cyrilzakka/clinical-trials huggingface dataset:
TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

This study is:

* A multicenter, prospective, randomized, phase 3 trial.
* To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
* 276 patients will be recruited.

Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* ECOG performance status 0-2
* Non-squamous cell type non-small cell lung cancer (NSCLC)
* Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
* No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
* No prior immunotherapy, biologic therapy
* Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Hemoglobin \>=9.0g/dl, Platelet \>=100,000/uL, neutrophil \>=1,500 /uL Creatinine \<=1.5 x upper normal limit or creatinine clearance \>=60 mL/min Bilirubin \<=1.5 x upper normal limit, Transaminases \<=2 x upper normal limit Alkaline phosphatase \<=2 x upper normal limit
* Written informed consent

Exclusion Criteria:

* Pregnancy, Lactating woman
* Woman in child bearing age who refuses to do pregnancy test
* Moderate or greater than grade 1 motor or sensory neurotoxicity
* Hypersensitivity to taxane
* Comorbidity or poor medical conditions
* Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
* Concurrent treatment with other investigational drugs within 30 days before randomization
* Active treatment with other anticancer chemotherapy
* EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
Diabetes Treatment With Glucobay in Combination With Sulfonylurea

In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of sulfonylurea under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.


Eligibility Criteria:
Inclusion Criteria:

* All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

* According to local product information
Effectiveness of MBSR Among Student Teachers

The aim is to evaluate the effectiveness of Mindfulness-based Stress Reduction among Danish student teachers on their mental well-being. The study is a randomised, controlled trial including 100 teachers.


Eligibility Criteria:
Inclusion Criteria:

* Danish student teacher

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine
The Effectiveness of Mental Health First Aid Intervention Among Undergraduate Students in Switzerland

Mental Health First Aid (MHFA) is an educational training program which has been proven effective at increasing knowledge, improving attitudes and reducing the stigma of mental illness among individuals/the general population. Although MHFA has proven effective world-wide, no study has examined the effectiveness of MHFA in Switzerland and very few studies have examined the long-term effects of MHFA and how they might be influenced by cultural differences. This study is a randomized control trial (RCT) that examines the effectiveness of a 12-hour MHFA training program that aims to improve undergraduate students' knowledge of, behaviours towards mental illness and to reduce stigmatization towards mental illness. All participants were 2nd-year students and they were randomly assigned either to an intervention group that would receive the MHFA training course or to a control group without any intervention during the study period. However, the control group had the option to receive the MHFA course after the 12 months of study follow-up was completed. Both groups were assessed at three time points: T0: Baseline survey from mid-September to October 2019, completed by both groups.

Intervention: MHFA training program from October 2019-December 2019. T1: Post-intervention with first follow-up survey three months after the MHFA training intervention completed by both groups (from March to May 2020). T2: Follow-up 12 months after the MHFA/ensa training intervention in December 2020 and completed by both groups.


Eligibility Criteria:
Inclusion Criteria:

* 2nd year undergraduate students from universities of applied science in Lausanne and Yverdon-les-Bains.
* ≥18 years old.

Exclusion Criteria:

* Working and part-time students.
Pain Management in Geriatric Hip Fracture

The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.

200X2 patients are recruited during two periods within the study period where regular oral analgesics is given for the first 200 patients while the rest of patient will receive oral analgesics upon demand

Eligibility Criteria:
Inclusion Criteria:

* Both sex of Age \> 65
* Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention

Exclusion Criteria:

* Age \< 65
* Pathological fracture
* Multiple lower limb fractures
* Old fracture
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy

ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* patients between 30 and 60 years

Exclusion Criteria:

* coagulopathy
* infection at insertion site
* patient refusal
Blood Management in Orthopedic Surgery

Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a restrictive transfusion policy is used.

Study design: a prospective, double randomized, open, multicenter study in which patients are stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1 and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.

Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus not randomized. Patients in both strata will be randomized for three modalities: a cell saver (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).

Inclusion criteria: All orthopedic patients of 18 years and older being considered for a primary or revision total knee- (TKR) or total hip replacement (THR).

Outcome measures:

Primary outcome: number of allogeneic red blood cell (RBC) transfusions.

Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay (days), peri- and post-operative complications during hospitalization, quality of life, cost analysis

Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (CS or D) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis.

Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).

Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).

Exclusion Criteria:

* Patients who refuse homologous blood (e.g.Jehovah's witnesses),
* Patients with untreated hypertension (diastolic blood pressure \> 95 mm Hg),
* Patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries,
* A recent myocardial infarction or CVA,
* Sickle cell anaemia patients,
* Malignancy in the operated area,
* Pregnancy,
* Unsuitability for peri-operative anticoagulation prophylaxis,
* Known allergy to erythropoietin,
* An infected wound bed,
* Revision of an infected prosthesis which is being treated with antibiotics, OR
* Patients with difficulty understanding the Dutch language (unable to give informed consent or patients who insufficiently control the Dutch language).
Intrathecal Stem Cells in Brain Injury

The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic evolution of the pediatric patients with hypoxic/ischemic brain injury.

There is accumulating evidence that shows that the placement of hematopoietic cells in the brain may increase growth-enhancing factors of axons and generate active neurons in the receptor. It has been found that after introducing hematopoietic cells in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be deliver more efficiently to the injured area, when compared to the intravenous route. Patients will be stimulated 4 times and then harvest the bone marrow. Bone marrow will be processed in order to obtain hematopoietic cells (CD34+) and minimize the erythrocytes amount. A inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with the "Battelle Developmental Inventory" before the procedure and one and six months after that. An MRI will be performed before the procedure and six months after that.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours.

