cyrilzakka/clinical-trials huggingface dataset:
Chicago Urban Resiliency Building (CURB)

The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. It is hypothesized that compared to teens in the wait-list control condition, teens in the CURB program will exhibit lower levels of depressed mood and/or more rapid changes in mood during the follow-up time.

Additional aims and hypotheses are provided here:

Aim 2: To determine whether or not participants in the CURB primary care/Internet based depression prevention intervention will have a significantly lower cumulative incidence of any depressive episode at 3 months compared to adolescents in the usual care wait-list group.

Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program will have a lower incidence of depressive episodes at 6 month follow-up.

Aim 3: To determine whether CURB is sustainable in primary care from the perspective of health care professionals and primary care physicians in urban primary care settings.

Hypothesis 3: We hypothesize that providers will rate the intervention (by component) feasibility, acceptability, willingness to perform intervention and sustainability \> 7 on a 1-10 scale (1, not feasible, 10 very feasible).

Eligibility Criteria:
Inclusion Criteria:

Adolescents:

* Male and female African American and Latino/a youth ages 13 -17 years old.
* Adolescents with depressed mood (\> 2 weeks duration) will be eligible unless they have already exceeded the diagnostic threshold for major depressive disorder or have a comorbid condition as defined in the exclusion criteria.

Parents:

* Parent of eligible adolescents

Primary Care Physicians (PCPs):

* Physician at one of the four Mile Square Health Centers.

Health Care Professionals:

* Employee at one of the four Mile Square Health Centers.

Exclusion Criteria:

* Adolescents undergoing active treatment for depression \[Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode\]
* Adolescents meeting probable diagnostic criteria for the following: Major depression, Substance and alcohol abuse, Panic attacks, Generalized anxiety disorder, Eating disorders, History of treatment for bi-polar disorder or schizophrenia or who are at elevated risk for suicide (often have suicidal thoughts or recent intent)
Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
* \>6 months post-injury
* International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
* Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow flexion
* Physically and mentally willing and able to comply with study protocol
* Lives in the immediate area and has no plans to relocate
* Provides informed consent and HIPAA release of medical information

Exclusion Criteria:

* Active infection
* Any return or ongoing clinical recovery of distal motor function within 6 months after injury
* Physically/mentally compromised
* Systemic disease that would affect the patient's welfare or the research study
* Immunologically suppressed or immunocompromised
* Currently undergoing long-term steroid therapy
* Active malignancy
* Pending litigation or receiving Workers Compensation related to injury or accident
* Pregnancy
* Significant contractures and/or limitations in passive range of motion in the arm or hand
* Poorly controlled upper extremity spasticity
* Uncontrolled pain or hypersensitivity
* Previous or current injury preventing use of tendon transfers to restore upper extremity function
* History of brachial plexus injury or systemic neuropathic process
* In the opinion of the Principal Investigator the subject would not be a candidate for the procedure
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?

This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD.

Aims and/or research question of the project

1. To determine the incidence of primary immunodeficiency in children \>2 years who present with IPD
2. To determine the types of immunodeficiency associated with IPD in children


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0 to 18 years admitted to one of the six centres with IPD.

Exclusion Criteria:

* Children who do not fulfil the age criteria for immunological evaluation at that particular site e.g. aged \<2 years at Royal Children's Hospital.
* Children with a known underlying condition predisposing to IPD i.e. nephrotic syndrome.
The Effect of Chlorella on Glycemic Control of Diabetes

Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia, especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella through increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic patients have not been studied. In order to clarify the hypoglycemic effects and mechanism of Chlorella in diabetic patients, the investigators conducted a 12-week randomized, double-blind, placebo-control trial on diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* type 2 diabetes with less than 2 kinds of oral antidiabetes drugs
* Hba1c: 7.0-9.0

Exclusion Criteria:

* type 1 diabetes
* pregnancy
* acute infectious disease
* autoimmune disease
* hemodynamic unstable
PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed Richter's transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
2. Availability of fresh or archived tumor tissue.
3. FDG PET-CT (disease) positive baseline scan with measurable disease.
4. ECOG performance status of 0-1.
5. Evidence of disease progression at study entry.
6. Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy.
7. Must have previously received at least one prior chemotherapeutic regimen for RT.

   - Previously untreated RT patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible.
8. Adequate bone marrow, renal, and hepatic function.
9. Normal Coagulation profile.
10. Agreement to use acceptable methods of contraception during the study and for ≥ 120 days after the last dose of PNT2258 if sexually active and able to bear or beget children.
11. Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).

Exclusion Criteria:

1. Concurrent non-hematologic malignancies requiring treatment.
2. No more than 2 prior regimens for DLBCL.
3. Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
4. Ongoing risk of bleeding.
5. CNS or leptomeningeal involvement of lymphoma
6. Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.
7. Pregnancy or breast-feeding.
8. Previous exposure to PNT2258.
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
* Subjects with \< 3 spontaneous bowel movements a week and experiencing bowel symptoms
* Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria:

* Evidence of clinically significant gastrointestinal disease
* History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation
* Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Epidemiological Study for Psychiatric Disorder Among Children and Adolescents

This 3-year school-based epidemiological study on child and adolescent mental disorders aims to obtain the prevalence rate and identify the psychosocial, individual, environmental, and familial risk factors for mental disorders including learning disability, autism spectrum disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders, phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use disorders in Taiwan.

