cyrilzakka/clinical-trials huggingface dataset:
The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery

The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.

When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients who undergo orthopedic surgery with duration of longer than one hour
* Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction)
* American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3

Exclusion Criteria:

* Peripheral vascular disease involving upper or lower extremity
* Orthopedic surgery which uses the tourniquet
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.

Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.

The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.

The study is designed as a double blinded randomized controlled trial. The physiotherapist responsible for the clinical testing and the patient are both blinded. The surgeon knows which group the patient is in but is not responsible for any of the testing. We will randomize with envelopes perioperatively. The participants are randomized in hence "ballon" or "not ballon". In advance of the randomization the surgeon will evaluate if the patient is candidate for partial suture before randomization. We plan to stratify the patients with partial suture to ensure homogeneity between the groups.

The operation will start with arthroscopic debridement and biceps tenotomy in both groups. The patients are thereby evaluated for partial suture and randomized. The insertion of the subacromial spacer is done at the end of the operation for those patients randomized to the group "balloon". Peroperatively the surgeon will classify the grade of osteoarthritis with Outerbridge classification and the state of the rotator cuff and the long head of the biceps tendon.

Postoperative mobilization will be the following:

* 0-2 weeks: Immobilization in a sling. The participant is advised to do simple exercises for shoulder mobilization. Restriction of movement above shoulder level.
* 2-6 weeks: Free mobilization. Advised to avoid heavy lifting.
* 6-12 weeks: Work on increasing range of motion, gradually introduce weight lifting.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.
* Persistent pain for at least 3 months, with documented failure of conservative treatment
* Age ranging from 60 years of age to 85 years of age

Exclusion Criteria:

* Significant shoulder osteoarthritis in the affected shoulder, Hamada classification \>2.
* Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification.
* Comorbidity to the degree that the patient will not be able to participate in the follow up program.
Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

Multiple sclerosis (MS) is a severe autoimmune disease that affects mainly young individuals. It is estimated that there are 17-20,000 affected persons in the Czech Republic.

Currently, MS remains an incurable but treatable disease. As of now, there are many drugs that are able to reduce the inflammatory part of the disease that prevails in its initial phases. The problem is the great variability of the severity of clinical course (from relatively benign to severe malignant courses) and different responses of particular patients to particular drugs. A personalized approach with long life monitoring and adjustment of treatment according to the activity of the disease is essential.

From this point of view registries represent one of the most important source of long term data that is used for evaluation of effectiveness and safety of different drugs in areal life setting.

The objective of this study is to compare effectiveness and safety profile in MS patients treated with a different Disease Modifying Drugs (DMDs) and Ocrelizumab using data from the real clinical practice from the Czech national multiple sclerosis patient registry (ReMuS).


Eligibility Criteria:
Inclusion Criteria:

* Each participant must provide informed consent to registry ReMuS in accordance with local regulations
* The patient is treated by any kind of DMDs
* Confirmed diagnosis of multiple sclerosis

Exclusion Criteria:

* Patient withdrawal of informed consent to registry ReMuS
Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients

Aim of this study is to develop and establish an indication-based algorithm for identifying particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic bone disease. A further aim was the establishment of an adequate psychosocial treatment within the clinical workday routine to support coping with illness and treatment.

Aim of this study is to develop and establish an indication-based algorithm for identifying particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic bone disease. A further aim was the establishment of an adequate psychosocial treatment within the clinical workday routine to support coping with illness and treatment.

Methods:

Patients with histologically assured sarcoma or metastatic bone disease are psycho-oncologically screened by a common cancer specific expert rating scale (PO-Bado: Basic Documentation for Psycho-Oncology, 6 items) at the time of admission before tumor resection. In the same line patients were asked to answer two standardized self-rating questionaires, namely the FBK-R10 (Questionaire for Psychosocial Burden of Cancer Patients, 10 items) and a modified form of the PHQ (Patient Health Questionaire, 2 items) to assess patients' burden of disease as well as the presence of depressive mood. Cancer patients exceeding a defined critical PO-Bado cut-off value (a minimum of 2 items scoring 3 or 1 item scoring 4) are expected to require psychosocial support and a psychosocial consultation/co-treatment iss initiated.

