cyrilzakka/clinical-trials huggingface dataset:
Cognitive Stimulation Therapy and Olderly People With Mild Cognitive Impairment

The aim of this study is to examine the effect of cognitive stimulation therapy on cognitive status and apathy in elderly individuals with mild cognitive impairment.

This randomized controlled experimental study is planned for 30 October - 25 December 2023, with a total of 60 people (30 in the control group and 30 in the intervention group) at the Elderly Care and Rehabilitation Center. The data of the research were collected from the Literature-Based Personal Information Form, Standardized Mini Mental Test (SMMT), Apathy Assessment Scale. Approval from the Clinical Research Ethics Committee and written permission from the participants were obtained to conduct the study. Individuals in the intervention group started with introduction and in the first week, pre-test administration and CST will be administered twice for 45 minutes.

For the next 7 weeks, it will be carried out for one week, with the introduction and pre-test application for individuals in the control group in the first week. They will continue their daily lives in two sessions for one week and two days. They will continue their lives in the following weeks.

Written informed consent form will be given to all individuals in the study. It will start after information about the measurement tools is given.

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study
* Being literate and speaking Turkish fluently
* Have communication and understanding skills
* Standardized Mini Mental Test result being between 18-23 points
* Having adequate vision and hearing functions for group participation

Exclusion Criteria:

* Presence of any sensory impairment
* Having a physical health problem that may impair group cohesion and integrity
MicroRNA Markers in Head and Neck Cancers

The purpose of this study is to investigate the presence of miRNA markers in saliva, blood, FNA and tissue specimens in patients with and without head and neck cancer and evaluate whether these miRNA markers can provide prognostic or diagnostic clinical significance in the treatment of head and neck cancer patients.

Micro RNA (miRNA) markers were initially discovered in 1993 and recent research has shown that they have great potential for use as both surveillance and prognostic markers in cancer treatment, as well as potential targets for cancer therapy. Recent research has identified several miRNA markers which appear to be potential markers for head and neck squamous cell carcinoma, and these have been tested in both mouse and human banked tumor samples. These investigators hypothesize that these markers may also be present in other tissues, including fine needle aspiration biopsy, blood, and saliva specimens, and will be sensitive and specific to patients with known head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 18 and 100
2. Patients who are seen and evaluated by a provider within the adult ENT clinic at University of Colorado Hospital
3. Patients that present with a current or past diagnosis of head and neck cancer -OR-Patients undergoing tonsillectomy or sleep surgery as standard of care (control group)

Exclusion Criteria:

1. Under the age of 18 or over the age of 100
2. Unwilling to participate
Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)

The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) program on Stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

The aim of this study was to evaluate the effects of mindfulness-based stress reduction (MBSR) program on stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

This study was designed as a single-blind pilot randomized controlled trial. It is planned to be conducted between November 2024 and January 2025 at Zeynep Kamil Women and Children's Diseases Education and Research Hospital.

Power analysis using G\*Power 3.0.10 showed that at least 44 samples were sufficient for 2 groups with Effect size 1. 72, 95% Power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).

Eligible women were randomized into the intervention group (n=22) and the control group (control) (n=22). Women assigned to the intervention group received the MBSR program. MBSR had eight weekly sessions of two hours each and a full-day retreat between the 7th and 8th sessions. The control group received routine care in the hospital but did not receive any other intervention during this period.

The pre-test data of the study were collected by the researcher using a face-to-face interview, a Personal Information Form containing demographic questions, and the measurement tools used in the study. At the end of the 8 weeks, the post-test data were collected using the same method.

The participants were given explanations about the MBSR program and it was stated how, for how long, and where to practice. The online MBSR program was completed by the participants in a way specific to each session (with mind, body, and breathing exercises). The MBSR program was implemented in this way for 8 weeks (eight sessions in total and one session per week). In addition, the participants were given homework (audio recording) to do throughout the week (until the next session) in the form of repeating mindfulness meditation practices. At the end of the eighth week, the measurement tools were re-administered to the participants who attended all eight sessions and completed their homework, and the post-test data were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-40
* Body mass index (BMI) ≥ 40 kg/m2
* Women with a diagnosis of polycystic ovary syndrome

Exclusion Criteria:

* Psychiatric illness
* Pregnant women
* Thyroid dysfunction
* Cushing's syndrome
* Hyperprolactinemia
* Cancer history
* Pharmacological treatment for obesity
* Any type of bariatric surgery
* Absence of any psychiatric illness or comorbidities
* Current enrollment in a stress reduction program
* Mindfulness practice within the past 6 months (regular formal practice at least once a week)
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy

The safety objectives of the study are to: evaluate additional long-term safety of SA-ER treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day (Part I); evaluate the safety of 12g /day SA (delivered by 1.5g of SA-ER tablets and 1.5g of SA-IR capsules 4 times per day) in the treatment of participants with GNE myopathy (Part II) over a 6 month treatment period; evaluate the safety of SA treatment at both 6g/day and 12 g/day (Part III \[SA-ER/SA-IR\] and Part IV \[SA-ER\]).


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in, and successful completion of the UX001-CL201 (NCT01517880) protocol OR (for 10 treatment naïve subjects):

  * Have a confirmed diagnosis of GNE Myopathy
  * Aged 18 -65 years of age, inclusive
  * Able to walk ≥ 200 meters and \< 80% of predicted normal during the 6-Minute Walk Test (6MWT; orthotics and assistive devices allowed)
* Must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
* Must be willing and able to comply with all study procedures
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study
* Females of childbearing potential must have a negative pregnancy test at Baseline and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause for at least two years, or have had tubal ligation at least one year prior to Baseline, or who have had total hysterectomy

Exclusion Criteria:

* Use of any investigational product (other than SA-ER tablets) to treat GNE myopathy
* Ingestion of N-acetyl-D-mannosamine (ManNAc) or similar SA-producing compounds
* Pregnant or breastfeeding at Baseline or planning to become pregnant (self or partner) at any time during the study
* Has had any hypersensitivity to SA or its excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects
* Have any co-morbid conditions, including unstable major organ-system disease(s) that in the opinion of the investigator, places the subject at increased risk of complications, interferes with study participation or compliance, or confounds study objectives.
Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial

The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.

RIRS has been widely adopted and used by urologists worldwide in the management of renal stones due to less invasiveness and efficacy, especially in small to moderate-sized renal stones. RIRS has several advantages over SWL for stones less than 2 cm diameter. Most importantly, removing the stone in one session without the need for other treatment modalities.

Furthermore, the application of RIRS has expanded to larger stones reaching up to 35 mm in some cases,in spite of not being the first line therapy for the larger stones. RIRS has advantages over the PCNL especially concerning complications. Namely lower or no bleeding events and the less invasiveness of RIRS.

Options for the treatment of intrarenal stones include fragmenting the stone then extracting large fragments using a basket or dusting the stone into very small fragments then leaving the (dust) to pass spontaneously.

The idea of dusting in RIRS emerges as a counterpart of the originally taught fragmentation and basketing of the stones. Aiming to reduce multiple entries and exits for the renal system and ultimately not requiring UAS or baskets during the surgery. Thus theoretically decreasing operative time and costs with the same SFRs, In addition to minimizing the risk of ureteral injury .

So there is a debate amongst surgeons whether to laser the stone to dust or fragment and retrieve intra-renal fragments. EAU guidelines on the surgical management of urolithiasis stated that dusting strategies should be limited to the treatment of large renal stones. Without clearly differentiating between dusting or fragmentation and basketing. Cho et al; favored fragmentation technique especially for large renal stones because the dust in dusting technique may affect visualization and obscure small stone fragments. But this was an opinion and not built on a direct comparative study.

Until now, there is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. And to date, no prospective randomized study has addressed the practice of active extraction vs. spontaneous passage

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be a suitable operative candidate for RIRS
2. Age ≥18 years
3. Normal renal function
4. ASA score Ⅰ and Ⅱ
5. Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

Exclusion Criteria:

1. Pregnant subjects
2. Uncorrected coagulopathy and active urinary tract infection (UTI)
3. prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
4. Patients who underwent transplant or urinary diversion.
5. Congenital abnormalities.
Safety Study of PI-0824 to Treat Pemphigus Vulgaris

The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Pemphigus vulgaris (PV) is an autoimmune disease affecting approximately 40,000 people worldwide. People with PV produce antibodies that attack the cells of the skin, resulting in blisters which, if left untreated, can lead to devastating infections and discomfort. Currently, most doctors who treat patients with PV will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies. Unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use. Peptimmune, Inc. has developed a new therapy for the treatment of PV, PI-0824. The goal of this therapy is to reduce the production of antibodies that cause PV blisters by acting only on the disease causing components of the immune system. It is hoped that use of PI-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system.

