cyrilzakka/clinical-trials huggingface dataset:
Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) can impaire cognitive function,the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population.Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.

Glucagon-like peptide-1 (GLP-1) is a member of an endogenous class of incretin hormones synthesized in intestinal epithelial L-cells.GLP-1 enhances glucose-dependent secretion of insulin,inhibits glucagon secretion, slows gastric emptying and reduces food intake. Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM. The effect on BMI,waist circumference, hip circumference, waist-to-hip ratio,fasting plasma glucose，glycosylated hemoglobin,blood lipids and cognitive function were measured to explore the effects of liraglutide in patients with T2DM.

The overall goal of this study is to explore the effects of liraglutide on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes。

Exclusion Criteria:

* Type 2 diabetes with acute diabetic complications.
* Type 1 diabetes.
* Other diseases affecting cognitive function (congenital dementia,brain trauma,severe heart dysfunction,severe kidney dysfunction,severe lung dysfunction,epilepsy,severe hypoglycemic coma,cerebrovascular disease,ischemic heart disease,etc).
* Alcohol abuse,mental illness and psychoactive substance abuse.
* History of thyroid disease.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
The Relationship of ACWR and FMS With Injury Risk in Adolescent Players

In this study, we examine how acute to chronic workload ratio and functional movement screen scores relate to injury risk in teenage athletes who play team sports.

At least 60 volunteer athletes who have played team sport for at least 1 year, have not been away from the field for more than 2 weeks, 15 years and older are planned to include this study. All participating athletes in this study will sign an informed consent form then their demographic information will be recorded. The injury risk of athletes will be evaluated by functional movement screen. The functional movement screen is a test battery consisting of 7 tests. These tests are deep squat, hurdle step, in-line lunge, active straight-leg raise, trunk stability push-up, rotary stability and shoulder mobility. To calculate the acute-chronic workload, internal workloads during training and/or matches will be added up over a period of 8 weeks. As part of the study, health professionals on the team will provide injury information for the athletes. Sports injuries will be classified based on the type of injury (contact or non-contact) and the area of the body affected. The severity of the injury will be determined as follows: minimal (1-3 days of missed sports activity), mild (4-7 days of missed sports activity), moderate (1-4 weeks of missed sports activity), and severe (4 or more weeks of missed sports activity).

Eligibility Criteria:
Inclusion Criteria:

* Be over 16 years old,
* Participating in a team sport for at least one year,
* The players who have not stayed away from their sport for more than two weeks,

Exclusion Criteria:

* Any history of orthopedic or neurological injury or pain that may interfere with normal training or competition during assessment,
* Structural deformities such as scoliosis and leg length inequality,
* Their level of activity differs from other athletes in the same sport will be excluded from the study.
Role of Myo-inositol and D-chiro-inositol on Oocyte Quality

Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).

The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.

Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.

Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.

In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET


Eligibility Criteria:
Inclusion Criteria:

* women undergoing IVF treatments
* Body mass index \<28
* FSH \<10IU/L
* Normal uterine cavity, anatomy and functions

Exclusion Criteria:

* PCOS
* Stage III or IV endometriosis
* Premature ovarian failure
* Poor responder
Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study

This pilot study is designed to investigate differences in folate-related genes (single nucleotide polymorphisms) and their relationship to the species of folate present on red blood cells.

The main questions to be addressed in this pilot study are:

1. what is the type of folate in red blood cells in individuals with different methylterahydrofolate reductase (MTHFR) genotypes
2. what is the relationship between other folate metabolism-related gene single nucleotide polymorphisms and type (species) of folate found in red blood cells
3. what is the relationship between folate and other B vitamin status, genotype and folate species
4. is there a relationship between serum ferritin status and folate metabolism

Whole blood will be taken from apparently healthy male and female volunteers, aged 18-65, which will be used to determine genotype for various folate metabolism-related genes. Furthermore, the type of folate present on the red blood cells will be assessed, and folate, vitamin B12, riboflavin and serum ferritin status determined.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Males and females
* Body Mass Index greater than 19.5 and less than 40
* Smokers and non-smokers

Exclusion Criteria:

* Pregnancy or been pregnant in last 12 months
* Diabetes
* Parallel participation in another research project if total amount of blood from combined studies is greater than 470ml
* Participation in another research project where blood samples were taken within the past 4 months, unless total blood volume does not exceed 470ml
* Any person related to or living with a member of the study team
* Has donated or intends to donate blood within 16 weeks (prior to or after) the study
A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.

The study consists of two parts. Part A is the single dose escalation study where subjects with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo . Part B is the multiple dose escalation study where subjects with chronic HBV infection will be assigned to receive two doses of RBD1016 or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
2. Male or female volunteer aged 18-55 years (inclusive);
3. Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
4. Subjects with chronic HBV infection, including immunotolerant subjects, treatment naïve subjects and treated subjects.
5. Ability to cooperate with study staff and comply with the study requirements and follow the protocol-specified procedures.

Exclusion Criteria:

1. Subjects with liver diseases other than hepatitis B, including hepatitis C, hemochromatosis, primary sclerosing cholangitis; alcoholic, drug-related or autoimmune liver diseases; primary liver cancer and indeterminate nodules on liver imaging test;
2. A history or manifestations of liver decompensation (e.g. Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis, etc.);
3. Transient elastography at screening revealing FibroScan value ≥ 9 kPa or liver biopsy evidencing hepatic fibrosis within 24 months;
4. The following laboratory findings: total serum bilirubin\> 2×ULN; serum alpha-fetoprotein\>50μg/L; serum albumin \<3.5g/dL; international normalized ratio (INR)\> 1.25; serum creatinine \> 1.5×ULN; any laboratory outliers of clinical significance that in the investigator's opinion may interfere with the interpretation of efficacy or safety data;
5. 12-lead ECG abnormalities with clinical significance;
6. Pregnant or lactating women or women of child-bearing potential who are unwilling to take effective contraception throughout the course of the study (refer to Appendix 3 for details);
7. Other factors that in the investigator's opinion would make it inappropriate for the subject to participate in the study.
Same-day Discharge After Reconstructive Pelvic Surgery

The purpose of this study is to determine the safety and acceptability of same-day discharge after surgery for pelvic floor disorders. The study hypotheses are that same-day discharge after reconstructive pelvic surgery is safe and improves patient satisfaction when compared to overnight hospitalization.

This study is a randomized clinical trial comparing same day discharge and overnight hospitalization after reconstructive pelvic surgery. Patients who are scheduled to undergo surgery for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) will be recruited at their preoperative visit. Patients will be counseled regarding the existing evidence demonstrating the safety of same day discharge after hysterectomy and pelvic floor reconstructive surgery. Eligible patients who provide consent will be randomized to same day discharge or overnight hospitalization following surgery.

Patients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the Post-Anesthesia Care Unit (PACU) for all patients. Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. If the patients require unplanned hospitalization (UH), the reason for hospitalization will be noted. Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.

At their postoperative office visit, all patients will complete surveys evaluating patient satisfaction. Demographic, surgical, and hospital admission data will be collected from the medical record. Information will also be collected regarding any complications, emergency department (ED) visits, unplanned office visits, readmissions, and reoperations within 8 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for pelvic organ prolapse, with or without concomitant hysterectomy or incontinence procedure.

Exclusion Criteria:

* Patients undergoing concomitant non-gynecologic procedure
* The presence of: gynecologic malignancy, American Society of Anesthesiologists (ASA) class \>2, severe cardiovascular or pulmonary comorbidities, prior anesthesia complication, or obstructive sleep apnea
* Anyone living alone with no family/friend/caretaker to assist the patient on day of surgery
AI-Guided Stress Management Breathing Practices Via a Wearable Device

This study explores the effectiveness of AI-guided breathing practices for stress management in adults. In this randomized controlled trial, 120 participants will be recruited and assigned to an intervention group (n=90) or a control group (n=30). The study includes four brief breathing practices, guided by a wristband. The intervention group will interact with an AI chatbot to receive a personalized daily breathing plan for 28 days, adjusted weekly based on feedback. Meanwhile, the control group will practice progressive muscle relaxation daily. It is hypothesized that, the intervention group will have significantly improvements in stress management and emotion regulation skills compare to the control group. These group differences are expected to persist at 1-month, 3-month and 6-month follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Currently enrolled college students.
2. Aged between 18 and 30 years old.

Exclusion Criteria:

1. Current or past history of psychotic disorders.
2. Using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.
Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life.

Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients.

SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version.

Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire.

In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 70 years old
* Patient with digestive, breast, gynecologic, ENT or lung cancer
* Patient receiving a cancer treatment from at least two months
* Patient having given his free, informed and express written consent

Exclusion Criteria:

* Patient having a radiotherapy treatment for an ENT cancer
* Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
* Patient unable to swallow soft food
* Patient having presented nausea and vomiting during the last 24 hours
* Patient with severe inflammation of the mouth or throat (ulcers, mucus)
* Patient with cognitive disorders and memory loss
* Pregnant women or breastfeeding
* Adult under legal protection (guardianship)
Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix

Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA.

The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows:

Group I (Study group): 20 molars were treated with hTDM. Group II:

(Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition.

Tomographic evaluation was performed immediate postoperatively and at 18 months.

Eligibility Criteria:
Inclusion Criteria:.

1. Bilateral immature permanent mandibular first molars with deep carious lesions.
2. Positive response to pulp testing.
3. Normal radiographic appearance.
4. Healthy children without any systemic disease that interferes with pulp healing.
5. Patient and parent cooperation.

Exclusion Criteria:

1. Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
2. Presence of periapical lesion, external or internal root resorption.
3. Carious furcation involvement.
4. Dystrophic calcification of the pulp.
5. Non restorable tooth.
Evaluation of an Intervention for Adolescent Girls in Karnataka

This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. The intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.

School-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. Demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education.

Primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will include school development and management committees (SDMCs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in collaboration with the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls in Standard 7

Exclusion Criteria:

* None
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
* Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
* Eastern Cooperative Oncology Group performance status of ?2

Exclusion Criteria:

* Decompensated cirrhosis or stage C (Index\>10) according to the Child-Pugh Classification
* Current history of chronic diarrhoea
* Reproductive potential not using adequate contraceptive measures
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.

Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Eligibility Criteria:
Inclusion Criteria:

* The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.
* Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
* The patient must be presenting a reasonably good nutritional status.
* Signed inform consent from the patient or legal representative.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

* The patient participates in another drug trial during the study.
* The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.
* The patient is unable to swallow medication tablets.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive
* BMI 18.5 to \<30 kg/m²
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception

Key Exclusion Criteria:

* History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* History of malignancy
* History of clinically significant stroke
* History of cognitive impairment
* Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding