cyrilzakka/clinical-trials huggingface dataset:
TeleHepC Treatment Trial

The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).

Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment.

In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV.

In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening.

A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.

Eligibility Criteria:
Inclusion Criteria:

1. live in the study area
2. have injected drugs or report recreational opioid use without injection in the last 90 days
3. are age 18 or greater
4. have chronic active, untreated hepatitis C (defined as positive HCV RNA)
5. are seeking treatment for hepatitis C infection.
6. are able to communicate in English (this is due to the fact that less than 5% of the population in which we are targeting will be non-English speaking; see "Non-English Speaking Subjects" for additional information).
7. are enrolled in health insurance

Exclusion Criteria:

1. Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including:

   1. increased abdominal or lower extremity swelling
   2. confusion consistent with hepatic encephalopathy
2. Are pregnant or breastfeeding
A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology criteria.
* For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,
* Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening
* Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.
* Other criteria apply, please contact the investigator for additional information

Exclusion Criteria:

* Patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.
* Patient has symptomatic chondrocalcinosis
* Patient has a history of fibromyalgia.
* Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
* Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
* Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
* Patient has a history of total or partial knee replacement in either leg.
* Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
* Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.
* Patient is intolerant to study drug, its excipients, and/or acetaminophen.
* Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
* Other criteria apply, please contact the investigator for additional information
Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment

This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.

This study is a monocentric prospective cohort study designed to monitor the care of patients undergoing an intra venous chemotherapy. Patients with a solid tumor (200 patients in total), starting a first cycle of intravenous chemotherapy with 21 days cycle will be included in this study. Patients will be followed all over the chemotherapy period through regular and defined telephone appointments carried out by a dedicated nurse. During phone call, a specific questionnaire will be used in order to retrieve data regarding patients toxicities, general care, quality of life, ...Actions taken following each phone call will also be documented (consultation, hospitalization, prescription,...). The main objective of this study is to evaluate the impact of this telephone follow-up program on the care of patients under chemotherapy treatment. In addition, a medico-economic analysis of this device compared with historical data from the national database SNIIRAM will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with a solid tumor.
2. Patient starting a first cycle of chemotherapy (+ - targeted therapy).
3. Patient starting intravenous chemotherapy including 21-day cycles.
4. Patient ≥18 years old.
5. Patient affiliated to a social security system in France.
6. Patient who signed the informed consent before study inclusion and before any study specific procedure.

Exclusion Criteria:

1. Patient already included in another interventional biomedical research.
2. Patient who began intravenous chemotherapy.
3. Patient who must receive an oral chemotherapy.
4. Patient who must be treated with a weekly chemotherapy or with concomitant radiotherapy.
5. Patient unreachable by phone.
6. Patient with no caregiver who can answer the phone in his place.
7. Pregnant or breastfeeding women.
8. Any psychological condition, family, geographic or social not to comply with medical monitoring and / or procedures in the study protocol.
9. Patient protected by law.
Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction

Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.

The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).

Eligibility Criteria:
Inclusion Criteria:

* age 18 years
* informed consent for operation and data use
* Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Exclusion Criteria:

* age \<18 years
* declined informed consent / data use
* pregnancy
EndoFLIP Use in Upper GI Tract Stenosis

The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.

To date there is no effective way to objectively characterize and predict response to endoscopic dilation of luminal strictures of the GI tract. Endoscopic dilation allows effective remediation of benign esophageal and upper GI tract strictures. Stricture dilation is performed after the stricture diameter is crudely gauged by the endoscopist. Stricture characteristics are based on the severity of symptoms and appearance. A stricture may be graded as mild, moderate, severe and as to whether or not the endoscope is able to traverse the luminal narrowing. By precisely measuring the diameter and length of a stricture, the endoscopist can know exactly what type of dilation is necessary. Benign esophageal strictures may also be refractory to dilation and thus require multiple sessions, prior to achieving successful remediation. The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation. The study will include patients with strictures referred for endoscopic dilation for the following indications: radiation induced strictures, peptic strictures, RFA induced strictures, EMR induced strictures, eosinophilic esophagitis, Zenkers diverticulum, and strictures related to surgical anastomoses. In patients with benign refractory esophageal strictures referred for endoluminal prostheses EndoFLIP will be used to characterize the stricture prior to stent placement.