To evaluate short-term effects of the psycho-social treatment the cancer-specific screening is repeated (PO-Bado, FBK-R10, PHQ) before discharge from the hospital. All diagnostic findings as well as a specific recommendation for the continuing treatment are integrated into the orthopedic discharge letter. Furthermore, all findings are shown and factored for decision making within the interdisciplinary musculoskeletal tumor board. For appraisal of treatment-based long-term effects the psycho-oncological screening is repeated within the orthopedic aftercare examinations 3 and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18
* initial diagnosis of a histologically assured sarcoma or metastatic bone disease

Exclusion Criteria:

* age younger than 18
* benign tumors
* patients with known sarcoma or metastatic bone disease
* patients with known other tumors
* fundamental neurological and psychiatric disorders
* prisoners
* patients with guardianship
Development and Management of Registry in Patients With Gynecologic Cancer in Korea

The goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.

Cervical cancer, endometrial cancer, and ovarian cancer represent gynecologic cancers. There are many open issues that need to be addressed, specifically the surgical method, disease recurrence and survival outcome in the so called "real world" setting. The aim of this observational study is to collect both retrospective and prospective medical information of gynecologic cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older
* Written informed consent (prospective cohort)
* Confirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer

Exclusion Criteria:

* Unconfirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer
A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.

Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.

Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent
2. histologically confirmed glioblastoma patients who will take TMZ treatment
3. KPS \>70
4. adequte end-organ function
5. prior major surgery \> 4 weeks (prior minor surgery \> 1weeks)
6. prior standard concurrent chemo-radiation therapy \> 4 weeks
7. prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks

Exclusion Criteria:

1. contraindication to TMZ
2. prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy)
3. uncontrolled systemic medical illness
4. pregnancy
RESIST: Understanding the Role of Depression in Heart Disease

This study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with depression.

Rationale: Depression is known to be associated with the development of cardiovascular disease and poorer prognosis after cardiac events, however the mechanisms that mediate these links are poorly understood. Inflammatory and neuroendocrine processes are thought to play an important role in this relationship. In addition, antidepressants have been shown to improve cardiac outcomes and have anti-inflammatory effects, whilst inflammation has been shown to be elevated in patients who do not respond to treatment. Several possible biomarkers for antidepressant resistance have also been demonstrated to be cardiovascular risk markers. These include acute phase inflammatory markers, such as interleukin-6 (IL-6), and hypothalamic-pituitary-adrenal axis (HPA) dysregulation.

Design: This will be conducted alongside a larger pharmacological trial, PANDA, where participants will be recruited from primary care and randomized to sertraline (SSRI) or placebo. The RESIST study will compare inflammatory cardiovascular risk factors between depressed patients taking sertraline, depressed patients taking placebo and healthy controls. This will be achieved by investigating the pharmacological effect of antidepressants on gene expression, glucocorticoid and mineralocorticoid receptor function and regulatory T cell (Treg) profiles.

Eligibility Criteria:
Inclusion Criteria:

* Depressed patients:

  * Meet ICD10 criteria from the Clinical Interview Schedule-Revised (CIS-R)

Exclusion Criteria:

* Depressed patients:

  * Are taking any anti-inflammatory drugs or drugs which interfere with HPA-axis function, endothelial function, circadian rhythm or any other pathways under investigation
  * Unable to read, understand and/or complete questionnaires
  * Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder
  * Vulnerable adults
* Healthy controls:

  * Have a history of depression
  * Are taking any anti-inflammatory drugs or drugs which interfere with HPA-axis function, endothelial function or circadian rhythm or any other pathways under investigation
  * Unable to read, understand and/or complete questionnaires
  * Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder
  * Vulnerable adults
Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma

Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment.

Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT...), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient.

In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up.

The patients will be enrolled before surgery and follow-up during 18 months. During patient participation, 20 ml of blood will be collected 7 times (before and after surgery, 6 months after diagnosis and every 3 months thereafter until 18 months of follow up).

Mutation analysis on tumor and healthy tissue will be performed on primary tumors and lymph node dissection, after removal by the surgeon.

Circulating tumor DNA will be detected on blood sample

Eligibility Criteria:
Inclusion Criteria:

* Operable Head and neck squamous cell carcinoma (T3-T4 stage and/or N+)
* No p16 expression
* Curative treatment proposed based on surgery + radiotherapy (+/- chemotherapy)
* PS\<3
* Written consent signed

Exclusion Criteria:

* Metastatic spread
* Previous radiotherapy of head or neck
* Previous HNSCC (except carcinoma restricted to glottis, with a surgery treatment alone and \>3 years of follow up without relapse)
Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia

The most used anatomical landmark for application of spinal anesthesia is Tuffier's line. Other alternative landmark is tenth rib. However there is no trial that compare these landmarks based on using ultrasonography.

The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for accuracy by using ultrasonography. 40 patients will be included in each groups. all of them will be assessed by ultrasonography during application of spinal anesthesia. And the investigators will examine the percentage of successful estimation of correct vertebral space.

Eligibility Criteria:
Inclusion Criteria:

* knee arthroscopic surgery

Exclusion Criteria:

* BMI\>30
* anatomical anomaly of vertebrae
Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity

Anhedonia and abnormalities in reward behavior are core features of overweight/obesity (OW), a highly prevalent condition within MDD populations, and is independently associated with reward disturbances. The investigators therefore aim to investigate the brain substrates subserving reward and motivation in adults with overweight/obesity.

The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms.

Herein, the investigators are primarily interested in three overlapping, yet distinct aspects, of anhedonia. The investigators are primarily interested in motivation, reward valuation, and reward learning towards addressing the measurement of each of these respective subdomains, eligible participants will complete validated gold standard measures (i.e. the Effort Expenditure for Rewards Task (EEfRT) (reward valuation), Probabilistic Reward Task (PRT) (reward learning), and the Monetary Incentive Delay (MID) task (reward anticipation)).

Twenty adults with overweight/obesity will complete all tasks at a single visit with two of the tasks being completed prior to MRI and one of the tasks (i.e. EEfRT) will be completed during MRI acquisition.

The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms. In addition, associations between performance on reward tasks and functional connectivity, as measured by MRI and DTI, a secondary objective is to ascertain whether associations exist between performance on the motivation reward tasks and gold standard measures of food intake (i.e. food diary) and energy expenditure (i.e. calorimetry).

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Meeting DSM-V criteria for: (i) Major depressive disorder (symptomatic or asymptomatic in any phase of the illness) or (ii) bipolar disorder I/II (symptomatic or asymptomatic in any phase of the illness)
* Ability to provide written and informed consent
* Obesity 30 kg/m2
* Weight under 440lbs
* Shoulder-to-shoulder width under 60 cm

Exclusion Criteria:

* Age below 18 or above 65
* Use of benzodiazepines or consumption of alcohol within 12 hours of assessments
* Abuse of marijuana
* Physical, cognitive, or language impairments sufficient to adversely affect data derived from assessments
* Diagnosed reading disability or dyslexia
* Clinically significant learning disorder by history
* History of moderate or severe traumatic brain injury
* Other neurological disorders, or unstable systemic medical diseases
* Pregnancy and post-partum period
* Presence of any contra-indications for MRI
* Weight above 440lbs
* Shoulder-to-shoulder width greater than 60 cm.

All subjects will be consented prior to initiating the study; \>45 BMI; suicidality as determined by clinical discretion
Alcohol and Gender Effects on Stress Circuit Function

The purpose of this study is to look at the stress hormone response to medication-induced stress and a placebo (an inactive compound) in non-drinking, recovering male and female alcoholics, with a specific emphasis on the differences between men and women in the two recovering alcoholic groups.

Women and men differ in the ways stress affects the development and maintenance of alcoholism. However, no published studies in alcohol dependent patients have examined sex differences in stress responsiveness that most likely mediate these effects and influence the clinical course and treatment of the disorder.

The long-range goal of this research program is to define aspects of the neural, genetic and environmental mechanisms differentially regulating the stress response in alcohol dependent women and men. The proposed study extends prior work revealing sex-dependent alterations in basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. Our central hypothesis is that sex differences in serotonin function or HPA sensitivity conspire with genetically influenced alterations in serotonin signaling to produce maladaptive stress responses in some alcoholic women. These altered stress responses may serve as the target of novel, sex-specific pharmacotherapies.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent.
* Are actively engaged in a recovery program for alcoholism;
* Have a current (within the past 12 months) diagnosis of DSM-IV alcohol dependence in early- (modified to a minimum of 4 months) full remission; and
* Are residing in a controlled sober living environment; and
* Agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only).

Exclusion Criteria:

* Have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease;
* Are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone);
* Are pregnant, or planning to become pregnant during the next 9 months;
* Have taken other psychotropic drugs (including SSRIs, MAO inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session;
* Have taken any investigational drug within 90 days of the first laboratory session; or
* Are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.