cyrilzakka/clinical-trials huggingface dataset:
Integrated Treatment for Cocaine and Mood Disorders - 1

The purpose of this study is to test whether cognitive behavioral therapy and bupropion hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and improve their mood.

The global aim of this study is to evaluate an "integrated" treatment approach for cocaine dependent patients with comorbid unipolar depression. It is hypothesized that a cognitive-behavioral psychotherapy that targets both disorders, in combination with a pharmacotherapy, i.e., bupropion, is expected to provide the best coverage for dual disorders and thus maximize treatment outcomes. Specifically, we will conduct a double blind, placebo-controlled clinical trial involving the random assignment of participants into one of four treatment conditions according to a full 2x2 factorial research design. One independent variable will be pharmacotherapy (bupropion versus placebo); the other independent variable will be psychotherapy (integrated CBT versus clinical management). The study will enroll 140 cocaine dependent patients with comorbid major depressive disorder. A secondary objective is to further elucidate "primary" and "secondary" paradigms of depressive illness symptoms in cocaine-dependent adults and better understand how this distinction influences treatment outcome. This will be accomplished by enrolling a subsample of patients with substance-induced mood disorder. Taken together, this proposal will examine the feasibility and relative efficacy of a novel integrated treatment model for dually-diagnosed patients.

Eligibility Criteria:
Inclusion Criteria:

* Generally physically healthy
* Aged 18-55
* Meets cocaine dependence by DSM-IV criteria
* Meets major depressive disorder or substance-induced depression disorder by DSM-IV criteria.
* Willing and able to participate in the 12 week treatment study and one year follow up.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Taking medications that interact with the study medication (MAO inhibitors, anticonvulsants, haloperidol, phenothiazines,selegiline, anesthetics
* Have other psychiatric diagnoses requiring therapy or medication.
* Physically dependent on opiates or alcohol.
* Currently being treated with bupropion hydrochloride (e.g. Zyban).
Postural Changes in Lung Volumes in Obesity

Postural changes are known to affect normal lung volumes. A reduction in sitting to supine functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine position. However, postural changes in lung volumes in the obese require further exploration. We aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.


Eligibility Criteria:
Inclusion Criteria:

* subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)

Exclusion Criteria:

* Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.
Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological evidence of adenocarcinoma of the prostate
* Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
* Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3).
* Minimum PSA must be ≥1.0 ng/dL.
* Age 18 years of age or older.
* ECOG performance status 0 or 1.
* Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment:

  * absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
  * platelets ≥ 100 × 10\^9/L
  * hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
  * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
  * total bilirubin ≤ 1.5 × ULN; \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
  * serum albumin ≥ 30 g/L (3.0 g/dL)
  * Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula
* Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies:

  * Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
  * Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy.
* Voluntary written consent prior to the performance of any research related activit

Exclusion Criteria:

* Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride).
* Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.
A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen

To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography

This is a randomized, double-blinded, split-face, comparative study.

This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.

Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.

At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
* Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.
* Subject who in the opinion of the treating investigator would need 2 biostimulator treatments for optimal clinical outcomes.
* Ability of giving consent for participation in the study.
* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.

Exclusion Criteria:

* Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
* Asymmetrical severity photodamage score between 2 sides of the midface.
* Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
* Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
* Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
* Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.

Primary objective:

\* Maintain and expand a database of cytogenetic information on leukemia patients.

Other objectives as funding permits:

* Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.
* Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.
* Provide quality control for all Southwest Oncology Group cytogenetic data.

OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.

PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia \[AML\], 500 with first-line acute lymphoblastic leukemia \[ALL\], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia \[CML\], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Registered on one of the following Southwest Oncology Group treatment protocols:

  * SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Can Video Clips Improve Patient Comprehension at the Emergency Department?

The aim of this study is to assess the utility of two interventional videos, showed to patients discharged from the ED with a diagnosis of atrial fibrillation or deep vein thrombosis. We have focused our attention on these two medical conditions because they share some important features: they are frequently seen in EDs; their main complication (stroke and pulmonary embolism) can cause significant morbidity and mortality; both conditions and their related complications are probably not very intuitive to comprehend for the general population. In fact, the understanding of these conditions implies the knowledge of a number of pathological processes, with which most people are unfamiliar.

The primary hypothesis is that patients enrolled in the study group will show a higher degree of comprehension of their medical condition and its related complications, as compared to the control group. Secondly, we will also analyze any possible effect of the videos on the knowledge of the therapy prescribed, return instructions and patients' satisfaction with the quality of communication in the ED.

Eventually, we will examine the association of some factors with the outcomes (age, sex, level of education, atrial fibrillation vs. deep vein thrombosis group).


Eligibility Criteria:
* Age \>18
* Being diagnosed with one of the two medical condition under study: patients with first-time diagnosis of deep vein thrombosis; patients with first-time diagnosis of atrial fibrillation; patients with second episode in life of atrial fibrillation who have never been prescribed take-home medications for its cure or prevention of recurrence (anticoagulants, antiarrhythmic drugs including beta-blockers)
* Being discharged home directly from the Emergency Department/Emergency Unit
* Capacity of the patient to understand the explanations and instructions provided by the doctor (this includes excellent command of the Italian language)
* Having provided a valid phone number
* Having signed the informed consent

In case of patients lacking capacity, and in all cases of patients who will be judged by the recruiting doctor as incapable to safely receive the discharge instructions, the caregiver will be enrolled to the study with identical modalities.

