cyrilzakka/clinical-trials huggingface dataset:
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.

PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.

The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant naïve to elafibranor, for whom the treating physician has decided to start treatment with elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.

Exclusion Criteria:

* Participant who started elafibranor treatment before baseline visit.
* Participant is currently participating in, plans to participate in or has participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives of the drug/active substance, whichever is longer, prior to baseline visit.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Effect of a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre

The study's primary objective is to test the hypothesis that a group-based health promotion intervention with patient education and practical exercises delivered at a Healthy Life Centre increases patient activation in people living with chronic pain. Due to many people living with chronic pain, interventions focusing on self-management and coping are on the agenda in primary care. This study will investigate whether a Healthy Life Centre in a municipality is a suitable setting for interventions targeting people living with chronic pain. Short and long term effect of an intervention developed in a health promotion and salutogenic framework will be investigated in a randomized clinical trial.

Previous research indicates that if self-management interventions are developed within a health promotion framework focusing on the participants' strengths, there is a beneficial effect on patient activation and thus on self-management behaviour. However, there is a lack of knowledge about which interventions will improve patient activation for persons with chronic pain. To be sustainable, such interventions should be delivered using the least possible amount of resources needed to get an effect. One way to do so is to deliver the intervention in primary care instead of in hospitals. The Healthy Life Centre is ideally situated to deliver these interventions. This is especially true due to their task of focusing on health promotion but also because they are set up to deliver low level interventions, meaning that it should be easy for everyone to access their services.

Eligibility Criteria:
Inclusion Criteria:

* pain for 3 months or more
* able to participate in one hour physical activity

Exclusion Criteria:

* not fluent in Norwegian
* chronic pain arising from active malignant disease
* serious mental health illness
* substance abuse issues
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction compared to EOX alone.

Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical efficacy threshold will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
* Inoperable locally advanced disease or resections with R2 outcome or recurrent or metastatic disease.
* CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
* Measurable and/or non-measurable disease as defined according to RECISTv1.1
* Age ≥ 18 years
* Written Informed Consent Form
* ECOG performance status (PS) 0-1
* Life expectancy \> 3 months
* HER2/neu negative patients and patients with HER2/neu positive status but not eligible to trastuzumab therapy in discretion of the investigator.
* Adequate cardiac, hepatic, renal, hematologic function.

Exclusion Criteria:

* Prior severe allergic reaction or intolerance to a monoclonal antibody, to the chemotherapeutics used in this study or any excipient in the respective formulations.
* Previous chemotherapy for advanced disease.
* Previous perioperative chemotherapy with curative intention within 6 months of start of study treatment. If interval is longer than 6 months (counted from the stop date of the perioperative chemotherapy), patients are allowed.
* Known HIV infection or known symptomatic hepatitis (A, B, C).
* Symptomatic cerebral metastases.
* Pregnancy or breastfeeding.
* Previous treatments with maximum cumulative doses of epirubicin \> 500 mg/m² and/or other anthracyclines and anthracenediones.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Considerations on the Transfusion Threshold in Cardiac Surgery

This is a retrospective observational study of the transfusion threshold in cardiac surgery.

There is controversy in the literature regarding the transfusion threshold to be adopted, especially in a patient who has undergone cardiac surgery. Some authors suggest that the transfusion should be done in a restrictive way when a certain threshold in hemoglobin is reached, in order to avoid the risks it implies, especially infectious.This threshold is very controversial and remains to be defined (variations in the literature from 7g / dL to 9g / dL). Other authors conclude that there is no superiority of a restrictive transfusion compared to a more liberal transfusion, with regard to the morbidity or medical costs.

It is therefore interesting to study, in a retrospective manner, the global and multidisciplinary management of patients who have undergone a cardiac surgery within the CHU Brugmann hospital, to analyze if they have been adequately transfused.


Eligibility Criteria:
Inclusion Criteria:

- Patients having undergone cardiac surgery (other than the placement of a pacemaker or defibrillator) within the CHU Brugmann hospital between 2006 and 2015

Exclusion Criteria:

* N/A
The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet

The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.

Clear cerebral infarction patients during hospitalization, treatment process, discharge and hemorrhage occurs, the stages F VIII level change and its correlation with bleeding adverse reactions. Analysis F VIII whether belong to hemorrhage occurs independent risk factors of adverse drug reactions,as well as the feasibility of predicting bleeding occurred adverse reaction index.

