cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Co-morbidity Scales

Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power.

Few studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.

The purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

1) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM.

Exclusion Criteria:

None
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.

Eligibility Criteria:
Inclusion Criteria:

* non-fertile women
* primary symptomatic uterine descent POP-Q≥2
* Scheduled apical POP repair with Splentis
* Willing and able to participate at study visits and to sign informed consent

Exclusion Criteria:

* Fertile women
* Recurrent apical prolapse
* Women with post hysterectomy vaginal vault prolapse
* Patients with active or latent infection of the vagina, cervix or uterus
* Patients with previous or current vaginal, cervical or uterine cancer
* Previous, current or planned pelvic radiation therapy
* Known allergy to polypropylene.
Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy

Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human being.


Eligibility Criteria:
Inclusion Criteria:

* These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions

Exclusion Criteria:

* Complications such as gastric and/or duodenal peptic ulcer, stenosis
* Esophageal, gastric or duodenal cancer or other malignancy
* History of stomach surgery
* A history of bronchial asthma, or known allergy to fluorescein.
* Pregnant or breast-feeding (for females)
* Below 18 or above 60 years of age
* Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).
Physical Activity Recommendation Behaviour in German Mental Health Nurses

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Nurses play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German nurses.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Eligibility Criteria:
Inclusion Criteria:

* Nurse
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None
Determination of Factors Effecting Falls in Patients With COPD

The aim of this study is to determine the factors affecting falls in patients with COPD.

The aim of this study is to determine the factors affecting falls in patients with COPD. In accordance with the purposes, at least 100 patients with COPD who are 45-80 years old and clinically stable for four weeks will be included. Tests and questionnaires will be used in order to determine the severity of disease. Lung function test and respiratory muscle strength will be performed. Six Minute Walk Test and Six Minute Pegboard and Ring test will be performed with an armband that measures energy expenditure for functional exercise capacity for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale will be used. Hand grip test, periphreal muscle strength test, Time up and go test and One minute sit to stand test will be performed. International Physical Activity Questionnaire - Short Form (IPAQ) will be used to determine physical activity level. Mini- Besttest and Activity-specific Balance Confidence Scale were used to determine fall risk. According to the results to be obtained factors affecting falls will be determined in patients with COPD. It will guide professional working in this field.

Eligibility Criteria:
Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group;

* Being between the ages of 45 and 80,
* Being literate,
* Willing to participate in the study,
* Having COPD classified as stage 1-2-3-4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) system,
* Being clinically stable for the past 4 weeks.

Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group;

* Having a history of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery,
* Having any neurological, neuromuscular, vestibular, or cardiac disease that could affect the measurements,
* Receiving long-term oxygen therapy.
Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age of 19-45
2. Body weight ≥ 55 kg and in the range of calculated IBW ±20%
3. Subject without a hereditary problems, chronic disease and morbid symptom
4. Suitable clinical laboratory test values
5. Subject who sign on an informed consent form willingly

Exclusion Criteria:

1. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
2. Gastrointestinal disease or gastrointestinal surgery
3. History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs
4. Galactose intolerance
5. Sitting systolic blood pressure ≥ 140 mmHg or\< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 beats per minute
6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin \> 2 x upper limit of normal range
7. Serum Creatinine \> upper limit of normal range
8. Drug abuse
9. Subject treated metabolizing enzyme inducers or inhibitors within 1 month
10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
11. Subject treated Investigational product(include Bioequivalence test) within 3 months
12. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
13. Continuously taking Alcohol \> 21 units/week
14. Cigarette \> 10 cigarettes/day
15. Subjects with planning of dental treatment or any surgery
16. Another clinical condition in judgement of investigator
Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain

Non-specific low back pain can be caused by the presence of active trigger points in the muscles of the lumbopelvic region. Trigger points are defined as hypersensitive points within a taut band of a musculoskeletal system that cause pain during contraction, stretching, or stimulation of said muscle. If these points are active, they can trigger referred pain, local tenderness, and vegetative responses. There is scientific evidence of the improvement of the treatment of these points through non-invasive manual techniques. The objective of this study will be to determine the effect of Strain Counterstrain and Myofascial Induction techniques in subjects with low back pain secondary to the presence of active trigger points in the lumbopelvic region. Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Strain Counterstrain technique and Myofascial Induction in participants with the presence of an active trigger point in the erector spinae muscle.

