cyrilzakka/clinical-trials huggingface dataset:
Amnion Chorion Membrane and Oroantral Communication

An oroantral communication is a relatively common yet, serious complication following the extraction of posterior maxillary teeth because of their close relationship to the maxillary sinus.

Several surgical techniques exist for the repair of oroantral communication, including local and free flaps, tissue expansion, allogenic tissue, and biomaterials.

The present study aims to evaluate the use of the BioXclude amnion chorion membrane in the repair of oroantral communication.

This study will be performed on ten patients who have oroantral communication after extracting posterior maxillary teeth. The oroantral communication will be repaired by using the BioXclude amnion chorion membrane.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be free of any relevant systemic diseases.
* Patients with recent oroantral communication (O.A.C) (24:72) hours .
* Good oral hygiene

Exclusion Criteria:

* An immune compromised state.
* Previous sinus disease.
* History of sinus surgery.
* Presence of intra-antral foreign bodies and need for cold well-luc procedure.
* Presence of intra-sinus pathology
Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections

This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion

Exclusion Criteria:

* Patient refusal
* Contraindication to nasal swabbing (arm 1)
* Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)
Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* patient who undergone open thyroidectomy
* 20\~70 years old
* ASA I\~III

Exclusion Criteria:

* hypersensitivity on Nefopam and Propacetamol
* Liver failure, chronic alcohol addiction
* severe hemolytic anemia, chronic nutrition deficiency
* history of seizure
* MI, MAO inhibitor
* pregnant, breast-feeding
* foreigners
Trial of Hemodialysis Based Exercise for Strength Improvement Study

Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.

Brief Summary:

Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:

(i) short physical performance battery; (ii) health-related quality of life \[EuroQOL-5D-5L\]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* On hemodialysis minimum of 3 times per week
* On hemodialysis \> 3 consecutive months

Exclusion Criteria:

* Inability to provide consent
* Inability to walk 4-metres
* Chest pain with exertion or myocardial infarction in past 6-months
* Pre-dialysis systolic blood pressure \> 200 mm Hg or diastolic BP \> 100 mm Hg in past 2-weeks
* Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
* Joint replacement or lower extremity fracture in previous 6-months
* Severe cognitive impairment
* Currently using corticosteroids \>5 mg/day
* Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
* Attending nephrologist feels exercise is medically contraindicated
* Scheduled living related kidney transplant in next 6 months
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F\&P Toffee Nasal or Toffee Nasal Pillows mask.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Eligibility Criteria:
Inclusion Criteria:

1. Persons who are ≥ 22 years of age
2. Persons who weigh ≥ 66 lbs (30 kgs)
3. Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
4. Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
5. Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
6. Persons who have an IPAP pressure of \< 20 cmH2O
7. Persons who currently use a PAP therapy device with data recording capabilities
8. Persons who are fluent in spoken and written English
9. Persons who possess the capacity to provide informed consent

Exclusion Criteria:

1. Persons who are intolerant to PAP therapy
2. Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
3. Persons using full face masks
4. Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
5. Persons who are pregnant or think they may be pregnant
6. Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.

Screening brain MRI scan is consistent with the diagnosis of AD.

Mini-Mental State Examination (MMSE) score greater than or equal to 10.

Other criteria apply.

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Other exclusion criteria apply.
Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients

PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.


Eligibility Criteria:
Inclusion Criteria:

* finish informed consent
* age≥18y and under 75y
* diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
* willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria:

* patient was treated by statins before randomization
* stable angina or ST elevation myocardial infarction
* without informed consent
* abnormal liver function before randomization, (AST，ALT≥3ULN)
* active hepatitis or muscular disease
* impaired renal function with serum creatinine level \> 3mg/dl
* impaired left ventricular systolic function with LVEF\< 30%
* participating in other studies
* non-PCI treated patients after coronary angiography will be washed out
Tryptophan for Impaired AhR Signaling in Celiac Disease

This is a prospective, randomized, double-blind, placebo-controlled exploratory trial to evaluate the effect of L-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease (CeD) and symptoms non-responsive to a gluten-free diet (GFD). Fifty participants, aged 18 to 75 years, who self-report persistent CeD-related symptoms despite taking a GFD for more than 1 year and who score \> 40 on the Celiac Symptom Index (CSI) will be randomized to receive L-tryptophan or placebo for 3 weeks.

