cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.


Eligibility Criteria:
Inclusion Criteria:

- 1.18 ≤ age ≤45, healthy male; 2.Subjects with body weight ≥ 50 kg, and 19≤BMI ≤26 kg/m2 ； 3.Subjects must agree to take effective contraceptive methods from signing informed consent to 6 months after the last administration.

Exclusion Criteria:

1. Subjects with known history or suspected of being allergic to the study drugs；
2. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
3. Subjects with eGFR less than 90 mL/min/1.73m2；
4. Subjects with systolic blood pressure less than 90 mmHg or more than 140 mmHg, and/or diastolic blood pressure less than 60 mmHg or more than 90 mmHg;
5. Subjects whoes12-Lead ECG QTcF was more than 450 ms or there were other abnormalities determined by the investigator；
6. Subjects with clinically significant abnormalities in coagulation function；
7. Subjects with infectious disease；
8. Subjects with positive of urine drug screen；
9. Subjects with acute illness occurred within 4 weeks prior to the screening period;
10. Subjects who required antimicrobial therapy within 4 weeks prior to the screening period;
11. Subjects with medical history of systemic inflammatory disease, autoimmune disease, recurrent herpes zoster, disseminated herpes zoster, disseminated herpes simplex;
12. Subjects with a history of tuberculosis (TB) within six months prior to the screening period;
13. Subjects with a history of hypoglycemic episodes or fasting blood glucose less than 2.8 mmol/L during screening；
14. Subjects who took inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 within 28 days before the study;
15. Subjects with contraindications for midazolam, warfarin, omeprazole, and repaglinide.
Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol

The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are:

Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression?

Participants will complete:

* an in-depth diagnostic screening interview prior to enrollment
* a set of mental health questionnaires at baseline and two weeks post-intervention
* a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Able to provide informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Speak and understand English
* Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
* Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)

Exclusion Criteria:

* Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
* Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
* Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
* Participants able to birth must not be pregnant or breastfeeding.
* Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
* Participants may not have undergone prior brain surgery
* Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
* Participants may not have had brain injury or concussion within the last three months
* Participants may not have a history of brain injury requiring current treatment
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

The purpose of the study is to determine how cognitive control training (CCT) changes behavior in youth with subclinical depressive symptoms. This research will show what types of behavior changes are important for CCT to help reduce depressive symptoms. In the future, we will use this information to try to improve how we prevent the development of depression, so that it can help more patients.

The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.

Eligibility Criteria:
Inclusion criteria:

1. Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
2. Males and females (age 9 - 17.99)
3. Participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of Michigan, if not already accessible to participant).
4. Self-reported depressive symptoms
5. Participants will be required to maintain a stable dose of medications

EXCLUSION CRITERIA

1. Color blindness
2. Unable to play the video game for any reason
3. Current K-SADS diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
4. Has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment
5. Endorses items #1, #2, #3, #4, #5. #6 on the C-SSRS Screener (Past-Month); i.e., has present suicidal intention/behavior.
6. Has had any changes to their medication in the 4-weeks prior to study enrollment
Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).


Eligibility Criteria:
Inclusion Criteria:

* impaired fasting glucose or impaired glucose tolerance
* angiographic evidence of coronary artery disease

Exclusion Criteria:

* diabetes mellitus type I or II
* preexisting antidiabetic medication
* unstable angina
* indication for coronary bypass surgery
* significant left main disease
* myocardial infarction within preceding 3 months
* ejection fraction \< 40%
* significant heart valve disease
* severe metabolic disorders
* severe disorders in lipoprotein metabolism
* thyroid disorders
* alcohol or drug abuse
* pregnancy
* participation in another trial
Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

This randomized pilot clinical trial studies how well propranolol hydrochloride works in treating patients with prostate cancer who are undergoing surgery. When stressed, the body makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may affect the signals in cells that cause tumor cells survival and death.

PRIMARY OBJECTIVES:

I. To compare activation of ADRB2/PKA/BAD signaling pathway in the prostate glands of men two hours after taking or not taking propranolol hydrochloride (propranolol) prior to prostatectomy, as indicated by phosphorylated CREB.

SECONDARY OBJECTIVES:

I. To compare activation of ADRB2/PKA/BAD signaling pathway in the prostate glands of men two hours after taking or not taking propranolol prior to prostatectomy as indicated by phosphorylated BAD.

II. To determine the difference in candidate transcript levels associated with ADRB2/PKA activation between individuals two hours after taking propranolol or not taking propranolol prior to prostatectomy.

III. To determine plasma propranolol levels in individuals taking propranolol two hours after administration prior to prostatectomy.

IV. To determine if plasma catecholamine levels in men with prostate cancer can be used as a biomarker to identify patients who show activation of ADRB2 signaling pathway in prostate tumors.

V. To determine perceived stress level differences in men with prostate cancer prior to surgery to examine possible association between perceived stress level and catecholamine levels in blood and activation of ADRB2 pathway in tumors.

VI. To determine perceived distress level differences in men with prostate cancer prior to surgery to examine possible association between distress level and catecholamine levels in blood and activation of ADRB2 pathway tumors.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive propranolol hydrochloride orally (PO) 2 hours prior to standard of care prostatectomy.

GROUP II: Patients receive no treatment prior to standard of care prostatectomy.

After completion of study treatment, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer undergoing prostatectomy
* Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Men taking propranolol on a daily for any reason are excluded
* Men with baseline systolic blood pressure (SBP) \< 110 or heart rate (HR) \< 60
* Men unable to swallow pills
* History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators
Neuroimaging Studies of Reward Processing in Depression

This study investigates stress-related signaling of glutamate and dopamine within the reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to predict depressive symptoms in the future. This will be achieved through various neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.