The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 2 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of low back pain and disability caused by low back pain, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when representing reliable results in differences between techniques.

Eligibility Criteria:
Inclusion Criteria:

* Presence of low back pain
* Presence of active trigger point in the erector spinae as described by Lawrence H. Jones

Exclusion Criteria:

* Participants who present dizziness, vertigo;
* Previous or scheduled surgeries in the lumbar spine and/or lower extremities;
* Suspicion of serious fractures or pathologies (tumor, inflammation, infection, rheumatological disorder, systemic disease, presence of fever);
* Diagnosis of radiculopathy or neuropathy;
* Structural deformity in the spine; spondyloarthropathy, disabling pain and physical disability;
* Use of pain relievers or anti-inflammatory drugs in the last 48 hours;
* Neurological or psychiatric disorder;
* Presence or suspicion of pregnancy
Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer

This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

In Europe, there are 447,000 new cases of colorectal cancer each year. Approximately 25% of patients present with metastases at initial diagnosis and almost 50% of patients with mCRC (metastatic colorectal cancer) will develop metastases

. Chemotherapy represents the backbone of treatment, and survival is linked with the administration of all three active cytotoxic agents (5-fluorouracil/folinate, oxaliplatin, and irinotecan) in the first line treatment of metastatic colorectal disease.

Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS (rat sarcoma viral oncogene homolog) wild type metastatic colorectal cancer (mCRC).

Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy (response rate, resectability...), but at the price of an increased rate of toxic effects.

This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type mCRC (metastatic colorectal cancer) population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer confirmed as RAS wild by tumor tissue analysis
2. Non resectable and measurable metastatic disease
3. Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease
4. Males or females aged over 18 years.

Exclusion Criteria:

1. Known brain metastases
2. RAS not assessable (e.g., material not available or insufficient)
3. The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX
4. History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years
The Accuracy of a Novel Platelet Activity Assay in Humans on Antiplatelet Agents: Pharmacodynamics and Comparison with Light Transmission Aggregometry

The purpose of this study is to test a novel diagnostic immunoassay of platelet function and compare it to the current gold standard platelet function assay by testing the response to aspirin and clopidogrel in a group of healthy volunteers and severely obese individuals and comparing the accuracy of the two tests. The secondary goals will be to evaluate the pharmacodynamic parameters of the antiplatelet agents across the two testing modalities and refine the cutoffs used for the novel assay.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age
2. Subject is willing to participate and provide informed consent
3. Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator
4. Groups A, B and C: BMI \< 30 kg/m2; Groups D and E: BMI ≥ 35 kg/m2
5. Subjects must be age ≥ 18 years old
6. Serum Creatinine \< 1.5 mg/dL
7. Platelet count ≥ 150 K/uL
8. Hematocrit ≥ 38%

Exclusion Criteria:

1. Pregnant. If female of child-bearing age, negative urinary pregnancy test required at time of enrollment. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant she should inform her treating physician immediately.
2. Established diagnosis of cirrhosis or active cancer
3. History of allergy to aspirin or clopidogrel
4. Any history of taking aspirin, antiplatelet drugs, NSAIDS, cyclooxygenase (COX)-2 inhibitors, warfarin, low-molecular weight heparin, thrombolytic agents, or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors) within 2 weeks prior to enrollment. (Refer to appendix)
5. Use of certain antibiotics, cardiovascular drugs, lipid-lowering agents, antidepressants, antihistamines, non-prescription drugs, and supplements within the past 2 weeks. (Refer to appendix)
6. Any major illness requiring hospitalization or surgery in the previous six months.
7. Personal history of gastrointestinal bleed in the last 24 months or diagnosis of peptic ulcer disease in the last 12 months
8. Lifetime personal history of hemorrhagic stroke.
9. Personal or family history of bleeding diatheses, including hemophilias, von Willebrand's disease, Bernard-Soulier syndrome, or Glanzmann thrombasthenia (unless otherwise confirmed not present in study subject)
Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by qualitative abnormalities in reciprocal social interactions and patterns of communication, and by a restricted, stereotyped, repetitive repertoire of interests and activities. The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications specifically in this population.