Eligibility Criteria:
Inclusion Criteria:

* \> or = to 18 years of age
* Referred for evaluation and treatment of benign esophageal luminal narrowing
* Clinical diagnosis of benign esophageal luminal narrowing with documentation and imaging
* Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study
* Willing and able to give informed consent
* No condition or comorbidity which would prevent the patient from undergoing a successful upper endoscopy

Exclusion Criteria:

* \< 18 years of age
* Pregnancy
* History of prior endoscopic dilation\* (\*unless referred for placement of stent)
* Coagulopathy
* Inability to traverse the stricture using standard techniques
* Patients unable to provide consent
Rare Cystic Benign Adrenal Incidentalomas

Benign complex cystic and vascular adrenal tumors comprise a group of lesions characterized by significant rarity. But, their detection is increasing due to improved radiologic imaging techniques. Nevertheless, they are still conflicting with other lesions. the investigators reviewed their experience with complex cystic benign adrenal tumors in adults, review previous reports to determine the appropriate diagnosis and management of these tumors.

Adrenal masses are incidentally found on computed tomography (CT) of the abdomen (so-called "incidentaloma") (AIs) approximately 4% of the time and in 8% in autopsy series. It is important to distinguish benign from malignant. Also, differentiating functioning vs nonfunctioning tumors. The majority of AIs are nonfunctioning , benign lesions account for 82.5% of cases including adenomas (61%), myelolipomas (10%), adrenal cysts (6%), and ganglioneuromas (5.5%), cortisol-secreting adenomas (5.3%), pheochromocytomas (5.1%), adrenocortical carcinomas (4.7%), metastatic lesions (2.5%), and aldosteronomas (1%).

The frequency of adrenal incidentaloma reported in the radiology literature varies according to imaging modality with computed tomography (CT) scans and magnetic resonance imaging (MRI), it ranges from 0.3 to 7%, whereas with ultrasound, it is 0.4-2 %. The evaluation and classification of adrenal vascular tumors and cysts remain a challenging, in spite of, the frequency of detection over the past years has been facilitated by advances in imaging and molecular histopathology. This overlap not only because of their scarcity but because these lesions are often obscured by the extensive hemorrhage. As a result, surgical excision of these lesions has to trend in the last decades.

Because of that, we retrieved our data to determine the clinical features, histopathological pathognomonic features and the long term outcomes for these lesions.

The computerized dedicated database of patients who were treated for adrenal tumors between January 2010 and December 2017 was reviewed. Only patients aged \>18 years were included in the study and their files were fully evaluated. The data collected were the age at the time of presentation, clinical features, medical history, adrenal metabolic profile, radiological tumor characteristics, treatment methods, and histopathological characteristics. In all cases, CT with contrast was performed unless contraindicated and MRI was performed. Also, basic hormonal assay including 24-hour urinary cortisol and plasma metanephrines were requested for all cases. Under general anesthesia with fixation of intra-arterial line, patients were explored laparoscopically or via the lumbar incision. Three days postoperative, the patient was discharged unless hormonal replacement therapy is required for a longer period of time. The patients were followed up by metabolic profile and radiologically after 6 and 12 months postoperatively then annually.

Eligibility Criteria:
Inclusion Criteria:

* cases with adrenal tumors above 18 years old with rare histopathology

Exclusion Criteria:

* age less than 18 years
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)

This is a phase 2, randomized, controlled clinical trial to study the efficacy of pramipexol or risperidone in the treatment of refractory ODC patients.

This study is a two-parallel-group clinical trial with duration of 28 weeks (recruitment phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 8 weeks. The primary endpoint of this study is the score in the Y-BOCS scale measured between baseline and EOT ( at week 16).


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 64 years;
2. European Portuguese as mother tongue;
3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria;
4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;
5. Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose with or without psychotherapy, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% to 35% relative to the score obtained before starting treatment with SSRIs (Rauch \& Jenike, 1994).

Exclusion Criteria:

1. Patients who have a complete response to drug treatment with or without psychotherapy, i.e. patients with a reduction in Y-Bocs score by 25% to 35% regarding the score obtained before starting treatment with SSRIS (Rauch \& Jenike, 1994);
2. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
3. Patients with bipolar disorder;
4. Patients with tick disorder;
5. Patients with borderline personality disorder;
6. Patients with social anxiety disorder;
7. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
8. patients with a history of neurological disease or traumatic brain injury;
9. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
10. patients who are passing or have passed in the last 6 months by a major depressive episode;
11. Patients that undergo deep brain stimulation;
12. Presence of sensory deficits impeding participation in clinical study;
13. Pregnant or in breastfeeding period;
14. Patients doing medication or receiving prohibited treatments;
15. Patients with contraindication to perform MRI.
Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.

