cyrilzakka/clinical-trials huggingface dataset:
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).

Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-17 years
* Confirmed deleterious FAP genotype based on central genetic testing or personal history ot \>2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of \> 2 adenomas and have a parent with FAP
* Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given

Exclusion Criteria:

* Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of \>2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.
* Sensitivity to COX-2 inhibitors
French National Observatory of Patients With Thymic Epithelial Tumor

RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.

RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a nationwide network for TET appointed in 2012 by the French National Cancer Institute. The objectives of the network are management of clinical tumor boards and central pathologic review of all cases. RYTHMIC Tumor Board is based on initial histopathological diagnosis.

RYTHMIC is a comprehensive tool for research:

* to improve the management of patients
* to monitor dedicated actions
* to screen patients for future translational and clinical trials

Eligibility Criteria:
Inclusion Criteria:

* patient with Thymic Epithelial Tumors

Exclusion Criteria:

* histology other than Thymic Epithelial Tumors
The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke

The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.

Intense skill practice with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplastic changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. In this study, using parallel group design methodology, we will test the effect of 2 practice parameter (i.e. spacing of practice and number of repetitions per task practiced per session) modifications on UE function following skill practice.

Forty subjects will complete multiple baseline testing and then be randomized, using random number table, to one of 4 groups: condensed functional task practice modeled after Constraint-Induced Movement Therapy (6 hours of practice/day, 5 days/week, 2 weeks), condensed functional task practice with a restricted number of tasks practiced, distributed, distributed functional task practice (Monday, Wednesday, Friday, 6 hours/session, 10 sessions), distributed functional task practice with a restricted number of tasks practiced. During therapy sessions, subjects will practice performing common activities with their paretic upper extremity. They will wear a mitt on their non-paretic upper extremity for up to 90% of their waking hours. Post-testing sessions will follow within one week of completing therapy with an additional follow-up testing session 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* hemiparesis due to unilateral stroke at least 3 months prior
* 18-90 years of age
* able to extend the paretic wrist 200 and at least 1 finger 100
* able to follow 2-step commands
* score \< 3 on the Motor Activity Log Amount of Use scale

Exclusion Criteria:

* have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy
* have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism

The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.


Eligibility Criteria:
Inclusion Criteria:

* Total testosterone level \<240 ng/dL
* Serum LH and FSH levels within normal limits

Exclusion Criteria:

* Elevated prolactin
* Evidence of Benign Prostatic Hypertrophy
* History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy
* Clinically significant endocrine/metabolic or cardiovascular disease
* Significant polycythemia
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease

This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.

The principal objective is to evaluate the changes in biomarkers of oxidative stress and,plasma amino acids, as well as improvement of clinical symptoms and brain function


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Idiopathic Parkinson's Disease
2. Subjects who are willing and able to participate in the trial and has provided written, informed consent.

Exclusion Criteria:

1. Subjects who are allergic to Whey protein (HMS 90®).
2. Subjects who are treated with chemotherapy .
3. Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
4. Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test
Renal Effects of Levosimendan in Cardiac Surgery Patients

Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

Exclusion Criteria:

* Patients younger 18
* Preexisting renal insufficiency
Depot Disulfiram for AIDS and ARC

To assess the safety and efficacy of depot disulfiram as a new treatment for AIDS and AIDS related complex.


Eligibility Criteria:
Inclusion Criteria

Patients must have a positive diagnosis of AIDS or AIDS related complex (ARC) according to the CDC criteria.

* Also patient must be:
* Able to understand the study.
* Strongly motivated to participate in the study, and willing to comply with all the conditions specified in the informed consent forms.
* Ambulatory and able to maintain an independent life outside the hospital.
* Free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

History of alcohol abuse.
Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16\~65 years.
* Serum HBsAg positive for over six months.
* Ultrasonographic evidences of cirrhosis

Exclusion Criteria:

* History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
* Prothrombin time is over 30s.
* Cirrhosis caused by other reasons except HBV infection.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Liver tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* Imaging evidences of vascular thromboses.
Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A

MyPKFiT is a web-based application recently developed by Baxalta for the use in patients treated with Advate. MyPkFit has its basis in Bayesian forecasting, which allows estimation of individual PK parameters by a sparse sampling schedule, where only 2-3 samples are taken between 4 and 48 hours post infusion. With myPKFiT, it will, therefore, be possible to define an individual PK curve for each patient based on just a few sampling points and hence, taking the bleeding phenotype and the life style into account, potentially adjust the prophylactic treatment accordingly to optimize cost-effectiveness.

As detailed in brief summary patients will, after accurate information verbally and written according to ethics approval, report bleeding events during previous 6 months. Blood samples are taken, FVIII analyzed (Advate patients) and the individual PK curve determined using MyPKFit. The curve will be discussed together with the patient and levels related to bleed events determined. If needed dose adjustment is done based on the curve. After a further 6 month follow-up bleeds will again be evaluated as well as factor consumption. In this way a better personalized treatment based on PK and clinical phenotype will hopefully be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults with severe hemophilia A (FVIII:C \<1 %), being treated with Advate for more than 50 exposure days (EDs

Exclusion Criteria:

* Current evidence of inhibitor as measured by the Nijmegen-modified Bethesda assay
* Use of another investigational FVIII product in the previous month
Magnesium As an Adjuvant Agent for Postoperative Pain

Participants are being asked to participate in this research study because they have elected to undergo periacetabular osteotomy (PAO). This research study is looking at if using IV magnesium during surgery can help to reduce pain after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy

Exclusion Criteria:

* illiterate or non-English speaking patients
* patients with 2nd or 3rd degree AV block
* patients with severe renal insufficiency
* patients with heart failure
* patients with bradycardia
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder

An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 to 65 years of age, inclusive
* meet criteria for chronic (diagnosis established \> 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score \> 60
* current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
* Agree to be fully hospitalized until at least Day 14 of the study
* Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH \> 40 mU/mL.