The overarching goals of this research are to investigate: (1) stress-induced glutamatergic abnormalities and their relation to disruption within the corticostriatal valuation circuit in MDD; (2) stress-induced DA signaling disruptions in MDD; and (3) the predictive validity of these two pathophysiological mechanisms. This will be achieved through an innovative integration of (1) proton magnetic resonance spectroscopy (MRS)-based assessments of glutamatergic metabolites in the mPFC; (2) functional magnetic resonance imaging (fMRI) probes of the corticostriatal valuation circuit with well-established stress manipulations (MAST) and assessments (cortisol and inflammatory markers); (3) positron emission tomography (PET)-based measurement of striatal DA release with well-established stress manipulations and assessments (cortisol and inflammatory markers); and (4) a naturalistic follow-up design.

Eligibility Criteria:
General Inclusion Criteria:

* All genders, races, and ethnic origins, aged between 18 and 45
* Capable of providing written informed consent, and fluent in English
* Right-handed
* Absence of any psychotropic medications for at least 2 weeks

Inclusion Criteria for Current Depression Group (MDD):

* Current DSM-5 diagnostic criteria for MDD (as diagnosed with the use of the SCID)

Inclusion Criteria for Remitted Depression Group (rMDD):

* History of at least one major depressive episode within the past five years
* Not currently depressed

Inclusion Criteria for Healthy Control Group (HC):

* Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse)

Exclusion Criteria:

* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
* Pregnant women
* Failure to meet standard MRI or PET safety requirements
* Serious or unstable medical illness
* History of seizure disorder
* History or current diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, OCD, PTSD, mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion)
* Simple phobia, social anxiety disorder, and generalized anxiety disorder will be allowed only if secondary to MDD and only in the MDD group
* History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
* History of use of dopaminergic drugs (including methylphenidate)
* Patients with a lifetime history of electroconvulsive therapy (ECT)
Comparison of Dental Pain Response in Children

Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.
* Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.
* Consent: Informed consent must be obtained from the child and their parents or guardians before the study.

Exclusion Criteria:

* Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.
* Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.
Percutaneous Pinning vs Orthosis and Early Mobilization

This study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. This will be achieved through a randomised clinical trial comparing the two methods.

Proximal phalangeal fractures of the hand are very common and affect patients of all ages. . Most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. If there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. Surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. Good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. This study will compare these two methods for treating fractures of the base phalanx of the fingers. Recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. Primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. Secondary outcomes are number of sick days and various patient related outcome measures.

Eligibility Criteria:
Inclusion Criteria:

-Fractures of the base phalanx of digit 2-5 in the hand.

Exclusion Criteria:

* Fracture older than 2 weeks.
* More than 25° of sagittal plane and/or 10° lateral angulation after reposition.
* Intra-articular step \>1mm.
* Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger.
* Open fractures.
* Patient age \<18 years.
* Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
OP-1 Putty for Posterolateral Fusions

The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.

A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.

Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
* Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
* Age 18 years or greater
* ECOG Performance Status 0 or 1
* Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.

Exclusion Criteria:

* Uncontrolled brain metastatic disease
* Platelet count \<100
* Absolute neutrophil count \<1.5
* Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
* Calculated or measured (Cockcroft and Gault formula) creatinine clearance \<30 mL/minute
* AST \> 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST \> 5 times the upper limit of normal
* Bilirubin \> 2 mg/mL
* Grade 2 or greater peripheral neuropathy
* Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
* Pregnant or nursing
* Other investigational drugs within 14 days of enrollment
* Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study
The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)
* At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan
* Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease
* Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria:

* NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171
* HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171
* Untreatable, unstable brain or meningeal metastases.
* Abnormal liver and kidney blood chemistries
* History of poorly controlled hypertension with resting blood pressure of \>150/100
* Recent (\< 14 days) major surgery or a surgical incision not fully healed
* Diabetes patients with type I insulin dependent diabetes or poorly controlled type II
* Significant hemorrhage or hemoptysis
* Presence of necrotic/hemorrhagic tumor or metastases
Collection of Human Metabolic Tissues

This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity.

The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including:

* Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)
* Identification of metabolic signatures, protein and miRNA in plasma
* Immunoinflammatory response in adipose tissue
* Polymorphisms SNP from whole blood
* Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age 18 - 65 years inclusive at surgery
3. IMC \> 35
4. Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
5. Specific criteria :

   * Type 2 diabetes group (D) (90 patients) : type 2 diabetes according to ADA criteria
   * Insulin resistance non diabetes group (IR) (80 patients) : HOMA-IR criteria ≥ 3
   * Insulin Sensitivity non diabetes group (N) (100 patients) : N1.HOMA-IR criteria \< 3

Non inclusion Criteria:

1. Vulnerability according to article L1121-6 of the Public Health Code
2. Protected adult or unability to give consent according to article L1121-8 of the Public Health Code
3. Unability to understand the design and aims of the study or to communicate with the investigator
4. Non affiliation to a social security system
5. Prior bariatric surgery (except lap-band procedure)
6. Serologic profile indicating hepatitis B, hepatitis C or HIV infection
7. Inflammatory, infectious or autoimmune disease (current or in the previous 3 month)
8. Malignancies within 5 years prior to inclusion or not considered as treated curatively
9. Concomitant use of steroids or NSAI or use in the 8 days before surgery
10. alcohol abuse/addiction
11. Anticipated poor compliance to study procedures
12. Other type of diabetes than type 2

Exclusion Criteria :

1. Cancelled bariatric surgery
2. Tissue collection not possible during the bariatric surgery