Exclusion Criteria:

* Patients with neurodegenerative or autoimmune diseases.
* Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure.
* Patients who do not sign the informed consent form.

Elimination Criteria

* Patients with severe meningeal abnormalities at the time of procedure.
* Patients who did not attend subsequent assessments 30 and 180 days after the procedure.
* Patients who die from causes related to neurological disease within 180 days after procedure.
* Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure.
* Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction.
* Patients choosing to leave the study.
Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

Children either living in the streets of Bujumbara or that are similarly affected by extreme poverty or violence are regularly exposed to traumatic events. Additionally, they often find themselves in situations where engaging in violent behavior appears to be useful or even necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and potential positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to enable reintegration into the family.

The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and ongoing aggressive behavior which in change facilitates reintegration into society.


Eligibility Criteria:
Inclusion Criteria:

* High degree of symptoms of posttraumatic stress disorder according to UCLA PTSD Reaction Index

Exclusion Criteria:

* Psychotic symptoms
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.


Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Dioptric power of IOL \>22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

Exclusion Criteria:

* Uveitis, pathology of the retina or the optic nerve
* Corneal scarring or irregularities
* Astigmatism \>1.5 D
* Amblyopia
* Perioperative complications
* Postoperative refractive error \>2.0 D of spherical equivalent
* Postoperative DCVA \<0.8 (ETDRS)
Impact of Statins on Cytokine Expression in Pneumonia

The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age,
* Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,
* Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and
* One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.
* Having one Food and Drug Agency approved indication for statin therapy

Exclusion Criteria:

* Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.
* Hospitalization \> 24 hours at time of the diagnosis of pneumonia.
* Hospitalization \> 48 hours at time of study enrollment.
* Residence in a skilled nursing facility.
* Previously diagnosed human immunodeficiency virus infection with a current CD4 count \< 200 cells/mm.
* Immunosuppression
* Patient or family decision to limit medical care ("comfort measures only").
* Known allergy to statin therapy.
* Active or planned pregnancy or breastfeeding.
* Inability to take oral medications at the time of study enrollment.
* Pre-existing liver disease or AST/ALT \> 10% the upper limit of normal.
* Creatinine phosphokinase (CPK or CK) \> 50% above the upper limit of normal.
* Partial ileal bypass.
* Concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (Zetia), nefazodone.
* Transfer from an outside hospital.
Activity Monitoring Assessment of Opiate Withdrawal - 4

The purpose of this study is to determine if hyperactivity accompanies abrupt opiate withdrawal in heroin addicts, to determine if computerized solid state activity monitors are capable of quantifying hyperactivity, and to quantify the physical and affective symptoms occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate these symptoms.


Eligibility Criteria:
Please contact site for information.
Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics

The management of headache disorders is too often based upon trial and error or on personal beliefs and opinions. Seldom it is based on scientific arguments. Therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patients.A prospective cohortstudy is designed to identify these prognostic patient characteristics. After testing, 186 headache patients (migraine, tension type headache and cervicogenic headache) will be randomly allocated to one of two treatment groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire, Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy treatment. After six weeks of treatment subjects will complete the headache inventory list and the Headache Impact Test a second time. The perceived effect will be registered allowing the distinction between responders (positive effect) and non-responders (no effect or worse). Logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders. Secondly the additional value of the physio-/ manual therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking
* Willing to participate
* At least 18 years old
* Combination of headache and neck pain
* Headache since at least two months and at least twice a month
* A combination of migraine, tension type headache and cervicogenic headache

Exclusion Criteria:

* Clusterheadache
* Trigeminusneuralgia
* Peripheral neuropathy
* A history with neck surgery
* Comorbidity with chronic muskuloskeletal pain like fibromyalgia
* Radicular pain in the upper extremity
* Osteoarthritis
* Down Syndroom
* Physio/ manual therapy treatment in the last 12 months for this headache complaint.
* The use of prescribed medication (like NSAIDs and triptans) for this headache complaint during the last two months
* Pregnancy
* Red flags as described in the Dutch General Practitioners Headache Guideline
Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures

This study investigates how reliability of patient reported outcomes can be affected with questionnaire burden and and the number of questionnaires given to study participants.

The primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. We will assess the internal consistency of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) Health Survey questionnaire as more questionnaires are applied.

The secondary objective is to evaluate how the number of questionnaires and the time it takes to complete them impact patient's preferences and values. We will measure the time taken by each participant to complete the EQ-5D-5L questionnaire to evaluate if it changes meaningfully as the number of questionnaires given to participants' increases. Additionally, we will assess patient preferences and values by asking how well the remotely collected PROMs reflect their health status, and how this changes relative to the number of questionnaires administered.

Our hypothesis is that there is a progressive decline in psychometric properties in the EQ-5D-5L, both in reliability and validity, as we increase the number of questionnaires given to participants. We also hypothesize that the time to complete the ED-5D-5L will increase as the number of questionnaires given to participants' increases, and that there is a threshold at which the patient feels there are no additional value to completing additional remote PROMS to adequately reflect their health status.

Eligibility Criteria:
Inclusion Criteria:

1. The patient presents to the in-person or virtual fracture clinic for his/her own appointment.
2. The patient has a fracture that is being managed either operatively or non-operatively.
3. Fracture occurred in the past 6 months.
4. The patient is 18 years of age or older.
5. The patient is able to read, understand, and write in English.
6. Patient provides informed, verbal or written consent.

Exclusion Criteria:

1. The patient is considered too ill or injured to participate in the study.
2. The patient is cognitively impaired, intoxicated or otherwise unable to provide consent or participate in the study.
3. The patient is co-enrolled in another study requiring completion of multiple additional PROMs.