cyrilzakka/clinical-trials huggingface dataset:
NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients undergoing CPAP therapy for OSAS and improve CPAP compliance

Subjects diagnosed with Obstructive Sleep Apnea Syndrome (OSAS) who have started CPAP treatment and have complained of dry mouth or developed worsening of a pre-existing dry mouth as an effect of CPAP treatment will test the effectiveness of NeutraSal mouthwash in preventing or reducing his/her dry mouth perceptions and improving their compliance with CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Patient should be above 18 years of age.
* Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
* Ability to attend visits at the research site
* Patient should be able to read and/or understand and sign the consent form be willing to participate in the research study

Exclusion Criteria:

* Patients with open mouth sores at study entry.
* Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
* Patients using any other prophylactic mouthwashes.
* Patients who are pregnant and/or nursing.
* Patients becoming pregnant during the treatment period will be removed from data.
* Patients on a low sodium diet
* Patients currently on medication or treatment for xerostomia
* Patients \< 18 years of age
* Hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate
Retrospective Evaluation of Plane Blocks in Laparoscopic Cholecystectomy

the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoed laparoscopic cholecystectomy ASA I-II-III

Exclusion Criteria:

* patients used another block or block combination
* no block performed patients
* procedure converted to open procedure
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.

To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement.

To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.

The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.

Eligibility Criteria:
Inclusion Criteria:atrial fibrillation

* atrial fibrillation
* heart valve replacement
* VTE

Exclusion Criteria:

* severe liver or kidney diseases
Comparison of Apexification and Regenerative Endodontic Therapy: a Retrospective Study

In this study, the effects of mineral trioxide aggregation (MTA) apexification and regenerative endodontic treatment (RET) methods on periapical healing was compared with fractal analysis (FD) and periapical index (PAI).

The fractal dimension analysis of each radiograph was performed using the box-counting method proposed by White and Rudolph \[1\] (Figure 1). All periapical radiographs in high resolution Jpeg format to be included in the study was converted to tagged image file formats (TIFF). Each ROI at 18 x 19 pixels and 2 mm from the radiographic apex was selected, cropped and amplified. "Gaussian Blur" was used to eliminate the brightness changes due to soft tissues and variable bone thicknesses. The resulting image was then be subtracted from the original image. Bone marrow spaces and trabeculae were separated from each other by adding 128 gray values to each pixel location. The fractal dimension was calculated after the binary, etching, dilate, inversion and skeletonization operations were done.

This study was carried out on the radiographic records of patients who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics, who had at least one immature incisor treated with MTA apexification and RET method, and who had at least one-year follow-up radiographs.

Cases in which all endodontic treatments were performed by the same pedodontist (GK) were examined.

Eligibility Criteria:
Inclusion Criteria:

* Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,

  * Having no systemic or periodontal problems,
  * Asymptomatic or diagnosed with apical periodontitis with fistula tract,
  * Not having external/internal resorption, fracture, more than one root/canal,
  * Root canal filling is sufficient for the MTA group,
  * Root canal filling and coronal restorations were completed in Istanbul University Faculty of Dentistry Department of Pedodontics,
  * Cases with periapical radiographs taken before the procedure and at least one year after the procedure was included.

Exclusion Criteria:

* Cases treated by different pediatric dentists,

  * Cases in which apexification is performed by different operators,
  * Cases with systemic or periodontal disease,
  * Cases with external/internal resorption, fracture, more than one root/canal,
  * Cases where root canal filling is not sufficient
  * Cases in which root canal filling and conoral restorations were completed over 2 years,
  * Cases without radiographs taken before or at least one year after the procedure,
  * Cases with artifacts in the periapical region on their radiographs
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.

The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old, male or female.
2. Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
3. Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
4. Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
5. ECOG performance status of 0-1.
6. With a life expectancy of ≥3 months.
7. Have adequate laboratory parameters and organ functions during the screening period.

Exclusion Criteria:

1. Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
2. Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
3. Patients with untreated or active central nervous system tumor metastasis.
4. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Outcomes That Matter and Questionnaires for Older People With Frailty

The goal of this qualitative study is to investigate what matters to older people living with frailty, and how this can be measured using questionnaires (Patient Reported Outcome Measures, or "PROMs").

