cyrilzakka/clinical-trials huggingface dataset:
Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression

Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self reported diagnosis of invasive breast cancer who has currently or within last 12 months been in active treatment (surgery, chemotherapy, or radiation) or on endocrine therapy
* Self-identified anxiety (persistent worry or nervousness), depression (feeling sad, little interest or pleasure in doing things or hopeless), or sleep disturbance.
* Breast cancer related treatment (surgery, radiation, chemotherapy) or endocrine therapy within the last 12 months
* Self identifies as Spanish speaking
* Self identifies as Latinx / Latina / Latino
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Non-Spanish speaking
* other diagnosis besides invasive breast cancer (ie Ductal carcinoma in situ (DCIS), fibroadenoma, abnormal mammogram but not yet with final diagnosis, non-breast cancer patients)
* comorbid bipolar affective disorder or psychotic disorder (as self-identified by patient after asking "do you have any other psychiatric conditions")
* inability to physically or psychologically attend group sessions, and by discretion of the study coordinator.
* Patients currently participation in stress reduction or mindfulness groups/interventions will be excluded from participation
* Cancer "survivors" if not in active or endocrine treatment
Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador

The availability of affordable hardware and rapidly growing content that can be freely accessed in the public domain raises the possibility of VR being used across the world globally and, in a very broad range of settings, including low-income populations and middle-income countries. The goal of this study is implement a randomized control trial using a low-cost VR mindfulness intervention within older adults in Quito, Ecuador compared. The control group will only receive a check-in phone call.

We created a guided mindfulness intervention using low-cost VR (smartphones and Destek V5 headsets) for older adults with anxiety in Quito, Ecuador. This project is a collaboration between the Technology and Aging Lab at McLean Hospital and the Universidad San Francisco de Quito in Ecuador. Our goal is to recruit 90 older adults with anxiety from various outpatient settings in Quito. They will be randomized to control or to the intervention group. The control group gets a phone call in which they are asked how they are doing during 10 weeks. Those in the intervention group will receive 10 sessions of mindfulness using VR. We will use the free "Sites in VR" app and select different nature scenes for each intervention. The intervention consists of a total of 10 sessions each lasting 30 minutes. In each session, we fit participants with the VR headset with a smartphone running the Sites for VR app. The phone, placed in the viewing compartment of the headset, shows a nature scene of the participant's choosing. Once participants have acclimated to the scene and understand how to look around the VR scene (by moving their heads in different directions), we will read a mindfulness script with a guided body scan and instructions to engage participants through experiencing the virtual reality nature scene with all senses. The Ecuador team was trained by the McLean Team on the specifications of the intervention, to review the protocol, and to resolve any problems encountered during the administration of the intervention. The mindfulness sessions will be recorded with video and audio for quality control and intervention supervision to ensure that there is consistency in how the intervention is implemented.

Eligibility Criteria:
Inclusion Criteria:

* Normal cognitive functioning or mild cognitive impairment determined using the Montreal Cognitive Assessment (MoCA), being able to give written consent, and being a Spanish speaker. Exclusion criteria were

Exclusion Criteria:

* moderate to severe cognitive impairment, blindness or severe vision problems, deafness or hearing problems, history of dizziness, and current psychosis or mania.
Bioactive Glass Granules in Filling of Bone Defects

This is a randomized clinical trial that will be carried out to examine the use of bioactive glass granules (S53P4) as bone graft substitute in filling small and large bone defects as compared with autogenous and allogeneic bone grafting, respectively.

This a single center randomized trial. The hypothesis of the study is that the selected synthetic bone graft (bioactive glass granules, S53P4, Vivoxid Ltd, Turku, Finland) is as good as traditional autogenous or allogeneic bone grating in filling of non-traumatic bone defects. A total of 48 patients (stratified into two groups) will be included. The underlying bone disease will include common bening and semi-malign bone tumors (such as enchondroma and giant cell tumors) as well as tumor-like conditions (such as fibrous dysplasia, fibrous cortical defect, solitary bone cysts, aneurysmatic bone cyst).

Group I (n=24) will include patients with small benign bone lesions amenable to evacuation and autogenous bone grafting as standard of care. The patients will be randomized to autogenous bone grafting or bioactive glass granule filling. The follow-up examinations up to 52 weeks will include plain X-rays at 4, 26, and 52 weeks as well as MRI ad 4 and 52 weeks.

Group II (n=24) will include patients with a large bone defect. As the selection criteria, large defects have been defined to be defects which need allogeneic bone grafting. The patients will be randomized to allogeneic bone grafting or bioactive glass granule filling. The patients will be followed up to 52 weeks. The follow-up examinations will include X-rays at 4, 26 and 52 weeks as well as PET/CT imaging and MRI at 4 weeks and 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* benign bone tumor or tumor-like condition
* age 18 years or more
* signed informed consent

Exclusion Criteria:

* a history of malignancy
* a medication affecting bone metabolism
* any device (such as pace maker) as contraindication for MRI imaging
* gravidity
Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.

PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.

OBJECTIVES:

* To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
* To determine the feasibility of conducting this study in the United Kingdom.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease \[spinal metastases only vs spinal and non-bony metastases\]). Patients are randomized to 1 of 2 treatment arms.

* Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
* Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant disease
* Proven diagnosis of metastatic spinal cord compression on MRI or CT scan

  * Single site of compression OR multiple sites that can be treated within a single radiation treatment field
* No patient for whom surgery or chemotherapy treatment is more appropriate
* No multiple myeloma as primary cancer

PATIENT CHARACTERISTICS:

* Life expectancy \> 1 month
* Not pregnant
* Willing and able to complete assessment forms
* Able to give informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
* Is greater than or equal to 21 years of age
* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment at Screening
* Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men

The purpose of the study is to evaluate the change in glucose and insulin metabolism(early markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.These results have been replicated in patients at risk for diabetes with documentation of impairment in insulin secretion in Vitamin D deficient subjects. Therefore, vitamin D could be implicated in the pathogenesis of type 2 diabetes, by affecting either insulin sensitivity or ß cell function, or both. However, there is paucity of literature on the effect of Vitamin D supplementation on insulin resistance or glucose metabolism. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

Eligibility Criteria:
Inclusion Criteria:

* Male
* ≥35 years of age
* Waist circumference ≥78 cm

Exclusion Criteria:

* Diabetic- Fasting Blood Sugar \>126 mg/dl or on anti-diabetic medication
* BP\>140/90 or on anti-hypertensive medication
* Receiving Vitamin D or calcium supplementation
* Chronic disease-renal/hepatic/malignancy/gastrointestinal
* On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
* Febrile illness or infective morbidity in the past 10 days
* Past history of nephrolithiasis
Cyclooxygenase-2 Expression in Tissue Samples From Patients With a Normal Cervix, Cervical Intraepithelial Neoplasia, or Early Invasive Cervical Cancer

RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer.

OBJECTIVES:

* Determine cyclooxygenase-2 (COX-2) levels in biopsy or surgical specimens from patients with normal cervical epithelium, cervical intraepithelial neoplasia, or microinvasive squamous cell carcinoma of the cervix.
* Correlate COX-2 levels with histological diagnosis and parameters of invasion (i.e., matrix metalloproteinase, microvessel count, and VEGF).

OUTLINE: Paraffin-embedded tissue samples are analyzed by immunohistochemistry for evaluation of cyclooxygenase-2 levels, microvessel count, and matrix metalloproteinase and VEGF expression.

Medical data for study analysis is obtained by retrospective review of patient charts.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Underwent hysterectomy with removal of a normal cervix for diagnosis unrelated to cancer or cervical dysplasia
  * Underwent cervical biopsy or removal of cervical tissue and diagnosed with cervical intraepithelial neoplasia (CIN) grades 1-3
  * Underwent cervical biopsy and diagnosed with microinvasive squamous cell carcinoma of the cervix
* Paraffin-embedded tissue samples of normal cervical epithelium, CIN, or microinvasive squamous cell carcinoma of the cervix must be available for examination

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Prostate Cancer in Renal Transplants Recipients

Kidney transplantation is considered the standard of care for patients with end-stage kidney disease under chronic dialysis treatment. Today, modern surgical techniques have dramatically improved the quality of life and the overall survival of renal transplant recipients (RTRs) . Besides, the use of novel immunosuppressors have increased the 1-year graft survival rate and decreased acute rejection rate . Unfortunately, several transplantation-related diseases including cancer, cardiovascular disease and infection may affect the survival of renal transplant recipients. It has been estimated that RTRs are 2- to 5- fold more likely to develop cancer compared to the general population. Therefore, the development of cancer has become a major concern as it is currently one of the main causes of death in RTRs. The increasing incidence of post-transplant malignancies is generally attributed to immunosuppression which leads to impaired immunosurveillance of cancer cells and virals infections capable of cancer development. Additionally, it has been observed a direct and specific pro-oncogenic effect on RTRs of immunosuppressive drugs and other immunosuppression-independent factors such as the increased age of RTRs, the male gender and the pre-transplant dialysis duration . Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs. Generally, the vast majority of post kidney transplantation prostate cancers are localised; however, due to the lack of randomized studies, no specific guidelines for the management of localized prostate cancer are available and, consequently, RTR patients are being treated with surgery or radiotherapy according to national or local guidelines. The concomitant use of immunosuppressors and the presence of the kidney graft in the pelvic cavity make the treatment of localised prostate cancer post kidney transplantation more challenging, highlighting the need for these patients to be addressed to urological oncology centres with surgeons familiar with oncological and transplant surgery.

Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs, however, little studies describe the real incidence of prostate cancer in RTRs.

The aim of this study is to retrospectively review a 25-year experience at the Florence Transplant Center in order to evaluate the incidence of prostate cancer and its possible clinical/pathological factors able to influence the survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing kidney transplantation in the period from July 1991 to September 2016
* Development of prostate cancer confirmed histologically
* Written informed consent

Exclusion Criteria:

• Lack of clinical and prognostic data on selected patients
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
* 18 to 80 years of age (inclusive at the time of informed consent).
* Diagnosis of Diabetic Macular Edema (DME)
* Vision loss in the study eye

Exclusion Criteria:

* Be pregnant or breastfeeding
* Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening
* Any other condition except for DME that could affect interpretation of study assessments
Individually Adapted Therapy of Alcoholism

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics. The secondary objective is to establish an association between patients' motivational type and drug effects. The aim is to improve alcoholism treatment by identifying characteristics for response to specific pharmacological relapse prevention. Such items could allow for an individually adapted pharmacotherapy of alcoholism. Specifically, we will study the possible dependence of the efficacy of naltrexone and/or acamprosate on different motivational types (reward versus relief craving) and genetic profiles referring to glutamatergic and opioidergic candidate genes. Lastly, the longterm costs and cost-effectiveness of the different treatment strategies for alcoholics chosen in our study are established.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence.
2. Participants must have had a minimum of 14 drinks (females) or 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and must have had two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
3. Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA \< 8) prior to randomization.
4. At least 2 weeks of inpatient treatment.
5. Participants can be abstinent for a maximum of 28 days prior to randomization.
6. Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups.
7. Participants have to sign a witnessed declaration of informed consent.

Exclusion Criteria:

1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder for whom medication is indicated, but no other Axis I disorders that are not medicated and are not severe enough to require medications.
2. Participants who require psychopharmacotherapy.
3. Participants who require therapy with any medications which pose safety issues.
4. Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen.
5. Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use.
6. Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation.
7. Participants with abnormal AST or ALT (more than 5 times the normal level).
8. Participants who are pregnant or nursing infant(s).
9. Women during childbearing years without an effective contraceptive method.
10. Participants developing sensitivity to the study medication.
11. Participants who are illiterate or are unable to read and write German.
Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of signing informed consent.
* BMI ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.
* For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
* History of at least one unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Change in body weight greater than 5 kg within 3 months prior to screening.
* Obesity induced by other endocrinologic disorders.
* History of pancreatitis.
* Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* History of major depressive disorder within the last 2 years.
* Any lifetime history of other major psychiatric disorder or suicide attempt.
Fluorocholine PET/CT Basket Trial

This is a single-arm, open-label, phase III trial in up to 2000 patients with known or suspected benign or malignant tumors which are known or suspected to be 18F-fluorocholine-avid.

Patients will receive regular standard clinical care. The only study-specific procedure will be the administration of 18F-fluorocholine followed by a PET/CT scan.

Diagnostic accuracy of 18F-fluorocholine PET/CT will be captured versus a composite clinical, radiological and histopathological standard of truth at follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Under referring physician's care
* Able to understand and provide written informed consent
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation for injection
* Known or suspected benign or malignant tumor which is known or suspected to be 18F-fluorocholine-avid as per current medical literature

Exclusion Criteria:

* Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
* Exceeding the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
* Unmanageable claustrophobia