cyrilzakka/clinical-trials huggingface dataset:
Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy

The aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. Smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes and applied a structured questionnaire in order to collect demographic and behavioural information. Further, expired carbon monoxide concentration were measured with a monoximeter. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using (RT-PCR).

Smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. All subjects received periodontal treatment and concurrent smoking cessation therapy. Smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. Periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. Further, periodontal maintenance was performed every 3 months.

A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). A structured questionnaire was applied in order to collect demographic and behavioral information. Expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using real time - PCR (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* smokers willing to stop smoking
* \>10 teeth
* periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)

Exclusion Criteria:

* systemic conditions considered as risk factors for periodontal disease,
* periodontal therapy in the last 6 months
* continuous systemic use of anti-inflammatory or steroidal drugs
Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis

Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis

To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis

Eligibility Criteria:
Inclusion Criteria:

* IMSS affiliated
* Glenohumeral arthritis diagnosed

Exclusion Criteria:

* Previusly treatment for the same disease
* No follow up
* Dead
Blephacura Versus Baby Shampoo to Treat Blepharitis

The aim of the study is to compare the effectiveness in treatment of chronic blepharitis either with a phospholipid liposome suspension compared to a conventional therapy recommendation using diluted baby shampoo.


Eligibility Criteria:
Inclusion Criteria:

* patients with blepharitis
* 100 eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved.

Exclusion Criteria:

* all patients that are not included in the group of inclusion criteria
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

This study aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of people with dementia.

The majority of patients with dementia live at home and cared by their families in Taiwan. Most of family caregivers have limited knowledge and care skills of dementia, therefore they experience great stress and caregiver burden which may have negative impact on their physical and mental health.

This two-group cluster randomised controlled trial aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of people with dementia.

The family care empowerment program consists of dementia care e-books, dementia virtual reality activity and family support group.

The interventional group will receive the care empowerment program using dementia care e-books, dementia virtual reality activity and family support group.

The control group will only receive dementia education manual and family support group with no dementia virtual reality activity.

Both groups will be assessed for their dementia knowledge, attitudes, care self-efficacy, empathy and caregiver burden at baseline, month 3, and 4.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 90 years,
* Taiwanese nationality,
* have provided care for relatives with dementia or cognitive impairment for at least three months,
* able to read Chinese and communicate in Chinese or Taiwanese,
* have a mobile phone or tablet and regular access to the internet,
* provide informed consent to participate in the study.

Exclusion Criteria:

* family members who do not meet the inclusion criteria,
* can not provide informed consent.
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants

Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.

Monitoring of a cohort of premature newborns with constitution of a collection of biological samples.

follow-up of newborns from birth up to 37 weeks of amenorrhea. The medical care of children will not be affected by their participation in the research.

* Sampling of amniotic fluid at the time of rupture of the water bag
* Sampling of the blood contained in the umbilical cord after clamping and section of the cord
* Sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward
* Collection of a daily stool sample until the end of hospitalization and when a NEC occurs
* Sampling of gastric residues during an episode of NEC
* Taking a daily sample of the newborn's enteral food
* Sampling of 500 µL of additional blood weekly during the punctures made for the treatment
* Daily statement of constants
* Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis)

  * Blood analysis: CBC, platelets and CRP (data analyzed as part of the treatment). Specific analyzes for research will assess: the level of tryptase, IL4 and TLR4. The samples will be stored and analyzed in the immunology laboratory of the CHU Clermont Ferrand (Pr B. Evrard)
  * Analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ECUN

Eligibility Criteria:
Inclusion Criteria:

* born prematurely \< 37 weeks of amenorrhea at the maternity ward of the CHU
* affiliated with a social security regime
* the holders of parental authority are able to give an informed consent to participate in the research

Exclusion Criteria:

* fetal pathology
* newborns whose holders of parental authority are under guardianship or under the age of 18
* refusal of participation by holders of parental authority
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
* Ineligible for hematopoietic stem cell transplant.
* Must have been treated with at least 2 prior systemic therapies.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
* Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

* Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
* History of central nervous system lymphoma (either primary or metastatic).
* Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.
* Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
* Active graft-versus-host disease.
* Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).
Study of Phenobarbital Inhibition of Catamenial Epilepsy

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.

We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients seeking medical attention for seizures
* Regular menstrual cycles
* At least 2 seizures per month
* Must be on at least one form of birth control other than abstinence
* Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
* If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
* Must be willing to take at least 400mcg of folic acid a day while in the study
* Must be able to detect, count or record seizures

Exclusion Criteria:

* Can not be pregnant or trying to become pregnant
* Can not have used hormonal birth control methods for at least 3 months prior to enrollment
* Can not have an allergy to Phenobarbital
* Can not have a history of non-epileptic seizures
* Can not have a know liver dysfunction or history of chronic hepatitis
* Can not have a history of neurological disorder or history of status epilepticus in the preceding year
* Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate
An Automated, Tailored Information Application for Medication Health Literacy

The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.

Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Currently treated with at least one medication for HIV infection
* No change in target medication anticipated in the next two months
* Able to participate in the study intervention in English

Exclusion Criteria:

* Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
* Not able to participate in the intervention using English.
Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants (18 years of age or older)
* Able to give written informed consent
* Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average
* Anticipated life expectancy of at least 1 month

Pre-Exclusion Criteria:

* Subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results
* Participants who have had IV sedation/opioid on previous BMB and who wish to receive IV sedation/opioid on this occasion or who in the opinion of the BMB operator would be advised to receive IV sedation/opioid on this occasion
* Concomitant use of other investigational agents
* Concomitant use of nephrotoxic agents such as gentamicin
* Uncontrolled INR (\>4)
* Personal or familial hypersensitivity to fluorinated anaesthetics
* Personal or familial malignant hyperthermia
* Respiratory rate of less than 10 per minute
* Has previously received methoxyflurane
* Known pre-existing renal or hepatic impairment
* Compromised Renal Function (creatinine ≥ 1.5 x ULNR)
* Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)

Exclusion Criteria:

* Premedication with anxiolytic (e.g. midazolam, diazepam)
* Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure
Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction

Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* patient with CA tongue and tumor size 2 cm

Exclusion Criteria:

* previous treatment
* history of head and neck cancer
Open-Label Placebo Treatment for Acute Postoperative Pain

This study is to evaluate whether the amount of morphine intake in acute postoperative pain following minimally invasive Transforaminal Lumbar Interbody Fusion (TLIF) can be decreased with an Open-Label Placebo (OLP) intervention (comprising the administration of sodium chloride (NaCl) injections and an evidence-based treatment rationale) in comparison to a "Treatment As Usual" (TAU) control group.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Scheduled to receive a TLIF procedure at University Hospital Basel (USB)
* 18 years or older
* German speaking
* Able to understand the study and its outcome measures

Exclusion Criteria:

* Known chronic pain, which is unrelated to problem targeted by the surgery
* Known neuromuscular disease
* Known mental disorders
* Known drug or massive alcohol intake or of other psychoactive substances
* Known kidney or liver disease (glomerular filtration rate (GFR)/ GFR \< 30)
* Contraindications to the class of drugs under investigation, e.g., known hypersensitivity or allergy to the investigational product
* Parallel participation in another study with investigational drugs
* More than 30 mg/day (equivalent dose of oral morphine) preoperative opioid consumption
Gut Microbiota and Glioblastoma Multiforme Prognosis

Glioma is the most common primary cancer of the central nervous system, and around 50% of patients present with the most aggressive form of the disease, glioblastoma. Conventional therapies, including surgery, radiotherapy, and pharmacotherapy (typically chemotherapy with temozolomide), have not resulted in major improvements in the survival outcomes with only a median survival of around 15 months.The main reason may be related to the highly immunosuppressive tumor microenvironment. In recent years, the microbiome has emerged as a key regulator of not only systemic immune regulation but brain circuitry, neuro-physiology and microglia development. We hypothesized that there is a link between the gut microbiota and the GBM development and evolution through the immune regulation cells (microglia and tumor related macrophagocyte) in the blood circulation to impact the prognosis( PFS and MST) of GBM patients.

We divide the paticipants into three groups. (total number = 200 subjects)

1. Radio/Chemotherapy group - 80 subjects
2. Radio/ without chemotherapy group - 70 subjects
3. Healthy volunteer group - 50 subjects

After the collection of stools before operation and 3 months after the operaton, we will analyze the composition and distribution of gut microbiota, and compare the results of three experiment groups.Then we will followe up the patients and analyze the correlation between gut microbiota and prognosis of GBM.

Eligibility Criteria:
Inclusion Criteria:

The participants diagnosed with glioblastoma multiforme by immunohistochemistry and molecular (IDH1, 1p19q, TERT) diagnosis of WHO 2016 classification of Gliomas.

The healthy volunteers.

Exclusion Criteria:

1. No cancer or IBD (inflammatory bowel disease);
2. No history of abdominal surgery;
3. No medication related to gastrointestinal motility within 3 months;
4. No oral antibiotic treatments previous 1 month before neurosurgery operation.
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption

ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries... However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear

Eligibility Criteria:
Inclusion Criteria:

* Patient with age above 18 years old
* Patients scheduled for spine surgery by anterior approach
* Patient who signed an informed consent form

Exclusion Criteria:

* Allergy to ropivacaine
* Weight \< 50 kg
* Contra indication to TAP block : sepsis in the point of draining, bleeding disorder
* Contra indication to paracetamol: severe hepatic insufficiency
* Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy
* Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, allergy
* Known allergy to active substance or at least to one excipient (propofol, paracetamol, morphine, remifentanil, cisatracurium)
* Allergy to fentanyl, atracurium, or benzin sulfonic acid derivative, to propacetamol
* Convulsions or previous convulsive disorder
* Severe respiratory insufficiency
* Abnormal hemostasis or anticoagulant treatment because of possible intramuscular injection
* Morphine intake 24 hours before surgery
* Chronic use of morphine, gabapentin, pregabalin
* Pregnancy or breastfeeding
* Patient unable to use Patient Controlled Analgesia (PCA) (old patient depends...)
* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty