cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases

Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash.

Methods \& Material: Twenty-four subjects, without systemic diseases, with plaque-induced gingivitis will be selected for this study. The patients were treated with scaling and root planing at the baseline; Oral hygiene instructions were given that included brushing twice- daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2 minutes, these patients were randomly ,equally divided into two groups, Group A: perform daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium, (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of each volunteer were measured.

In this study, 34 patients referred to periodontics Department that no serious systemic disease in terms of periodontitis and disease Gingivitis (ie pockets of periodontal tissue to a depth of less than or equal to 4 mm without CAL in the jaw down or up) the following explanation necessary for the procedure tastings consent, the index of oral hygiene (plaque index) index # Turesky, pocket depth and to control the inflammatory condition \* bleeding index bleeding during the probe based on Carter and Barnes (if any bleeding number 1 and its absence 0) and attachment loss were evaluated areas. The amount of pigment (Stain) after of using mouthwash based on S.I (Stain Index) was evaluated .

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria: adult patients with gingivitis, older than 18 years old, systemically healthy, and having at least 20 teeth.

Exclusion Criteria:patients with cavitated caries, no periodontal pockets larger than 4 mm, orthodontic appliances or removable prostheses, allergies to cetyl pyridinium or CHX, use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health, oral prophylaxis outside of study; use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination, pregnancy or nursing, smoking.

Study Population 34 eligibles were enrolled in the study, was designed as a Randomized, Double-blind clinical trials.
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.

The purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut to assess small intestinal dysbiosis

In order to diagnose an increased bacterial density in the small intestine (e.g small intestinal bacterial overgrowth) metabolic activity of the microbiota colonising the small intestine is measured by exposing these bacteria with readily fermentable carbohydrates and measure subsequently (e.g. for 2 hrs) the change of the concentration of hydrogen (H2) and/or methane in the exhaled breath that results from carbohydrate fermentation in the small intestine. This is the principle of existing breath hydrogen tests, but they are poor at distinguishing where in the intestine the H2 is being produced, and their sensitivity is diminished by 'noise' in the breath H2 as a consequence of hydrogen or methane producing bacteria in the colon and this is frequently observed in the routine clinical setting. These shortcomings can be theoretically overcome by using the Atmo Gas CapsuleR which measures after ingestion gas concentrations during gastrointestinal transit in the lumen of the gut. As a consequence at the site of fermentation parts per hundred can be measured, rather than the parts per million (ppm) when methane or hydrogen are measured in the exhaled breath. An additional advantage is that the location of the capsule is known, and therefore the source of gas production from increased bacterial load can be determined. Preliminary studies using the gas capsule have shown good correlation of patterns of breath H2 with those of regional H2 patterns generated by the gas-sensing capsule. In fact, the capsule demonstrated far greater sensitivity in measuring H2 production and a vastly superior signal-to-noise ratio in response to a fermentable load than breath testing. Hence, investigating the utility of the gas-sensing capsule as a means for 'direct' assessment of microbial density presents an opportunity to overcome the shortcomings associated with the current breath test.

Eligibility Criteria:
Inclusion Criteria:

Patients aged over 18 years presenting to the Department of Gastroenterology \& Hepatology at the Princess Alexandra Hospital who require and are booked for an upper gastrointestinal endoscopy as part of the routine diagnostic work up of e.g. otherwise unexplained gastrointestinal symptoms.

Exclusion Criteria:

* Radiation Enteritis
* Pregnancy
* Gastric bezoar
* Swallowing disorders/dysphagia to food or pills
* Obese, with BMI over 35
* Suspected or known strictures of the GI tract
* Fistulas or physiological/mechanical GI obstruction
* GI surgery within the past 3 months
* Diverticultis
* Patients with implantable or portable electro-mechanical medical devices, e.g. pacemakers
The Effect of Pre-anesthetic Education on Cardiac Surgery Patients' Anxiety Level

The study aims to investigate the effect of pre-anesthetic education on patients undergoing cardiac surgery

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects identification was done using identification form, medical record, Mini Mental State Evaluation (MMSE) and Internal Classification of Diseases (ICD) 10. Subjects' anxiety level were measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS) with the help of the researcher to explain the questions. Then, education were given to the subjects, guided by a flow chart made by the researcher, using verbal and emphatic non-verbal language. If during education subjects got anxious with or without cardiovascular emergencies, education would be stopped, subjects would be eased down. Subject's family would be called in. If the subjects agreed to continue, the study would be carried on, otherwise subjects were dropped out. Benzodiazepin and midazolam 0.5 mg/kgBW would be considered and consulted to a psychiatrist. On the day after the education and discussion, subjects filled in APAIS again before entering the operation room. APAIS score recorded before and after anesthesia would be presented in the means, and analyzed by SPSS using paired T-test (or Wilcoxon test as the alternative test).

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65 years old
* Subjects able to read and write properly
* Subjects have adequate communication ability
* Subjects were able to speak Indonesian language properly
* Subjects were planned to undergo cardiac surgery
* Subjects have given informed consent for the anesthetical and surgical procedures.

Exclusion Criteria:

* Subjects who did not give informed consent
* Subjects who had done a cardiac surgery before this study commenced,
* Subjects who had a cognitive/psychiatric problem that decreased communication ability
* Subjects in antianxiety and/or antidepressant treatment.

Drop out criteria:

* Subjects who had anxiety sign and symptoms with/without cardiovascular alarming signs and could not be eased down during education
* Subjects decided to drop out the study.
Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial

Observational studies support an association between bottle feeding beyond 15 to 18 months of age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency, behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic households, choose to feed their children by bottle much beyond this age. Recognizing the need for further educational interventions for bottle feeding, the TARGet Kids! Research Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9 month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational intervention for parents of 9-month-old children could reduce bottle use and iron depletion at 2 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT

Exclusion Criteria:

* N/A
Exercise Training and Testosterone Replacement in Heart Failure Patients

The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients

In this study, we are evaluating:

* hospital length of stay and readmission
* muscle sympathetic nerve activity
* functional capacity
* body composition

Eligibility Criteria:
Inclusion Criteria:

* heart failure
* hypogonadism
* left ventricular fraction ejection \< 45%

Exclusion Criteria:

* chronic renal failure
* normal testosterone
* pace maker
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students

The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern.

Some pelvic floor physical therapists are beginning to experiment with using phonation and vocalization cues to elicit different pelvic floor movements . However, there is a significant gap in the literature about the coordination and movement between the pelvic floor and glottis during speech and phonation, and there is an urgent need to identify the voices accompanied by increasing pelvic floor tone and integrating them into pelvic floor strengthening programs and voices accompanied by lowering pelvic floor tone and integrating them into pelvic floor down-training programs. To date, there has been only one study describing pelvic floor displacement during vocalization tasks. So this study aims to investigate pelvic floor muscle displacement during respiratory and phonatory tasks using trans-abdominal ultrasound to assess respiratory and phonatory tasks that can relax or enhance pelvic floor tone and be integrated into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

- 1. They should be virgin, healthy female physiotherapy students. 2. They have regular menstruation (3-8 days in duration, with 21-35 days in-between).

3. Their ages will range from 18 to 25 years old. 4. Their body mass index (BMI) will range from 18 to 24.9 Kg/m2. 5. Their waist- hip ratio will be less than (0.8).

Exclusion Criteria:

1. Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
2. Pelvic floor dysfunction.
3. Professionally trained singers.

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Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.

5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Urine incontinence refractory to traditional treatment

Exclusion Criteria:

* Arrhythmia, pacemaker implantation
Prospective Robotic-Guided Registry of Spine Surgery

This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.

It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.

The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Eligibility Criteria:
Inclusion Criteria:

* Any pediatric, adolescent or adult patient
* Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.

Exclusion Criteria:

* Pregnancy
* active infection
* malignancy
* primary abnormalities of bone
* primary muscle diseases (e.g., muscular dystrophy)
* neurologic diseases
* spinal cord abnormalities/lesions
* paraplegia.
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~55 years in healthy male volunteers
* 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight ≥55kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Caries Detection With Two Different Caries Detecting Devices

The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression. The secondary aim is to compare the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Patients of TUSDM Comprehensive Care Clinic
* Adult patients over the age of 21
* Extreme/High Caries Risk classification per TUSDM Caries Management by Risk Assessment (CAMBRA) form
* Presence of 2 or more initial active primary carious lesions on a free coronal surface of any tooth by visual assessment, QLF, and LumiCare™
* Presence of at least 1 cavitated lesion
* Updated (no more than 6 months old) bite wing radiographs available.
* Patients who responded either yes/no to use of e-cigarettes/vapes
* 1 active caries, 1 inactive caries and 1 sound tooth surface.

Exclusion Criteria:

* Low or moderate caries risk classification per TUSDM CAMBRA form
* No clinically detectable carious lesions on free coronal surfaces
* No cavitated caries lesions
* Carious teeth with caries lesions concomitant with extrinsic stains, fluorosis, or developmental defects.
* Patients who responded yes to the use of conventional cigarettes or smokeless tobacco
BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer

This is a Phase Ⅰ/Ⅱa, multi-center, open-label study, aiming to evaluate the safety, tolerability, pharmacokinetic (PK), and efficacy of BR790 in combination with anlotinib in adult participants with advanced NSCLC.

