cyrilzakka/clinical-trials huggingface dataset:
Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function

The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance.

The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with sever chronic intestinal disease requiring long term parenteral nutrition
* Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
* With a stable dose of LCPN for at least 1 month at recruitment time
* Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
* Age \>18
* Being available for 2 medical consultations in a 6 month period
* Who gave its written informed consent to participate to the study and without legal protection
* Social security coverage

Exclusion Criteria:

* Lesser expected parenteral nutrition length than duration for the entire trial
* Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
* Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance \< 30 ml/min
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.

Eligible subjects will be randomized to an innovative FFM-indexed feeding or the standard feeding for up to 2 weeks. The essential component of the FFM-indexed feeding will be the difference in milk prescription dosing that we propose to set the feeding volume to index FFM rather than total mass. In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk, whereas the standard feeding will include a feeding volume goal of 150 ± 10 mL/kg (body weight)/day. Infants will receive either breast milk or formula feedings per the standard feeding protocols. Body composition (PEAPOD system) and appetite-regulating hormones (ARH) levels of enrolled infants will be assessed at baseline (test-1) and at the end 2-week study intervention period (test-2). Subjects will be followed for clinical and growth outcomes until neonatal intensive care unit (NICU) discharge and through 6 months of age. Growth will be followed through 6 months of age by retrieving anthropometric measurement records from pediatricians at well-child visits (2-, 4-, 6- and 6-month visits). Parents will be called at these time points to obtain a history of any further feeding difficulties.

Eligibility Criteria:
Inclusion Criteria:

* LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \> +1.0 in body composition measurement

Exclusion Criteria:

* Infants on any respiratory support, Infants on enteral feeding duration \> 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes/anomalies
Chlorthalidone in Chronic Kidney Disease

It is estimated that in the United States there are approximately 8 million individuals who have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and is often poorly controlled due to an expanded volume state; diuretics are frequently prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less potent, their use may be associated with less acute kidney injury, but as yet there are no firm data to support that thiazide diuretic therapy can improve BP among subjects with advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced CKD either alone or in combination with loop diuretics and concluded that thiazides may be useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their safety and efficacy in moderate to advanced CKD.

This is a placebo-controlled, double-blind, randomized controlled trial of chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years.
2. Calculated glomerular filtration rate (GFR) by 4-component Modification of Diet in Renal Disease (MDRD) formula \< 30 ml/min/1.73m2 but ≥15 mL/min/1.73m2. The hospital laboratory uses isotope dilution mass spectrometry (IDMS) calibrated creatinine and the appropriate formula is used to estimate GFR.
3. Hypertension. This is defined as BP of either ≥130 systolic or ≥80 mmHg by 24-hour ambulatory BP monitoring.
4. Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required prior to randomization.

Exclusion Criteria:

1. Use of thiazide or thiazide-like drugs in the previous 12 weeks.
2. Use of furosemide in a dose \>200 mg/d.
3. BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
4. Expected to receive renal replacement therapy within the next 3 months.
5. Myocardial infarction, heart failure hospitalization, or stroke ≤3 months prior to randomization.
6. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
7. Known hypersensitivity to thiazide or sulfa drugs.
8. Organ transplant recipient or therapy with immunosuppressive agents.
Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation

The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting.

Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ASA physical status 1 and 2
* Patient undergoing Bascom operation in prone position

Exclusion Criteria:

* Pregnancy
* Current regular use of drug belonging to the class of opioids
* Allergy/ intolerance to drugs included in multimodal analgesia regime
Oral Omadacycline Vs. Placebo in Adults with NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)

The total duration of subject participation in the study is approximately 5 months which includes a total duration of study treatment for approximately 3 months (84 days). Eligible participants will be randomized 1.5:1 to receive 3 months of treatment with either omadacycline or placebo (monotherapy). The study will use a double-dummy design in order to maintain the study blinding.

Eligibility Criteria:
Key Inclusion Criteria:

* Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
* Has at least 2 of the following NTM-infection symptoms present at Screening and Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss.
* At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to Screening and 1 positive culture at Screening
* Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening
* In the opinion of the investigator, guideline-directed antibiotic therapy for treatment of MABc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable
* Additional inclusion criteria as per protocol

Key Exclusion Criteria:

* Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC
* Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening
* Has any of the following medical conditions:
* Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to Screening
* Active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to Screening
* Radiologic evidence of cavitary disease
* Known active pulmonary tuberculosis
* Cystic fibrosis
* History of lung transplantation
* Another advanced lung disease with a known percent predicted forced expiratory volume in 1 second \< 30%.
* Disseminated or extra-pulmonary NTM disease
* Has been previously treated with omadacycline
* Has a history of hypersensitivity or allergic reaction to tetracyclines
* Additional exclusion criteria as per protocol
Hydromorphone and C-section

This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women undergoing cesarean section

Exclusion Criteria:

* Any comorbidities other than obesity, hypertension, fetal anomalies
Belimumab in Remission of VASculitis

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
* Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
* Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
* Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
* Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Key Exclusion Criteria:

* Pregnant or nursing.
* Receipt of a B cell targeted therapy (other than rituximab) at anytime
* Receipt of an investigational biological agent within the past 60 days.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

Hypotension after spinal anaesthesia for cesarean deliveries is frequently encountered. Phenylephrine an α-agonist is commonly used for the prevention and treatment of spinal-induced hypotension. Phenylephrine causes baroreceptor-mediated bradycardia leading to subsequent reduction in cardiac output. Preservation of heart rate and cardiac output is important in high-risk conditions such as placental insufficiency, fetal distress and maternal cardiac disease. Recently, norepinephrine has been found as effective as phenylephrine in treatment of spinal induced hypotension. When norepinephrine is used as a bolus, it is effective at maintaining blood pressure while also conferring a greater heart rate and cardiac output compared to phenylephrine.


Eligibility Criteria:
Inclusion Criteria:

Elective cesarean delivery under spinal anaesthesia ASA PS II Age ≥18 years Singleton pregnancy beyond 37 weeks' gestation Weight between 50 and 100 kg Height between 150 and 180 cm

Exclusion Criteria:

Patient refusal to participate Allergy or hypersensitivity to Norepinephrine or Phenylephrine Preexisting or pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities Use of monoamine oxidase inhibitors or tricyclic antidepressants
A 14-item Questionnaire Regarding Career Preferences Among Chinese Medical Undergraduate Students.

This survey was performed as part of a career choice research program for undergraduate medical students. All students received a QR code link to the survey as part of their course work.

This survey was performed as part of a career choice research program for undergraduate medical students. All students received a QR code link to the survey as part of their course work, although participation was voluntary and anonymous. All participants received verbal and online explanations of the questionnaire and were informed that informed consent would be assumed if they completed and submitted the questionnaire. The questionnaire was administered, and data were collected using a free online tool.

Eligibility Criteria:
Inclusion Criteria:

* Participants from several four-year student classes medical students were enrolled.

Exclusion Criteria:

* Students who did not complete or declined to complete the questionnaire.
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
* At least one measurable lesion according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Baseline left ventricular ejection fraction (LVEF) at least 50%

Exclusion Criteria:

* Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
* Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
* Past medical history significant for any cardiac or central nervous system (CNS) disorders
* Poor hematologic, renal, or hepatic function
* Chronic corticosteroid therapy
Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)

The main purpose for this study is to provide access to 3,4 DAP, a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and autonomic dysfunction.

More than half of LEMS cases are associated with malignancy, usually small cell lung cancer. These paraneoplastic cases progress more quickly than primary autoimmune LEMS. An overlap syndrome with other autoimmune diseases is often detected in LEMS patients.

3,4 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential. 3,4 DAP is less likely to provoke epileptic seizures than its precursor, 4-aminopyridine, because it is less able to cross the blood-brain barrier. 3,4 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies.

Eligibility Criteria:
Inclusion Criteria: -Male or female majority between 45 and 60 years of age

* diagnosed with Lambert-Eaton Myasthenic Syndrome.
* subjects must be taking full dose of pyridostigmine

Exclusion Criteria: - does subject have a history of liver problems?

* does subject have a history of prolonged QTc syndrome (which is a condition where there is prolongation between the start of the Q wave and the end of the T wave in the heart's electrical cycle).
Non-invasive Ventilation and Physical Activity

As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in patients with neuromuscular disorders and thoracic deformations, we hope, by starting non-invasive ventilation and improving these symptoms, to increase their physical activity.

Patients with neuromuscular disorders and thoracic deformations develop alveolar hypoventilation during their disease progression. At that time, non-invasive ventilation(NIV) can be started as treatment.

Fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation. NIV has the intention to improve these symptoms but no research has been performed whether these improvements also objectively improve physical activity. Further on, no research has been performed on muscle strength and muscle fatigue.

Patients' physical activity, physical capacity and sleep quality will be measured before NIV initiation, after 3 months and 1 year of NIV use.

To start NIV, patients will be admitted to our sleep laboratory for 5 days/4 nights. Polysomnography will be used during NIV titration.

Physical activity will each time be measured by 2 activity monitors during 5 days.

Eligibility Criteria:
Inclusion Criteria:

* restrictive pulmonary function test AND
* symptoms of nocturnal alveolar hypoventilation or
* increased daytime pressure of arterial CO2 (PaCO2) (\>45 mmHg) or
* \>= 10 mmHg increase in PaCO2 during sleep in comparison to a normal awake supine value

Exclusion Criteria:

* patients \< 16 years
* severe cardiac arrythmias or conduction disturbances
* severe mental disturbances
* amyotrophic lateral sclerosis
* total wheelchair-dependent patients