cyrilzakka/clinical-trials huggingface dataset:
Incidence of Postoperative Sore-throat Incidence

Postoperative sore throat is a distressing but frequent symptom presented by the patients on the floor upon awakening from General Anesthesia, where endotracheal intubation is part of the Anesthetic protocol. Its incidence ranges between 21-71.8%. Good skills and availability of trained staff to cause minimal tissue damage are expected to reduce the incidence. Risks factors associated will be analyzed.

Post-operative sore throat (POST) is a common complication of endotracheal intubation. It ranges from 21 to 71.8 %. Various factors contribute to the development of POST, like, female sex, smoking, intubation difficulty and Suxamethonium use, high endotracheal cuff pressure, airway suctioning, long duration of surgery, mucosal injury with laryngoscopy, or pharyngeal airway use and larger size endotracheal tubes \[9\]. POST has also been associated with laryngeal masks, injury with laryngoscopy, or pharyngeal airway use and larger size endotracheal tubes. Basically it is mucosal damage of the throat and trachea which releases inflammatory mediators and produces soreness. POST leads to postoperative dissatisfaction. Patients of POST are uncontended following general anesthesia. Its preemptive amelioration, has been studied using various pharmacological interventions. The list includes, but is not limited to, Benzydamine hydrochloride (BH), aspirin, ketamine, lidocaine and dexamethasone. There is limited evidence based literature available about the incidence of POST in the investigator's locality in the country. The investigators plan to collect data in General OT of Rehman Medical institute (RMI), Peshawar. The city of Peshawar is the largest city of Khyber Pakhtunkhwa, a province of Pakistan, having a population of approximately 2 million. The objectives of our study is to know the magnitude of the problem and ascertain factors associated with postoperative sore throat among patients undergoing elective surgery under general anesthesia with endotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Any patient of either gender aged 18- 60 years
* Patients of American Society of Anesthesiologists (ASA) physical status 1 and 2 receiving General Anesthesia with ETT

Exclusion Criteria:

* Patients having ASA 3 or above physical status
* Recent or ongoing Upper Respiratory Tract Infection (URTI)
* Patients going to ICU intubated
Safety and Preliminary Efficacy of L-arginine in Severe Falciparum Malaria

Background: Mortality from severe malaria remains \~15% despite the use of the most rapidly parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome. Our overall goal is to determine if adjunctive treatment with L-arginine is safe and improves outcomes in severe malaria. In studies to date, we have shown that L-arginine is safe in moderately severe malaria, increases nitric oxide production and improves endothelial function. We now propose to extend these studies to patients with severe malaria.

Aims: To determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of L-arginine infusion in severe malaria.

Hypothesis: L-arginine will improve endothelial function, lactate clearance time and tissue oxygen delivery compared to saline with no clinically significant adverse effects.

Methods: Based on previous pharmacokinetic modeling and simulations, we propose a phase 2A randomised controlled trial of L-arginine vs saline in severe malaria, each given over 8 hours. If safety is demonstrated this will be followed by a phase 2B open-label study of 24-hour infusion of L-arginine in severe malaria with safety and preliminary efficacy compared with the 8 hour infusions given in phase 2A.

The primary outcomes will be the improvement in endothelial function and lactate clearance in patients given L-arginine infusion compared with those who received saline. Among the secondary outcomes will be safety and the effect of L-arginine vs saline on tissue oxygen delivery (NIRS).

Data from both phase 2A and 2B will be used to generate a pharmacokinetic/ pharmacodynamic model.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. age 18-60 years
2. informed consent obtained
3. time of commencement of artesunate ≤18 hrs before infusion of L-arginine
4. any level of P. falciparum parasitemia, and one or more of the following criteria: i. acute renal failure (creatinine \>265umol/L) ii. hyperbilirubinemia (total bilirubin \>50 umol/L) with either renal impairment (creatinine \>130umol/L) or parasitemia of \>100,000 parasites/uL iii. blackwater fever iv. hyperparasitemia (\>10% parasitised red cells) v. cerebral malaria (Glasgow coma score \<11) vi. Hypoglycemia vii. Respiratory distress (RR \>32)

Exclusion Criteria:

1. pregnancy or lactation
2. diabetes
3. serious pre-existing disease (cardiac, hepatic, kidney)
4. systolic blood pressure \<90 mmHg after fluid resuscitation
5. initial iSTAT test showing any of the following values: i. K+ \> 5.5 meq/L ii. Cl- \> 110 meq/L iii. HCO3- \< 15 meq/L
6. known allergy to L-arginine
7. evidence of concurrent bacterial infection
8. concurrent therapy with any of the following medications: iv. spironolactone, v. oral nitrates, vi. phosphodiesterase inhibitor (eg sildenafil \[Viagra\]) vii. alpha-blocking antihypertensive agents (eg prazosin) viii. L-arginine
Does Endorphin Massage Reduce the Anxiety of Pregnant Women?

Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage.

The sample size of the research was calculated using G\*Power 3.1.9.4 software as a minimum of 34 with 95% power, 0.01 alpha, and 0.9 effect size. The sample size was planned as experimental (n=34) and control (n=34) groups. To ensure the equality of the samples in both groups, a simple randomization method was used, where pregnant women with odd hospital protocol numbers will be included in the experimental group and those with even numbers will be included in the control group. Pregnant women who are admitted for pre-cesarean section care will be informed about the study, and their voluntary consent will be obtained both in written and verbal form. Pre-tests will be administered to both the experimental and control groups at 08:00, and blood samples will be taken to measure cortisol levels. Subsequently, an intervention will be applied to those in the experimental group, while those in the control group will receive routine nursing care. At 09:00, post-tests will be administered to both the experimental and control groups, and blood samples will be taken again to measure cortisol levels. The pre-test and post-test results, as well as the mean cortisol levels, will be compared between the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Being admitted to the hospital for cesarean section
* Being willing to participate in the research

Exclusion Criteria:

* Having psychiatric illness
* native language not Turkish
AndraValvulotome Post-Market Study

The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation.

The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome.
* Patient has to be consented and a informed consent form needs to be signed.
* Patient is able to and willing to participate in the 30 days follow-up.
* Vein diameter is at least 2mm (4F system) and 3mm (5F system).
* Vein diameter does not exceed 8mm (OTW-version) or 6mm (TIP-version)
* Bypass needs to be a continuous vena saphena magna with a length of at least 20cm.
* Rutherford category III - VI

Exclusion Criteria:

* Patients who have not completed 18 years of age
* Patients who are pregnant or assuming to be pregnant, and breast feeding.
* Patients who cannot participate due to medical or physical condition based on the decision of the physician.
* Life expectancy less than 1 year
* Known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid.
* Rutherford category 0-2
* Using varicose vein
* Exclusion criteria based on IFU
Internet Surveys and Their Impact on Adherence for Rosacea

An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.

An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group.

At each visit, review of the internet survey use will be done to assess adherence to the medication. . Disease severity measures ((Clinician's Erythema Assessment (CEA), and Lesion counts will be obtained. QOL will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent.
* Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment score which includes erythema in the assessment).
* Access to a computer and the internet.

Exclusion Criteria:

* Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
* Use of topical therapy for rosacea within 2 weeks of baseline.
* Use of systemic corticosteroids within 4 weeks of baseline. Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
* Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein.
* Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
* Subjects with severe cardiovascular disease or vascular insufficiency.
Retrospective Study of the Survival of Patients Suffering From Hiv-related Progressive Multifocal Leukoencephalopathy

Retrospective medical chart review of HIV-infected patients diagnosed with progressive multifocal leukoencephalopathy


Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients
* Diagnosed with progressive multifocal leukoencephalopathy
* Minimal follow-up of one year OR patient deceased less than one year after diagnosis

Exclusion Criteria:

* Loss of follow-up within 12 months after diagnosis
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians

Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory technician
* Pain intensity \>= 3 (scale of 0-10)
* Pain duration \>= 3 months
* Pain frequency \>= 3 days per week

Exclusion Criteria:

* life threatening disease
* pregnancy
Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis

Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity.

Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy.

Severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.

More research into existing antibiotics with novel mechanisms of action are required to combat the increased resistance and decreased development of antibiotics. Efforts were exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and pharmacokinetic properties of antibiotics.

Meropenem is administered mostly via a 30-min infusion, as some data indicate rapid degradation after reconstitution. Dose recommendations from two pediatric studies using Monte Carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed increased minimal inhibitory concentrations (MICs), more specifically, for Pseudomonas aeruginosa. A prolonged-infusion strategy has not been tested in neonates, although some data suggest that extremely small infusion volumes may significantly affect the drug amount actually delivered.

Aim of work:

The objective of our study is to compare the clinical and bacteriological efficacy of conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill neonates, with a proactive focus on reducing ventilator days in ventilated patients, length of stay in NICU, and neonatal mortality.

Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis (LOS) at admission or during their NICU stay and receive meropenem for at least four days

Exclusion Criteria:

* Acute or chronic renal failure
* Hypersensitivity or allergy to meropenem
Drug-Drug Interaction Between PK101-001 and PK101-002

To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ≥ 19 years of age (on the day of screening)
* No congenital or chronic diseases and no abnormal signs determined by medical examinations
* Not abnormal or not clinical significant lab values
* 90mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg
* 18Kg/(m)\^2 ≤ (BMI) ≤30Kg/(m)\^2

Exclusion Criteria:

* Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
* Subjects who were administered medications of prohibition within 10 days
* Heavy drinking within 30 days (female: over 14units/week, male:over 21units/week)
* Heavy smoker within 30 days (over 20 cigarettes per day)
* Subjects who previously participated in other clinical trials or bioequivalence Test within 90 days
* Subjects who donated whole blood within 60 days or donated component blood within 14 days or received blood transfusion within 30 days
* Subjects who have hypersensitivity for investigational products
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants

Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.

Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants below 30 weeks of gestation

Exclusion Criteria:

* congenital anomalies
* severe asphyxia
CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

The purpose of this study is to validate the online cohort of EGID patients enrolled in the RDCRN CEGIR CR. In order to achieve this objective, the investigators will determine the agreement between self-reported EGID information by the enrollees and their physician's report and medical records. All participants enrolled in the RDCRN CEGIR CR with EGIDs will be invited via email to participate in this study.

All individuals with EGID and enrolled in the RDCRN CEGIR CR will be invited to participate in this survey. As of 04/28, 1567 EGID patients have enrolled in CEGIR CR \[EoE=1,217, EG=56, EGE=65, EC=52; multiple diseases=177\]

The survey will be conducted through a pre-designed questionnaire. The questionnaire will be sent to participants via an introductory email wherein subjects will be informed about the purpose of this study. The questionnaire will gather self-reported clinical information (such as diagnosis, endoscopic procedures, histological findings in mucosal biopsies, and therapeutic plan). Consent will be obtained from participants to contact their physicians and allow their physicians to share relevant clinical information from their medical records.

Physicians identified by participants will be emailed a website link which will take them to a questionnaire. This questionnaire is designed to gather relevant information as documented in the patient's clinical records. Physicians will be able to submit the information online. It is anticipated that responding to this questionnaire would take less than 10 minutes of their time.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the RDCRN CEGIR Contact Registry, and with Internet access.
* Diagnosis of EGID (EoE, EG, EGE, EE and/or EC)
* Age: all ages. Parents/guardian of children \< 18 years of age will respond to the questionnaire on behalf of their child.

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Unaffected family members of EGID patients
* European Union participants who did not complete General Data Protection Regulation requirements.
Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.

The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.

Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female between 18 and 60 years
2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
3. Subject without any medication (except oral contraception)
4. Subject without previous digestive surgery history (except appendicectomy)
5. Capability to pass manometric probes through each nostril
6. Subject with health insurance
7. Written informed consent
8. No participation to another study at the same time

Exclusion Criteria:

1. Age under 18 years or upper 60
2. Pregnant woman or lactation
3. Incapability to give consent
4. No written informed consent
A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
* Evidence of T790M mutation to enroll in Cohort A.
* Evidence of measurable disease by radiographic technique.
* Adequate organ function.

Exclusion Criteria:

* Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
* Symptomatic brain metastases.
* Uncontrolled or significant cardiovascular disease.
* Pregnant or breastfeeding.
Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort

The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.

The "M2M-thrombose" study is a prospective epidemiological multicenter study involving patients with a lower limb trauma in winter sport resorts. The following initial data required are type of immobilization, treatment with LMWH (Low Molecular Weight Heparin), type of injury (serious or not) and the rolling of the step (normal or abnormal) or no weight bearing.

A 3 month follow-up by phone will be realized by the Investigation Clinical Center in Grenoble. Data about risk factors of thromboembolic diseases, anticoagulant therapy, medical history, new event since inclusion (hospitalization, surgery, lower limb trauma or thromboembolic events) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* patients seen during a consultation with a physician of mountain
* lower limb trauma seen within 48 hours
* patient resident in France

Exclusion Criteria:

* conditions requiring an immediate hospitalization
* prisoners
* pregnant, nursing or parturient woman
* refused participation in follow-up