Eligibility Criteria:
Inclusion Criteria:

* Guidelines prepared by the diagnostic criteria(according to the diagnostic criteria of the Fourth National Stroke Conference prepared,have been more than one times skull CT and/or MRI)was confirmed for ischemic stroke,and requires the use of antithrombotic therapy(including thrombolysis, anticoagulation, antiplatelet) patients
* Willing and able to comply with the study protocol and visits planned

Exclusion Criteria:

* At the same time the presence of other active malignancy.
* There is known brain metastases or leptomeningeal metastases
* Systemic active infection ( ie infection leads to body temperature ≥38 ℃)
* The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .
* Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.
* Uncontrolled diabetes.
* Severe / unstable angina, New York Heart Association (NYHA) class III or IV symptoms of congestive heart failure
* there is other reason (not the antithrombotic drugs) caused by bleeding.
* The presence of an autoimmune disease or a history of organ transplant patients require immunosuppressive therapy
* Psychiatric presence may increase the risks associated with study participation or study drug , or may interfere with the interpretation of study results
* Pregnant and lactating women
* Bleeding disorders may exist on admission
* The researchers added that the study is not appropriate to the circumstances
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.

Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population.

150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 70 and 90 years of age with displaced femoral neck fractures
* Intact cognitive function
* Ability to walk with or without a walking aid prior to falling.

Exclusion Criteria:

* Dementia
* Fractures in pathologic bone
* Patients not belonging to the hospital community
* Patients with sepsis or local infection
* Fracture not eligible to be treated with a hemiarthroplasty
Internet Based Exercise Training in Type 2 Diabetes

Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and exercise has positive effects on glycemic control and cardiovascular disease (CVD) development in these patients. Encouraging physical activity and exercise with using internet-based technology provides; potential to reach more people via comparatively low cost, 24 hour accessibility to services and for clinician, more frequent communication ability with the patient. In literature, there is no study examined exercise training via internet in patients with Type 2 DM. For this reason, considering the lack of the literature, the investigators aimed to compare the effects of internet based combined exercise training on glycemic control, functional capacity and physical activity level with supervised group training in patients with Type 2 DM. The purpose of the study is to provide convenience of rehabilitation access, glycemic control, offer an alternative physiotherapy and rehabilitation service which can help to improve physical activity level and obtain quantitative data for the applicability and contribution of internet based exercise training in patients with Type 2 DM.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c level between %6,5-11
* Patients who can reach 420 meters in 6 minutes walking test
* Patients who are available high speed internet from home, work or mobile phone

Exclusion Criteria:

* Non-Cooperation

  * Uncontrolled Hypertension and cardiac arrythmia
  * Severe neurological and pulmonary disorder
  * Patients who had Percutan Transluminal Coronary Angiography or cardiac pacemaker
  * Previous Myocardial Infarction
  * Previous amputation
  * Major musculoskeletal problem
  * Chronic renal failure
  * Patients who had hip or knee prothesis within 5 years
  * Diabetic ulceration pr neuropathy
  * Pregnancy
  * Breastfeeding
  * Hemolytic anemia
* Renal anemia
FLIPS: Ferfer Liposomal Iron Performance Study

To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels

Anemia, described as a low blood Haemoglobin concentration, has been shown to be a public health problem that impacts low-, center- and high-earnings nations and has great unfavorable health results, as well as unfavorable influences on social and monetary development . even though the most dependable indicator of anemia on the populace stage is blood Haemoglobin attention, measurements of this attention by myself do now not determine the cause of anemia. Anemia may additionally result from a number of causes, with the maximum great contributor being iron deficiency. approximately 30%- 50% of instances of anemia are taken into consideration to be because of iron deficiency.

Doctor will evaluate on the basis of inclusion or exclusion criteria, lab values and overall assessment and then enroll in this clinical trial. During the study patient will visit the Doctor four times, Day 0 week 4, week 8 and week 12. Doctor will investigate the Hemoglobin level and Hematocrit level and also evaluate the adverse effects and tolerability of Ferfer® at week 2 and week 8. Doctor also instructed to take the food supplements, twice daily, once in a morning and once in evening independently by food intake as Ferfer® has no interaction with food.

Eligibility Criteria:
Inclusion Criteria:

* Iron deficiency anemia (Hemoglobin \<8 to \>5 g/dl)
* Subjects able to provide written informed consent;
* Subjects already treated with other iron supplements or drugs that experienced side effects (not including allergy) related to iron administration.
* Wash out period will be a week

Exclusion Criteria:

* Had a history of iron intolerance
* Hypersensitivity and allergic of Vit C and Vit B12
* Not willing to take informed consent
Rectal Cancer Trial On Defunctioning Stoma

The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Eligibility Criteria:
Inclusion Criteria:

* Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion Criteria:

* Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

Prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondylar humerus fractures.

The goal of the SPAS trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. The study will be designed as a prospective, double-blinded, two-arm, non-inferiority trial. The control arm will receive standard of care preoperative prophylactic antibiotics. The intervention group will receive a preoperative saline placebo. The primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. Secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. The hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. Inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. Immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. Because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. With a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant.

Eligibility Criteria:
Inclusion Criteria:

* Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4

Exclusion Criteria:

* Inability to secure consent
* Open fractures
* Polytrauma
* Pathologic fractures
* Flexion type fracture
* Associated compartment syndrome
* Allergy to cefazolin which precludes its use
* Skeletally mature patients or patients greater than 18 years of age
* Medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization.
* Inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction
Homeopathy for Overweight and Obesity in Mexican Adolescents

This study evaluates the efficacy of a multidisciplinary intervention (diet, exercise, motivational support and homeopathy or placebo) for overweight and obesity in Mexican adolescents. Half of study participants will receive the multidisciplinary intervention plus Calcarea carbonica ostrearum, a homeopathic medicine, while the other half will receive the same multidisciplinary intervention plus placebo.

Overweight and obesity in children and adolescents are a major public health issue in Mexico. Whilst many factors (genetic, cultural, socioeconomic and environmental) contribute to develop obesity during childhood, a multidisciplinary intervention (nutritional, behavioral and exercise) is the best approach to improve weight loss. In Mexico, the use of homeopathy for obesity is widespread. Although there are some homeopathic medicines used for obese individuals, there is a lack of well-designed clinical trials to demonstrate its efficacy in weight loss. Calcarea carbonica ostrearum is a homeopathic mineral medicine. Previously, it has been demonstrated that Calcarea carbonica has an effect in reducing the percentage of fat in adolescents.

Therefore, a randomized, placebo-controlled, double-blind, parallel, superiority trial with a 3 month study duration, will be conducted to prove the efficacy and safety of Calcarea carbonica ostrearum in reducing weight, body mass index (BMI) and fat percentage, as well as, to prove its effect on the lipid profile, fasting serum glucose, glycosylated hemoglobin and insulin.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 19 years old.
* At least elementary school.
* Overweight (BMI ≥ 85th but \<95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile).
* Fasting serum glucose \<126 mg/dl.
* Glycosylated hemoglobin \<6.5%.
* With symptoms that match with Calcarea carbonica ostrearum.
* Willingness to participate, and verbal and written consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Cases already undergoing treatment (homeopathic, nutritional or structured physical activity) for obesity within last three months.
* Currently use of metformin, orlistat, insulin, other antidiabetic medication, contraceptive pills, medications with effects on lipid metabolism \[thiazide and loop diuretics, β and α receptor blockers, antiepileptic drugs (carbamazepine, phenytoin, valproic acid, phenobarbital), antipsychotics (clozapine), protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), tamoxifen, raloxifene, isotretinoin, acitretin, ciclosporin, azathioprine, sirolimus\].
* Any condition that prevents physical exercise.
* Diabetes, hypertension, thyroid diseases, Down syndrome, mental retardation.
User Testing of the Evivo Screening Test

The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium Screening Test ("Evivo Screening Test").

Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was designed to differentiate between high and low levels of Bifidobacterium in infant stool. This study is intended to confirm the precision of results for this screening test, as well as its ease of use, in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0-6 months.
* Generally healthy infants.

Exclusion Criteria:

* Infants should not have an acute infection.
* Not intended for use with stool containing meconium.
* Infants with jaundice should not be tested until it has resolved.
* This test should not be used for infants with carbohydrate malabsorption syndrome, which may present with one or more of the following persistent signs: abnormally foul-smelling, mucus-containing, and/or green frothy stools.
Decision Impact Trial of KidneyIntelX

The current trial is designed to evaluate how the results of KidneyIntelX test impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.


Eligibility Criteria:
Inclusion Criteria:

* 23 years of age or older.
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-60 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients who are currently on Enbrel.