cyrilzakka/clinical-trials huggingface dataset:
Early Peanut Introduction: Translation to Clinical Practice

The recent finding that early introduction of peanut can prevent \~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. These questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. To that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut IgE, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.

400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study. All subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines. Participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.

Eligibility Criteria:
Inclusion Criteria:

* Infants age 4-11 months
* Have at least one of the following criteria:

  1. physician diagnosis of milk, egg or other non-peanut food allergy,
  2. at least moderate eczema as defined by a SCORAD score of at least 25 on present or previous evaluation, OR a rash that required the application of topical creams or ointments containing corticosteroids or calcineurin inhibitors and occurred on at least 7 days on two separate occasions, or is described by the parent or guardian as "a bad rash in joints or creases" or "a bad itchy, dry, oozing or crusted rash".
  3. a first degree relative (parents or siblings) with either a physician diagnosis of IgE mediated peanut allergy OR reported history of symptoms consistent with IgE mediated peanut allergy (onset of symptoms within 2 hours of exposure, AND symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with exposure, AND no subsequent exposure to peanut without symptoms).

Exclusion Criteria:

* History of feeding problems
* History of eosinophilic gastro-intestinal disease
* Significant medical history (aside from eczema, food allergy or history of wheeze)
* History of peanut reactions or tolerance prior to baseline screening
A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy

The goal of this observational is to compare in describing fetal health conditions. The main questions it aims to answer are:

* fetal electrocardiogram (fetal heart rate and fetal rhythm)
* electrohysterography (uterine contractions).

Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If there is a comparison group: Researchers will compare clinical CTG equipment to see if this wearable device.

The investigators put the patch of the wearable device on the abdomen of the pregnant woman and continued the test for thirty minutes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a gestational cycle greater than 36 weeks

Exclusion Criteria:

* male
* Pregnant women with a gestational cycle less than 36 weeks
Finding Solutions to Thrive After Birth Asphyxia in Africa

Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. In low-income countries (LICs), families often lack the resources to care for affected children. For those with disabilities, stigma is high, and social and emotional impacts are substantial. Improving our understanding of NE in LICs is crucial if intervention strategies are developed. Providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential.

The primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with NE in Uganda.


Eligibility Criteria:
Inclusion Criteria:

* Male and female neonates meeting the criteria for birth asphyxia
* Gestational age ≥ 36 weeks and birth weight ≥ 1800 g;
* Admitted to Kawempe Hospital or Nsambya Hospital within 48 hours of life;
* Need for continued resuscitation after birth and/or 5-minute Apgar score ≤5;
* Evidence of neonatal encephalopathy by an abnormal neurological exam (modified Sarnat score of 2-3 or abnormal aEEG).

Exclusion Criteria:

* Absent heart rate at 10 minutes/imminent death
* Neonates with major congenital malformations
* Neonates with grade 3 AKI (serum creatinine rise ≥3x lowest previous creatinine or creatinine \> 2.5 mg/dL = 221 mcmol/L or receipt of dialysis)
* Neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cUS) performed on day 1-2 of life
* Mother living permanently outside 20km radius of Kawempe Hospital or Nsambya Hospital
* Neonates whose parents are unwilling or unable to give informed written consent to enter the study
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients

This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye.
* Schirmer test without anesthesia ≥ 1 and \< 10 mm wetting over 5 minutes in at least 1 eye.
* Tear break up time \< 7 seconds in at least 1 eye.
* Corneal staining score ≥ 3 (National Eye Institute \[NEI\] grading scale).
* Conjunctival redness of ≥ 1.
* Ocular surface disease index of modest to severe.
* Ability to provide informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Hemoglobin \< 10 g/dl.
* Total white blood count (WBC) outside the range of 3000-14,000/µl.
* Platelets \< 100,000/µl.
* Use of ocular, periocular, or systemic steroids within 60 days prior to screening.
* Use of contact lenses or prior corneal refractive surgery in either eye.
* Requirement of eye drop use during the study.
* Anesthetic or neurotrophic corneas.
* Temporary punctal plugs.
* Recent or planned exposure to live vaccinations.
* Other protocol-defined inclusion/exclusion criteria may apply.
External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)

Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.

The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years.
* Received pancreatoduodenectomy.
* Informed consent has been signed.

Exclusion Criteria:

* Age less than 18 years
* Emergency surgery
* Past history of pancreatic surgery.
Identification of Respiratory Profiles From Nasal Pressure Signals

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries.

Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used.

As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.


Eligibility Criteria:
Inclusion Criteria:

* Age of majority
* Health volunteers

Exclusion Criteria:

* Pregnancy
* Age of minority
* Protected adult
* Person deprived of liberty
* Respiratory pathology
* Non affiliation to the health care system
Micro vs. Standard Trabeculectomy Study

The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.

This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 40
* Planning to have a trabeculectomy

Exclusion Criteria:

* Life threatening or debilitating disease
* Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
* Contralateral eye already enrolled in study
Cardiac Rehabilitation to Improve Breast Cancer Outcomes

To develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. Considering this program is secondary to the Michigan Medicine Cardiac Rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis stage I-III
* Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy)
* Age 18 years or older
* At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: \>2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (\>60 years) at cancer treatment, OR Left ventricular ejection fraction \<50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Planned surgery during the study period.
* Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction \<35%)
* Metastatic cancer
* Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise)
* Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)

Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 (included) and 84 (included),
* Patient with intrauterine myoma, with indication for surgical management by laparoscopic myomectomy, or uterine pathology with indication for surgical management by laparoscopic hysterectomy,
* Patient affiliated or beneficiary of a health insurance scheme,
* Patient agreeing to participate in the study after having received the written information document and signed the consent form.

Exclusion Criteria:

* Patients under 18 or over 84 years of age,
* Patients with contraindications to MRI (pacemaker, ocular metal splinters, etc.),
* Impossibility of planned surgery,
* Patient with endometrial cancer contraindicating laparoscopic surgery,
* Known pregnant or breast-feeding patient,
* Patient of legal age, under guardianship or curatorship,
* Patients whose regular follow-up is impossible for geographical, psychological, family or social reasons (these reasons will be collected).
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.

OBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.

OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.

PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma including mixed mesodermal tumors of the uterus Cell types NOT allowed: Malignant mesothelioma Chondrosarcoma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable) No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.75 mg/dL Albumin at least 2.5 g/dL AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present) Alkaline phosphatase less than 2.5 times ULN No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.) Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior cardiovascular disease Other: No other severe medical illness No psychosis No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to sole index lesion No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs
Neoadjuvant Herceptin in Patients With Breast Cancer

The purposes of this study are to better understand how Herceptin causes tumors to become smaller and to find out how effective Herceptin, together with chemotherapy, is in treating advanced breast cancer.

We want to determine the effects of Herceptin and to determine its efficacy in women with HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of an array of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin.

The other aim of this study would be to determine clinical response to therapy with Herceptin and Taxotere.

Eligibility Criteria:
Inclusion Criteria:

* All patients must be female.
* Informed consent must be signed.
* Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size \> 4 cm, and/or are deemed surgically inoperable.
* Her2/neu overexpressing tumors defined as HercepTest score of 3+, or \>/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive.
* Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
* Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
* Performance status (World Health Organization \[WHO\] scale) \< 2 and life expectancy \> 6 months.
* Age \> 18.
* No metastatic disease without concomitant primary breast cancer.
* No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

* Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
* Severe underlying chronic illness or disease.
* Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) \< 50%.
* Patients on other investigational drugs while on study.
* Severe or uncontrolled hypertension defined as blood pressure (BP) \> 180/100 on three separate occasions.
* History of congestive heart failure.
* History of coronary arterial disease.
Sodium Management in Acute and Chronic Heart Failure

The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.


Eligibility Criteria:
Inclusion Criteria:

* Decompensated HF due to ischemic or nonischemic cardiomyopathy,
* \>18 years of age,
* HF according to Framingham criteria
* NYHA functional class III
* EF \<40%,
* Serum creatinine \<2,5 mg/dL
* BUN \<60 mg/dL,

Exclusion criteria:

* NYHA class \> III or \< III,
* Cerebral vascular disease,
* Dementia,
* Cancer,
* Uncompensated diabetes,
* Severe hepatic disease
* Patients requiring pacemaker
* Previous RCT implantation
* Alcoholic habit
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.

Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.

Eligibility Criteria:
Inclusion Criteria:

* Anticipated Mechanical ventilation for at least 72 hrs.
* Need for enteral feeding
* men and woman aged 18 or older.

Exclusion Criteria:

* Abdominal surgery with inability to feed enterally.
* FiO2 greater than 80%
* Bronchopleural fistula
* Hemodynamic instability in spite the use of vassopressors.