At Visit 1, consented participants will receive study instructions and be randomized 1:1 to L-tryptophan or placebo (SimpleCap). A dietitian will counsel all 50 participants on how to maintain a low tryptophan, gluten-free diet. This diet provides an adequate intake of protein (50 g/day) and energy (1800 kcal/day) while limiting the consumption of high tryptophan-containing foods. Study participants will receive all their intervention capsules at Visit 1 to be taken for 3 weeks, starting the day after Visit 2. At Visits 2 and 3, just before and after the intervention, participants will complete dietary and symptom questionnaires, provide blood, stool, and urine samples, and undergo upper endoscopy to obtain aspirates from the second part of the duodenum, using a sterile catheter followed by six duodenal biopsies, 2 from the first part (bulb) and 4 from the second part of the duodenum. Dietary compliance will be assessed 3-day recalls which will further be analysed by using ESHA Food Processor, a Nutritional Analysis Software.

Eligibility Criteria:
Inclusion criteria:

* 18 and 75 years of age
* Celiac disease (CeD) diagnosis: Individuals with histological and serological evidence of CeD serology (positive biopsy and anti-tTG IgA)
* Persistent CeD related symptoms (\>40 on the Celiac Symptom Index) despite \>1 year of a gluten free diet (GFD)

Exclusion criteria:

* Acid anti-secretory and antacid medications
* Antibiotics, antibacterial agents or probiotics, currently, or within the last 8 weeks
* Current organic gastrointestinal or other autoimmune diseases, such as inflammatory bowel disease or diabetes mellitus (type 1)
* Lactose and/or fructose intolerance
* History of bariatric surgery, fundoplication or gastrectomy (partial or complete)
* Connective tissue disease
* Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, Helicobacter pylori infection, diverticulosis and melanosis coli
* Chronic treatment with high dose opioids
* Alcohol or drug abuse
* Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection
* Allergy or sensitivity to any component of the study medication or placebo
* Use of lithium and monoamine oxidase inhibitors (MAOIs)
* Participation in another dietary treatment study within the last 4 weeks
Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care

This Veteran Affairs (VA) Quality Improvement project aims to understand which data-driven implementation strategies promote evidence based practices that improve high-quality care for Veterans with cirrhosis.

Nearly 120,000 Veterans in care have cirrhosis, or advanced liver disease, from alcohol, hepatitis C, fatty liver disease, or other causes, and this number is rapidly increasing. There are life-saving measures that providers can take to prevent harm from cirrhosis. The three most impactful of these measures include providing access to post-discharge follow-up and screening for liver cancer and esophageal varices (veins that can cause catastrophic bleeding). However, only about one-third of Veterans receive care aligned with these three evidence-based practices (EBPs). Therefore, there is an urgent need to improve access to high-quality care for Veterans with this common condition.

By focusing on strategies that most successfully encourage implementation of evidence-based practices the investigators can address the urgent need to improve the quality and timeliness of care for Veterans with cirrhosis who receive care at VA hospitals. This quality improvement intervention seeks to understand which implementation strategies, or discrete activities that are conducted to promote EBP implementation, improve cirrhosis care. The aims of this evaluation are to: (1) empirically determine which combinations of implementation strategies ('data-driven strategies') are associated with the successful implementation of EBPs for Veterans with cirrhosis, (2) use Intervention Mapping to operationalize the 'data-driven' implementation strategies developed in the first aim, and (3) evaluate whether applying data-driven implementation strategies increases the use of EBPs for cirrhosis, using a hybrid type III stepped wedge cluster randomized trial. The investigators will measure cirrhosis care at all VA sites and use the data from aims 1 and 2 to provide feedback to all sites. The investigators anticipate that more intensive implementation interventions will directly impact 12 of the lowest-performing sites.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who have cirrhosis, or advanced liver disease, and receive care at VA.

