cyrilzakka/clinical-trials huggingface dataset:
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups

The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.

The objective of this study is to determine whether participation in a group program incorporating mind-body techniques decreases symptoms of posttraumatic stress in adolescents. Students will be screened for posttraumatic stress using the Harvard Trauma Questionnaire and eighty-two qualifying students will be randomly assigned to a 12-session mind-body group program or a wait-list delayed intervention group. The program will be conducted by the teachers at a high school in Kosovo and include meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques. Changes in posttraumatic stress symptoms will be measured using the Harvard Trauma Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Students having posttraumatic stress (PTSD) as defined according to a scoring algorithm of the Harvard Trauma Questionnaire previously described by the Harvard Refugee Trauma group and used in a Kosovar Albanian population. This definition of PTSD requires a score of 3 or 4, on a Likert scale of 1-4, on at least one of the four of the reexperiencing symptoms (Criterion B), at least 3 of the 7 avoidance and numbing symptoms (Criterion C), and at least 2 of the 5 arousal symptoms (Criterion D) in addition to exposure to a traumatic event (Criterion A).

Exclusion Criteria:

* No specific exclusion criteria. Students having PTSD symptoms as defined above may participate in the study.
Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

This study assessed whether a short course pulmonary rehabilitation programme with periodic reinforcement exercise training and phone call reminders would help to increase physical activity in COPD patients and also decrease readmissions for AECOPD.

Objectives: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study assessed whether a short course pulmonary rehabilitation programme with periodic reinforcement exercise training and phone call reminders would help to increase physical activity in COPD patients and also decrease readmissions for AECOPD.

Hypothesis: The above programme can reduce readmissions for AECOPD

Design: Randomised control trial. Patients will be randomised to the intervention or usual care group

Subjects: Patients discharged from hospital after an episode of acute exacerbation of COPD

Study instruments: Activity monitor, quality of life questionnaire

Interventions: The Intervention group will receive a short course pulmonary rehabilitation training as out-patient in the physiotherapy department for 4-8 sessions, 2 hours each time, 1-2 times weekly. The training is scheduled in the way that each subject would have at least 4-8 weeks supervised training by trained physiotherapist. Home exercise will be taught and the case manager will give phone calls to the subject every 2 weeks to provide support and reinforcement for having continuous exercise at home for one year. Patients will be invited to attend reinforcement out-patient physiotherapy training once very month or every 2 months if they are willing to attend.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD exacerbations

Exclusion Criteria:

1. History of asthma, lung resection or other significant pulmonary disease like pulmonary fibrosis.
2. Active infection like pulmonary tuberculosis
3. Unable to complete assessment due to physical and/or cognitive impairment
4. Completed a pulmonary rehabilitation program in the previous 24 months.
5. Having short life expectancy like subjects with terminal malignancy or intractable heart failure
Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.

Clinical Phase: pre-CE study

Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy

Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes.

Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "Performance level acceptable" to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial.

Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure.

Planned Trial Period: 3 months

Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia. A pre-CE, single use cystoscope.

Eligibility Criteria:
Inclusion Criteria:

* Adults (males and females), ≥18 years of age or older, presenting for cystoscopy
* Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes
* Willing to participate in a clinical trial

Exclusion Criteria:

* History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes
* History of prior bladder/urethral reconstructive surgery
* Presence of symptomatic urinary tract infection (UTI)
* Known unpassable urethral stricture
* Unable to read and/or understand the study requirements
* Unable or unwilling to provide consent to participation in the study
* Pregnant or lactating women
Can Exercise Rewire the Brain Addiction Circuitry?

The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD.

