cyrilzakka/clinical-trials huggingface dataset:
Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Patients with head and neck cancer who underwent irradiation have a higher risk of developing severe carotid stenosis, and eventually develop to transient ischemic attack or stroke. However, it's still not clear whether early intervene in vascular risk factors is benefit for patients after radiotherapy.

Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo group.

It is a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled from six centers in Guangdong Province and randomized 1:1 to atorvastatin group (20mg per night, totally 2 years) or placebo group. All Patients will be followed up for 2 years. Ultrasound and Transcranial Color Doppler (TCD) will be used to evaluate the changes of intima-media thickness (IMT) and occurrence of plaque formation of carotid arteries. Safety will be monitored every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma.
* Prior irradiation \<3 years prior to study entry.
* Male or fertile women who are willing to take contraception during the trial.
* Age 40-65 years old.
* Carotid stenosis \< 50%.
* LDL-C between 100mg/dL（2.5mmol/L）and 190mg/dL（4.9mmol/L）.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of bleeding related to tumor or radiotherapy during or after radiation.
* Evidence of tumor invasion to major vessels(for example the carotid artery).
* Severe complications, such as history of stroke, myocardial infarction, liver diseases, thyroid dysfunction, inadequately controlled hypertension and epilepsy.
* Familial hypercholesterolemia.
* Taking lipid-lowing drugs.
* Aspartate aminotransferase(AST) or alanine aminotransferase(ALT) \>upper limits of normal (ULN), creatinine \>ULN.
* Allergic history of atorvastatin.
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion

The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.

Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.

This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.

Eligibility Criteria:
Inclusion Criteria:

1. via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
2. age:18-70years
3. better liver function (Child-Pugh，class A or B)

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance;
5. serious heart、lung、kidney disease
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

The purpose of this study is

1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment

   and
2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
* Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian

Exclusion Criteria:

* Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy

The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

ctDNA in diffuse large B cell lymphoma (DLBCL) has become an essential dynamic biomarker. Due to its short half-life, ctDNA is a real-time reflection of tumoral evolution and is a non-invasive biomarker that can be used for patient evaluation and follow-up. The quantity of ctDNA before treatment is correlated with tumoral mass, international prognostic index (IPI) and prognosis. The principal mechanism of ctDNA release is tumor cell apoptosis and it is well established that tumor cell apoptosis is observed in the hours following immuno-chemotherapy. However, the kinetics of ctDNA concentration in the hours following immuno-chemotherapy administration is unknown.

Modelizing the kinetics of ctDNA during this early timeframe could help to better predict chemo-sensitivity and better reflect genetic heterogeneity of the tumor, through release of a larger quantity of ctDNA compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diffuse Large B Cell Lymphoma
* TEP-TDM at diagnosis
* Inform Consent form signed
* Performance status 0 or 1
* Hospitalized on clinician decision for first cycle of R-CHOP or R-miniCHOP

Exclusion Criteria:

* Histology other than Diffuse Large B Cell
* Patient under guardianship or curatorship
* Incapacity to understand the study or conform to the constraints of the study (language barrier, psychological barrier, geographic barrier...)
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 60 years of age
2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.
3. life expectancy of at least 3 months.
4. ECOGPS ≤ 1
5. Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 upper limit of normal \[ULN\],AST ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.

Exclusion Criteria:

1. Pregnant and latent women, no contraception for women of childbearing age
2. Have taken other treatments
3. Be allergic to endostatin and other ingredient
4. Gastrointestinal Hemorrhage
5. Have Participated any clinical trail during the last 4 week
6. ECG: QTC ≥ 480 ms
7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
8. Cardiovascular and mental disease
9. HIV-1 infected
10. HBV, HBV infected ,Hepatitis B surface antigen positive
11. Patients on therapeutic doses of heparin or antiplatelet agents.
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males aged 20 to 64 years at screening.
2. Non-smokers
3. In case of hepatic impaired patients
4. In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
5. Subjects within ±20% of the ideal body weight
6. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

1.History of portosystemic shunt surgery.
Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR

The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

A prospective randomized single-blind clinical trial will be conducted at the Hôpital du Sacré-Coeur de Montréal and Hôpital Jean-Talon. All patients admitted for total knee arthroplasty (TKA) between January 2012 and September 2013 Outcome variable: Patient receiving Floseal or SOC

Variables under study:

Primary end point:

Need of transfusion post-op (yes/no, how many)

Patient will be transfused if :

Hg \< 80 g/L plus if patient is symptomatic: orthostatic hypotension, tachycardia (pulse\> 100/min, hypotension (\< 90/60), hx : CVA, CAD)

Secondary end point:

1. Efficacy (during hospital stay)

   * Pre-op and post-op Hg (\> 100; 80-100; \<80)
   * Hemovac blood drainage (ml)
   * Per operative bleeding (ml)
2. Safety (Follow up: 6wks, 6 ms, 12 ms, 24 ms)

   * Post-op complications: infection, pain, oedema, allergic reaction.
   * Functional outcomes: Knee Society Score (KSS), Western Ontario and McMaster Universities questionnaire (WOMAC), International knee documentation committee form (IKDC)

Eligibility Criteria:
Inclusion Criteria:

* All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.

  * TKA done without the use of a tourniquet except while cementing only (±10 minutes)
  * TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants

Exclusion Criteria:

* • Prior osteotomy or knee surgery within last 6-8 wks

  * Active, local infection or systemic infection
  * Participation in any other pharmaceutical or clinical investigation
  * Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets \< 50 x 109 per litre)
  * Patients with known allergies to materials of bovine origin
Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma

Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe asthma partly controlled with ICS or ICS/LABA
* FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

Exclusion Criteria:

* Diagnosis of COPD
* History or current evidence of significant cardiovascular disease
* Uncontrolled concomitant disease
The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients with Biochemical Failure Status Post Salvage or Radical Radiation Therapy

The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.

The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Eligibility Criteria:
Inclusion Criteria:

* T3a +
* PSA \> 20
* Gleason 8 or higher
* Karnofsky performance status ≥ 70.
* Signed study-specific informed consent

Exclusion Criteria:

-
Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study

This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition

Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.

In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.

Inclusion criteria:

* age between 55 years and 80 years
* unilateral internal carotid artery stenotic degree ≥ 70%
* right-hand-dominant
* free of dementia, and depression
* modified Rankin Scale: 0 or 1
* education ≥6 years
* obtained written informed consent.

Exclusion criteria:

* contralateral internal carotid artery stenosis ≥ 50%
* posterior circulation diseases
* MMSE \< 26, which is a cut-off value for mild cognitive impairment
* severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure)
* any contraindications for MRI scan (e.g., metal implants)
* Non atherosclerotic stenosis, such as dissection, vasculitis.

Eligibility Criteria:
Inclusion Criteria:

* age between 55 years and 80 years
* unilateral internal carotid artery stenotic degree ≥ 70%
* right-hand-dominant
* free of stroke, TIA, dementia, and depression
* modified Rankin Scale: 0 or 1
* education ≥6 years
* obtained written informed consent.

Exclusion Criteria:

* contralateral internal carotid artery stenosis ≥ 50%
* posterior circulation diseases
* MMSE \< 26, which is a cut-off value for mild cognitive impairment
* severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
* any contraindications for MRI scan (e.g., metal implants)
Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder

The purpose of this study is to develop and test the effectiveness of Cognitive-Behavioral Therapy (CBT) for children and adolescents suffering from Body Dysmorphic Disorder.

The main purpose of this trial is to develop and investigate the effects of a CBT protocol for children and adolescents with BDD. It is important to investigate CBT in this population given the disorder's early onset and poor trajectory if left untreated.

In the first phase of this trial, we will develop the treatment manual, adapting the adult manual for use in a pediatric population. In the second phase of this trial we will test the effectiveness of the CBT treatment in 12 pediatric BDD patients. We intend to treat 12 children and adolescents with BDD. All patients will receive CBT. We will also examine treatment feasibility and acceptability (e.g., retention and reasons for treatment refusal and dropout, expectancy, and motivation), and we will explore predictors of outcome. Therapeutic progress will be broadly assessed with measures of beliefs, behaviors, mood, functioning, and quality of life before, during, and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM-IV BDD or its delusional variant, which must be present currently and for at least 6 months prior to study entry
* Total score of at least 24 on the 12-item BDD-YBOCS, adolescent version, which includes a score of at least 2 on item 1 (1-3 hours/day of preoccupation with the perceived defect)
* Score of at least moderate on the Clinical Global Impressions of Severity (CGI-Severity)
* Score of \< 60 on the Child Global Assessment Scale (C-GAS)
* Ability to communicate meaningfully with the investigators and competent to provide written assent; both parental informed consent and adolescent assent must be obtained

Exclusion Criteria:

* Alcohol or substance abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, body image concerns accounted for primarily by an eating disorder or weight concerns. If subjects have another comorbid diagnosis, the BDD has to be the primary concern.
* Recent (within the past 6 months) suicide attempt, or suicidal ideation as indicated by a K-SADS score of 4 or higher that is active or warrants consideration of hospitalization
* Need for inpatient or partial hospital treatment
* Current psychotherapy and failure to benefit from ten or more sessions of previous CBT treatment
* Participants can be receiving psychotropic medication, but they must be on a stable dose for 2 months prior to the study baseline assessment and maintain this dosage throughout the course of the study
Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test

Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of "sedation" based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing


Eligibility Criteria:
Inclusion Criteria:

18 years of age or older

scheduled for Wada testing at MUSC

Exclusion Criteria:

No exclusions
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder

The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-17 years
* Caregiver able to participate in treatment
* One day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment)
* endorsement of one or more DSM-IV symptoms of Substance Use or Alcohol Dependence/Abuse
* meet ASAM criteria for outpatient substance use treatment
* meet DSM-IV criteria for ADHD (with or without onset prior to age 7)
* not enrolled in any behavioral treatment

Exclusion Criteria:

* MDD
* Bipolar Disorder
* Mental Retardation
* PDD
* medical or psychiatric illness requiring hospitalization
* current psychotic features
* currently suicidal
Safety and Efficacy of WIN-901X in Asthma

This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 20 and less than 80 years of age
* Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
* FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
* No history of smoking at least one year prior to the screening
* Having voluntarily signed an informed consent

Exclusion Criteria:

* Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
* Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
* Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
* Have malignant tumor