Exclusion Criteria:

* N/A
A Clinico-biological Database of Lung Cancers

This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.

Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.


Eligibility Criteria:
Inclusion Criteria:

* Documented new diagnosis of lung cancer by histology or cytology, or lung tumor leading to lung cancer suspicion without diagnosis for which an antineoplastic treatment is indicated
* Indication of a treatment by surgery, chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy as first line of lung cancer treatment
* ability of the subject to follow study procedures
* Age \> 18 years
* Subject must have at least one measurable and/or assessable lesion in regard with RECIST 1.1 criteria
* Subject is registered with a social security scheme
* Subject is taken in charge at Pneumology department of Lille UH
* Subject has signed an informed consent form

Exclusion Criteria:

* Patient with a history of treatment by antineoplastic chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy, or presenting a contra indication to antineoplastic treatment administration
* Subject is not willing to sign the informed consent form
* Subject is not registered with a social security scheme
* Subject is not francophone
* Subject is deprived of his/her liberty or under trusteeship
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of blindness among adults in North America. The current standard of care for patients with exudative ("wet") AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of patients with exudative AMD, and could offer an alternative, safer and less burdensome therapy.


Eligibility Criteria:
Inclusion Criteria:

* Must agree to sign informed consent form, and to comply with protocol requirements, including study visits.
* Must have clear optic media in the study eye that is capable of producing high-quality fundus images.

Exclusion Criteria:

* Has active CNV due to causes other than AMD in the study eye.
* Has retinal vascular disease or retinal degeneration other than AMD in the study eye.
* Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within 90 days prior to the study.
* Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30 days prior to the study.
* Has active inflammation, infection, or other severe ocular disease in either eye.
* Has aphakia in the study eye.
* Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either eye.
* Is a contact lens wearer and is unable to discontinue their use in both eyes for the duration of the study.
* Has a serious allergy to, or experienced a prior significant adverse reaction to fluorescein angiography (FA) or indocyanine green angiography (ICGA).
* Has participated in any other clinical trial and/or has taken any investigational drug or product within 90 days prior to the study.

Other protocol-defined inclusion/exclusion criteria could apply.
Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families

Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis.

In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize.

The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis.

In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize.

The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

To do this, parents and children fill out a paper questionnaire, which is completed by their doctor, when they come to the hospital for consultation, hospitalization, or to perform lung function tests.

Concerning children and parents, these questionnaires include a part aimed at prioritizing each person's objectives and a second part collecting general information regarding their characteristics (age, sex, asthma history, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Minor patients aged 8 years to 17 years and 11 months inclusive with a diagnosis of asthma made by a doctor and a basic treatment for asthma
* Holders of parental authority for patients meeting the above criteria
* Doctors caring for children with asthma
* Information and non-opposition of holders of parental authority and minor patients to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Difficulties in French writing and / or speaking
Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators

The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain management in people commencing orthodontic treatment. The study design is a randomized controlled trial.

Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly, and the other side will be treated by a placebo procedure. Pain assessment will be measured using Visual Analog Scales (VAS).

The hypothesis of this study is that laser irradiation decreases the amount of pain following the insertion of orthodontic separators.

Here we have two groups:

The first group will undergo one dose of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

The second group will undergo two doses of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Participants should have healthy periodontal structures, healthy teeth.
* Presence of first molar in both side of the jaw.

Exclusion Criteria:

* systemic diseases
* chronic pain or neurological pain
Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement

This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.

Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.

Eligibility Criteria:
Inclusion Criteria:

* • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.

  * Patient's age between 30 - 50 years.
  * Both sexes.
  * The patient should be psychologically accepting the procedures.
  * Patients should be systemically free.

Exclusion Criteria:

* • Uncooperative patients regarding oral hygiene measures performance.

  * Patients with para functional habits.
  * Smokers.
  * Pregnant or lactating women.
  * Patients who underwent any periodontal surgeries in the study site during the six months prior to study.