cyrilzakka/clinical-trials huggingface dataset:
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age at screening
* Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
* Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
* Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

* Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
* Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
* Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.

* Written informed consent 130 patients with type 1 diabetes to be included
* age 18-70
* HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be \<1,5%
* Treated with multiple insulin injections or insulin pumps
* Variation in weight less than 5kg within last year
* Using SMBG on a daily basis
* Mental capacity and stability to participate
* No hypoglycemia unawareness
* No likelihood that patient will drop out or not perform according to protocol
* Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
* 9 months follow-up
* Possible 12 month extension after initial
* Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.

Eligibility Criteria:
Inclusion Criteria:

* Hba1c 8% or higher, less than 1,5% variation within last year
* Age 18-70
* Multiinjections or insulin pumps
* Stable weight (\<5kg variation last year)
* Mentally stable

Exclusion Criteria:

* Hypoglycemia unawareness
* Mental incapacity
Building Employment Skills Through Therapy for Veterans

Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.

The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
* Severe/extreme functional disability \[World Health Organization Disability Assessment Scale (WHODAS) score \> 50\]
* Clinical stability (as per primary mental health provider)
* Receiving treatment at the Veterans Administration
* Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)
* Eligible for and willing to be enrolled in Supported Employment program
* Age 18 to 65
* Proficient in English
* Able to give informed consent

Exclusion Criteria:

* Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
* Current opioid or stimulant dependence (SCID)
* Not appropriate due to safety concerns (based on risk assessment)
NON-COlorectal Liver METastases Undergoing Liver Resection

Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.


Eligibility Criteria:
Inclusion criteria:

* Signature informed consent
* Age ≥ 18 years
* Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
* Liver resection performed.

Exclusion criteria

* ASA IV
* Severe psychiatric pathology
* Unable to follow a clinical examination pattern during observation.
* Patient submitted exclusively to interventional locoregional procedures other than liver resection.
Presence of Nanoparticles in the Amniotic Fluid

The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated.

Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans.

The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.

The analysis will be done on 100 amniotic fluid samples and 100 blood samples. Particle size analysis will be performed by a technique of dynamic light scattering, which permits the distribution by volume or by number of NP according to their size. Parallel to the different chemical species present in the sample must be measured by atomic emission spectrometry with inductively coupled plasma.

The results of this study will be useful for further studies on the fetal toxicity of NP in humans.

Eligibility Criteria:
Inclusion Criteria:

* Patient major
* Patient to receive an amniocentesis for medical reasons other than study (serum marker of the first quarter with an increased risk of trisomy 21 greater than 1/250, amniodrainage, sonographic sign of call)
* Patient who have given their free, informed and signed

Exclusion Criteria:

* Inability to make withdrawals
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder

The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor

Exclusion Criteria:

* Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.
Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression

Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for Major Depressive Disorder (MDD), Recurrent
* Montgomery-Asberg Depression Rating Scale (MADRS) score \> 18

Exclusion Criteria:

* Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
* Any history of substance dependence
* Substance abuse within the past 6 months
* Significant risk of suicide, as defined by score \>4 on item 10 of the MADRS or in the clinical judgment of the study physician
* Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
* For the subset of unmedicated MDD patients, any psychotropic medications within 4 weeks prior to scanning. For the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication.
* Inability to give informed consent
* Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body)
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies

The investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

Lactate level is one of the easy-to-measure parameters that are frequently used in anesthesia and intensive care clinical practice, especially to evaluate the severity of disease and the response to treatment. In patients with high lactate levels, the first considerations are hypoperfusion and sepsis. However, many causes such as trauma, seizures, ischemia, diabetic ketoacidosis, thiamine deficiency, malignancies, liver dysfunction, genetic disorders, toxins, drugs, etc. can be associated with increased lactate. Many tissues in the body can produce lactate. 25% of production is from muscle, 25% skin, 20% brain, 20% RBC and 10% bowel cells. Some malignancies, especially hematological cancers, have also been associated with increased lactate. In recent years, it has been reported that serum lactate levels are associated with the degree of glial tumor malignancy, and that lactate can even be used as a non-invasive malignancy biomarker in brain tumors. In a recent study, it was reported that the type of 'glioblastoma multiforme' among patients who underwent craniotomy with the diagnosis of intracranial brain tumor was an independent influencer factor for preoperative and postoperative hyperlactatemia. Anesthesia is one of the factors that can affect lactate levels due to its effect on systemic perfusion and the hepatic effects of anesthetic drugs. It looks like that there is no study in the literature on the effect of anesthesia technique on hyperlactatemia in patients who underwent craniotomy. Therefore the investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective craniotomy for an intracranial mass
* adult patients

Exclusion Criteria:

* emergency
* In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)
Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks

The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for Post-thoracotomy Pain Syndrome(PTPS).