Exclusion Criteria:

* Pregnant or lactating women
* administration of clozapine within 60 days prior to Baseline
* DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
* Severity of psychosis rated severe or higher (CGI-S 6 or 7)
* Known suicidal risk (modified ISST score\>7)
* Requiring disallowed concomitant psychotropic medication following enrolment into the study
* Current evidence of clinically significant or unstable illness
* Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH\>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).
Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis

The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:

Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.

Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.

All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.

All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (\>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD \>4mm at ≥2 teeth.

Exclusion Criteria:

* Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Have type 2 diabetes;
2. Body mass index (BMI) of ≤ 45.0 kg/m2;
3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding;
2. Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

Erector Spina Plane (ESP) block has been widely used in recent years, and it is also used in the control of postoperative analgesia in many types of surgery due to its proximity to the central area and its wide spread feature. In this study, the investigators aimed to demonstrate the effectiveness of ESP block on postoperative pain management in anterior cervical disc and fusion surgeries.

This study includes ASA I-II patients aged 18-65 years who will undergo Anterior Cervical Disc and Fusion Surgery at C5 or C6 level under general anesthesia under elective conditions. In the preoperative period, the participant groups will be divided into two separate groups, Group cESP and Group sCPB, according to the type of block applied.

Groups will be compared according to demographic data, duration of surgery, perioperative drug consumption, postoperative pain scores, additional analgesic requirement and presence of shoulder pain. The blocks will be applied with the help of an 8-12 mHz linear probe after the patients are determined by the closed envelope method. In group cESP, block will be applied using in-plane technique at the level of C6 or C7 transverse vertebral corpus in the fascia between the semispinalis capitis muscle and the posterior scalene muscle. During the block, a total of 20 mL volume of 0.25% bupivacaine concentration will be given bilaterally to all patients. Group sCPB will be administered using 10 mL of 0.25% bupivacaine by entering from the C4 level from the right side of the neck from the posterior side of the sternocleidomastoid muscle. It was planned to routinely administer 10 mg/kg paracetamol and 2x10 mg tenoxicam iv to all patients for postoperative pain control. Patients will be taken to the recovery unit in the postoperative period, where their analgesic needs, frequency of nausea-vomiting, VAS scores, and additional problems will be followed up by the nurse who was included in the study blindly. After 1 hour of follow-up in the Recovery Unit, the participants will be directed to the service. The participants' VAS scores and additional analgesic needs will be recorded at 6, 12, and 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) Classification I-II
* Anterior Cervical Disc and Fusion Surgery

Exclusion Criteria:

* Patients with bleeding diathesis
* Neurological disease,
* BMI (Body Mass Index) less than 19 or greater than 30
* The presence of infection in the neck area
* Patients who do not accept the procedure
Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.

Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups of low back pain patients with psychosocial risk factors.

The purpose of the study is to investigate whether patients referred to secondary care with low back pain and coexisting psychosocial risk factors will have a better treatment outcome when participating in a pain management course in addition to usual care.

This will be investigated in a randomised study design, where 130 patients with chronic low back pain and psychosocial risk factors will be randomly allocated to either usual care or a cognitive-therapy based pain management intervention in addition to usual care.

The patients will be followed for one year after inclusion, and patientreported outcomes on disability, pain, sick leave, quality of life and pain coping will be collected by the use of questionnaires at baseline, 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Non-specifick low back pain lasting ≥ 3 months
* Psychosocial risk profile defined as a fear avoidance score \>24 (Örebro Musculoskeletal Pain Questionnaire) and/or a bodily distress score \>15 (Common Mental Disorder Questionnaire) and/or health anxiety score \>9 (Common Mental Disorder Questionnaire)
* Speaks and understands Danish
* Age ≥ 18 years

Exclusion Criteria:

* Inflammatory or malignant disease
* Spine surgery within the last year
* Untreated or severe depression
* Psychiatric course of treatment within the last year
* Abuse of drugs or alcohol
* Pregnancy
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic treatment requires banding of posterior teeth
* Orthodontic treatment requires the placement of two or more separators
* Able to swallow analgesic pills
* English speaking
* Age 9-17
* Minimum weight requirement of 88 pounds

Exclusion Criteria:

* Orthodontic appliances are present in the mouth
* Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
* Antibiotics or analgesics are currently in use
* History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
* Significant cognitive impairment
Better Weight-Better Sleep (BWBS) Trial

The hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only.

Objective: To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive behavioral intervention, or to a combination of the BW intervention and a better sleep intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results merit replication in a larger primary care-based trial with a longer continuous intervention and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 to 39.9
* ages 18 to 84
* PCP permission
* patient in Family Medicine Center with an encounter in the last six months

Exclusion Criteria:

* various obesity and sleep related disorders