This study is a Phase Ⅰ/Ⅱa, multi-center, open-label study of BR790 in combination with anlotinib with a dose escalation part followed by a dose expansion part in adult subjects with advanced NSCLC. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75 years old.
* Subjects with histologically or cytologically confirmed locally advanced or relapsed metastatic driver negative (EGFR, ALK, ROS, etc.) advanced NSCLC，whose disease progressed after at least 2 previous standard therapies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) .

Exclusion Criteria:

* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has uncontrolled moderate to massive effusion.
* Central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day).
* Other kinds of malignancies within 5 years or for now.
* Has not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L, PLT\<100×10\^9/L, Hb\<100g/L; TBIL\>1.5×ULN, ALT or AST\>2.5×ULN (without liver metastases) , ALT or AST\>5×ULN (with liver metastases);Cr \>1.5×ULN, urine protein≥++，or confirmed 24h urine protein≥1.0g;INR \>1.5×ULN, PT\>1.5ULN or APTT \>1.5×ULN.
* Previous use of other SHP2 inhibitors (such as TNO-155, JAB-3312, JAB-3068, RLY-1971, RMC-4630, etc.)
* Has used anlotinib before
* The first assessment of efficacy was PD, or occurred ≥grade 3 adverse reactions with antitumor angiogenesis small-molecule drugs (e.g. Apatinib, surufatinib, fruquintinib, etc.), or less than 6 months after the last antitumor vascular therapy.
* Has got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (5.0), alopecia and grade 2 peripheral neuropathy are not included.
Progesterone-modified Natural Cycle for FET

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 to 44 years undergoing FBT
* Body mass index (BMI) 18-35 kg/m2
* Having regular ovulatory cycles

Exclusion Criteria:

* Untreated uterine adhesions
* Medical contraindications to estrogen and progesterone therapy
* Illnesses contraindicating assisted reproductive technology or pregnancy
* History of recurrent implantation failures (\> 2 embryo transfer failures)
The Role of IL-22/IL-22BP Axis in Atopic Dermatitis

Interleukin 22 (IL-22) is known to be regulated by IL-22 binding protein (IL-22BP), a soluble, inhibitory receptor. The potential role of IL-22BP in atopic dermatitis (AD) is mostly unknown and deserves further investigation. The main objective of this study is to better understand the potential protective role of IL-22BP through the assessment of its expression at the Messenger Ribonucleic Acid (mRNA) and protein levels in skin and serum which will be correlated to the severity of the diseases and through the identification of its cellular sources in lesions. The results of this study will help to correctly interpret the levels of IL-22 in AD and will potentially allow identifying biomarkers for patient stratification and predicting clinical outcomes to targeted therapeutic agents.

This is a single-visit study. All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area

. It is planned to include 45 patients (15 patients per severity group: SCORAD \]25-50\] , \]50-65\]; 50-65; \>65).The first 20 patients included will be group 2 and 3 patients (SCORAD \> 50).

The patients will be adults with AD recruited from the cohort of patients followed up in the Dermatology department of Nantes University Hospital. A refusal rate of 4/5 is expected. Recruitment can therefore be envisaged in 18 months (2.5 patients/month). Patients will be recruited during follow-up consultations or at the first consultation in the department. Recruitment will be coordinated by the clinical research team (CRT). Blood samples will be taken by the CRT Nurse. The skin and blood samples will be sent to the CIMNA/ Immunology Laboratory Nantes University hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients with AD according to UK Working Party criteria
* Patients affiliated to French social security system
* Patients who gave written consent after reading the protocol
* Moderate to severe AD (SCORAD score\>25)
* Presence of at least one lesional and one non-lesional skin area in the area covered by the clothing
* No immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months

Exclusion Criteria:

* Minor patients
* Pregnant and/or breastfeeding women
* Patients under guardianship or tutorship
* Inability to understand information and instructions
* Patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months
* Patient included in a clinical trial
* Documented allergy to the anesthetic (xylocain)
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions

The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years old
* Global Deterioration Scale score (GDS) of 2
* High school or higher levels of education
* With informed consent

Exclusion Criteria:

* Evidence of neurologic or medical conditions
* Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV)
* Mini-mental status examination score of 25 or less
* Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
* Intelligence quotient less than 70
* Any history of head trauma involving loss of consciousness or seizure
* Contraindications to magnetic resonance imaging (MRI)
* Use of psychotropics in last 3 months
* Allergic adverse reactions to Fermented Codonopsis lanceolata
* Participation in other clinical trials during the study period that might affect the outcome of the present study
* Use of oral contraceptive medication
* Current pregnancy or breast-feeding