cyrilzakka/clinical-trials huggingface dataset:
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions

Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF-α. Including skin healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.

Severe cutaneous adverse drug reactions, including Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome(SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a life threatening disease. There is no gold standard in the therapy of SCAR. Treatment with high dose systemic corticosteroids is controversial. Although there have been recent reports of success with various therapies such as plasmapheresis and high-dose intravenous immunoglobulins, their efficacy is not yet proven. Assessment of these therapies is difficult because of their non-specific immunosuppressant or immunomodulating modes of action. Recent studies have shown evidence of the pathogenetic importance of tumour necrosis factor (TNF)-a, suggesting a new therapeutic approach in selective blockade of TNF-a using specific antibodies. We report successful treatment TEN using monoclonal IgG anti-TNF-antibodies. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF-α. Including skin healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient with clinical and pathological diagnoses of severe cutaneous adverse drug reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or Durg reaction with eosinophilia and systemic symptoms.
2. Male or female patient aged more than 4 years.
3. Inform consent obtained.

Exclusion Criteria:

1. Pregnant or breastfeeding female.
2. Allergic to any anti-TNF-α biological product.
3. Active or latent tuberculosis confirmed with Chest X-ray.
4. Severe active infection and septicemia.
5. Active Hepatitis B or C carrier.
6. Suspected HIV carrier with CD4 count less than 200.
7. Patient with poor compliance or with safety concerns judged by investigator.
The Effect of Laughter Yoga Practiced After Burn Dressing

Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. Research shows a relationship between burn dressing changes and increased pain, anxiety, and stress. It can also be said that anxiety negatively affects wound healing. This study aimed to determine the effect of Laughter Yoga, a non-drug method, on reducing or completely eliminating pain and anxiety after burn dressing and increasing the level of mental well-being. This study is planned to be conducted in a randomized manner.

The Burn Center will consist of patients receiving treatment at the Burn Clinic. Data will be obtained through the Introductory Information Form, Visual Analogue Scale (VAS), State Anxiety Scale and Warwick Edinburgh Mental Well-Being Scale. Patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. Sampled individuals will be placed into intervention and control groups using a random number table created with MS Excel software. The average hospital stay of patients is three weeks. Within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group.

For the control group, STAII State Anxiety Scale, Visual Analog Scale (VAS) and Warwick Edinburgh Mental Well-Being Scale levels will be determined in the same periods without any application. The data obtained will be analyzed with appropriate statistical methods using the SPSS for Windows 23.0 program (Statistical Package for the Social Sciences).

Eligibility Criteria:
Inclusion Criteria:

* Receiving inpatient treatment in hospital due to burns,
* Between the ages of 18 and 60, (sick individuals over the age of 60 may have chronic diseases and have problems complying with commands)
* Those with moderate or large severity burns (according to the Turkish Ministry of Health, Burn Injury Treatment Algorithm (11)).
* In individuals with 2nd degree burns, the total burn width does not exceed 40%, and in those with 3rd degree burns, the total burn width does not exceed 10%,
* At least 2 days have passed since the burn injury (the inflammatory phase has passed during the wound healing process and is in the proliferation phase),
* Not in the maturation phase according to the wound healing process, No burns in the abdomen and head and neck area (due to preventing the possible negative effects of Laughter Yoga on the specified areas)
* Patients who volunteer to participate in the research will be included in the study.

Exclusion Criteria:

* Using anxiolytic and sedative drugs,
* Having a psychiatric illness,
* Patients with communication disabilities will not be included in the research.
Making Decisions About Depression Medications

The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.

To determine the ability of decision aids to effectively translate a depression comparative effectiveness research (CER) review into practice, the investigators have developed a literacy-sensitive depression treatment decision aid, DEPRESSION MEDICATION CHOICE, which adapts the Agency for Healthcare Research and Quality (AHRQ)'s Effective Healthcare comparative effectiveness review and associated patient guide about antidepressant medicines to satisfy the needs of clinicians, patients, and other major stakeholders. The investigators will conduct a randomized study to estimate the effect of the decision aid on patient knowledge, patient involvement in decision making and decision-making quality, and on three and six-month measures of medication adherence and mental health, when compared with usual care.

Eligibility Criteria:
Inclusion Criteria:

* Presumed diagnosis of depression (PHQ-9 of 10 or greater)
* As judged by clinician, need to initiate drug treatment for depression
* Identify primary care clinician as main depression provider
* Agree to be available for follow-up survey 6 months after treatment decision

Exclusion Criteria:

* Has prior diagnosis of bipolar disorder
* Has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)
Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).

The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.

This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* Surgical pathology of the leg or the foot with garot tyre of thigh
* Age included between 6 months and 12 years
* Status ASA I or II

Exclusion Criteria:

* Bilateral or one-sided surgical gesture realized without garot tyre
* Cutaneous infection in the point of draining
* Clinical confusion of the coagulation
* Allergy informed in the local anesthesics of amino-acid class
* Evolutionary neurological pathology of the operated limb
* Renal, respiratory, cardiac or hepatic insufficiency.
Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient

Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given their informed consent and expressed interest in participating in the study
* Asthmatic Patients

Exclusion Criteria:

* Patients with communication difficulties.
* Persons who obtain symbicort but not for their own use.
* Patients with other major diseases: Heart problems, COPD, EMPHYSEMA, lung cancer, AIDS.
* Patients with a respiratory infection.
* Patients with seasonal asthma.
* Pregnant women
* Patients who have previously participated in a health education study in asthma.
Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.

A recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. The survival impact of oophorectomy has not been defined yet in this clinical setting. The incidence of microscopic ovarian metastasis has been reported to be approximately 10%. Therefore, the investigators propose a prospective study of oophorectomy followed by standard chemotherapy versus standard chemotherapy alone to determine whether oophorectomy increases survival.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18
2. histologically confirmed adenocarcinoma of colon
3. documented ovarian metastasis in CT or MRI or PET-CT
4. advanced (stage IV), metastatic, or recurrent
5. ECOG performance status of 0\~2
6. adequate marrow, hepatic, renal and cardiac functions
7. no prior surgical treatment to ovary
8. provision of a signed written informed consent

Exclusion Criteria:

1. patient who refuses oophorectomy
2. medical condition in which surgery cannot be tolerated Any waiver of these inclusion and exclusion criteria must be approved by the investigator on a case-by case basis prior to enrolling the subject. This must be documented by the investigator. No subject will be allowed to enroll in this study more than once.
Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use

Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These drugs are available for oral or intravenous dosing and are prescribed at daily, weekly, biweekly, or monthly intervals. Among the many thousands of individuals who currently take these medications, certain individuals experience "atypical" femur fractures preceded by prodromal pain, changes in cortical thickening of bone, or bisphosphonate related osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of the jaws for 8 weeks or more and requires surgical treatment.

This study will attempt to identify genomic and rna biomarkers that may play a role in differential metabolism of bisphosphonates or indicate tendency toward the severe adverse events associated with these drugs.

Collected specimens were subjected to Affymetrix DMET™ Plus Solution analysis. Manuscript is in preparation.

Eligibility Criteria:
Inclusion Criteria:

* Any adult (male or female) age 18 or over meeting any of the following criteria:
* All participants must be able to provide informed consent for themselves.
* History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)
* No History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)

Exclusion Criteria:

* Children age 17 or younger
* Adults who cannot or do not make medical decisions for themselves
* Persons known to be under the jurisdiction of the Department of Corrections
* Individuals who are pregnant.
Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery

Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.

In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Non-major scheduled abdominal surgery.
* Patient will receive Sufentanil intraoperatively for induction and maintenance of general anesthesia
* Written or oral informed consent to participate in the study.

Exclusion Criteria:

* Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
* Repeat surgery at the same surgical site in less than 3 months.
* Pregnancy.
* Ambulatory surgery.
* Endoscopic surgery.
* Surgery with loco-regional or perimedullary anesthesia without general anesthesia
* Intraoperative use of an opioid other than Sufentanil.
* Hypersensitivity to sufentanil
* Legally protected patients (under judicial protection, guardianship, curatorship).
* Patients suffering from psychiatric pathologies.
* Patients suffering from neurodegenerative pathologies.
* Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc...)
SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register

The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:

How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?


Eligibility Criteria:
Inclusion Criteria:

* diagnose chronic heart failure, at least 3 months prior to diagnosis
* Age 18 years
* Signed informed consent

Exclusion Criteria:

* Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
* Lack of capacity to consent
* minors
* persons who are housed on judicial or administrative order in an institution
* pregnant and lactating women
Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer

Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports have shown that metformin can induce TSH suppression without change in T3 and T4 concentration. The purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.


Eligibility Criteria:
Inclusion Criteria:

* papillary or follicular thyroid cancer
* stage 1 or 2 according to TNM system version 6
* surgery and radioiodine treatment
* levothyroxine suppression treatment

Exclusion Criteria:

* cardiopulmonary failure
* liver failure
* renal failure
* pregnancy
* drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with symptomatic anemia associated with CKD
* Participants with renal anemia who are not treated with an ESA:
* Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
* Participants with renal anemia who are on maintenance ESA therapy:
* If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
* Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
* Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent

Exclusion Criteria:

* Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
* Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
* History of hemoglobinopathy
* Anemia due to hemolysis
* Pure red cell aplasia
* High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
* Pregnancy or breast-feeding
* Women of childbearing potential without effective contraception
* Administration of another investigational drug within 1 month before screening or planned during the study period
Program Evaluation of an In-school Daily Physical Activity Initiative

The school system is one setting in which children's physical activity levels may be increased through daily physical activity (DPA) policies and initiatives. Adherence to DPA policies is typically poor and results are limited in regard to the associated benefits for participating children. Therefore, the purpose of this study was to evaluate a range of psychosocial outcomes following a community-led, in-school DPA initiative for 9-14 year old children and youth. This program evaluation examined the impact of a DPA program consisting of 20 minutes of teacher-led DPA for 20 consecutive weeks. Student outcomes were measured using a questionnaire administered at three time points: baseline, mid-intervention, and post-intervention. A teacher questionnaire regarding program adherence and student behaviour was completed at post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participants will include males and females between the ages of 9-14.
* Participants must be enrolled in one of 30 elementary school classes across the participating seven elementary schools.
* Participants need to be able to read and write in English

Exclusion Criteria:

* Participants not enrolled in one of the participating classes.
* Unable to read and write in English.
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.

Eligibility Criteria:
Inclusion Criteria:

* Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
* Only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled.

Exclusion Criteria:

* Women who are pregnant