Thoracic surgical procedures are among the most painful operations, and their outcomes are affected adversely by postoperative discomfort. Post-thoracotomy pain syndrome (PTPS) is a well-recognized complication of thoracotomy. Post-thoracotomy pain control improves patient satisfaction and decreases postoperative complication morbidity. Epidural analgesia used to be considered as the best method of pain relief after major surgery despite its side-effects, which includes hypotension, respiratory depression, incomplete or failed block, etc. Recently, paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile for post-thoracotomy pain. Dexmedetomidine(DEX) is a Food and Drug Administration-approved, parenteral, selective α2-agonist that induces anxiolytic and analgesia without respiratory depression. It could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects . Current studies with regard to the effectiveness of DEX as an adjunctive medicine, used in ultrasound-guided continuous thoracic paravertebral blocks for PTPS. The mechanical withdrawal threshold and VAS scores are recorded. The consumption of opioid and general anesthetics during perioperative period are also recorded. To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation among the groups.Also,to measure and compare the level of inflammatory factor in different group.A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ～Ⅲ patient undergoing thoracotomy;
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18～25kg/m2

Exclusion Criteria:

1. Mental illness;
2. Epidural anesthesia or thoracic paravertebral blocks contraindicated;
3. People who have Slow-type arrhythmias or hypotension;
4. People who have lung infection or sleep apnea syndrome;
5. People who have chronic renal failure;
6. Alcohol or drug abuse;
7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
8. Local anesthetics allergy;
Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue

After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.

After a BI , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by blue enriched withe bright light in order to improve fatigue and quality of life.

The main objective is to decrease fatigue and the secondary objectives are to improve quality of life,decrease daytime sleepiness and increase vigilance.

This is a randomized clinical trial with 2 groups blue enriched withe bright light versus nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl estimate the fatigue severity scale score , the quality of life the score (SF12), the sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will included patient with severe BI more than six months after the BI.

Eligibility Criteria:
Inclusion Criteria:

* Severe brain injury patients more than 6 months after the trauma
* Out of the phase of post-traumatic amnesia (score in Galveston Orientation and Amnesia Test (GOAT) upper to 75)
* Initial score on the Glasgow coma scale inferior or equal to 8 within the first 24 hours after brain injury, except sedation
* Age from 18 to 65 years old
* Fatigue severity score ( FSS) superior or equal to 4 and/or a score on the sleepiness Epworth scale superior or equal to 10 and/or a score to the quality questionnaire of sleep of Pittsburg \> in 5
* Having given a writing informed consent
* Registered on the Social Security

Exclusion Criteria:

* Non-stabilized psychiatric neurological affection and/or endocrine diseases or drug addiction
* Major depression diagnosed with the "MINI" depression scale
* Cognitive, behavioural or motor disorders incompatible with use of phototherapy glasses
* Night workers or transméridien journey in the last month
* Chronic fatigue syndrome before the accident
* Deafness
* Major obesity (BMI \> 33)
* High risk of apnea syndrome in the Berlin questionnaire
* Consumption of long half-l hypnotics or stimulants
* Treatments with antidepressants are tolerated if the dose is stable during all the participation on approval and for at least one month before the inclusion.
* Eye lesion, in particular of the retina
* Photosensibility
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct)

Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.

The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.

Other objectives of the study include:

* Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)
* Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)
* Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic
* Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy
* Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy
* Stage IIIC or initial pleural IV
* Planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy
* Having been informed and signed the informed consent of this study
* Affiliated with a social security scheme

Exclusion Criteria:

* Stage IV with visceral metastases (pulmonary, hepatic ...)
* Contraindication to surgery and / or chemotherapy
* Pregnant or lactating woman
* Patient under guardianship or curatorship