cyrilzakka/clinical-trials huggingface dataset:
4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) Among Young Adults

The goal of this clinical trial is to develop a comprehensive Training Program intervention for social media addiction called the 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) and to learn if the 4-STEP-TPS will address and help manage the problems related to social media addiction. Other key objectives include the management of dysfunctional patterns, the promotion of positive patterns and healthy lifestyle, and the promotion of daily life activities and productivity.

Young Adult participants will take the 4-week 4-STEP-TPS Program with 1 weekly session in either individual or group settings or be placed on a waitlist control.

Participants In this research, a sample of N=400 young adults will be initially enrolled for eligibility screening assessment from all over Pakistan using purposive sampling techniques. The participants' age range will be 18-30 years having no physical/psychiatric/psychological conditions. N=90 participants after the eligibility assessment and screening will be allocated to experimental and waitlist treatment condition.

Expected Outcomes This study will provide valuable information to the mental health practitioners to treat and develop the guidelines and protocol for young adults with social media addiction. This 4-STEP-Training Program will provide understanding and insight to the participants about the problems related to social media addiction. Further, this training program will address the dysfunctional patterns associated with social media addiction, including FoMO and phubbing, as well as fatigue, insomnia, and psychological distress. Moreover, this training program will improve participants' productivity and flourishing while significantly reducing the level of social media addiction.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-30 years
* No physical, psychiatric, or psychological conditions
* Minimum score of 84 on the Social Networking Addiction Scale (SNAS)
* Minimum score of 60 on the Secure Flourish Index (SFI)

Exclusion Criteria:

* Age below 18 or above 30 years
* Presence of any physical, psychiatric, or psychological conditions
* Score below 84 on the Social Networking Addiction Scale (SNAS)
* Score below 60 on the Secure Flourish Index (SFI)
Fornix and NbM as Targets of Stimulation In Alzheimer's Disease

The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with informed consent;
2. 45-75 years of age;
3. At least 6 years of education;
4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
5. Clinical Dementia Rating Scale (CDR): 1.0-2.0;
6. Positive findings with amyloid PET imaging;
7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria:

1. Fazekas scale\>2;
2. Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
3. Modified Hachinski ischemic score\>4；
4. Young Mania Rating Scale\>11(Young, Biggs, Ziegler, \& Meyer, 1978);
5. Any suicidal tendencies in recent 2 years;
6. Cornell Scale for Depression and Dementia\>10;
7. Familial AD;
8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
9. Surgical history of the central nervous system;
10. Severe cardiovascular/pulmonary disorders.
Serum and Tissue Level of Interleukin-15 (IL-15) and IL-15 Receptor Alpha (IL-15Rα) in Mycosis Fungoides

Estimation of serum and tissue level of IL-15 and IL-15 R α in mycosis fungoides prior to after treatment.

Twenty patients will be recruited from the cutaneous lymphoma clinic who are either recently diagnosed with MF or presenting with recurrent MF following cessation of treatment.

An informed written consent will be obtained from all patients. Clinical assessment: Patients will be assessed clinically for extent by BSA as well as MF staging and type.

For MF staging, in addition to extent, diagnostic skin biopsies will be assessed for depth of the infiltrate. Radiological assessment including chest x-ray, pelvi-abdominal ultrasound as well as lymph node examination, ultrasound and biopsy if required. Biochemical assessment including complete blood count, liver and kidney function tests, lipid profile as well as lactate dehydrogenase and beta 2 microglobulin.

Standardized photographs will be taken at initial assessment as well as following resolution of the biopsied lesion.

Baseline biochemical assessment at the beginning of the study: Serum samples as well as 4mm lesional punch skin biopsies will be taken prior to starting phototherapy treatment to assess serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked immunosorbent assay (ELISA).

Phototherapy treatment: Patients with superficial lymphocytic infiltrate will be assigned to either NB-UVB sessions, while those with deep infiltrate will be assigned to PUVA. Patients will undergo thrice weekly sessions.

Patients will be clinically assessed on monthly basis to monitor response to treatment and record any side effects.

Biochemical reassessment: Serum and lesional biopsies will be retaken following resolution of the biopsied lesion to assess serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked immunosorbent assay (ELISA).

Afterwards, the biopsied lesion will be covered if the patients was having other unresolved lesions and monthly follow up will be carried to detect lesional recurrence. Any reported recurrence during the estimated study duration of 6 months will be re assessed for both serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked immunosorbent assay (ELISA).

