cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5 mg tablet. Dosing periods were separated by a washout period during fasted study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in 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 of prescribed 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 judgment 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.
Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines

The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV. Patients free of disease after surgical resection will also be eligible.
* For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
* Patients must be HLA-A0201 positive.
* Patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent.
* Patients must have a Karnofsky performance status of at least 80.
* LDH \< than or = to 2x upper limit of normal value; albumin \> than or = to 3.5 mg/dl.
* A CBC prior to vaccination with WBC \> or = to 3000, platelets \> or = to 100,000.
* Patients must be free of detectable brain metastases.

Exclusion Criteria:

* Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. Patients must be fully recovered from any previous therapy or surgery.
* Patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase.
* Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
* Patients who have preexisting retinal or choroidal eye disease will be excluded.
* Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
* Pregnant women or women who are less than 3 months post-partum are not eligible. Women who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative BHCG within 2 weeks of vaccination) nor be nursing during treatment.
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.

100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had \>2 SOFA score and \>6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS \&VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Those who had an age between 18-65 years old
* patients ventilated for more than 10 days
* with conscious level more than 8/15 on Glasgow Coma Scale

Exclusion Criteria:

pediatric patients below 18 years of age
An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC)

The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED.


Eligibility Criteria:
Inclusion Criteria:

* ED providers (physicians, nurse practitioners, physician assistants)
* Working full-time in the ED

Exclusion Criteria:

* Part-time ED providers
Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients

In France, hospitalised elderly patients (EP) aged \>75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Dependence related to hospitalisation, partly avoidable, occurs in 30 to 60% of patients aged over 70. Faced with this situation Geriatric Mobile Teams (GMT) were created in 2002 to meet the need for geriatric expertise in hospitals and in the community by making punctual evaluations. Expert and multidisciplinary, the GMTs are a referring team for "advice, information and training for health care teams" for the care of vulnerable EPs. The GMTs are dependent on an exclusively medical demand system. The lack of knowledge of a specific care for EPs by nurses and nursing assistants and the occasional contribution of GMTs prevents a systematic targeted a for EP. Over the past 30 years, an American nursing programme (NICHE) aimed at improving the overall care of EPs in hospitals has shown that the training of geriatric resource nurses in speciality wards brought about a significant change in hospital geriatric culture. The training is based on evidence based practice including the HELP programme targeting confusion. The HELP programme has shown that nurses and nursing assistants play a pivotal role in reducing the incidence of hospital confusion. In the USA, the implementation of NICHE begins with the creation of a team of nursing leaders (geriatric/education/clinical care experts), dedicated to the coordination of the training and the companionship of geriatric resource nurses. Within the framework of the targets of the Ségur de la santé 2020 and Ma Santé 2022, our hypothesis is that an adaptation of NICHE to the French health context could improve specific care for EP in specialist wards, reduce the occurrence of complications and reduce the length of stay. Indeed, the GMT would ensure this coordination role in the training and support of a nurse and nursing assistant duo, based on the model of hygiene correspondents, in order to disseminate good geriatric practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and over hospitalised in a participating specialtist wards
* not objecting to the study,
* including those under guardianship or curatorship.

Exclusion Criteria:

* Patient not affiliated to a social security scheme
* Patient at the end of life
taPentadol cLinical prAcTice IN belgiUM

Multicenter observational study to determine the long-term tolerability and analgesic effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory to other strong opioids.

