cyrilzakka/clinical-trials huggingface dataset:
Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment

Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months.

A total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 30-65
* Have not received periodontal treatment in the last 6 months,
* Does not have any systemic disease and does not use drugs,
* Not using local or systemic antibiotics in the last 3 months,
* HbA1c \<%7 for the controlled T2DM group,
* HbA1c ≥7% for the uncontrolled T2DM group,
* For female patients who are not in the pregnancy or lactation period,
* Non-smoker,
* Not regularly using mouthwash/mouthwash.

Exclusion Criteria:

* Not being willing to participate in the study,
* Under 30 years old, over 65 years old
* Having any systemic disease affecting the periodontal condition,
* To use any medication that may affect the inflammatory process in the last 3 months,
* Using local or systemic antibiotics in the last 3 months,
* To have had periodontal treatment in the last 6 months,
* Being in pregnancy or lactation period for female patients,
* Using mouthwash regularly
* Smoking
The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar

The effect of content of barley beta-glucans in bread on postprandial blood sugar will be measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult subjects who will test three barley beta-glucan containing bread formulations (food) in comparison with a reference white bread. Objective of the study is to investigate the influence of the content of barley beta-glucan in bread on glycaemic index (incremental area under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing breads in comparison to reference white bread.


Eligibility Criteria:
Inclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged above 18 years at the time of the signature of ICF
* No known food allergy or intolerance
* No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
* Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
* Body mass index (BMI) \> 25

Exclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged above 18 years at the time of the signature of ICF
* No known food allergy or intolerance
* No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
* Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
* Body mass index (BMI) \> 25
Long-Term Follow Up of CLN6 Batten Disease Subjects Following Gene Transfer

This is a long-term safety and efficacy study in subjects with CLN6 Batten disease who previously received a single intrathecal administration of AT-GTX-501.

This is a long-term safety and efficacy study in subjects with CLN6 Batten disease (also know as variant late infantile neuronal ceroid lipofuscinosis associated with mutation(s) in the CLN6 gene \[vLINCL6\] disease),who previously received a single intrathecal administration of AT-GTX-501. The assessments described in this long-term follow-up (LTFU) study (AT-GTX-501-02) are performed following and in addition to the initial 2 years of post-treatment assessments in the treatment study (AT-GTX-501-01). In this LTFU study, subjects complete safety and efficacy assessments throughout the study's 3-year duration. Combining the duration of the initial treatment study and this LTFU study, the overall duration reflects a follow-up period up-to 5 years since gene transfer via AT-GTX-501.

The primary outcome for this study is to assess the long-term safety of AT-GTX-501 in subjects with CLN6 Batten disease.

The secondary outcome measure of this study is to assess the long-term efficacy of AT-GTX-501 in subjects with CLN6 Batten disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject received AT-GTX-501 (scAAV9.CB.CLN6) in the study "Phase I/IIa Gene Transfer Clinical Trial for Variant Late Infantile Neuronal Ceroid Lipofuscinosis, Delivering the CLN6 Gene by Self-Complementary AAV9."
* Subject completed or prematurely discontinued from the study "Phase I/IIa Gene Transfer Clinical Trial for Variant Late Infantile Neuronal Ceroid Lipofuscinosis, Delivering the CLN6 Gene by Self-Complementary AAV9."
* Subject has a legally authorized representative who has provided written informed consent and authorization for use and disclosure of personal health information or research-related health information.

Exclusion Criteria:

* None
Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases

Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility Criteria:
* Signed and dated informed consent.
* Male or female up to 4 years old.
* Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month.
* Without any active pathology requiring a change in ocular treatments within the last month before inclusion.
* Best corrected far visual acuity (VA) \> 1/10
Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.

After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.

the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.

the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.

Eligibility Criteria:
Inclusion Criteria:

* primary sleeve gastrectomy

Exclusion Criteria:

* stomach disease
* prior surgery on the stomach
Orthoptic Changes Following Photorefractive Keratectomy

Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative near exotropia. A significant reduction in means of convergence and divergence amplitudes (P\<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P\<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative NPC\>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline stereopsis \>60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in patients undergoing PRK may improve or remain unchanged after operation and postoperative deviations can develop following this surgery. Diminishing of fusional amplitude and increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a preoperative orthoptic examination in patients with any concerning histories and/or motility issues on routine exam is recommended before performing PRK.


Eligibility Criteria:
Inclusion Criteria:

\>18 yrs / refractive errors / with consent

Exclusion Criteria:

\< 18 / corneal opacity - keratoconus

Dry eye / diabetes / collages vacuolar disease
A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS

Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.

Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score \>= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A

,1 0 0 per arm .

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 50 years of age, inclusive.
* Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
* Expanded Disability Status Scale (EDSS) \>=score 3.5 (Appendix B).
* Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
* Laboratory values within the following limits:

  * Creatinine 1 . 5 x high normal.
  * Hemoglobin
LEAP2 on Postprandial Glucose Metabolism and Food Intake

The study aim to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.

In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined. Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP-2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. Interestingly, LEAP-2 was recently shown to antagonize ghrelin function in response to feeding in mice. Moreover, the mature murine LEAP-2 peptide is identical in mice and humans. Thus, LEAP-2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction.