Twenty healthy controls will be recruited and assessed for both serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment

Exclusion Criteria:

* Patients with any contraindication to phototherapy (e.g., any other skin cancers or photosensitivity); or to psoralen (e.g., liver disease).
* Subjects with history of solid or hematological malignancy as leukemia.
* Patients with autoimmune disease as SLE.
* Patients who received treatment for the past one month.
* Pregnant and lactating females.
Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. A double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. On 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be performed. The aim is to investigate whether purified anthocyanins are able to increase FMD at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged 18-45 years old
* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study
* able to give signed written informed consent
* signed written infomred consent form
* healthy male subjects (no clinical signs or symptoms of CVD.

Exclusion Criteria:

* cardiovascular disease, acute inflammation, cardiac arrhythmia, renal failure, heart failure (NYHA II-IV), diabetes mellitus, C-reactive protein \> 0.5 mg/dL, malignant disease, hypotension (≤100 / 60 mm Hg)
A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes

Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN.

Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are accepted targets for this treatment. Researchers are willing to compared12-month outcomes for patients who had undergone bilateral stimulation of the GPi or STN. Forty-two Asian patients with primary Meige syndrome who underwent GPi or STN neurostimulation were recruited between Nov. 2023 and Nov. 2025 at the Department of Neurosurgery, Qilu Hospital. The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M) and disability subscale (BFMDRS-D) at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. Secondary outcomes included health-related quality of life, sleep quality status, depression severity, and anxiety severity at 3 days before and 12 months after DBS surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Primary Meige syndrome was diagnosed by an experienced neurologist.
2. All patients had received systematic and regular treatment for at least 1 year before surgery, including oral drugs and local injection of botulinum toxin A, but the efficacy was not apparent, as the ability to engage with daily life and the quality of life of the patients significantly decreased.
3. Tere were no other serious systemic diseases, such as severe organic heart disease, severe lung, liver and kidney dysfunction, and coagulation dysfunction.
4. Tere was no history of neurological diseases other than Meige syndrome, such as Parkinson's disease or severe cognitive dysfunction.
5. Tere were no serious psychiatric disorders, such as schizophrenia.
6. Preoperative head magnetic resonance imaging (MRI) examinations were normal. Patients of missing follow-up and incomplete clinical data were excluded from the cases.

Exclusion Criteria:

1. Unilateral facial spas and blepharospasm.
2. Patients with severe disease such as coronary heart disease, stroke.
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who achieved at least a partial response (PR) following platinum-based first-line therapy.


Eligibility Criteria:
1. Male and female patients with extensive disease SCLC ≥ 18 years of age receiving first line treatment;
2. Histology of SCLC or mixed histology of SCLC if SCLC histology is at least 80%;
3. Completion of 4 cycles of first-line therapy with a platinum-based regimen and no other prior chemotherapy;
4. Documented evidence of tumor response as assessed by investigators after the first 2 cycles of platinum-based chemotherapy followed by a confirmed PR or CR at the end of fourth cycle by CT or MRI scan;
5. Brain metastases are allowed only after cranial irradiation, if not requiring continuous treatment with steroids or anticonvulsants;
6. ECOG performance status 0 or 1;
7. Adequate organ function with total bilirubin, lactate dehydrogenase \[LDH\], alkaline phosphatase \[AP\], gamma glutamyltransferase \[GGT\], albumin, creatinine, urea, electrolytes, and coagulation parameters ≤ 1.5 × upper limit of normal (ULN), and with aspartate aminotransferase \[AST\] and ALT ≤ 2.5 × ULN in the absence of liver metastases or ≤ 5.0 × ULN in the presence of liver metastases;
8. Adequate hematological parameters: absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; leukocyte count ≥ 3.0 × 109/L; lymphocytes ≥ 1.0 × 109/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L;
9. Patients with reproductive potential agree to use effective contraceptive measures throughout the study;
10. Negative pregnancy test in women of childbearing potential;
11. Signed informed consent form (ICF).
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer

Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic solid tumor
* Age\> 18 years
* Signed consent

Exclusion Criteria:

* Patients with diseases associated with vascular lesions known.
* Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
* Mental pathology that can interfere with the proper conduct of the study.
* Refusal of consent.
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments.

This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopically confirmed diagnosis of ulcerative colitis
* Score of 6-10 on the Disease Activity Index (DAI)
* Moderate to severe mucosal appearance

Exclusion Criteria:

* Previous colonic surgery
* Other treatments for ulcerative colitis that have not been stabilised
* Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure
* History of tuberculosis
The Effectiveness of an Exercise Program on Scapulohumeral Rhythm, Range of Motion, and Stability in Young Female Handball Players

The primary objective of this study is to investigate the effectiveness of a shoulder girdle exercise program in improving stability, range of motion, and motor control in female handball players.

The aim of this study is to investigate the effects of a structured shoulder girdle exercise programme on stability, range of motion (ROM) and motor control in female handball players. The study will be conducted over a period of 8 weeks and will involve 60 participants aged 17-30 years recruited from professional handball clubs. Participants will be randomly assigned to either the experimental group, which will follow a modified version of the Watson programme, or the control group, which will continue with their standard training programme. Aims: - To compare the effects of the upper scapular rotation-oriented exercise intervention with a standardised upper extremity exercise programme. - Scapulohumeral rhythm assessment: To assess scapulohumeral rhythm at different angles of shoulder flexion (30°, 60°, 90° and 120°) in young female handball players, with a focus on identifying potential asymmetries between the dominant and non-dominant limbs. - Analysis of scapular kinematics: To measure scapular upward rotation, anterior/posterior tilt and medial/lateral translation at different degrees of shoulder flexion to identify movement patterns associated with scapular dyskinesis. - Functional stability analysis: To assess upper extremity functional stability using the Y-Balance Upper Quarter Test (YBT-UQ) and the Closed Kinetic Chain Upper Extremity Stability Test pre- and post-exercise to identify potential correlations between stability improvements and changes in scapular rhythm and muscle activation. - Isometric strength measurement: To evaluate isometric strength in shoulder abduction, internal rotation and external rotation using the Lafayette HHD handheld dynamometer to assess the impact of the intervention on shoulder muscle performance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with no reported health problems
* No history of shoulder or elbow surgery within the past 2 years
* Received information about the study
* Written consent from the participant to participate in the study, including video recording and photography

Exclusion criteria:

* Injury or trauma to the upper extremity within the past 3 months
* Illness that prevents participation in the study or tests
* Heavy physical activity of the shoulder girdle within 2 hours prior to the study
* Orthopedic surgery or physiotherapy treatment of the shoulder girdle
NSAID vs Steroid in Trabeculectomy Wound Management

This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 18 years
* Uncontrolled open angle glaucoma
* Scheduled to undergo stand-alone trabeculectomy
* No previous incisional glaucoma surgery
* No ocular surgery of any kind in prior 6 months

Exclusion Criteria:

* steroids and/or NSAIDs contraindicated
* poor corneal epithelial health
Effectiveness of RL- vs LL-starting Position in Unsedated Water Immersion Colonoscopy

Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients.

Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients. Our previous studies showed that water immersion method reduced the VAS score, accelerated the intubation time significantly without different changing cecal intubation rate. Previous right-sided vs. left-sided starting position colonoscopy study in sedated patients with air insufflation colonoscopy method showed that right-sided starting position improved the abdominal discomfort score and faster cecal intubation time. We want postulate that the right-sided starting position can also maximize the water method advantages in lowering the discomfort score, faster cecal intubation time and higher cecal intubation rates, and it will improve patient acceptance of water unsedated colonoscopy and willingness to repeat.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years old with the indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of the need for diagnostic colonoscopy examination.

Exclusion Criteria:

* Patients who refuse to participate, patients with obstructive lesions in the colon distal of the cecum. , patients with experienced colon resection, patients who are hemodynamically unstable, and patients with severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure ).
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.


Eligibility Criteria:
Inclusion Criteria:

* for screening

  1. ≥19 to ≤75 years of age at the time of written informed consent
  2. Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
  3. Able and willing to actively participate in TLC programme
  4. Signed ICF for voluntary study participation
* for randomization

  1. sUA level ≥7.0 mg/dL
  2. ACR/EULAR 2015 score ≥8

Exclusion Criteria:

1. Medical history

   Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.
2. Concurrent disease or laboratory test abnormality

   Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR \<30 mL/min/1.73m\^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m\^2
3. History of gout flare between 2 weeks before written informed consent and immediately before randomization
4. Any cardiovascular abnormalities that might affect the study
5. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
6. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
7. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
8. Hypersensitivity to the IP (epaminurad or febuxostat)
9. Pregnant or lactating woman.