Tapentadol, a centrally acting analgesic. It is indicated in Europe "for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics" (IR formulation/oral solution) and "for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics" (SR formulation). Tapentadol is reimbursed in Belgium since May 1, 2018. The reimbursement was obtained through an article 81 procedure (Chapter IV) which means that the reimbursement is currently restricted to the time frame of the contract and that during that period certain questions and uncertainties regarding the use of tapentadol in a Belgian setting need to be answered. In order to answer the questions raised by the Belgian Healthcare authorities, this study will be performed evaluating the application of oral tapentadol in routine clinical practice in Belgium. The study is conceived as a nation-wide multicentre prospective non-interventional trial. The primary endpoint and secondary endpoints of this study are guided by the questions that need to be answered during the course of the contract reimbursement, as established by the Belgian health authorities.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should be capable of giving their informed consent;
* Males and females, 18 years and older;
* Patients suffering from severe pain;
* Pain symptoms refractory to strong opioids (in previous treatment);

  * Due to side effects
  * Due to insufficient analgesic effectiveness
  * Due to opioid induced hyperalgesia.

Exclusion Criteria:

* Severe renal and/or hepatic insufficiency;
* Known and/or strong suspicion of allergy to tapentadol;
* Previous treatment with tapentadol;
* Presence of any condition for which tapentadol is contraindicated as per its approved labelling information in Belgium;
* The patient has no access to a mobile phone and web browser. During the study, an online system is used to receive messages (SMS and e-mail) for the completing of the online assessments (through web browser).
The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS

In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging.

After informing the patients about the study and possible risks, written consent was obtained from all patients. After routine anesthesia technique was applied to the patients, supraglottic airway device was inserted. The placement of the airway device was evaluated with ultrasonography. Airway pressures reflected on the anesthesia device were recorded. The correlation between airway pressures and ultrasonographic images was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with informed consent from their parents
* Patients with ASA I-II physical status
* Patients with appropriate fasting time
* Those with an operation time of less than 2 hours

Exclusion Criteria:

* ASA III-IV physical status patients
* Patients with respiratory tract infections
* Patients undergoing head and neck surgery
* Patients with oropharyngeal pathology
* Patients with gastrointestinal obstruction
* Patients with tracheomalacia
* Patients who need to be intubated for anesthesia applications
Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction. The central hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to identify a subgroup of patients with low back pain who will respond favorably to mechanical lumbar traction. If these clinical tests can identify a subgroup of patients with low back pain who respond favorably to lumbar traction, additional studies, including randomized clinical trials will be necessary to further test and validate the use of this cluster of clinical tests. The rationale for this research is to examine the connection between provocative lumbar compression testing and lumbar traction as a means of decompression

Eligibility Criteria:
Inclusion Criteria:

* Complaints of low back pain with or without pain into the lower extremities
* Pain of at least 2/10 according to the Numeric Pain Rating Scale
* Score of at least 20 or greater on the Oswestry Disability Index

Exclusion Criteria:

* Medical red flags consistent with non-mechanical back pain (i.e. recent weight loss, history of cancer, night sweats, fever)
* Previous surgery to the lumbar spine
* Current pregnancy
* Any neurological symptoms in the lower extremities
* Evidence of central nervous system involvement
* The inability to lie prone for 15 minutes
A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria

* Diagnostic evidence of probable Alzheimer's disease (AD) consistent with the Diagnostic and Statistical Manual for Mental Disorders-version IV (DSM-IV)
* Hachinski Ischemic Score
* Functional Assessment Staging (FAST) scale greater than or equal to 6 at Screening.
* Mini-Mental State Examination (MMSE) score of 1 to 12 at Screening
* Subjects who are on a stable Aricept- dose of 10 mg immediate release (IR), taken as a single, daily dose for 3 months prior to the Screening Visit
* Evidence consistent with Alzheimer's disease (AD) on any cranial image on magnetic resonance imaging (MRI) or computed tomography (CT) scan or etc. obtained within 24 months prior to the Screening Visit. Subjects who have any observations of dementia other than Alzheimer's type after the last image diagnosis should be reconfirmed.
* Age 50 years
* Written informed consent is to have been obtained from the subject (if possible) or from the subject's legal guardian or other representative

Exclusion Criteria

* Subjects with dementia other than Alzheimer's type
* Subjects with significant neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, a history of head injury with loss of consciousness, or a history of brain surgery followed by persistent deficits
* Subjects with allergy to donepezil hydrochloride or piperidine derivatives
* Subjects with a cause of Alzheimer's disease (AD) which is supported by any laboratory tests such as Vitamin B12, folate levels, triiodothyronine, free triiodothyronine, thyroxine, thyroid stimulating hormone (TSH) or serologic test for syphilis
Effect of Music and Mindfulness Meditation

The purpose of the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be undergraduate college students majoring in a music degree.
* Participants must self-report feeling general anxiety at a level of 7/10 recently.
* Participants must be proficient English-readers and -speakers and be full-time enrolled students.
* Students of any gender and race/ethnic group may be included.
* Participants must be novice meditators, having fewer than 10 total meditation experiences.
* Students of any year will be accepted if they are considered undergraduate students by the university.

Exclusion Criteria:

* Self-reporting feeling general anxiety below a 7/10 recently.
* Having more than 10 total meditation experiences.
IRAD2 : Patients With Respiratory Failure at Home

Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

* first group, 100 patients : control group, patients followed with no add-on intervention
* Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.

Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion

State of the art :

The IRAD2 trial is evaluating a 3-month home intervention which includes education, oral supplements, exercise and androgenic steroids in undernourished patients with chronic respiratory failure. The main objective is to increase the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life. Secondary end-points include a reduction in exacerbation rates by 25%, a reduction in health-related costs and an increase in survival during the year following intervention.

Material and methods :

This interventional, multi-centre, prospective, two-armed parallel, controlled trial is being conducted in 200 patients. In both groups, "Control" and "Rehabilitation", 7 home visits are scheduled during the 3-month intervention for education purpose. In the "Rehabilitation" group, patients will receive 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women, oral dietary supplements (563 kcal/d) and exercises on an ergometric bicycle 3 to 5 times a week.

Expected results :

In the event of significant responses to intervention, this trial would validate a comprehensive and global home-care for undernourished patients with chronic respiratory failure combining therapeutic education, oral supplements, androgenic substitution and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* well informed and consenting person
* woman is old enough to procreate
* Assisted respiratory treatment at home for 3 months : oxygenotherapy \> 8 hours per day and/or assisted ventilation \> 6 hours per day.
* PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.
* Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.
* malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.

Exclusion Criteria:

* Sleep apnea with daytime drowsiness (drowsiness scale of Epworth \> 9/24)
* Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).
* History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.
* Inability to follow a rehabilitation program
Preliminary Study to the Manufacturing of a Non-stick Membrane for Surgery Using Patient's Own Cells (MESO-PATCH)

The objective of this study, which will be realised in vitro on human samples, is to test 2 cell sources isolated from peritoneum for adult mesothelial cells (peritoneal samples) and from adipose tissue for the adipose stem cells (adipose tissue samples). The latter will be differentiated towards the mesothelial phenotype and morphotype. The 2 routes will be compared and the most satisfactory one will be chosen to make a non-stick patch.

* Patient information and collection of a signed informed consent
* Clinical data collection: surgery date, age, weight, height, medical and surgical history
* Prospective collection of peritoneal and adipose biopsies of patients during their surgery at the Oscar Lambret Center (Dr L. BRESSON)
* Transportation of the samples to the 1008 INSERM Unit.
* Isolation of cells from the samples : mesothelial cells from the peritoneum and adipose stem cells from adipose tissue
* Cell culture and expansion of mesothelial cells; and cell culture and differentiation of adipose stem cells
* Identification by the morphotype and phenotype of mesothelial cells
* Comparison of the results according to the cell source, peritoneum or adipocyte, to the purity of cells and to the efficacy of the expansion

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years old,
* Planned surgery For peritoneal samples : abdominal surgery (laparotomy or coelioscopy) For adipose tissue samples : breast reconstructive surgery (lipomodelage)
* Informed and signed consent

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship or tutorship
* For peritoneal samples : previous abdomino-pelvic radiotherapy or abdominal surgery ; peritoneal carcinosis