The study hypothesis is that LEAP-2 alters postprandial glucose metabolism and decreases appetite as well as food intake in relation to a liquid mixed meal and a standardised ad libitum meal compared with saline (placebo) in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Age between 18 and 25 years
* Body mass index between 20-35 kg/m2
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Allergy or intolerance to ingredients included in the standardised meals
* First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) \>48 mmol/mol
* Regular tobacco smoking or use of other nicotine-containing products
* Any ongoing medication that the investigator evaluates would interfere with trial participation.
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study

Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases

Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured

Eligibility Criteria:
Inclusion Criteria:

Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene

Exclusion Criteria:

History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication
"Dialogue Circles" to Reduce the Level of Caregiver Overload in Complex Chronic Patients and Advanced Chronic Disease

The increase in life expectancy and the decrease in the birth rate have led to an aging population and a higher prevalence of chronic diseases. This has generated the need for informal caregivers of older adults to face health care situations of this population. On the other hand, it has become evident how the epidemiological profile has changed over the last 50 years, with a decrease in infectious diseases and a higher prevalence of chronic non-communicable diseases, which increase the demand for family caregivers. Caring for a dependent family member can negatively affect the caregiver's health in his or her affective and working life. In the first phase, a cross-sectional descriptive study will be carried out and in the second phase, an experimental study, randomized clinical trial (RCT) with simple masking will be conducted Objectives: Phase I general objective is to describe the sociodemographic characteristics of the study sample. Specific in this phase are to analyze the relationship between level of caregiver strain and sociodemographic variables collected from primary caregivers, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living, to analyze the relationship between level of caregiver strain and the patient's ability to perform activities of daily living. To analyze the relationship between level of caregiver overload and deterioration in the patient's cognitive sphere. To analyze the relationship between overload and the instrumental activities that the patient can perform. To analyze the relationship between overload and mental health from a positive perspective. Phase II: the general objective is to determine the efficacy of the nursing intervention, dialogue circles, to reduce the level of overload perceived by caregivers of patients identified as complex chronic patients and chronic advanced disease. The specific objectives are to compare the level of overload perceived by the main caregivers before and after the intervention between the experimental group and the control group, and the degree of satisfaction with the dialogue circles nursing intervention. It will be carried out in Catalonia, in the populations of the metropolitan area of Barcelona, belonging to the Primary Care Service (SAP) Baix Llobregat Centre.


Eligibility Criteria:
Inclusion Criteria:

* - Primary caregivers of patients identified as Patient Chronic and/or advanced chronic disease who are in the case management service portfolio in the basic areas of SAP Baix Llobregat Centre and Delta de Llobregat.
* Primary caregivers with the abbreviated caregiver burden scale administered.

Exclusion Criteria:

* Caregivers under 18 years of age.
* Occasional caregivers.
* Professional or contracted caregivers.
* Primary caregivers of patients diagnosed with any type of dementia.
* Primary caregivers participating at the time of the intervention in some type of individual or group psychological intervention.
* Not wishing to participate in the study.
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.

After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Must be ASA score I-III
* Must be 18-75 years old
* must undergo cardiac surgery

Exclusion Criteria:

* emergency surgery,
* bleeding diathesis,
* presence of contraindications to LA agents used in this study,
* use of chronic opioids,
* psychiatric disorders.
* prolonged extubation
* presence of infection at the injection site.
* cardiovascular conditions (EF\<40, LMCA obstruction)
Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug Metabolis/Transport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia

The main component in the treatment of acute myeloid leukemia (AML) is consist of anthracycline (such as daunorubicin or idarubicin) and cytarabine. Inter-individual variability of transport/metabolism of the chemotherapeutic agent and several genetic pathways involved in the drug action might be associated with different response following the treatment for AML usually consisted of chemotherapy and/or transplantation. One of potential pathways involved in the drug action is DNA repair pathway, accordingly single nucleotide polymorphisms (SNPs) in the DNA repair machinery pathway might be a predictive marker for therapy outcomes in AML.

Several genes were involved in the DNA repair machinery which are 1) Nonhomologous end joining (NHEJ) pathway involved in the G1/S phase, 2) Homologous recombinational repair (HRR) pathway involved in the S/G2 phase. XRCC4, LIG4, MRN and ATM are well known genes involved in the NHEJ pathway, while MRE11, RAD50, NBS1 (MRN), RAD51, XRCC2, XRCC3, RAD51B, RAD51C, RAD 51D, RAD52 or RAD54 are known to be associated with HRR pathway.

A study suggested that the SNPs in the DNA repair pathway was involved in the susceptibility of secondary AML developing after chemotherapy or autologous hematopoietic stem cell transplantation, thus these SNP markers could become a predictive marker for secondary AML. However, it has never been investigated for multiple candidate pathways simultaneously with relateively larger number of patients. Accordingly, the current study attempts to investigate the potential role of the genotype markers in multiple candidate pathways, esp. focused on the DNA repair machinery, with respect to response following chemotherapy or survival of AML patients.

Total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at the Samsung Medical Center, Seoul, Korea will be included, and genomic DNAs will be extracted and will be examined for their genotypes of the candidate SNPs involved in the DNA repair pathways. Then statistical analysis will be pursued for single marker analysis, haplotype analysis and for the construction of genetic risk model based on the multivariate analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute myeloid leukemia
* 15 years or older
* patients treated with induction/consolidation chemotherapy
* patients with available bone marrow sample

Exclusion Criteria:

* acute biphenotypic leukemia