Eligibility Criteria:
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)

Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.


Eligibility Criteria:
Treatment Inclusion Criteria:

* Ages 12 months and older

Treatment Exclusion Criteria:

* Children under 12 months of age
* Pregnant women in their first trimester
* History of adverse reaction to benzimidazoles

Outcome Sampling Inclusion Criteria:

* Resident of study clusters
* Ages 12 months and older
* Willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent
* Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)

Outcome Sampling Exclusion Criteria:

* Less than 12 months of age
* Individuals who do not typically reside in the study cluster
* Nonconsenting or assenting individuals, as applicable
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries

The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.

Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. A parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 2.5- to 3-year-old children. Those eligible will be randomized to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two sites serving primarily underserved, minority and low-income populations in Southern California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center - Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which serves Latinos and African Americans. Both sites are part of a consortium of community clinics (SYHC Inc) and are located 15 miles apart from each other.

Annual study dental examinations will be performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. Children identified as needing dental care will be referred for appropriate treatment.

Eligibility Criteria:
Inclusion Criteria:

* Family resides in the South Bay or Central San Diego area
* Parent/Guardian can consent in English or Spanish
* Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration)
* Child is cooperative and behaviorally suited for the clinical trial interventions
* Child is a registered patient at San Ysidro Health Center Inc.

Exclusion Criteria:

* Any siblings of participants
* Child with cavitated lesions
* Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period
* Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol
Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus

The aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for 6 months on carotid intima media thickness and cardiovascular risk factors in subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Age from 15 to 60 years
* Patients diagnosed with Type 1 Diabetes Mellitus.
* Diabetes duration more than 1 year.
* Both genders.
* C - peptide less than 0.3 nmol/L

Exclusion Criteria:

* Patients with type 2 diabetes mellitus, LADA (latent autoimmune diabetes in adults), MODY (maturity-onset diabetes of youth), or other types of diabetes other than type 1 diabetes mellitus.
* Pregnant patients or desire to become pregnant in the next 6 months.
* Family history of medullary thyroid cancer or multiple endocrine neoplasia 2
* History of pancreatitis
* Familial hypercholesterolemia
* Use of adjunctive treatment to insulin (SGLT-2 \[sodium-glucose cotransporter-2\] inhibitor, Pramlintide, metformin)
* Start of treatment with statins, ezetimibe or PSCK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, amlodipine, metoprolol in the last 6 months before the study.
* Bariatric surgery
* Use of medications (immunosuppressants, calcineurin inhibitors, mTOR (mammilian target of rapamycin) inhibitors, corticosteroids, aspirin, or anticoagulants)
* Metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, Reye's disease, LCAT (lecithin-cholesterol acyltransferase) deficiency)
Short-term Effect of Pomegranate Juice on Blood Sugar and Its Controlling Hormones in Pre-diabetic and Type II Diabetic Patients.

Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8 mmol/L after approximately 12 hours fasting. Blood samples were collected in plain tubes before (-5 minutes) and at 1 and 3 hours after drinking pomegranate juice. Blood samples were centrifuged and serum was collected and stored for glucose and hormonal analysis. Patients were recruited from those of earlier stages of type 2 diabetes, and many of them already drink pomegranate juice as of its benefits for their health).

The exclusion criteria included subjects with renal or hepatic disease, pregnancy, treatment with insulin, and hormone therapies. Participants who had either smoked cigarettes or taken antioxidant supplements, lipid-lowering drugs, and oral hypoglycemic agents, such as metformin (glucophage) or sulfonylureas, within the preceding 12 hours were also excluded.

The study was explained to all of the recruited subjects by the clinical researchers, and written informed consent was obtained prior to enrollment. Approval for the study was provided by the IRB Committee at Jordan University of Science and Technology (Irbid, Jordan).


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes at early stages of progression (Fasting serum glucose: 7.1 - 15.8 mmol/L)
* Healthy individuals (Fasting serum glucose \< 7 mmol/L)

Exclusion Criteria:

* Subjects with renal
* Subjects with hepatic disease
* Pregnant women
* Subjects under treatment with insulin and any other hormonal therapies
* Smoking 12 hours before the intervention
* Antioxidant supplements 12 hours before the intervention
* Drugs administration: Lipid lowering drugs, oral hypoglycemic agents such as metformin or sulfonylureas 12 hours before the intervention.