cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Hypertension in Extremely Preterm Infants

Extremely preterm infants are at risk for developing bronchopulmonary dysplasia (BPD) and associated chronic pulmonary hypertension (PH), a consequence of altered pulmonary vasculature. This condition occurs in about 25% of babies with BPD, and the association grows with increasing BPD severity. Other risk factors have been described as well. Morbidity and mortality associated with prematurity and/or BPD increase significantly in the presence of PH.

Thus, international guidelines encourage the use of standardized screening protocols for this condition. However, several questions regarding these recommendations are left unanswered, such as a clear definition for PH in this population.

The research aim is to prospectively evaluate prevalence, risk factors and clinical course of PH in these children. The investigators aim to identify at-risk infants early on and ultimately improve survival making use of an early targeted intervention.


Eligibility Criteria:
Inclusion Criteria: Preterm infants with

* Gestational age \<28 0/7 weeks
* Birth weight \<1000 grams

Exclusion Criteria:

* Major congenital malformations
* Structural airway or lung disease
* Congenital heart disease
* Lack of parental consent
Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy with may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis.

OBJECTIVES: I. Assess the toxic effects of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy. II. Determine the Maximum Tolerated Dose (MTD) of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy. III. Access the toxic effects of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine. IV. Determine the MTD of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine.

OUTLINE: Part I: Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to radiation therapy. Whole pelvic radiation treatment is given on days 1-5 followed by 2 days of rest. The treatment volume encompasses all suspected pelvic disease with a minimum of 1 cm margin. Cycles repeat weekly. Dose of vinorelbine is escalated in cohorts of at least 3 patients until maximum tolerated dose (MTD) is determined. Part II: Paclitaxel is infused over 1 hour immediately following vinorelbine at the MTD, as determined in part I. Dose of paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined. At least 6 patients are treated at the MTD for both parts I and II of the study. Patients are followed for late and chronic toxicities.

PROJECTED ACCRUAL: Projected accrual is 12 patients per year for approximately 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced carcinoma of the uterine cervix, vagina, or bladder or other pelvic malignancy for which whole pelvic radiation therapy is planned Metastatic disease is permitted

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal limits Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No unstable angina or myocardial infarction in previous 6 months Other: Not pregnant No significant concomitant illness, uncontrolled infection, or cirrhosis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior whole pelvic radiation therapy Surgery: Not specified
Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure

The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* women and men
* age 30-75 years
* chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
* disease duration ≥ 6 month
* medical therapy accruing to guidelines (drug, devices, including CRT)
* written informed consent

Exclusion Criteria:

* acute myocarditis
* instable angina
* heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
* severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start
* preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
* uncorrected valve regurgitation or stenosis (\> second degree)
* safety concerns regarding or other reasons against exercise training
* severe depression
* regular exercise training within the last 6 weeks
* life expectancy \< 1 year
Micturition Reeducation in Children With Cerebral Palsy

This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with a brain injury.

Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (Ozturk, 2006). The incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population.

Incontinence in children is often treated with urotherapy. This is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. Additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (Neveus, 2006). Recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (Mulders, 2010).

Despite the high prevalence of incontinence in children with CP the possible treatment strategies in this population are poorly investigated. Far too often, urinary incontinence in children with CP is considered a normal, unavoidable and even a minor problem.

Aim: Investigate the influence of individualized urotherapy on the (in)continence of children with CP.

The included children with CP will be randomized and stratified for type of CP and mental abilities into 2 groups: the intervention group and the control group. The intervention group will receive immediate therapy. After one year of therapy, a follow- up of 6 months will be applied. The control group will start 6 months later and information will be used as control group. Incontinent children without CP will receive therapy and will also act as control group.

Eligibility Criteria:
Inclusion Criteria:

* Daytime urinary incontinence with or without enuresis and/or fecal incontinence
* Cerebral palsy (Arms of children with CP)
* Normal development (Arms of children without CP)

Exclusion Criteria:

* Isolated urinary tract infections
* Isolated enuresis
* Isolated dysfunctional voiding
* Isolated fecal incontinence
* Anatomical abnormalities
* History of genitourinary or renal surgery
* Medication for incontinence during the last 3 months
* Pelvic reeducation during the last 6 months
* other neurologic problems influencing continence
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.

The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, age 18-45 years;
* BMI between 18.0-27.0 kg/m2
* Determined by investigator to be in general good health according to medical history, comprehensive physical examination;
* Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ;
* Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.

Exclusion Criteria:

* Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial;
* Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination;
* HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive;
* QTcF \> 450ms;
* Allergic constitution;
* Intolerance of venipuncture and/or history of haemorrhage or needle fainting;
* Drug or alcohol abuse;
* Have used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days;
* Blood donation or massive bleeding within 3 months (greater than 450 mL);
* Participants in any drug clinical trial within 3 months.
* Birth planning in the next six months.
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
* in complete remission

Exclusion Criteria:

* Hereditary or secondary nephrotic syndrome
* Estimated glomerular filtration rate (GFR) \< 60 mg/min/1.73 m\^2
* Body weight \<16 kg
* leukocytopenia (absolute neutrophil count \< 2000/mm\^3) or anemia(Hct \< 25%)
* Severe gastrointestinal disease
* chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
* prior live vaccine inoculation within 6 weeks (from the study enrollment)
* GOT/GPT elevation or hyperbilirubinemia
* malignant disease
* Pregnant or Breast feeding
* Previous history of mycophenolate mofetil use
* Participation to other therapeutic trial within recent 3 months
* Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients

This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\>60 years of age) who have experienced a traumatic brain injury.

