cyrilzakka/clinical-trials huggingface dataset:
Antipsychotics and Gene Expression in Soft Tissues

Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.

Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Male.
* Healthy, defined as absence of relevant diseases.
* Caucasian.
* Aged 18-45 years.
* Body-Mass-Index (BMI): 18-25 kg/m2.
* Signed informed consent.
* No signs of impaired glucose tolerance as evaluated by Oral Glucose Tolerance Test (OGTT) before study inclusion during screening, normal total cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator.
* No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).

Exclusion Criteria:

* Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
* History of hypertension, blood pressure \> 140/90 at screening, cardiovascular disease.
* Body mass index out of the range of \<18 and \>25 kg/m.
* Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
* Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
* Contraindications against the use of the drug according to the Summary of Product Characteristics (SmPC).
* Any drug intake 2 weeks prior to first study day.
* History of excessive bleeding tendency/hemophilia.
* Presence of relevant illness within the last 3 weeks.
* Currently enrolled into an other clinical study with Investigational Medicinal Products (IMPs).
* Last study participation less than 4 weeks.
* Suspected non-compliance with study instructions and life-style requirements.
* History of alcohol or drug abuse.
* Blood/Plasma donation within 4 weeks prior to study day.
* Previous exposure to antipsychotic drugs.
* Nicotine consumption at time of enrolment (at least 3 months of non-smoking required).
Tissue Factor Expression in Stage C Heart Failure

Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p \< 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p \< 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Previous studies suggest that markers of coagulation are elevated in heart failure (HF). Tissue factor (TF) plays the cardinal role in initiating the coagulation cascade. This study determines TF expression in HF and its association with disease progression.

Methods: Monocytes were obtained from 50 NYHA function class II-IV HF patients and 25 age-matched disease-free volunteers. TF protein, TF procoagulant activity, and tissue factor pathway inhibitor (TFPI) were determined.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure subjects with symptomatic heart failure (New York Heart Association \[NYHA\] functional class II to IV) due to either idiopathic dilated cardiomyopathy or ischemic cardiomyopathy and had a left ventricular ejection fraction \< 0.35.
Developing Tools for Dialysis Decision Support

The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.

This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.

Eligibility Criteria:
Inclusion Criteria:

1. Age \&gt;=65
2. Estimated GFR \&lt;25 ml/min/1.73m2
3. English speaking
4. Not a candidate for kidney transplant based on nephrologist assessment.

Family/caregiver inclusion criteria:

1. age \&gt;=21
2. English speaking

Exclusion Criteria:

a. Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid

Eligibility Criteria:
Inclusion Criteria:

* NSCLC Brain metastasis

Exclusion Criteria:

* KPS\<60
Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery

This is a single site, prospective, non-blinded, non-randomized, before/after study. This study is designed to evaluate the impact of monitoring and reversal guidelines for neuromuscular blocking drugs on the post-operative outcomes for patients undergoing laparoscopic gastric bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* scheduled for an elective laparoscopic gastric bypass procedure

Exclusion Criteria:

* age less than 18 years
* pregnancy
* prisoners
* significant co-existing lung disease including asthma or chronic obstructive pulmonary disease (COPD) requiring regular medication
* patients who require supplemental oxygen pre-operatively to maintain a hemoglobin saturation (SpO2\>98%)
The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes

The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters.

Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about the operation parameters. With randomized controlled trial, Patients of BMI\>21kg/m2 with type 2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-65 years old
* History of diabetes is less than 15 years
* Fasting c-peptide≥1.6
* BMI≥21kg/m2；
* Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups

Exclusion Criteria:

* Psychological and mental disorders
* Serious important organs such as heart and lung disease cannot be tolerated surgery
* Complex history of abdominal surgery in the abdominal cavity adhesion
* Pregnancy or lactation
Saliva Profiles in Children With Congenital Heart Disease

The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.

Using heart failure medications may cause low salivary pH and buffering capacity.As improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up.

This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.

Eligibility Criteria:
Inclusion Criteria:

* 3-12 years
* Caridac problems

Exclusion Criteria:

* other ages
* syndromes
* other systemic diseases
A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

This study is designed to investigate the efficacy and safety of a supervised neuromuscular exercise program versus a standard home exercise program for patients with post-traumatic symptomatic anterior shoulder instability.

Participants with at least one week of symptom duration are randomly assigned to either a 12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program versus a standard HOMe EXercise (HOMEX) program.

The H1-hypothesis is that the SINEX program results in a greater increase in quality of life and physical function than the HOMEX program at the primary endpoint at three months follow-up from baseline

A common, and very painful, injury for individuals in their second and third decades is a traumatic dislocated shoulder. This injury accounts for almost 50% of all joint dislocations registered in the emergency departments. Due to post-traumatic laxity and injuries to the surrounding shoulder tissue, one major problem is the risk of developing a chronic recurrent instable shoulder affecting patients both physically and psychologically decreasing their overall quality of life.

Biomechanically, proprioceptive changes and decreased sensorimotor control are found in patients with post-traumatic shoulder instability inhibiting the ability to control and stabilize the glenohumeral joint. In other similar musculoskeletal disorders, recent studies clearly shows positive effects of progressive neuromuscular exercise.

Finally, no studies have yet investigated the effect of a structured, physical exercise-training regime based on neuromuscular principles targeting the shoulder joint.

This trial is performed as a randomized, assessor-blinded, controlled multi-center trial with cooperation from various shoulder outpatient clinics located at different hospitals in The Region of Southern and Northern Denmark.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-39
2. Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid)
3. Limited ability to maintain a desired level of physical activity (sports/leisure/work) due to pain and/or symptoms in the affected shoulder within the latest week.

Exclusion Criteria:

1. Humeral fracture and/or bony bankart (visible on conventional radiographs at the time of presentation) warranted for surgery decided by the orthopedic (no other axial or appendicular musculoskeletal injury)
2. Prior surgery in affected shoulder joint
3. \>5 anterior shoulder dislocations (verified by journal or subjective evaluation)
4. Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder
5. Sensory and motor deficits in neck and shoulder
6. Pregnancy
7. Inadequacy in written and spoken Danish
8. Not willing or able to attend 12 weeks of supervised exercise therapy
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
* men and women 18-65 years and able to work
* understand spoken and/or written Swedish or English language
* be able to start treatment within 3 weeks from trauma
* consent form signed

Exclusion Criteria:

* earlier injury to, or surgery of either of the shoulders
* simultaneous fracture of the clavicle or acromion
* associates neurovascular injury
* severe osteoporosis
* open dislocation
* open growth plate of the acromion
* local skin damage
MOVE UP Lifestyle Intervention for Caregivers

In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight management (MOVE UP) was effective in producing a mean loss of \>= 5% body weight, with increased physical activity and reduced fatigue. This research will pilot a modified and streamlined version to see if it will be similarly effective for caregivers of family members or friends who have dementia, physical and/or developmental issues, or health problems.

The investigators aim to test the feasibility of delivery of a modified and streamlined lifestyle program in volunteer community settings and to provide pilot data to inform the design of future randomized controlled trials that may improve physical and mental health in older adults (50-75) who are providing care for a family member or friend who has dementia, physical and/or developmental issues, or health problems. Current objectives include:

1 . Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a streamlined 12-session (4-month) community-based translational behavioral weight management program. The pilot program will be delivered by a staff interventionist.

2. Implement and evaluate the program's impact on weight and healthy lifestyle changes, including physical performance outcomes, at 2 sites, each with at least 6 eligible obese and caregiving adults ages 50-75 years old.

Eligibility Criteria:
Inclusion Criteria:

1. 50-75 years of age
2. BMI \>=27.0, but \<45.0
3. Able to consent for participation and data collection.
4. Medical clearance from physician/health care provider before session 2 in program.
5. Ability to walk with or without assistive device.
6. Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability.