In the context of a pragmatic trial, we did not set exclusion criteria in terms of education level and comorbidities of the enrolled patients.

Exclusion criteria:

* Previous diagnosis of deep vein thrombosis
* Two or more previous episodes of atrial fibrillation; or one previous episode of atrial fibrillation for which the patient has been prescribed one of the following take-home medications: anticoagulants, antiarrhythmic drugs including beta-blockers.
* Being hospitalized
Lay Health Advisors for Sexually Transmitted Disease Prevention

Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.

This is a demonstration project which includes the development, implementation, and evaluation of HoMBReS: Hombres Manteniendo Bienestar y Relaciones Saludables (Men Maintaining Wellness and Healthy Relationships). Applying a community-based participatory research (CBPR) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. The intervention is designed to: reduce sexual risk behaviors among Latino seasonal farmworkers; enhance access to sexually transmitted disease/HIV healthcare services; and develop effective data collection methods among Latino men.

Eligibility Criteria:
Inclusion Criteria:

LHA (lay health advisor) and participants:

* To be eligible for participation in this study as a lay health advisor (LHA), an LHA must:

  1. self-identify as Latino or Hispanic;
  2. work as a migrant or seasonal farmworker;
  3. be a member of the Liga Hispana de Fútbol de NC;
  4. be 18 years of age;
  5. be literate in Spanish; and
  6. provide informed consent.

Exclusion Criteria:

* Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.
Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery

The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are:

Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases?

Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications.

Participants will:

* Undergo baseline assessment including eye examination and measurement of intraocular pressure.
* Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery.
* Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
* Participant must be over 18 years of age
* IOP \> 16mmHg on at least two consecutive occasions separated by one month
* Two sighted eyes with visual acuity of 20/200 or better
* Informed consent from patient

Exclusion Criteria:

* Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
* Previous incisional glaucoma surgery
* Incisional glaucoma surgery scheduled within 1 year of intervention
* Corneal disease affecting visualization of anterior chamber of the eye
* Treatment or plan to treat with topical or systemic steroids
* Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
* Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.
The Study of Wuling Capsule in Treatment Chronic Tinnitus

To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life.

To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life. Patients with chronic tinnitus complicated with mild to moderate anxiety or depression were randomly divided into two groups. The experimental group was given oral treatment with Wuling capsule, and the control group was given gurusu treatment. The improvement of tinnitus, sleep, anxiety and depression in patients was evaluated at 2,4 and 8 weeks after treatment, respectively, and the efficacy of Wuling capsule in improving tinnitus combined with anxiety, depression and tinnitus was analyzed。

Eligibility Criteria:
Inclusion Criteria:

* Tinnitus with a history longer than 6 months;
* 7 \< HAMD score \< 24 and / or 7 \< HAMA score \< 21;
* No antianxiety, depression or antipsychotic treatment within 2 weeks.

Exclusion Criteria:

* objective tinnitus;
* tinnitus with defined causes;
* accompanied with acute infection, acute trauma, perioperative, chronic disease in the acute stage;
* with mental illness family history;
* HAMD score greater than 24 points or HAMA score greater than 21 points;
Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adolescents actively enrolled in a middle or high school in the Boston area who are between the ages of 13 and 19 (inclusive);
* Average use of cannabis at least 3 times per week during the 3 months prior to study enrollment;
* Cannabis use reported within 7 days of study enrollment;
* No immediate plan to discontinue cannabis use;
* Have a parent or legal guardian who is competent and willing to provide written informed consent for the active study phase (if under the age of 18);
* Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
* Competent and willing to provide written informed consent (if age 18 or older);
* Able to communicate in English language;
* Have a parent/guardian who can communicate in English language;
* Able to commit to 27 study visits in approximately 6 months;
* Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.

Exclusion Criteria:

- Any severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).
Healthcare Transition of Adolescents With Chronic Health Conditions

At least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. This international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population.

The primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age.

The secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. Positive care experiences and low anxiety will predict better health-related quality of life during the transition period.

A cohort of 504 young patients will be followed for three years. Patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with a chronic medical condition (duration at least 6 months prior to recruitment)
* Attend care and/or follow-up at either the New Children's Hospital in Helsinki, Finland or the Royal Children's Hospital in Melbourne, Australia in one or more of the following disciplines: endocrinology, gastroenterology, cardiology, rheumatology, neurology, pediatric surgery, nephrology and solid organ transplantation.
* Care to be transferred to adult services within 0-12 months following recruitment

Exclusion Criteria:

* Lack of fluency in study languages (Finnish, Swedish and English)
* Cognitive limitations that inhibit responding to questionnaires
Retrospective Data Analysis in Crohn's Disease

The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent