cyrilzakka/clinical-trials huggingface dataset:
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis

This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers.


Eligibility Criteria:
Key Inclusion criteria:

* Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.
* Male or female subjects with ATTR-PN who had not undergone liver or heart transplantation at time of enrollment.
* If female, subject was post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control

Key Exclusion criteria:

* Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)
* Pregnant or breast feeding female subjects.
* Clinically significant medical condition that, in the opinion of the investigator, would place the subject at an increased risk to participate in the study.
* An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value \>3 × upper limit of normal (ULN) that, in the medical judgment of the investigator, was due to reduced liver function or active liver disease.
* Sexually active males with partners of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 3 months after last dose of study drug.
Early Life Intervention in Pediatrics Supported by E-health

Childhood obesity in early life contributes to the development of specific NCDs, i.e. adult obesity. Unhealthy diet and low level of physical activity are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of NCDs. Early preventive measures to improve lifestyle behavior are of utmost importance. The aim of ELIPSE-I is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering total energy intake/total energy expenditure (TEI/TEE) ratio in their children with BMI \>97 centile (ELIPSE-I).

ELIPSE-I represents a single-blind randomized controlled parallel-group clinical trial. In ELIPSE-I, 148 children, matched for sex, 6-12 years of age with a BMI \>97 centile based on national growth charts will be included. Children will be recruited at the children's university hospital and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of the TEI/TEE ratio in children with obesity. Secondary endpoints in ELIPSE-I include lowering the severity of obesity, cardiometabolic risk factor improvement, reduction in chronic low-level inflammatory biomarkers, and improved children's quality of life. A further endpoint is acceptance and usability of the app.

Eligibility Criteria:
Inclusion Criteria:

* German speaking parents
* Any ethnic background/race
* Children should live/grow-up in the same household as the parental participant
* Children with an age- and sex-matched BMI \>97 centile according to Swiss national growth charts
* Children who newly attend the outpatient weight management clinic at the Division of Pediatric Endocrinology at the University Children's Hospital Bern
* Signed informed consent form from parent(s)

Exclusion Criteria:

* Syndromic obesity
* Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
* Insufficient knowledge of German language
* Participation in another clinical trial targeting similar objectives
Detection of Coronary Stenosis With Intravenous Microbubbles

To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.

The objective of this clinical study will be to visualize both coronary and carotid arteries as well as detect myocardial perfusion following a routine intravenous injection of Definity (0.05-0.20 millimeters), Optison (0.1-0.4 millimeters) or PESDA (0.05-0.2 mL). Following these injections , we will attempt to Contrast Pulse Sequencing on the Siemens Acuson Sequoia system to image both the coronary and carotid arteries, as well as the Myocardial perfusion.

Eligibility Criteria:
Inclusion Criteria:

* subjects scheduled for routine echocardiogram to look for evidence of Coronary artery disease or a stress echocardiogram
* women of child-bearing potential must be taking a medically approved form of birth control with a negative urine pregnancy test
* be conscious and coherent, and be able to communicate effectively with study personnel
* last eight patients will be diabetics who smoke
* provide informed consent after receiving a verbal and written explanation of the purpose and nature of the study

Exclusion Criteria:

* severe valvular heart disease by Doppler Echocardiography
* females of child-bearing potential who are not taking a medically approved method of birth control will be excluded. If the patient is pregnant she will be excluded.
* patients who are allergic to blood or blood products will be excluded
* have contraindication to Optison, Definity, or PESDA (pulmonary HTN, cardiac shunt)
* non diabetics, non smokers
IGF Level in Breast Cancer Patients Treated With Metformin

The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.

One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with MBC
* patients older than 18
* nondiabetic patients
* patients who received only chemotherapy

Exclusion Criteria:

* patients with non-metastatic breast cancer
* patients receiving hormonal therapy or radiotherapy
* patients with diabetes
* history of cardiac diseases
* hypersensitivity, or allergy to metformin.
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days.
* Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers.
* Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment.

Exclusion Criteria:

* Patients that only receive one dose of ceftazidime in total
* Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
* Not meeting inclusion criteria
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers.

Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants under 32 weeks gestational age and less than 1500g birthweight.
* Born at BCNatal Hospital Clínic between years 2014-2019.

Exclusion Criteria:

* All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded.
* Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)
Probiotics and Hemodynamic Changes in Cirrhosis

This is a single-center blinded randomized interventional placebo-controlled study of the effect of probiotics on hemodynamic parameters and liver function in cirrhosis.

Forty patients with Child-Pugh class B and C cirrhosis will be randomized in a 1.5:1 ratio to test and control arms. Patients in the test arm will receive probiotic Saccharomyces boulardii (A07FA02 - Saccharomyces (Enterol) Biocodex Ltd, France, registration number LP-000622 from 21.09.2011) for 3 months, patients in the control arm will receive placebo for 3 months. All patients also will receive standard treatment: spironolactone 100 mg/day in ascites and carvedilol 12.5 mg/day in esophageal varices. The patients will be blinded. At inclusion and after 3 months after starting of probiotic/placebo treatment, systemic hemodynamics parameters (cardiac output and systemic vascular resistance), liver function (serum albumin and total bilirubin level, international normalized ratio, presence and degree of ascites or hepatic encephalopathy), the gut microbiome, biomarkers of bacterial translocation (presepsin, lipopolysaccharide), intestinal permeability (claudin 3), systemic inflammation (tumor necrosis factor alpha ) and endothelial dysfunction (nitrites, endothelin) will be assessed. After the end of the study, an interim analysis of the effect of the probiotic on aforementioned systemic hemodynamics and liver function indicators will be carried out. If there is a positive effect, a full analysis of all the aforementioned factors contributing to its development will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Child-Pugh class B or C;
* Age between 18 and 70 years;
* Signed informed consent.

Exclusion Criteria:

* Use of lactulose, lactitol, or other prebiotics, probiotics, antibiotics, or metformin in the past 6 weeks before inclusion;
* Alcohol consumption in the past 6 weeks before inclusion;
* Inflammatory bowel disease;
* Cancer;
* Prematurely discontinuation of the consumption of tested probiotic/placebo;
* Started taking antibiotics, other probiotics, or prebiotics during the follow-up period;
* Refusal to participate during the follow-up period.
Physiologic Change of Posterior Ocular Segment During Pregnancy

Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.

The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.

Ocular anterior segment changes during pregnancy are the followings

* Melanogenesis of eyelid and facial skin -\> melasma
* Cellular alteration of lacrimal and meibomian gland -\> dry eye symptoms
* Increased corneal thickness and corneal curvature -\> contact lens intolerance
* Increased lens thickness -\> loss of accommodation
* Decreased intraocular pressure -\> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* Age \> 18 years
* Gestational age \< 12 weeks
* Written informed consent

Exclusion Criteria:

* High risk pregnancy such as multifetal pregnancy and preeclampsia
* History of vitreoretinal diseases such as retinal vasculitis
* History of intraocular laser treatments or intraocular surgeries
* History of systemic diseases such as diabetes mellitus and thyroid disease
* Refractive error; spherical equivalence \> 4 diopters
* Clear ocular media
* Could not be taken the images by non-dilated pupil

Withdrawal Criteria:

* Preterm labor; gestational age \< 34 weeks
* Multifetal pregnancy was demonstrated by ultrasound
* Severe labor and delivery complications such as
* Severe postpartum complications such as postpartum bleeding
* Taking hormone during the follow-up period
Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

The reported prevalence of disproportionate pain and disability among patients recovering from a fracture of the distal radius varies widely. Literature reports numbers between 1% and 37%, perhaps in part because it is poorly defined, known by so many different names, subjective, and unverifiable.

The investigators are interested in the effect of vitamin C after distal radius fractures on objective measurement of finger motion, patient reported outcome measures, and pain intensity, instead of the previously used, subjective and imprecise criteria for complex regional pain syndrome.

Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius fracture will be asked to participate in this clinical trial. Patient will be randomly assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as regarded by the treating physician at follow-up or for 6 weeks.

The investigators hypothesize no difference in finger stiffness at 6 weeks measured by distance to palmar crease of the index through little finger between patients taking vitamin C or placebo after a distal radius fracture. Additionally, the investigators assess finger stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper extremity function and pain score both measured at six months.


Eligibility Criteria:
Inclusion Criteria:

* All adult (age 18 or greater) patients presenting to the Hand and Orthopaedic Trauma Services of the Massachusetts General Hospital (MGH) within two weeks of a fracture of the distal radius, either operatively or nonoperatively treated

Exclusion Criteria:

* Patients with severe kidney failure, known allergy for vitamin C or pregnancy
* Multiple fractures, except for ulna fractures
Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study

Obesity is a disease not always attributable to nutritional imbalance, frequently associated with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to explore pituitary morphology and its association with pituitary function and metabolic phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease in a cross-sectional .


Eligibility Criteria:
Inclusion Criteria:

* Adult obese

Exclusion Criteria:

* psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function
Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

This is a randomized control trial to determine whether electroacupuncture(EA) intervention with Morphine can reduce the intraoperative pain and early post-operative complications in patients undergoing catheter ablation of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Atrial fibrillation
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. A history of allergy to acupuncture;
2. With uncontrolled congestive heart failure;
3. Having significant valvular disease;
4. Having moderate-to-severe pulmonary hypertension;
5. With myocardial infarction or stroke within 6 months of screening;
6. With Significant congenital heart disease;
7. Ejection fraction was \<40% measured by echocardiography;
8. Allergic to contrast media;
9. Contraindication to anticoagulation medications;
10. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
11. Left atrial thrombus;
12. Having any contraindication to right or left sided heart catheterization
Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Exclusion Criteria:

* ASA classification IV
* Unable to make a written, informed consent
* Allergic to neuromuscular blocking agents, anesthetics, opioids
* Patients with neuromuscular disease
* Hepatic failure
* Renal failure
* History of malignant hyperthermia
* Morbid obesity with BMI\>35 kg/m2
* Patients enrolled in another clinical trials
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. PAH diagnosis confirmed with right heart catheterization (RHC):

   * Idiopathic or heritable PAH, or
   * Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or
   * PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) I, II or III
3. Male or female ≥ 3 months and \< 12 years of age (maximum age at randomization is 11.5 years)
4. Body weight ≥ 3.5 kg
5. Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air)
6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. During the study, all background treatments should remain stable
7. Signed informed consent by the parents or legal representatives

Exclusion Criteria:

1. PAH etiologies other than listed above
2. Non-stable disease status
3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost
4. Systolic blood pressure \< 80% of the lower limit of normal range
5. Aspartate aminotransferase and/or alanine aminotransferase values \> 1.5 times the upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:

   * Glibenclamide (glyburide)
   * Cyclosporin A
   * Sirolimus
   * Tacrolimus
   * Fluconazole
   * Rifampicin (rifampin)
   * Ritonavir
   * Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
   * Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment