cyrilzakka/clinical-trials huggingface dataset:
Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates

Pneumonia is a medical condition that, if not treated promptly, can lead to life- threatening complications. The prolonged slow expiration technique is a new type of chest physiotherapy that helps infants discharge bronchial secretions which accumulated due to pneumonia.

Pneumonia is an infective lung condition that is one of the most common risk factors for neonatal death. Pulmonary infections, most common caused by anaerobic bacterial infection, result in the accumulation of pus in the pleural cavity. Preterms, neonates with respiratory infections, and underdeveloped lungs all require the use of a prolonged slow expiration technique.

Prolonged slow expiration technique is the only chest clearance technique that provides both effective clearance and a soothing effect. Another recommendation for this technique is lack of application of emerging techniques of respiratory physiotherapy. Although the technique is effective, it is rarely in practice over the conventional methods of chest physiotherapy.

During prolonged slow expiration, intrathoracic pressure gradually rises due to thoracoabdominal compression, preventing bronchial collapse and flow disruption that occurs during forced expirations.

Eligibility Criteria:
Inclusion Criteria:

* Age since birth till 2 months
* Clinical findings of pneumonia: tachypnea, chest recession, fever, cyanosis and cough
* Radiological diagnosis of pneumonia (x-ray): lober or segmental consolidation, nodular or coarse patchy infiltration, diffuse haziness and air bronchogram.
* Neonates on oxygen therapy.

Exclusion Criteria:

* Neonates with congenital cardiopathy.
* Neonates with surgical incision in thorax or abdomen.
* Neonates with neurological intervention.
* Neonates with obstruction of upper air way.
* Neonates with gastroesophageal reflux and laryngeal affection.
A Prospective Study of EUS Guided Celiac Block

The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
* Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Patient must provide signed written informed consent

Exclusion Criteria:

* Patients that have had a previous celiac plexus block are eligible for this study
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.

This multicenter randomized, non-blinded clinical trial compared two parallel groups of patients with bullous pemphigoid treated with oral methylprednisolone in combination with either azathioprine or mycophenolate mofetil. Patients were randomly assigned, irrespective of severity of disease, to receive either 0.5 mg per kg body weight (BW) methylprednisolone (Urbason®, Aventis Pharma, Bad Soden, Germany) with 2 mg per kg BW azathioprine sodium (Imurek®, GlaxoSmithKline, Munich, Germany) once daily or 0.5 mg per kg BW methylprednisolone once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany), given twice daily (2 g/d). The initial dose was maintained until blister formation ceased, crusts as well as erosions disappeared, and re-epithelialization of previous lesions started. The corticosteroid dose was then sequentially reduced by 10 mg every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5 mg-steps every two weeks until 10 mg per day. Afterwards, corticosteroid reduction was performed in 2.5 mg-steps every two weeks until zero. After discontinuation of corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial dosage as monotherapy for an additional 4 weeks. Subsequently, azathioprine was reduced by 0.5 mg per kg BW every four weeks to a dose of 100 mg per day. Thereafter, azathioprine was tapered in 25 mg-steps every four weeks until discontinuation of treatment. Mycophenolate mofetil was reduced in 500 mg/d-steps every four weeks to 1,000 mg per day. From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical lesions suggestive of bullous pemphigoid
* subepidermal blistering upon histological analysis of skin biopsies
* linear deposition of IgG and C3 along the dermo-epidermal junction
* deposition of autoantibodies at the blister roof upon split-skin analysis

Exclusion Criteria:

* treatment with oral or topical corticosteroids, and other immunosuppressive drugs during the previous four weeks
MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.

MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells. PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of this study is to study the effectiveness of PD-325901 in patients with colon cancer, breast cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies will be taken of a tumor before and once during treatment to measure the effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.

The study prematurely discontinued on March 15, 2007 due to a safety concern, specifically ocular and neurological toxicity presented at 10 mg twice-a-day and higher doses.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment biopsy
* Biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. Prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) No prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
* Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: Serum creatinine \<1.5 x ULN, total bilirubin \<2 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<3 x ULN (\<5 x ULN for patients with liver involvement); absolute neutrophil count (ANC) \>1500/ul; and platelet \>100,000/ul
* Hemoglobin \>9.0 g/dL. Treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. Patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
* Serum calcium \<1 x ULN and phosphorus \<1 x ULN
* Patients having reproductive potential must use adequate method of birth control. Patients may not be pregnant or breastfeeding.
* ECOG Status of 0,1, or 2.
* Must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
* Must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
* Must be able to give written informed consent.

Exclusion Criteria:

* No parathyroid disorder or history of malignancy associated hypercalcemia
* No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
* No concurrent serious infection or life-threatening illness (unrelated to tumor)
* No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
* No untreated brain metastases.
AVODART® Alopecia Post-marketing Surveillance (PMS)

Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients according to the prescribing information

Eligibility Criteria:
Inclusion Criteria:

* Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
* Subjects with no experience of treatment using dutasteride
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol
* Subjects who prescribed with dutasteride according to the Prescribing Information

Exclusion Criteria:

* Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information. Subject who give informed consent is enrolled. However, if institution waives the requirement for informed consent, informed consent is not required. In this case, monitoring does not proceed.
Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.

The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular Carcinoma diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
* Inoperable HCC or refusal to surgery
* Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
* Patients without evidence of extrahepatic metastasis
* The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
* The targeted tumors is more than 2cm away from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel)
* No previous treatment to target tumors by other forms of RT
* Liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
* Age of ≥18 years
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Laboratory Parameters WBC count ≥ 1,500/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 30,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no uncontrolled ascites
* No serious comorbidities other than liver cirrhosis
* Signed informed consent form prior to study entry

Exclusion Criteria:

* There is evidence of extrahepatic metastasis.
* Age of \<18 years
* Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7)
* Previous history of other forms of RT adjacent to target tumors
* Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* Multicentric HCCs, except for those with the following two conditions: (i) multinodular aggregating HCC that could be encompassed by single clinical target volume and within single clinical target volume; (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
* Pregnant or breast feeding status
* Previous history uncontrolled other malignancies within 2 years
Women Health Cohort for Breast, Bone and Coronary Artery Disease

A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013.

To evaluate whether bone mineral density and breast arterial calcification can predict coronary artery disease in women older than 40 years

Eligibility Criteria:
Inclusion Criteria:

* Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography at health promotion center of Seoul National University Bundang Hospital.

Exclusion Criteria:

* Women who have history of breast surgery or intervention
* Women who have history of myocardial infarction or revascularization
* Too poor image quality of coronary CT angiography for interpretation
* Renal dysfunction with serum creatinine ≥ 1.4mg/dL
Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.

About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice.

In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity.

There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients.

On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥70 years old
* Cytologically or histologically documented NSCLC
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
* World Health Organisation (WHO) performance status 0-2
* Non-frail patients according to Comprehensive Geriatric Assessment
* Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part)
* No prior chemotherapy (for phase II part)
* Life expectancy of at least 12 weeks
* Serum bilirubin less than 1.5 times the upper normal limit
* Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
* Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min
* Neutrophil count more than 1.5x 109 /L
* Platelet count more than 100x 109 /L
* Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

Exclusion Criteria:

* Hemoptysis
* Central nervous system metastases
* Clinically significant cardiovascular disease
* Medically uncontrolled hypertension
* Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
* Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network

The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables


Eligibility Criteria:
Inclusion Criteria:

* Trauma laparotomy within 90 minutes of arrival

Exclusion Criteria:

* Patients with a known allergy to cephalosporins or β-lactamase inhibitors
* Prisoners
* Pregnant and lactating women
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral or knee disarticulation amputation
* Received prosthesis between 4 - 24 months prior
* Currently uses prosthesis
* K2 ambulator status
* Able to speak English or Spanish language
* Age ≥ 65 years at Baseline Assessment (one month after enrollment)
* Minimum Socket Comfort Score (SCS) of 6/10

Exclusion Criteria:

* Upper limb involvement
* Individuals ≥ 275 lbs
* Unable to provide informed consent
* History of acute or chronic residual limb breakdown
* History of 2 or more socket adjustments or replacements in the past 6 months
* Amputation of the contralateral limb
* Active malignancy
* Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical \& Scientific Affairs personnel
* Patient unable or unwilling to follow study procedures
* Pregnant women, institutionalized persons, and children
Endotracheal Intubation During Resuscitation

We hypothesized that the BONFILS is beneficial for intubation of manikins while performing CPR. In the current study we compared the performance of the BONFILS and the Macintosh laryngoscopes with respect to their effectiveness and time to successful ETI during chest compression (CC) using an adult manikin.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.

The research aims to determine the impact of 30-day supplementation of melatonin on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.

Athlete's body, by its high oxygen demand and increased aerobic metabolism, is exposed to the formation and oxidizing action of reactive oxygen species (ROS). Imbalance between the mechanisms of ROS generation and antioxidative defense of the body can lead to oxidative stress expressed by elevated concentrations of lipid peroxidation products, such as malondialdehyde, isoprostanes (8-iso-PGF2α), oxidized low-density lipoprotein molecules (ox-LDL). The body's defense against ROS includes two systems: nonenzymatic and enzymatic. Small-molecule antioxidants include reduced glutathione (GSH). Due to the presence of -SH groups, glutathione has strong reductive properties. The compound is a substrate for glutathione peroxidase (GSH-Px) which decomposes hydrogen peroxide and organic peroxides. Among antioxidant enzymes are also: superoxide dismutase (Cu-Zn-SOD, scavenges superoxide anion radical), catalase (CAT, reduces hydrogen peroxide), and glutathione reductase (GR, reduces oxidized glutathione). Another well-known small-molecule antioxidant is melatonin, hormone of the pineal gland. It has been demonstrated that this compound can reduce hydrogen peroxide, scavenge hydroxyl radical and deactivate nitric oxide radical.

Another manifestation of disruption of homeostasis in the body of a professional athlete are enhanced inflammatory processes. This can be explained by the fact that during physical effort of varied intensity, increased activity of myeloperoxidase and higher levels of mRNA for tumor necrosis factor, interleukin-1 and -6 are observed. Interleukin-6, also known as myokine, is a particularly important marker of intense physical effort released from damaged muscles. Myokine is also the main upregulator of the synthesis of C-reactive protein (CRP) in the liver, hence measuring the concentration of the protein can indicate the intensity of inflammatory processes in an athlete's body. It has been demonstrated that melatonin, in addition to its hormonal and antioxidant properties, can modulate inflammatory processes by reducing the synthesis of proinflammatory cytokines.

Taking into account the multidirectional function of melatonin, it seems interesting to establish the impact of 30-day supplementation of this hormone on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.

Eligibility Criteria:
Inclusion Criteria:

* sign informed consent form for participation in the study

Exclusion Criteria:

* diseases
* the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators