cyrilzakka/clinical-trials huggingface dataset:
Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment

This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.

The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being \>18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
* ASA I or II
* \>18 years old

Exclusion Criteria:

* Maxillary or mandibular anterior tooth
* Diagnosis of pulp necrosis or reversible pulpitis
* Tooth deemed non-restorable
* \<18 years old
* ASA III, IV, or V
* Patients who are contraindicated to take ibuprofen
* Patients with allergies to any medications being assessed in this study
Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence

This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the:

* incidence of coughing during emergence of general anesthesia
* time needed for emergence following a desflurane-based anesthesia
* incidence of sore throat after extubation.

The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control group following a desflurane-based anesthesia.

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.

Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the tube's cuff. The addition of bicarbonates is required to increase its diffusion to the underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its neutral base form over a period of 6 hours.

In vitro studies have demonstrated that the optimal time for local anesthetic diffusion through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with alkalinized lidocaine at least 90 minutes before intubation could be appropriate for surgeries expected to last less than two hours.

This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized lidocaine to prevent coughing during emergence in short-duration surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective short-duration surgery under general anesthesia (expected duration of less than 2 hours)
* Physical status 1-3

Exclusion Criteria:

* Asthma or severe pulmonary disease
* Pulmonary tract infection
* Anticipated difficult intubation
* Current use of cough medicine
* Contraindication to lidocaine
* Pregnancy
* Airway surgery
* Inability to provide informed consent
* Patient refusal
Robotic Versus Laparoscopic Surgery for Deep Endometriosis

The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.

The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists physical status classification) 1-3
* Diagnosed deep endometriosis (MRI)
* Patient has symptoms
* Operative treatment is indicated
* Patient is able to give informed consent

Exclusion Criteria:

* ASA \> 3
* Recurring rectosigmoid endometriosis
SLC2A1 Variants and Diabetic Nephropathy

Cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of high extracellular glucose resulting in intracellular activation of deleterious biochemical pathways. Expression of GLUT-1, the major glucose transporter in mesangial cells, is increased and participates in the induction of diabetic nephropathy. Variants in the gene encoding GLUT-1 (SLC2A1) have been associated to this diabetic complication. The aim of this study was to test whether polymorphisms in SLC2A1 confer susceptibility to diabetic nephropathy in Brazilian type 1 diabetes patients.

In this study, 449 patients, included between October 2004 and October 2012, were sorted into three groups according to diabetic nephropathy stages: without (persistent normoalbuminuria, n=248), incipient (microalbuminuria, n=82) and overt diabetic nephropathy (macroalbuminuria or proteinuria or renal replacement therapy, n=119). Measurements of urinary albumin-to-creatinine ratio (ACR) or urinary albumin excretion rate (UAER) were used to define DN: patients with persistent normoalbuminuria (\<30 mg/g creatinine or \<20 μg/min) were classified as without DN (n=248); patients presenting persistent microalbuminuria (30-300 mg/g creatinine or 20-200 μg/min) were classified as having incipient DN (n=82); and patients presenting persistent macroalbuminuria (\>300 mg/g creatinine or \>200 µg/min), proteinuria (\>500 mg/24 h) or renal replacement therapy were classified as having overt DN (n=119). Genotyping of polymorphisms was performed by Real Time PCR using fluorescent -labelled probes.

Eligibility Criteria:
Inclusion Criteria:

* Overt 10 years of Diabetes Mellitus

Exclusion Criteria:

* Patients presenting autoimmune diseases, HIV or HCV infections
* Patients with glomerular filtration rate \< 60 mL min-1 1.73 m2 without diabetic retinopathy
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer

This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than or equal to (\>=) 18 years of age
* Gastric adenocarcinoma, Stage II, IIIa or IIIb
* Potentially curative resection of tumor within 6 weeks prior to randomization
* Previously untreated with chemotherapy or radiotherapy

Exclusion Criteria:

* Serious concomitant medical illnesses that would limit life expectancy to less than (\<) 5 years
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
* Any evidence of metastatic disease (including presence of tumor cells in the ascites)
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction

This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.


Eligibility Criteria:
Inclusion Criteria:

1. Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
2. Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.

Exclusion Criteria:

1. Subjects who are unable to read or speak English.
2. Patients desiring autologous reconstruction.
3. BMI \>40.
4. History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
5. Current nicotine and/or tobacco use.
6. Documented diagnosis of chronic pain.
7. Women who are pregnant or breast-feeding \*
8. Women who decline the use of acellular dermal matrix (ADM).
9. Surgeon decision not to proceed with tissue expander reconstruction.
10. Women undergoing single stage (straight to implant) reconstruction.
Prospective Outpatient Registry of Myocardial Infarction Patients

The investigators enrolled 160 patients who visited Moscow state outpatient clinic №9 (and its two branches) within six months after acute myocardial infarction. The enrollment lasted from 01.03.2014 to 01.07.2015. The observation period is five years. During the first year after enrollment in the study, patients had follow-up visits every two months, from second-year every six months. Analysis of the prescribed therapy and its changes was carried out by the cardiologist in the clinic for the entire observation period, taking into account the concomitant diseases /indications/contraindications. Endpoints (the death, repeated cardiovascular complications (AMI, stroke), emergency hospitalization due to worsening of the main cardiovascular disease, the appearance of clinically significant cardiac arrhythmias, invasive interventions) were defined during out-patient visits and telephone contact


Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone AMI and applied no later than 6 months. after discharge from the hospital to the Moscow outpatient clinic № 9 from March 1, 2014, to December 31, 2015;
* availability of discharge summary with confirmed AMI;
* permanent residence on the territory of Moscow and the Moscow region;
* the signing of informed consent to the processing of personal data.

Exclusion Criteria:

* patients with the absence of discharge summary from the hospital with a proven history of AMI;
* visit the clinic in a period exceeding six months from the AMI;
EFFICACY OF COLCHICINE IN IMPROVING CLINICAL OUTCOMES IN PATIENTS WITH MILD TO MODERATE COVID-19 PNEUMONIA IN LAHORE: A RANDOMIZED CONTROL TRIAL

This study is for patients suffering from COVID-19 pneumonia (mild to moderate cases) ; especially in developing countries where expensive drugs are not available.

Colchicine is an economically favourable anti inflammatory drug readily Used for gout patients but is being given experimentally in Covid 19 patients .

Study has been designed in this way that drug has been given carefully to patients on which there will be no to minimum side effects . It is only to see beneficial effects if any present in Covid pneumonia patients which will be observed by clinical \& lab improvement.

Colchicine, an anti-inflammatory drug used conventionally to treat gout and pericarditis. This study shows effectiveness of colchicine in enhancing clinical outcomes in mildly to moderately severe COVID-19 pneumonia patients.

Improvement will be observed in terms of shorter hospital admissions and oxygen dependency .

Eligibility Criteria:
Inclusion Criteria:

* Patients with laboratory-confirmed COVID-19 infection through a PCR test using a nasopharyngeal swab specimen, or the presence of at least two of the following four inflammatory criteria: C-reactive protein (CRP) level \> 4 mg/dL, D-dimer level \> 1 mg/L, ferritin level \> 1000 ng/mL, along with fever ≥ 38 °C and respiratory distress Patients having supplemental oxygen requirement. Patients who provide informed consent to participate in the study. Patients having normal levels of serum Ca2+ and K+; QT interval \<450 ms at 12 derivations ECG (Colchicine has been associated with potential cardiac side effects, including disturbances in electrolyte levels and QT interval prolongation. Normal levels of these electrolytes help minimise the risk of cardiac arrhythmias or other adverse events.

Exclusion Criteria:

Known hypersensitivity or allergy to colchicine or any of its excipients. Patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m\^2 or advanced liver disease (Child-Pugh Class B or C). Patients taking medications known to have significant interactions with colchicine, such as strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole), P-glycoprotein inhibitors (e.g., cyclosporine), or medications associated with myelosuppression (e.g., azathioprine, cyclophosphamide). Patients with pre-existing medical conditions that, in the opinion of the investigator, could pose a significant risk or interfere with the interpretation of the study results (e.g., severe heart failure, uncontrolled arrhythmias, uncontrolled diabetes, or active malignancies).

Pregnant or lactating individuals. Patients deemed by the investigator to be in imminent danger of death or unlikely to survive the duration of study due to some other disease
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients

It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients

Exclusion Criteria:

* none
Qigong and Exercise Therapy for Low Back Pain in Adults

The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
* low back pain more prominent than other pain in the spine
* average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
* intellectual and physical ability to participate in the study
* informed consent

Exclusion Criteria:

* low back pain related to malignancy
* low back pain due to an accident
* inflammatory joint disorders
* previous spine surgery
* protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
* actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc.
* planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc.
* use of pain drugs for other diseases (\> 1x/week)
* pregnancy
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
* participation in another clinical trial in the last 6 months before study entry
An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.

To evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail.

The appearance of the infected toe nail in those suffering from the disease may have a greater impact on quality of life than the severity of the disease. It is believed that a visual improvement in the appearance of the infected toenail at an earlier stage could have a positive impact on quality of life and encourage compliance with treatment. The aim of this consumer study is to evaluate the quality of life of consumers with onychomycosis and investigate its relation to the appearance of the infected toenail within the initial 4 weeks of treatment with Scholl Fungal Nail following its purchase from an eCommerce platform.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Consumers who have purchased the product online
* Consumers who are willing to participate in the study

Exclusion Criteria:

* Female consumers who are pregnant or breast feeding
* Participants with Diabetes (Type I or II)
Effects of Stimulus Validity on Speech Recognition

The effects of talker variability will be investigated with four groups of listeners (young normal-hearing; old normal-hearing; young hearing-impaired; old hearing-impaired). Experimental conditions will include between-talker differences, speaking rate, lexical difficult and semantic/linguistic context. A preliminary experiment will evaluate the relative merit of adaptive vs fixed-level methods of stimulus presentation.


Eligibility Criteria:
Hearing impaired
Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers

A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.

Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F

At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).

At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subject, aged 19- 50 years at screening.
2. Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} \* 0.9

Exclusion Criteria:

1. History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
2. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
3. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
4. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)\]
5. Participation in any other study within 2 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)
Integrated Diagnostics for Early Diagnosis of Liver Disease

This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.

Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early.

The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests.

This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to Community Liver Assessment Clinic.
* Male or female \> 18 years of age.
* Females will be non-pregnant and non-lactating.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
* Isolated bilirubinaemia.
* Known pre-existing liver disease.
* Acutely unwell.
* Suspected malignancy.