The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.

The use of medications in adolescents and young adults with ASD is extremely common. few data address the effectiveness and harms of medications specifically in this population. A previous study reported the first case study demonstrating clinical improvement in mood and eye fixation scores from intranasal ketamine treatment in a "complicated" subject with autism spectrum disorderHowever,The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.

Eligibility Criteria:
Inclusion Criteria:

1. meet autism diagnostic criteria based on DSM-5/ADI-R/ADOS
2. children aged 2 years through 15 years of age
3. parents/guardians can cooperate with the study and sign informed consent
4. ASA score I or II

Exclusion Criteria:

1. with epilepsy or other genetic diseases
2. changes in drugs or in any intervention during the study
3. Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history
4. Airway instability, tracheal surgery, or tracheal stenosis per medical history.
5. History of drug or alcohol abuse
6. Central nervous system masses or hydrocephalus per medical history
Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices

The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.

CONCORDE registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. Patient treatment was at the operator's discretion at the time of the invasive procedure. A standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.

Eligibility Criteria:
Inclusion Criteria:

* suspected coronary artery disease
* referred to invasive coronary angiography

Exclusion Criteria:

* hemodynamic instability
Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

This research investigates the potential advantages of intensive preventive statin treatment for healthy men aged 45-80 and women aged 55-80 who possess a high genetic predisposition to coronary artery disease (CAD). By specifically targeting the top 20% of individuals with elevated CAD polygenic risk scores (PRS), the study seeks to find out whether this tailored approach can notably decrease the occurrence of cardiovascular disease and mortality over a five-year period when compared with usual care. Despite the potential of PRS in pinpointing individuals at heightened risk for cardiovascular disease, there is a lack of focused and prospective investigations in existing research. This study aims to bridge this gap by examining whether preventive statin therapy for individuals with high CAD PRS is not only effective in diminishing cardiovascular events but also economically viable. The comparison between the statin treatment arm and standard care practice is conducted in a pragmatic manner at the primary care level.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 45-80 on 1 January 2025
* Women aged 55-80 on 1 January 2025
* CAD PRS top 20% confirmed by the Estonian Biobank (we intend to sample top 15% PRS individuals but we might have to also include 15-20% PRS individuals to fulfil the required sample size)
* The family physician of the study participant has been contracted to participate in the trial
* Written informed consent has been provided to participate in the trial

Exclusion Criteria:

* Diagnosed with ischemic heart disease (I20-I25), stroke or transient ischemia (I60-64, I69, G45), peripheral vascular occlusion (I65-66, I67.2, I70, I73.9), diseases of liver (K70-K77), end stage renal disease (N18.0), mental and behavioural disorders due to psychoactive substance use (F10-F19).

  -- The diagnosis must be present at least 2 times on a health claim or prescription within at least a 6-month period between 1.01.2022-31.12.2024.
* Currently using statin treatment:

  * The individual has at least 1 prescription from ATC groups C10AA or C10BA between 01.01.2022- 31.12.2024.
  * The individual has answered in the recruitment call that he/she is currently using statins or has been prescribed statins in the past 3 years.
* Has familiar hypercholesterolemia (APOB, PCSK9, LDLR genes verified by the Estonian biobank)
* Is currently participating in other clinical trials.
* Has been taking investigative trial medication during the past 30 days prior to study inclusion.
* Co-morbid physical or mental illnesses that prevent the individual from granting consent or participating in the trial (according to the judgement of the investigator).
* Individuals taking:

  * a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C);
  * ciclosporin
  * fusidic acid orally or by injection.
* Individuals with a substance abuse disorder (alcohol, narcotic substances).
* Individuals with hypersensitivity to the active substance (rosuvastatin or atorvastatin) or its excipients.