cyrilzakka/clinical-trials huggingface dataset:
Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough

Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).

Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:

Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%

The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.

Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).

The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept \< or = 20 centimeter of water (cmH2O).

The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon.

All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* American Society of Anesthesiologists classification (ASA) category 1 or 2
* High pressure, low volume endotracheal tube - (Lo-pro)

Exclusion Criteria:

* Ear nose and throat and cranial surgery
* Ear nose and throat pathologies
* Asthma and bronchial hyperreactivity
* Chronic cough
* Diabetes
* Cognitive disorders
* Swallowing disorders
* Corticotherapy during the last week
* Allergy to lidocaine
* Urgent surgery
* Nasogastric, oro-gastric
* Ventral position
* More than 2 intubation attempts
* Continuous intravenous infusion of lidocaine intraoperatively.
Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fed Condition

Objective:

compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck \& Co., Inc.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were Included from the study based on the following criteria:
* Sex: male.
* Age: 18 - 45 years. .
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption ofprescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,
* Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Port Size and Post-Operative Pain Perception by Patients

The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).

Minimally invasive approaches trade a single longer incision for 4-5 smaller incisions that allow abdominal access and abdominal insufflation through "ports". The increase in operative times is mostly due to the need to pass suture, needles, cameras and instruments through the abdominal ports. While, it is intuitive that smaller abdominal ports will result in less pain at the incision site, the port size is also limited by instrument size and the size of the needle. When ports are smaller, it can take a little more time for a needle or instrument to be passed into the port.

There is a paucity of research comparing different port sizes as they relate to participate pain and operative time especially in a randomized controlled trial setting. The investigators goal would be to determine if there is a difference in pain perception by patients when the assistant port size varies by 50% (8 mm to 12 mm).

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic surgery for pelvic organ prolapse.
* proficiency in English .

Exclusion Criteria:

* Not proficiency in English
* Previous participation/randomization in the study at a previous visit
* Pregnant women cannot participate
* History of abdominal wall pain
* Chronic pain patients
Prognostic and Diagnostic Value of Biomarkers and Cardiac Functional Parameters in Patients With Chronic Heart Failure

The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* with symptoms and signs in NYHA Ⅱ\~Ⅳ
* with cardiac structural changes confirmed by echocardiography

Exclusion Criteria:

* with other severe diseases combined and will be alive for less than 12 months
* hard to participate in the investigation or accept the follow-up visits
* pregnant or lactating women
* during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions
A Self-efficacy Based Dietary Intervention

To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging.

Healthy eating is linked to improved survival and quality of life among cancer survivors. However, previous studies showed that most cancer survivors were not adhering to dietary recommendations despite having made changes post-diagnosis.

Conventional nutrition counseling interventions are often used in this population. However, they are labor and cost intensive and involved multiple sessions with participants. Written materials have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated. Therefore, we propose to develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging. Methods to increase self-efficacy include performance accomplishment, persuasion, modelling and peer-modelling.

A prospective, randomized controlled trial design will be used to test the effectiveness of the intervention. A total of 168 adult Chinese cancer survivors, diagnosed with non-metastatic cancer (Stages 0-III), and have completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy will be recruited.

Participants will be randomly assigned into one of two groups at a 1:1 ratio, using computer-generated block randomization sequences. The first group will be an active control group. Participants in this group will receive knowledge-based dietary information through an instant messaging applications biweekly for 6 times. The second group will be the intervention group. Participants will receive biweekly self-efficacy enhancing materials for 6 times. Materials will provide information about behavior-health link, provide information on consequences, provide instruction, and provide opportunities for social comparison. For example, the materials will provide recipe ideas and meal planning samples from fellow cancer survivors. All materials will be developed by a registered dietitian and will be consistent with published dietary guidelines for cancer survivors.

Participants will have follow-up appointments at 3 months. Their dietary quality and skin carotenoid status will be monitored. It is hypothesized that dietary quality will be better and skin carotenoid status will be higher for participants in the intervention group compared to participants in the active control group.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Diagnosed with cancer, non-metastatic (Stages 0-III)
* Ability to read Chinese and speak Cantonese or Putonghua/Mandarin
* Completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy
* Attending clinic with nutrition counseling at study site

Exclusion Criteria:

* Ethnicity other than Chinese
* Diagnosed with mental, hearing, speech, or cognitive disabilities
Post - Hospital Syndrome: Profile of Functional Status by Malnutrition

Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

The majority of geriatric hospitalized patients are at high risk for malnutrition at discharge, which has negative impact on post-hospital outcomes. In a cross-sectional analysis in malnourished, geriatric patients we will evaluate frailty-status and functional status using objective and subjective methods at hospital discharge. Moreover, we will investigate the association between nutritional Status and frailty, sarcopenia, quality of life and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Informed written consent
* Existing or risk of malnutrition
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor

Exclusion Criteria:

* Age \< 60 years
* Lack of informed written consent
* No risk of malnutrition
* Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
* Life expectancy of \< 3 months according to treating doctor
Does LAH May Improve the Pregnancy Outcomes?

A defect in the hatching stage is considered an important cause of implantation failure. Therefore, assisted hatching (AH), which involves artificial disruption of the zona pellucida, has been proposed as a method for improving the capacity of the embryo to implant. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the validity of LAH in ART.

Hatching is a very important process for successful implantation involving the breaking of the embryo out of the zona pellucida at the blastocyst stage. Inadequate hatching of the blastocyst might lead to implantation failure in ART. Currently, a variety of AH techniques have been used including zona thinning and the opening or complete removal of the zona by laser. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the investigator aim to discuss the effectiveness of LAH in ART.

In this study, patients were randomly divided into control and LAH groups. A quarter of zona pellucida of the cleavage-stage embryo was thinned to 6.6 μm. All operation was performed in the empty region without contact to the blastomere in order to minimize the blastomere damage. The ZP of blastocyst was drilled with laser, the ZP opening 20% of its initial length. The operation was performed in the opposite region of ICM in order to minimize the damage. In the control group, embryos were transplanted without LAH. The rate of clinical pregnancy, live-birth, miscarriage, multiple gestation were evaluated. This research intends to discuss whether LAH can improve the clinical outcomes in ART, and further choice the appropriate LAH action site.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF/ICSI-ET cycle；
* The zone pellucida of the cleavage-stage embryo is thicker than 8 μm.

Exclusion Criteria:

* Number of embryos transferred per cycle \>2;
* The transferred embryos including fresh and frozen cycle in the same cycle;
* Embryos developed from the frozen-thawed oocytes.
Postoperative Atrial Fibrillation and Long-term Survival

The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.

The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.

Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.

Eligibility Criteria:
Inclusion Criteria:

* previously cardiac operation, CABG or AVR

Exclusion Criteria:

* Previous Atrial fibrillation
Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma

Glioblastomas represent 40% of all tumors of the central nervous system (CNS) and are among the most lethal tumors. Temozolomide (TMZ) combined with radiotherapy was the first substance to significantly improve the overall survival (to 14.6 months) as compared to surgery and radiotherapy alone and increased the proportion of patients surviving more than 2 years to 26%. TMZ showed the best efficacy in patients with a methylated O6-methylguanine-DNA methyltransferase (MGMT) promoter in part by eliminating stem cell-like tumor cells. Among patients with a methylated MGMT promoter, the median survival after treatment with combined radio-chemotherapy was 21.7 months, as compared to 15.3 months among those who were assigned to radiotherapy only. In the absence of methylation of the MGMT promoter, there was a smaller and statistically insignificant difference in survival between the treatment groups.

Doxorubicin is one of the most effective substances in vitro against cells derived from glioblastoma. However, it has no significant effect in vivo due to poor blood-brain-barrier penetration. In a tumor model, tissue and CSF-concentrations of doxorubicin were substantially increased when sterically stabilized liposomes were used resulting in a comparable clinical response using approximately half of the dose of stabilized liposomes compared to conventional doxorubicin. A pegylated formulation (PEG-liposomal Doxorubicin) even further improved the penetration of the blood-brain barrier. Case series and two phase II-studies in patients with recurrent glioblastoma have shown modestly promising results for PEG-Dox.

In this study, the investigators treated patients with recurrent glioblastoma with 20 mg/m2 PEG-Dox on days 1 and 15 of each 28-day cycle. To determine the dose limiting toxicity of PEG-Dox combined with prolonged administration of TMZ, the investigators performed a phase I part ahead of the phase II study. To investigate, by means of a historical control analysis, if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients, the investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes as in the EORTC26981/NCIC-CE.3 study.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed glioblastoma
* centrally confirmed histology
* Karnofsky performance score (KPS) \> 70%
* stable corticosteroids within 2 weeks before inclusion
* leucocytes \> 3/ul, thrombocytes \> 100/ul, Hb \> 10 g/dl
* additional standard criteria

Exclusion Criteria:

* other tumor in history
* pretreatment with radiotherapy to the brain
Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant

We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.

We genotyped the APOA5 -1131T\>C in individuals with impaired fasting glucose (IFG) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL) were referred to the Department of Family Medicine or Internal Medicine. They were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program

Exclusion Criteria:

* Current and/or past history of cardiovascular disease including angina
* Liver or kidney dysfunction
* Thyroid or pituitary disease
* Unstable weight loss/gain (≥2 kg) over the previous 6months
* Pregnancy or lactation. Subjects who were taking medication were also excluded
GRAPE • Glycemic Response of Amylopectin Containing Drinks

To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.

The aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.

Subjects: 9 non-diabetic (HbA1c \< 6.5) males aged 30-55 years with body mass indices ranging from 27.5 to 35 kg∙m-2. Individuals with impaired glucose tolerance will be included as long as they are not diagnosed with diabetes and their HbA1c is less than 6.5.

Preliminary Testing: Medical history, weight, height, body composition via dual x-ray absorptiometry (DXA) and glycosylated hemoglobin (HbA1c) measurement.

Protocol: After a 10-hour overnight fast, subjects will complete 3 experimental visits in which they will ingest one of three beverages in a randomized order. During experimental visits subjects will either be given the following 3 experimental drinks:

* Full SP-glucose balance formula (200 kcal)
* Energy smart carbohydrate blend (50 g, 200 kcal)
* Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 g, 200 kcal)

Eligibility Criteria:
Inclusion Criteria:

* BMI 27.5 to 35 kg∙m-2

Exclusion Criteria:

* Diagnosed diabetes
* HbA1c \> 6.5
* competitive athletes
* body weigh change \> 3kg during last month
Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

The purpose of this study is to determine whether treatment of thyroid disease during pregnancy decrease the incidence of adverse outcome, and to compare the impact of Universal Screening versus case Finding strategy in detecting thyroid dysfunction

Thyroid disease during pregnancy has been associated with multiple adverse outcomes including miscarriage, preterm delivery, postpartum thyroiditis and decreased IQ in the offspring. Whether or not all women should be screened for thyroid disease during pregnancy (Universal Screening), screening should be confined to women at high risk for thyroid disease (Case Finding), or no screening should occur is controversial. For this purpose, pregnant women in the first trimester are randomly assigned to the Screening group or Case finding group. All women in the Screening group and high-risk women in the Case Finding group are immediately tested for FT4, TSH and TPO antibodies. Low-risk women in the Case Finding group have their sera tested postpartum. levothyroxine or PTU are given in hypothyroid and hyperthyroid women respectively. Outcome Measure: total number of adverse events occurring during pregnancy and in the neonatal period controlling for clustering of outcomes within women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Within 11 week of gestation

Exclusion Criteria:

* Already known thyroid disease