cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation of OptiThyDose

The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).

Thyroid diseases can affect people from birth to adulthood, ith some being present at birth (congenital) and others developing later in life (acquired). These diseases need to be treated quickly and properly because if left untreated, they can impact brain development, thinking abilities, growth, puberty, and other important body functions. However, treating thyroid diseases in children can be challenging, as it's important to avoid both under- and overdosing.

Algorithms that help determine the best individual dose for children with thyroid diseases could reduce the risk of long-term problems, like impaired thinking and growth. This is especially important because cases of thyroid diseases in children are increasing worldwide.

OptiThyDose is a new mathematical model developed to help doctors find the right dose for children with thyroid diseases.

The primary goal of this multicentric, randomised, two-arms and single-blinded study is to test how well OptiThyDose works for children with two types of thyroid diseases: Congenital Hypothyroidism (CH) and Graves' Disease (GD).

If proven effective, OptiThyDose could help ensure more accurate dosing of thyroid medications, leading to better hormone control, fewer side effects, and improved health outcomes in children with Congenital Hypothyroidism (CH) and Graves' Disease (GD).

Eligibility Criteria:
Inclusion Criteria:

Congenital hypothyroidism (CH)

* Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample

Graves' disease (GD)

* Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ/MMZ during follow-up according to:

  * Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies)
  * Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood)

CH and GD

* The study participant must be accessible for scheduled visits, treatment and follow-up.
* Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and/or his/her legal representative(s) in accordance with national legal requirements

Exclusion Criteria:

CH and GD

* Exclusion of newborns from mothers with GD
* Exclusion of patients in case of a life-threatening event

GD

* Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.:

  * known toxic thyroid nodules proven by ultrasound/scintigraphy
  * known amiodarone induced hyperthyroidism
  * known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism
  * known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Eligibility Criteria:
Inclusion Criteria:

* Provided consent to participate in the study
* Male or female, 12 years of age and older
* Clinical diagnosis of asthma for at least 1 year prior to the randomization
* Clinic PEF of greater than or equal to 50% of predicted normal value
* Subject must be appropriately using one of the treatments for asthma listed in the protocol
* Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
* Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
* requiring treatment with systemic corticosteroids
* an asthma-related hospitalization

Exclusion Criteria:

* History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
* Concurrent respiratory disease other than asthma
* Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
* Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
* Presence of a bacterial or viral respiratory infection that is not resolved at randomization
* An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
* More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Subject must not meet unstable asthma severity criteria as listed in the protocol
* Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
* Pregnancy, breast-feeding or planned pregnancy during the study
* A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Amr's Maneuver and Postpartum Hemorrhage

The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Primary:

Compare the incidence of post partum hemorrhage (PPH\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Secondary:

Comparing:

* The amount of blood loss in each arm of the study
* Hematocrit before and after labor
* Duration from delivery of placenta till discharge from the delivery room

Eligibility Criteria:
Inclusion Criteria:

* All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included

Exclusion Criteria:

* Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery
Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year

Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
* Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
* Male and female \* 18 years old.
* Informed consent signed up.
* Performance status grade 0 - 2 (ECOG).
* SGOT and SGPT \<3N
* Serum bilirubin \< 1.5 N
* Serum creatinine \< 1.5 N
* No HSC graft planned
* B-HCG negative for female with potential childbearing

Exclusion Criteria:

* Absence of complete hematologic response
* Extramedullar involvement
* Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
* Depressive syndrome not controlled
* Not controlled dysthyroidy
* Auto-immune pathology not controlled
* Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study
* Significant cardiac disease (grade 3 or more)
* Known seropositivity for HIV
* Active viral hepatitis
* Other malignant disease
* Other experimental medication
Sanitary Napkins for Urinary Assessment of Micronutrients

This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.

Urinary collection in newborns and infants can be difficult. Our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. Participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. Participants weight, height, age, nutritional supplement use and diet will be assessed.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers Written informed consent

Exclusion Criteria:

BMI \< 18,5 and \>24,9 Use of medication (except contraceptives) Smoking
Augmenting Clozapine With Sertindole - SERCLOZ

The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.

Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.

Eligibility Criteria:
Inclusion Criteria:

* ICD10 diagnosis of schizophrenia (F20.0-3)
* Clozapine treatment minimum 6 months
* Total PANSS \>65
* No antipsychotic other than clozapine drug 1 month prior inclusion

Exclusion Criteria:

* QTc \>500 ms
* Violence to SPC of clozapine or Serdolect
* Major depression
* Significant substance misuse interfering with participating in the study
* Cardiovascular disease
Effect of the Use of Low Intensity Therapeutic LASER

Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.

100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients with diabetic foot ulcers;
* Patients aged 18 and over.

Exclusion Criteria:

* Patients with autoimmune diseases
* Patients with concomitant psychiatric disorders
* Patients with contraindications to treatment methods
* Patients with infected diabetic foot ulcers.
Retrospective Pulmonary Valve Replacement Imaging

This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies.

Congenital heart defects having a component of pulmonary stenosis (narrowing) are often palliated in childhood by disrupting the pulmonary valve. This arrangement can provide an excellent quality of life as these children grow and enter young adulthood. Unfortunately, the pulmonary insufficiency that is created by disrupting the pulmonary valve results in volume overload of the right heart. This may eventually lead to right ventricular dilation and irreversible right heart failure. In addition, volume load of the right heart may affect the inter-ventricular septum and left heart function as well. Placement of a competent pulmonary valve at a subsequent operation, hopefully at a time without the replacement valve size constraints present at the initial operation, is a means to eliminate the volume overload and prevent these further sequelae.

Unfortunately, the optimal timing for subsequent pulmonary valve replacement is controversial. One of the currently used indications for valve replacement includes a right ventricular to left ventricular volume ratio greater than two. However, determining the boundaries of the right ventricle by echocardiography and magnetic resonance imaging is difficult in the absence of a pulmonary valve. The boundaries are determined by an arbitrary estimation of where the pulmonary valve should be. Other potential indicators for pulmonary valve replacement may be right ventricular area and right ventricular strain, determined by echocardiography. These measurements are not affected by the absence of the pulmonary valve. They may provide better markers for impending right ventricular failure and a simpler means to follow serial improvement following valve replacement.

While the emphasis after pulmonary valve disruption typically lies on the right ventricle, there is evidence that the left ventricle may become impaired as well. Volume load on the right ventricle causes bowing of the inter-ventricular septum and affects left ventricular function. Echocardiographic imaging of the left ventricle may also be important to follow serial improvement of the left heart following pulmonary valve replacement.

All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University Hospital between January 1, 1994 and December 31, 2006. We will review approximately 125 patients' charts for patients between the ages of 1 and 65 years of age who have required pulmonary valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* history of Tetralogy of Fallot or Pulmonary Stenosis
* Pulmonary Valve Replacement
* Surgery at Children's Healthcare of Atlanta or Emory University Hospital between 1.1.94 and 12.31.06
* between 1 and 65 years of age

Exclusion Criteria:

* Those who do not meet inclusion criteria
Use of Transexamic Acid in Hip Replacement

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.

Treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. In association with the investigators aging society, the number of patients who will need THA may increase significantly in the next few years \[1\]. However, in THA, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. Such transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. Several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. The antifibrinolytics include aprotinin, tranexamic acid (TXA), and ε-aminocaproic acid, which have different mechanisms of action \[8\]. TXA is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. Compared with other antifibrinolytic drugs, TXA is cheaper and safer than aprotinin and more potent than the others. Numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. However, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary THA
* Diagnosis - not fracture, elective surgery
* Revision THA

Exclusion Criteria:

* Known allergy to TNA
* Acquired or congenital coagulopathy
* Current anticoagulation therapy
* Preoperative hepatic or renal dysfunction
* Severe ischemic heart disease (Serious cardiac or respiratory disease)
* A history of thromboembolic disease
* Refusal of blood products
* Pregnancy or breastfeeding
Agreement and Accuracy of Different Devices Corneal Measurements

To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 99 years
* Presence of keratoconus
* Signed informed consent

Exclusion Criteria:

* Contact lens history within 5 days
* Pathologic changes of the lid or conjunctiva on slit-lamp examination
* History of corneal ocular surgery/Previous corneal cross-linking
Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.

The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively.


Eligibility Criteria:
COHORT A:

Inclusion Criteria:

* Age \>= 18 years
* Single testicular lesion, with \< 2 cm diameter and \< 30 % testicular volume involvement;
* Negative Serum Tumour Markers;
* Suitable for testis sparing surgery;
* Informed consent.

Exclusion Criteria:

* None

COHORT B:

Inclusion Criteria:

* Age \>= 18 years
* Single/multiple post-chemotherapy retroperitoneal lymph node lesion, with \> 1 cm (non seminomatous) / \> 3 cm (seminomatous) diameter in patients with previous testicular germ cell primary tumour;
* Negative Serum Tumour Markers;
* Suitable for retroperitoneal lymph node dissection;
* Informed consent.

Exclusion Criteria:

* None
A Non-Interventional Study of the Occurrence Rate of Non-Small Cell Lung Cancer, Colon Cancer, Breast Cancer, Gastric Cancer and Malignant Melanoma in Turkey, and Diagnosis and Treatment Characteristics

This non-interventional study will assess the occurrence rate of non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the diagnostic methods and treatments used. Data will be collected over 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with non-small cell lung, colon, breast, gastric cancer and melanoma
* Participants who give consent to the collection of their information after the first record and pathological confirmation of their cancer

Exclusion Criteria:

* Participants not living in the city or representative region of the study center
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient at least 12 years of age
* Both genders; females of childbearing potential must be willing to use birth control method
* Clinical diagnosis of asthma for ≥12 weeks
* Best pre-bronchodilator FEV1 of 40%-90% predicted
* Reversibility of FEV1 of at least 12% and 200mls
* Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
* Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits

Exclusion Criteria:

* History of life-threatening asthma
* Respiratory infection within last 4 weeks leading to change in asthma management
* Asthma exacerbation within last 3 months
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, or medications related to study drugs
* Taking another investigational medication or medication prohibited for use during the study.
* Previous participation in a vilanterol (GW642444) study