Despite several waves of epidemiological studies in adult and elderly mental disorders in the past decades, revealing inconsistent results, little is known about the prevalence of mental disorders in the child and young adolescent population in Taiwan. However, there is an increasing trend of child and adolescent mental disorders over the past decades consistently reported across countries. With the revision of the Diagnostic and Statistical Manual of Mental Disorders to the current version-5th edition (DSM-5), there has been no epidemiological study using DSM-5 in youth population in the world. The DSM-5 was published in October 2014. It warrants an epidemiological study on child and adolescent mental disorders using the DSM-5 as diagnostic criteria in Taiwan.

This is a two-stage design to conduct screening for mental disorders including autism and all neuropsychological studies in addition to questionnaires. Moreover, clinical assessment will be conducted among urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling. All the screen positive (estimated n = 900) and 10% of screen negative (estimated n = 360) will receive the full diagnostic interview (K-SADS-E to obtain the pregnancy, developmental and medical history. For students who leave of absence, we will visit them at home to complete all the assessments.

The investigators anticipate this study will provide the prevalence of a wide range of developmental and psychiatric disorders in children and our results will also provide a comprehensive risk factors for each psychiatric disorder identified in this study, including neurocognitive, developmental, familiar, and environmental factors. The individual, combined, and interactive effects of these predictors can be identified in this study. This study will definitely provide precious data for the government to develop a preventive program for mental disorders and a promotion program for mental health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling

Exclusion Criteria:

-
10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies

The purpose of this study is to assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Histological and/or cytological confirmed advanced solid malignancies
* WHO performance status\<2

Exclusion Criteria:

* History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
* ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin \> 1.5 x ULRR, Serum creatinine\>1.5 x ULRR or creatinine clearance of \<50mL/min calculated by Cockroft-Gault
* Recent (\<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy
Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone

The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:

• effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.

Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
* sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
* had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.

Exclusion Criteria:

* medical and general contraindications for the surgical procedure;
* heavy smokers (\>10 cigarettes/day);
* an active infection at the implant site.
Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.

Eligibility Criteria:
Inclusion Criteria:

* measurable metastatic adenocarcinoma of the colon or rectum
* no prior systemic therapy for metastatic disease
* adjuvant therapy must have been completed \>/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed \> 6 months prior to study entry
* must have tumor tissue available for EGFR and thymidine phosphorylase evaluation
* ECOG PS 0-1
* age \>/= 18
* adequate organ function: WBC\>/=3,000, ANC \>/=1,500, platelets\>/= 100,000, total bilirubin \</= 1.5X ULN, AST\&ALT \</= 2.5X ULN, create clearance \>/= 50mL/min
* negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
* ability to understand and willing to sign written ICF
* able to swallow and absorb oral medication

Exclusion Criteria:

* medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing)
* history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
* surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
* urine protein:creatinine ration \>/=1.0 at screening
* evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
* prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin
* underlying neuropathy \>/= grade 2
* TIA or CVA w/in 6 months
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects

The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome


Eligibility Criteria:
Inclusion Criteria:

* signed consent form
* men and women\> 18 years \<80 years
* APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

Exclusion Criteria:

* Pregnancy or lactation
* Change in medication during the last 2 months
* severe walking disturbance
* uncertain diagnoses
* No previous invasively confirmation of PH
* acute diseases, infections, fever
* Serious lung disease with FEV1 \<50% or TLC \<70% of target
* Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina

ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. Follow-up will be at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

ORBITA-2 will enrol patients who meet all 3 of the following criteria:

1. Angina or angina-equivalent symptoms
2. Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis
3. Evidence of ischaemia, arising from at least one of the following options:

   1. Positive dobutamine stress echocardiography
   2. Positive cardiac MRI perfusion scan
   3. Positive nuclear medicine myocardial perfusion scan
   4. Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram

Exclusion Criteria:

1. Age younger than 18
2. Age older than 85
3. Recent acute coronary event
4. Previous coronary artery bypass graft surgery
5. Significant left main stem coronary disease
6. Chronic total occlusion in the target vessel
7. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
8. Contraindication to antiplatelet therapy
9. Severe valvular disease
10. Severe LV systolic impairment
11. Severe respiratory disease
12. Life expectancy less than 2 years, pregnancy, unable to consent
A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017

Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)

The investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the HPV genotypes included in the vaccine from baseline to month 7 and 24.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment.
* Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
* Be ≥18 years and \<of 36 years.
* Patient with chronic infection with HIV-1.
* Viral HIV load \<50 copies / ml and CD4\> 200 cells / uL for at least the last six months.
* Transgender men or women who have had insertive or receptive anal sex with other men

Exclusion Criteria:

* Previous history of anal cancer.
* Have previously received any vaccine against HPV.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers

This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight between 40 and 100 kilograms (between \~88 pounds and \~220 pounds)
* Use of contraception
* Stable health
* Negative tests for alcohol, tobacco, and drugs of abuse

Key Exclusion Criteria:

* History of clinically significant disease
* Pregnancy