The research questions are:

1. What outcomes matter to older adults living with frailty?
2. What are participants' perceptions of PROMs that could measure these outcomes?

Our estimated sample will be 15 older adults, approximately 5 people living with mild frailty, 5 living with moderate frailty and 5 living with severe frailty. Participants will take part in one 90-minute interview.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 65
* Indication of frailty in one of the following ways:

  * Clinical diagnosis of frailty
  * Assessment of at least "4" on the Clinical Frailty Scale by a healthcare professional
* Having mental capacity to consent to participate as defined under the Mental Capacity Act (2005). This will be assessed in the telephone conversation prior to the interview by a researcher who has received Mental Capacity training
* Available to be interviewed by face-to-face interview at the National Institute of Health Research (NIHR) Exeter Clinical Research Facility or as a home visit, or as an online meeting

Exclusion Criteria:

* Not able to participate in face-to-face interview or use video call technology
* Not assessed as frail
* Not able to express thoughts and opinions in sufficient depth for analysis, even with facilitation by a relative or carer. This will be assessed in the telephone conversation with the researcher prior to the interview.
* Lacking capacity to consent to participate as defined under the Mental Capacity Act (2005). An individual would be unable to participate if they cannot:

  * Understand the information relevant to the decision of participating
  * Retain that information
  * Use or weigh up that information as part of the process of deciding whether to participate
  * Communicate their decision to other people
Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation

The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.

Blood samples and data will be collected from subjects with atrial fibrillation and normal controls. The primary aim of future research using these samples is to identify mechanisms and pathogenesis of atrial fibrillation. Through this information, we hope to identify targets for new therapies and improve knowledge and understanding of atrial fibrillation. Identification of disease genes could improve strategies that prevent progression of atrial fibrillation to more persistent disease.

Eligibility Criteria:
Inclusion Criteria for Atrial Fibrillation group:

* Male or female at least 18 years old
* Subjects with a history of or current Atrial Fibrillation
* Subjects able to give informed consent Exclusion Criteria for Atrial Fibrillation group: no history of atrial fibrillation

Inclusion Criteria for Controls:

* Male or female at least 18 years old
* Subjects with no history of Atrial Fibrillation
* Subjects able to give informed consent Exclusion Criteria for controls: History of atrial fibrillation
Effect of Extubation on Respiratory Function

The extubation phase is a risky period of anesthesia management. During this step, serious complications can arise: hypoxemia, laryngospasm, pharyngeal obstruction, pneumonia... In spite of these complications, extubation and its impact on respiratory function, particularly on the Functional Residual Capacity (FRC), remains poorly studied because of the difficulty to make bedside measurements.

The PulmoVista 500 is a clinical routine which provide effective non-invasive bedside measurements. It would be interesting to evaluate the impact of extubation on respiratory function, and more specifically FRC changes during and after extubation.

This study will allow a better physiopathological knowledge and a quality improvement patient extubation management.

The aim of this study is to evaluate the variation of functional residual capacity and its distribution before and after extubation.

Patients with scheduled surgery and receiving general anesthesia with orotracheal intubation are included and the measurements will be performed in the post-interventional monitoring room (PICU). EELI data will be collected before extubation and then at T0, then T5, T10, T15 and T20 minutes. No subsequent follow-up is required.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years
* Patient in operating room for scheduled surgery
* Patient receiving general anaesthesia with orotracheal intubation
* Patient given written consent after information
* Patient covered by social security or equivalent regimen

Exclusion Criteria:

* Patient undergoing thoracic and spinal surgery, due to the presence of dressings that interfere with measurements,
* Patient who has undergone intracerebral surgery because of possible communication difficulties upon awakening,
* Patients with a body mass index (BMI) \> 50 (measurements not possible)
* Pregnant or breastfeeding patient,
* Patient contraindicated to the use of a thoracic electroimpedancemetry technique: dressings, wounds, presence of a pacemaker, defibrillator or any other active implant.
* Patient deprived of liberty by a judicial or administrative decision or patient subject to a legal protection measure (guardianship, curatorship...)
* Patient in a period of exclusion from another research protocol
* Any other reason that, in the opinion of the investigator, could interfere with the evaluation of study objectives
Effect of Xylitol on Oral Microbiota in Children

1. The present controlled, randomized, doubleblind study aims to answer the following questions:

   * How will the "normal flora" be affected by the xylitol consumption?
   * Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
   * The association of the test results will also be compared with the caries status at the baseline.
2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.
3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
4. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.

Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.

The present controlled, randomized, doubleblind study aims to answer the following questions:

1. How will the "normal flora" be affected by the xylitol consumption?
2. Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
3. The association of the test results will also be compared with the caries status at the baseline.

After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).

Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.

Eligibility Criteria:
Inclusion Criteria:

* high SM count

Exclusion Criteria:

* low SM count,
* ongoing medication
Study of MOC31-PE in Antigen Positive Carcinomas

Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been extensively investigated for their possible use as anti-tumor agents although not in carcinoma patients with minimal residual disease. Various ITs have been tested in early clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins directed against carefully selected epithelial cell surface molecules may have a potential for eradicating also dormant metastatic tumor cells, as their action is independent of cell proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE), inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of elongation factor 2 in the ribosome complex.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirm epithelial carcinoma, verified to be positive for the targeting antigen(Ep-CAM/epithelial glyco protein 2)according to the criteria given below.
* Tumor specimens verified to be positive for the targeting antibody,i.e.EGP2 positive (MOC31) by immunocytochemical or histochemical staining.
* Signed written informed consent
* Patients with no clinically symptomatic central nervous system (CNS) involvement.
* Both gender, age 18 -75 years old.
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Adequate hematologic, renal and hepatic function defined as: Neutrophils \> 1.5 x 10\^9/L;Platelets \> 100 x 10\^9/L; Creatinine \< 120 umol/L; Total bilirubin within normal range. Liver enzymes (ALAT and ASAT \<2.5 UNL: alkaline phosphatase \< 1.5 UNL and yGT \< 1.5 UNL).
* Coagulation parameters (pT, PTT) within normal range.

Exclusion Criteria:

* No medical history of Hepatitis B or C infection
* Patients must have no ECG abnormalities
* Patients must not be HIV positive
* Female premenopausal patients should not be pregnant (must have a negative pregnancy test prior to inclusion) and should not be lactating.
* Patients must use effective contraception if of reproductive potential.
* Prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to study enrolment
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male and female subjects aged between 18 and 75 years (inclusive) at screening.
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential.
* Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
* For healthy subjects: Normal renal function confirmed by a creatinine clearance at screening according to Cockroft and Gault adjusted to age of:

  1. ≥ 80 mL/min/1.73 m2 for subjects ≤ 50 years of age.
  2. ≥ 70 mL/min/1.73 m2 for subjects 51-60 years of age.
  3. ≥ 60 mL/min/1.73 m2 for subjects 61-75 years of age.
* For subjects with hepatic impairment: Degree of liver function impairment due to liver cirrhosis according to the Child-Pugh classification:

  1. Group A: Mild hepatic impairment, Child-Pugh score 5-6.
  2. Group B: Moderate hepatic impairment, Child-Pugh score 7-9.
  3. Group C: Severe hepatic impairment, Child-Pugh score 10-15.

Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* For healthy subjects:

  1. History of alcoholism or drug abuse within the 3-year period prior to screening.
  2. Relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
Loaded Gait Training on Gross Motor Function in Cerebral Palsy

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured.

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy (CP).

52 children with bilateral spastic CP, aged 5 to 7 years, were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training 3 times per week for an hour for 3 months.

Gross motor functions were measured by the Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains, while knee extensor strength was measured by a hand-held dynamometer.

Eligibility Criteria:
Inclusion Criteria:

* Age: five to seven years old, classified as levels II and III on the GMFCS.
* Spasticity grade from 1+ to 2 based on the Modified Ashworth scale.
* Able to understand and follow verbal commands and instructions (with a score above 80 on the Stanford Binet Intelligence Scale).

Exclusion Criteria:

* Genetic or metabolic disorders.
* Brain tumours.
* Musculoskeletal dysfunction that would interfere with our intervention (e.g. tightness of the posterior knee joint capsule that causes passive knee extension lag, or fixed contracture of the knee joint).
* Surgical intervention in the lower limbs within the preceding 12 months.
* Botulinum toxin injections in lower limb muscles within the last six months.