery disease), active infection, a history of term medication, trauma to the hip and smoking were excluded from the study.
Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.

The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

  1. Part 1. Dose Escalation: solid tumors, previously treated
  2. Part 2. Dose Expansion:

  i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases \<2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
* ECOG performance status 0 or 1
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Predictive Factors Study

This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acromegaly.
* Males and females aged 18 years and older.
* Signed informed consent (patient must give consent to the collection of retrospective data).
* Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
* With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
* If already being treated with ATG:

Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).

* Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.

Exclusion Criteria:

* The subject has had radiotherapy in the last 5 years.
* The subject has had surgery in the last 3 months.
* The subject has already been included in this study.
* Participation in an interventional trial, or receiving experimental drug.
A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures
* Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
* Females must be post menopausal or surgically sterile Self-identified as Hispanic

Exclusion Criteria:

* Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
* Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
* Current smokers, including the use of tobacco containing products in the past 1 month of randomization
* Patients requiring dialysis
Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

The purpose of this phase 2 study is to examine if inhibiting IL-17A activation using the biologic drug Taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries.

The purpose of this phase 2 study is to examine if inhibiting IL-17A activation using the biologic drug Taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries. Inhibition of the IL-17A pathway can slow or reverse the inflammation causing airway narrowing in patients with idiopathic subglottic stenosis. This would have a significant impact on quality of life for patients living with this diagnosis as it may help them to avoid frequent surgical procedures, recoveries and associated costs.

This is a single arm, open-label study where all participants will receive drug. The study population is patients with a documented diagnosis of idiopathic subglottic stenosis who are followed at Yale New Haven Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* diagnosis of idiopathic subglottic stenosis

Exclusion Criteria:

* History of active or latent tuberculosis infection
* History of inflammatory bowel disease
* Pregnancy or lactation
* Known allergic reactions to study drug
* Disease involving the vocal cords
* Individuals who are taking drugs known to trigger angioedema, including use acquired angioedema from drugs such as ACE inhibitors (e.g. Lisinopril) and nonsteroidal anti-inflammatory drugs (NSAIDs) and individuals with a history of other forms of angioedema such as hereditary and Clesterase deficiency
Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery

Primary prosthetic surgery for the treatment of gonarthrosis is currently one of the most prevalent surgical treatments in Traumatology. The Arthroplasty Register in Catalonia, which started in 2005, counted more than 60.000 knee prothesis until 2015. Regarding the peridiocity for taking control radiographs in patients undergoing knee replacement surgery, there is no consensus. This means, that in similar studies that evaluate the results of prosthetic surgery, there is a great variability in radiological follow-up protocols, especifically during the firts post-operative years. Given the high prevalence and the long survival period demonstrated by these implants, it seems reasonable to be able to establish the real value of the radiographs performed during the first year of follow-up after surgery. From this perspective, the aim of our study is to evaluate if conducting just two radiographs instead of five during the first postoperative year after the surgery, has any influence on the clinical and functional results of our patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who voluntarily agree to be part of the study and sign the informed consent
* Patients awaiting prosthetic knee surgery with a diagnosis of gonarthrosis without age limit (\>18 years)
* All cases of prothesis cemented to the tibia and femur will be included, regardless of whether or not the patellar component is prosthetic
* Patients with knee prothesis and cruciate ligament retention, with ultracongruent polyethylene or posterostabilized as a maximum degree of prosthetic constriction
* The implants will be the usual ones used in our Center for primary prosthetic knee surgery, Journey (smith-Nephew) and Persona or NexGen (Zimmer)

Exclusion Criteria:

* Patients who do not voluntariily agree to participate
* Patients undergoing primary prosthetic surgery in relation to tibial plate fractures
* Patients awaiting a unicompartimental or patellofemoral prothesis
* Patients who, for any reason, want to leave the study during the follow-up period