cyrilzakka/clinical-trials huggingface dataset:
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* HBeAg positive chronic hepatitis B
* Compensated liver disease

Exclusion Criteria:

* Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
* Antiviral, anti-neoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
* Evidence of decompensated liver disease
* Chronic liver disease other than viral hepatitis
Pulse Oximetry Performance Comparison in Newborns

The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
* Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
* Subject is ≥ 29 weeks gestational age.
* Subject can accommodate multiple sensors.

Exclusion Criteria:

* Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded.
* Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
* Currently participating in any other study expected to confound study results in the opinion of the investigator.
Infiltration Analgesia After Caesarean Section

Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.

According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* volunteer
* age over 18 years
* spinal anesthesia
* ASA 1-2
* no allergy to used medications
* no medications which have effect on pain perception

Exclusion Criteria:

* patient's refusal to participate
* marked systemic disease
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between the ages of 40 and 70 years, inclusive.
* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).
* Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

Exclusion Criteria:

* Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* A history or active presence of clinically important medical disease.

Additional criteria apply.
Controlling and Lowering Blood Pressure With the MobiusHD™

To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Eligibility Criteria:
Inclusion Criteria:

* Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy

Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)

Inclusion Criteria:

- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening

Exclusion Criteria:

* Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely
* Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging
Analysis of the Microbiome in Rosacea

The skin and gut microbiome of rosacea patients differs from individuals without rosacea and that the microbiome suffers from unique derangements in rosacea patients following antibiotic therapy.

This study was proposed to examine microbial signatures of the skin and gut microbiome in patients with moderate to severe rosacea and to identify differences between microbe communities in patients with rosacea and volunteers without rosacea using 16S ribosomal ribonucleic acid (rRNA) polymerase chain reaction (PCR) amplification, sequencing and computational phylogenetics and to assess alterations in the gut and skin microbiota of patients with moderate to severe rosacea in response to varying formulations of antimicrobial treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 years old.
* Participants must have a current diagnosis of moderate-to-severe erythematotelangiectatic or papulopustular rosacea or free of rosacea to serve as control.
* Participants must have the ability to understand and communicate with the investigator.
* Participants must be willing and comply with the requirements of the protocol.
* Participants must provide written informed consent

Exclusion Criteria:

* Subjects unable to provide informed consent.
* Subjects with significant medical history or concurrent illness that the investigator feels are not safe for study participation.
* Recently treated (4 weeks for topical antibiotics/steroids/other anti- inflammatory medications on the face, 8 weeks for systemic antibiotics/steroids/other immunosuppressive agents) or current (skin) diseases that would affect clinical evaluation and skin sampling.
* Subjects with a history of facial surgeries and cosmetic procedures (i.e. laser therapy, resurfacing, dermal fillers, and deep chemical peels) within 6 months.
* Subjects with facial features (i.e. significant hair growth) that would affect clinical evaluation and skin sampling.
* Participants with a history of chronic gastrointestinal disease, diabetes mellitus, cardiac disease or immunodeficiency disease.
* Intake of proton pump inhibitors, H2 receptor antagonists, laxatives, or antidiarrheal medication, NSAIDs, or antacids within 2 weeks prior to enrollment.
* Participants with a history of major surgery of the GI tract (5 years).
* Participants with a known hypersensitivity to tetracyclines or doxycycline or topical ivermectin
* Subjects unwilling to avoid facial washing for 24 hours prior to sampling and to come to sampling visit without make-up.
* Subjects with known allergy to lidocaine and epinephrine.
* Subjects with known bleeding disorders.
* Subjects with a history of keloids or excessive scarring.
* Pregnant subjects. Self-reporting will be used to determine whether a patient is pregnant
Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.

This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.

Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.

This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.

Disease and study population Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.

The study will be extended to all the centers of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 500 cases will be collected.

The main objective of the study is to collect the safety and efficacy of the vaccine against SARS-CoV-2 in cancer patients, as well as its potential interactions with antineoplastic therapies.

The data collection will take place throughout the year 2021

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer of any stage and histology who have or have not contracted COVID-19 and who have been vaccinated with an EMA approved COVID-19 vaccine.
* Age equal to or greater than 18 years

Exclusion Criteria:

* Patients who have not received an EMA approved COVID-19 vaccine.
Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.

Eligibility Criteria:
Inclusion Criteria:

* Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)

  * Familial hypercholesterolemia,
  * NPB,
  * NPC
  * Partial lipodystrophy (PPARg mutations and laminin A/C mutations)
* Intention to be treated and participate to the treatment - Written informed consent

Exclusion Criteria:

* Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
* Alcohol abuse (quantitative limit \>20g/day for men and \>10g for women)
* Illiteracy
* Patients younger than 10 years.
* Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.
Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

Many patients with endometriosis experience extra genital and abdominal symptoms as a major part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal structure and function elicited by the endometriotic elements, which may cause a "visceral syndrome" with the above mentioned symptoms.