The proposed research plan focuses on the identification of changes in the structural and functional brain parameters (e.g. volume, brain activity), in response to a physical exercise (PE) protocol, on the neurocircuitry of addiction, after a 4 month-intervention program in college binge drinkers (BDs). The main objectives of this proposal are: O1) to evaluate the potential benefits of PE on the brain structure and function, particularly in the neurocircuitry of addiction, in a sample of Portuguese college students with a binge drinking pattern of alcohol use; and O2) to determine whether the PE intervention reduces craving and alcohol consumption levels in BDs. The present project will involve: i) a pre-intervention comprehensive evaluation of behavioral (alcohol consumption), psychological (craving levels), physiological (VO2, HRV), and neurological (neuroimaging) variables; ii) a training phase consisting of 48 sessions (3 weekly sessions\*16 weeks) of aerobic (exp group 1), agility-cognitive (exp group 2) exercise and stretching (control group; iii) a post-intervention evaluation of behavioral, physiological, and neurological (neuroimaging) variables; iv) and a 6 months' follow- up evaluation of behavioral, physiologicaln and cognitive variables. A randomized controlled trial will be implemented at the University of Minho. It will include a total of 60 college students with a binge drinking pattern of alcohol intake, 20 participants per condition.

Eligibility Criteria:
Inclusion Criteria:

* binge drinking \> or = 5 ; \> or =4 for women alcoholic drinks
* in the same time window (±2h)
* at least once per month
* \<150 minutes of physical activity per week

Exclusion Criteria:

* Major and/or unstable medical conditions
* Physical limitations that may constraint the practice of exercise
* Cardiovascular and respiratory insufficiency
* History of traumatic brain injury or neurological disorder
* Non-corrected sensory deficits
* Personal history of psychopathological disorders
* Family history of alcoholism or substance abuse in first degree relatives
* Consumption of medical drugs with psychoactive effects (e.g., sedatives or anxiolytics) during the month previous to the assessment
* Use of illegal drugs and AUDIT scores \>20
* MRI contraindications
* Current or previous (past year) participation in a physical exercise program
Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement

The aim of the study is to assess whether the direction of skin incision affects pain within the first 24 hours, patient comfort 7 days after the procedure, procedure time, and the occurrence of early complications related to vascular port implantation.

The vascular port implantation procedure is used in patients who require long-term access to veins, e.g. during chemotherapy, long-term drug administration or blood collection. This procedure is performed under local anesthesia, by cannulating the internal jugular vein - left or right and making an incision to place the port on the chest wall (so-called "pocket") in the subclavicular area on the side of the cannulated vein.

Vessel cannulation is performed percutaneously using an ultrasound machine and fluoroscopy. The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision can be made transversely or longitudinally, depending on the preferences of the physician performing the procedure. In both cases, this does not affect the further course of the procedure. Both methods of creating a vascular "pocket" are commonly used. The procedures are performed as part of one-day stays, and after the procedure, patients are discharged home.

To the best of our knowledge, this is the first study that will compare the direction of the skin incision. In our study, we wanted to compare pain in the first 24 hours, patient comfort after 7 days of the procedure, procedure time, occurrence of early complications related to vascular port implantation. Patients undergoing the vascular port implantation procedure will be divided into two groups, one will have a transverse incision, and the other a longitudinal incision in order to place the port in the subcutaneous tissue. Patients will receive a questionnaire to fill out (in the appendix to the application) and will have their pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure. Additionally, on the 7th day after the procedure, I will be asked to assess any discomfort associated with the presence of the vascular port on a scale of 0-5. Data will be collected by phone. Additionally, we will measure the procedure time and occurrence of any complications related to port implantation.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

Age \> 18 and \< 80 years Informed consent Need for central venous access port implementation under local anesthesia

Exclusion Criteria:

Impaired blood clotting Ongoing antiplatelet drugs therapy, except acetylsalicylic acid Trauma or surgical past history on both shoulder girdles Known central venous thrombosis (subclavian vein, upper vena cava) Known pneumothorax Septic state Agranulocytosis
The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage

The REgistry Study on multimodality trEAtment foR Cerebral Hemorrhage (RESEARCH) aims to address these challenges by establishing a comprehensive national registry. This initiative will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH across various regions. By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.

Cerebral hemorrhage, also known as intracerebral hemorrhage (ICH), is a severe neurological condition characterized by abrupt bleeding within the brain tissues, leading to high rates of mortality and morbidity worldwide. In China, where the burden of cerebrovascular diseases is substantial due to the aging population and prevalence of risk factors such as hypertension and diabetes, the impact of ICH is particularly pronounced. Despite advancements in medical science, the prognosis for patients suffering from ICH remains poor, with a high proportion of survivors experiencing significant disability.

Current treatment protocols for ICH involve a range of strategies, from conservative management to surgical interventions. However, the heterogeneity in clinical practices and patient responses highlights a significant gap in standardized treatment efficacy.

This registry study is not only pivotal for enhancing the understanding of effective treatment combinations but also crucial for identifying potential disparities in the application of treatment modalities across different healthcare settings. Through the analytical power of this large-scale, multicentric data, RESEARCH will contribute significantly to optimizing treatment paradigms and ultimately, shaping policy changes that aim to reduce the mortality and enhance the recovery rates of patients suffering from cerebral hemorrhage.

There is an urgent need to evaluate these multimodal treatment approaches on a broader scale to understand their real-world effectiveness and develop guidelines that can be systematically applied to improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral hemorrhage

Exclusion Criteria:

-
Gene Therapy for Wet AMD

FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients ≥45 years old at the time of signing the ICF;
* Clinically diagnosed with nAMD;
* Presence of active CNV
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters;

Exclusion Criteria:

• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
Gastric Cancer Screening Quality Improvement System Establishment

Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods. First, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from March 2008 till February 2009 and from March 2013 till February 2014, when the levels of serum pepsinogen were achieved from the patients. In the second period from March 2015 till April 2015, quality assurance program will be activated. Endoscopists will be educated on the Kimura-Takemoto classification for chronic atrophic gastritis. After that their diagnosis will be tested and they will have feedback and discussion all together. In this period, inter-observer agreement rate will be assessed serially. Third, prospective trial will run from May 2015 till April 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. Finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until December 2020.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received endoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.

Exclusion Criteria:

* Age \< 18 years
* Those who refused to be included in the research
* History of gastric cancer
* Current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin
* Active/healing stage of gastric ulcer or gastric ulcer scar
* Active/healing stage of duodenal ulcer
* History of previous surgical or endoscopic resection of stomach
Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF

study the effect of omega 3fatty acids on the vascular calcification biomarkers Fetuin -A and Osteoprotegerin (OPG) in dialysis patients.

2-All Participants agreed to take part in this clinical research and provide informed consent.

3-Patients undergo both undergo hemodialysis (HD) will be enrolled from dialysis unit in al Moussa Hospital Alexandria.

4-Serum samples will be collected for measuring the biomarkers. 5-Our design is randomized, controlled, open-intervention study. 6- All enrolled patients will be divided into 2 groups, Group 1 will be 40 patients that will take omega 3fatty acids and Group 2 will be 20 patients will not take omega 3 fatty acids.

7-All patients will be followed up during 6 months' period. 8-Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results.

9-Measuring outcome: the primary outcome is the increase of the serum levels of the vascular calcification biomarkers after 6months.

10-Results, conclusions, discussion and recommendations will be given.

Inclusion criteria:

* 60 hemodialysis patients, (20-80) years old.
* Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6months).

Exclusion Criteria:

People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.

Methodology:

* Feutin-A and Osteoprotegrin (OPG) will be determined by ELISA.
* Serum lipid levels, phosphorus, calcium, Parathormone (i-PTH), alkaline phosphatase, albumin and creatine levels.
* BMI

Eligibility Criteria:
Inclusion Criteria:

* 60 hemodialysis patients, (20-80) years old.
* Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6 months).

Exclusion Criteria:

* People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol
* Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (\> 12% and \>150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or \> 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined by the protocol
Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy

The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question\[s\] it aims to answer are:

Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C

This study aims to collect demographic data, biochemical indicators during pregnancy, pregnancy complications, and fetal outcomes through the hospital HIS and LIS systems to investigate the impact of HCV infection on pregnancy outcomes, mother-to-child transmission, and long-term child development, and to provide assistance in the clinical management of pregnant women with HCV infection.

Eligibility Criteria:
Inclusion Criteria:

* normal (anti-HCV negative) or RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
* pregnant women aged 20-45 years
* complete pregnancy data available

Exclusion Criteria:

* Combination of other liver diseases such as viral hepatitis (hepatitis A, B, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease
* Combination of other viral infections with potential loss of liver function
* Mental illness
* Patients with immunosuppression
* Mother with cirrhosis or liver tumour