Exclusion Criteria:

1. Past MOVE UP participant.
2. If weight loss in the past year is \>=10% body weight.
3. Use of wheelchair; participant must be willing and able to increase physical activity.
4. Uncontrolled diabetes mellitus (FBS \> 30 \& A1C \> 11%); to be assessed by physician on medical release.
5. Uncontrolled hypertension (SBP \> 180/110) %); to be assessed by physician on medical release.
6. Recent overnight hospitalization (past 6 months).
7. Active treatment for cancer (including melanoma).
8. Significant visual or hearing impairment.
9. Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
10. Inability to communicate in English/lack of translator.
11. Currently enrolled in another research study that could impact study outcomes or interfere with either study. Exclude if less than 12 months post-graduation from previously enrolled study.
12. Currently enrolled in a weight loss program, such as Weight Watchers.
13. Inability or unwillingness to attend the majority of sessions.
14. In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
15. Unable to obtain medical clearance by session 2.
16. Not acting as a caregiver.
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device

To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.


Eligibility Criteria:
Inclusion Criteria:

* Patient requires closure of femoral artery puncture resulting from arterial access procedure.
* Patient is ≥18 years of age.
* Patient is willing to provide written informed consent prior to study device use.
* Patient is willing and able to adhere to data collection and follow-up requirements.

Exclusion Criteria:

* Patient is participating in another clinical trial which has the potential to impact hemostasis.
* Patient has an active groin infection or systemic infection.
* Patient has undergone a vascular access procedure within the past 90 days.
* Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)
The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength

The aim of the study is to measure the position of the metacarpophalangeal joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.

The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.

The force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch). Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP joint of the thumb in maximum flexion and extension will also be measured. A total of about 300 healthy volunteers will be examined, with no history of trauma or disease to tendons or joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and health sciences will be part of the research team.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years

Exclusion Criteria:

* (previous) pathology of the joints, ligaments or tendons of the thumb
Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study

Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up. Outcome measures: improvement of VA, decrease in central foveal thickness as measured by Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.

Choroidal neovascularization (CNV) in Vogt-Koyanagi-Harada (VKH) disease is associated with poor visual prognosis. Several treatments have been suggested, though there is still no standard therapy. CNV diagnosis will be based on fundus biomicroscopy (presence of serous retinal detachment with or without retinal hemorrhages), fluorescein angiography (FA) (presence of early phase hyperfluorescence with late phase leakage) and OCT findings (hyperreflective lesion related to a CNV complex with serous foveal detachment or intraretinal fluid with increased foveal thickness). Inflammation will be considered active if anterior chamber cells or optic disc leakage in FA is observed. Each patient will undergo a complete clinical exam, including best corrected visual acuity (VA) (Snellen charts). Once active CNV is identified, a loading dose of 3 injections of IV bevacizumab will be proceeded monthly and systemic immunosuppression will be introduced or intensified. After the first 3 injections, the patient will be clinically examined and OCT will be proceeded monthly. The persistence of intra/subretinal fluid in the OCT will indicate one more IV bevacizumab injection. Immunosuppression status evaluation will be done at 3, 6, 9 and 12 months of follow up and intensification will be done if inflammatory signs or persistence of intraretinal fluid is observed. Presence of intra/subretinal fluid and manual measurement of retina central foveal thickness (CFT) will be proceeded in horizontal scan by the same examiner.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Vogt-Koyanagi-Harada disease based on Revised Diagnostic Criteria presented by the International Committee on VKH disease in 2001;
2. Presence of choroidal neovascularization identified by fundus biomicroscopy, fluorescein angiography and OCT.

Exclusion Criteria:

* Media opacities precluding posterior segment exam, ametropia over 5 dioptries, glaucoma (defined as a disease with characteristic damage at the optic nerve or characteristic visual field defect with compatible nerve fiber layer lesion), Age related Macular degeneration, impossibility to increase immunosuppression.
Effect of Collagen Matrix Graft on Palatal Fistula Formation After Cleft Palate Repair

Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance.

Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair.

Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues.

The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.


Eligibility Criteria:
Inclusion Criteria:

* Non-syndromic cleft palate
* Must be between nine months to two years
* Must have not previously had cleft palate surgery
* Must consent to participate in the study

Exclusion Criteria:

* All blood dyscrasias
* All connective tissue dysfunctions