The investigators hypothesize that dietary treatment will improve the experience of gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study investigating patients with both endometriosis and IBS, is to test the application of a low FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot study is to investigate the applicability of a placebo diet in patients with endometriosis and to investigate the compliance in both intervention group and control group. In addition, the aim is to investigate whether the participants find the diet manageable and whether they are able to identify the placebo diet.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 18-50 years
* Fluid spoken and written Danish
* Diagnosed endometriosis (laparoscopy and/or MR-scan) at least one year ago and sufficient treated regarding medicine and surgery. Participant will be asked to bring a copy of their medical record from the hospital or from www.sundhed.dk to verify the diagnosis.
* Diagnosis of irritable bowel syndrome according to the Rome III criteria. Both previous diagnosis and undiagnosed patients are included, as long as the study group evaluates that the patient meets the Rome III criteria.
* Accept to follow a controlled exclusion diet for all meals for four weeks with only few accepted deviations from the diet.

Exclusion Criteria:

* Premature menopause
* Organic bowel disease (Celiac disease, IBD, bowel endometriosis, malignant disease)
* New therapeutic interventions during study period (medical/lifestyle/psychological). Already ongoing treatment is accepted.
* Psychiatric disorder, psychotropic drugs
* Patients, who the dietician accesses are familiar with low FODMAP diet and therefore is able to identify the placebo diet
* Patients with complicated dietary needs, e.g. severe allergies or intolerances (including lactose and fructose intolerance), athletes, any type of vegetarianism or metabolic diseases
* Pregnancy or planned pregnancy during the study period
Is Milk Associated with Glycemia in the NICU

The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. To do so, prospectively 100 infants receiving HM-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.

The purpose of this study is to determine if concentrations of these hormones in prepared HM feeds are associated with metabolic disturbances in the recipient infant. A prospectively study 100 infants receiving HM-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. Insulin and PTHrP will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control.

Hypothesis 1 Feed dose of insulin and PTHrP will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed.

Hypothesis 2: Over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving HM products.

Eligibility Criteria:
Inclusion Criteria:

* Infants eligible to receive human milk (HM)-derived fortifiers. To qualify for these fortifiers, infants must be born \<30 weeks gestation and/or weigh \<1250g at birth. Enteral or oral feeding modes both qualify for participation. Additional supplementation to feeds beyond HM-derived fortifier (such as medium-chain triglycerides) is acceptable.
* Infants initially on intravenous nutrition will still be eligible for consent. Feed sample collections from these infants will commence once they advance to consume HM-based feeds once HM-derived fortifier is prescribed.

Exclusion Criteria:

* Infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded.
* Infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded.
* Non-English speaking subjects will be excluded as the team of study personnel includes those that speak English only.
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, 30 to 65 years of age on the date of informed consent.
2. The subject has an established diagnosis of T2DM.
3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.

Exclusion Criteria:

1. The subject has a history of type 1 diabetes mellitus.
2. The subject has a history of renal transplantation.
3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.
4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function

The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence

Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.

1. Oscillation at proper frequency.
2. Lung volume and airway opening.
3. Expiratory flow rate or expiratory bias.
4. Humidifying of inspired air.

Multifunctional breathing device, the BreatheMAX, is the only breathing device made in Thailand. The BreatheMAX device possess many properties or techniques that benefit for respiratory care particularly 3 in 4 mechanisms for secretion clearance. The unique important aspect is the simultaneously providing several beneficial effects in one breath which are 1) Oscillation in the range of ciliary beat frequency 2) Biofeedback of respiratory effort that could encourage the deeper breathing performance, 3) Humidifier of inspired air, 4) Loaded breathing for inspiratory muscle training and generate PEP. These 4 functions would be very useful for increase secretion clearance particularly in more peripheral airway which are the most difficult to be cleared and be a risk of atelectasis and infection in patients with MV whose natural secretion clearance mechanisms are compromised, respiratory muscle weakness weak and low immunity.

Therefore, the combination of inspiratory and expiratory breathing exercise through the BreatheMAX breathing device may increase or promote more secretion clearance and improve lung function than expiratory breathing exercise alone in intubated patients, both with and without mechanical ventilation dependence

Eligibility Criteria:
Inclusion Criteria:

* Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following
* Clinical and radiologic diagnosis of pulmonary infection
* Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound
* Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data
* Stable of hydration status or positive fluid balance at least 2 days before collects the data
* Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia
* Good conscious and well cooperation

Exclusion Criteria:

* Pneumothorax (nontreated)
* Massive hemoptysis
* Acute myocardial infarction (with angina chest pain)
* High intracranial pressure (\>20 mm Hg)
* Major arrhythmia
Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC

The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained
* Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy

Exclusion Criteria:

* History of other malignant tumors.
* The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
* History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process