This study aims to determine the effect of supplemental N-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a traumatic brain injury (TBI).

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* present to emergency department within 3 hours of documented TBI

Exclusion Criteria:

* patients without TBI
* patients with a history of TBI greater than 3 hours prior to presentation
* patients under the age of 60
* currently enrolled in an ongoing research study
* patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI)
* Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.
Definitive Radiation for High-Risk Spine Metastases

This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery


Eligibility Criteria:
Eligible patients must have:

* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
* Metastatic spine involvement documented by imaging
* Involvement of maximum 3 contiguous vertebral bodies at the index site
* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
* An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending
* ECOG Performance Status of 0-3

Patients are ineligible if they have:

* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
* Had previous surgery or radiation to address the target spinal metastases
* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.


Eligibility Criteria:
Inclusion Criteria:

* Adult women patients (\>18 years of age and \<90 years of age)
* Research authorization (consent)
* Pre-operative diagnosis of clinical Stage 1 endometrial cancer
* Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
* Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy

Exclusion Criteria:

* Severe coagulopathy or severe thrombocytopenia
* Severe anemia
* Severe cardio-pulmonary comorbidities demanding minimization of operative time
* History of liver disease
* Iodide allergy
* Emergent operation
* Additional surgical risk as determined during surgery at the discretion of the attending
* Impaired capacity to make informed medical decisions
SMS Reminder for Forgotten Ureteral Stents

Ureteral stents has become an indispensable instrument for urology practice as a result of widespread use of endourological interventions. Removal of stents could be sometimes neglected by patients or physicians. This omission may lead to legal and medical problems for urologists, health institutions and also for patients. In this study, the investigators offer a computer program providing two sided recall to prevent this nasty complication with sending automatic message by short message service (SMS) to both the patient and the urologist.

In this study, first an institutional subscription agreement was signed between our university and a mobile phone cell company which is supporting SMS sending program. In the second step, by making software plug-in to our hospital's patient follow up program, two programs were integrated. According to this integration, after stent insertion, in case of entering the numerical code corresponding of ''ureteral stent application'' procedure during the stage of epicrisis preparation, the patient follow up system warns the official recording the epicrisis to enter the stent removal time. Patient follow up system transfers this information to SMS sending program. After several weeks of the procedure, if the stent needs to be removed, the software automatically sends a warning message to the patient and the physician. If the patients attends to urology department and undergoes stent removal, the official enters the code of "endoscopic stent removal" to the patient follow-up program. Then the program stops to send warning message.

By the software plug-in to patient follow up program, SMS sending was made mandatory not to forget or skip none of the patients during the epicrisis writing procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had ureteral stent insertion.

Exclusion Criteria:

* Patients who did not want SMS message from us or want to give cell phone number.
Calcium and Vitamin D Intakes in Children

Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 + and VitD intake \< 70% of dietary reference intakes (DRIs) were invited to participate in prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan, Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1) serum VitD levels were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory healthy subjects (male and female, age range 3-17 years) consecutively observed at our Department for routine clinical examination because vaccination program were considered eligible for the study.

Exclusion criteria

* malnutrition (defined as a weight/height ratio \<5° centile);
* presence of chronic systemic diseases (celiac disease, inflammatory bowel disease, food allergy, cystic fibrosis, malignancy, immunodeficiency, tuberculosis, genetic-metabolic disease, primitive bone disease, diabetes and endocrine disorder);
* and use of systemic steroids in the previous 3 months.
Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain

Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale.

This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.


Eligibility Criteria:
Inclusion Criteria:

* Acute low back pain (no more of 4 weeks)
* Spanish speaker
* Between 18-65 years

Exclusion Criteria:

* Patients in whom diathermy is a contraindicated therapy
* Pacemaker
* Pregnant
* Not intact skin
* Thrombophlebitis
* Hypotension
* Anticoagulated patient or with local surgical intervention
Impact of a Triage Liaison Physician

Due to an increasing number of patients admitted in emergency departments, many patients cannot be evaluated immediately after their admission. The function of "triage liaison physician" was introduced in Spring 2015. The objective of this study is to evaluate the impact of this new function on patients' flow in the ED.

Geneva University Hospitals (GUH) emergency department (ED) admits more than 64000 patients every year. These patients are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level triage scale. The SETS imposes time objectives until the first medical evaluation (20 minutes for SETS 2, 2 hours for SETS 3). In 2014, only 60% of level-2 and 63% of level-3 emergencies were evaluated within 20 and 120 minutes respectively.

A triage liaison physician was introduced in Spring 2015 with the mission to help triage nurse in their decisions and to evaluate quickly the patients that cannot be immediately installed in an ED evaluation room.

The objective of this study is to evaluate the impact of the triage liaison physician on the times to first medical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* \>= 16 y
* admitted in GUH ED

Exclusion Criteria:

* patients triaged to outpatient clinics
Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries

In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries

After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist Classification (ASA) I-II patients
* 1-7 aged patients
* patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)

Exclusion Criteria:

* Use of anticoagulants
* Allergy of medications to be used
* Presence of infection the area where the block will be applied
* American Society of Anesthesiologist Classification (ASA) III-IV patients
* The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
* Patients who do not agree to participate in the research, parents/legal guardians
* Patients who were operated on with a different incision than planned for any reason.