Tuberculosis can cause lung parenchymal destruction, volume loss, secondary bronchiectasis. Patients with TB destroyed lung complain chronic respiratory symptoms, such as chronic cough, sputum, dyspnea, exercise intolerance, and acute exacerbations. Some of them have chronic airflow obstructions on pulmonary function tests, similar to those of smokers.

Previous large randomized controlled trials, targeting patients with smoking related moderate to severe COPD,demonstrated that tiotropium improved quality of life and respiratory symptom with tolerable long-term safety. The investigators want to evaluate whether tiotropium can improve chronic respiratory symptom,an lung function in patients with COPD due to TB destroyed lung.

Eligibility Criteria:
Inclusion Criteria:

* previous pulmonary tuberculosis history
* never smoker or light smoker (\<10 pack-year)
* destruction of lung parenchyme, lung volume loss,secondary bronchiectasis due to tuberculosis in chest radiographs or chest CT, confirmed by board-certificate radiologist
* airflow obstruction confirmed by pulmonary function test, FEV1/FVC \<70%

Exclusion Criteria:

* patients do not agree with study enrollment
* patients with active tuberculosis or current antituberculous medication
* patients under chemotherapy or other immunosuppressant therapy such as glucocorticoid.
* active infection such as pneumonia, tuberculosis
* patients who are illiterate
* patients with dementia
* pregnant or to be pregnant
* previous lung resection surgery history
Partial Liver Radiotherapy for Unresectable Liver Metastases

This study is designed to treat tumors in the liver that cannot be removed surgically and chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery than has been used before.

The purpose of this study is to evaluate safety and feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer. This study would also evaluate local control rate within irradiated area and to assess failure patterns and survival of patients treated with conformal liver radiation.

Eligibility Criteria:
Inclusion Criteria:

* liver metastases unequivocally seen on contrast enhanced CT and/or MRI from colon or rectal cancer, previously confirmed pathologically as adenocarcinoma
* either 1) the tumor must be unresectable, 2) the patient must be medically inoperable, or 3) extra-hepatic metastases are present (making hepatic surgery an inappropriate treatment option)
* good performance status (0-1)
* Age \> 18 years. Adult patients of all ages, both sexes and all races will be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study
* life expectancy \> 3 months

Exclusion Criteria:

* patients with active hepatitis or clinically significant liver failure
* patients receiving anticoagulation treatment with warfarin or heparin
* prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver
* clinically apparent ascites
* central nervous system metastases
Celebrandome: Preliminary Study

The Dove Self Esteem Project, has provided our research team with funding to develop a 60- minute workshop for Hispanic/Latinx Youth between the ages of 11 to 16 years old that builds body confidence. This workshop was developed based on prior curriculum the investigator has developed for The Dove Self Esteem Project and designed with two teachers and several adolescent children.

The aims of the current study are to: 1) examine the efficacy of the workshop, and 2.) evaluate the extent to which children like the curriculum and find it useful. Children will be randomized to control group or intervention group; however, the control group will eventually go through the workshop after 2 surveys. It is hypothesized that children in the intervention group will report higher body satisfaction scores, greater self- esteem, more awareness of body talk and less engagement in appearance comparisons relative to the control group. It is hypothesized that children will report liking the workshop, finding it useful and engaging.


Eligibility Criteria:
Inclusion Criteria:

* Youth who are 11 to 16 years of age
* Youth who identify as Hispanic/Latino/Latinx
* Youth who are fluent in English

Exclusion Criteria:

* None.
Immunization Against Tumor Cells in Sezary Syndrome

This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome.

In the laboratory, researches found that special white blood cells, called dendritic cells (DCs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. Autologous (from your own body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.

Although the etiology of CTCL is not completely understood, immunologic factors appear to play an important role.

Dendritic Cell (DC)-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors. Importantly, DC-tumor cell immunization has the potential to simultaneously stimulate CD4+ and CD8+ T cell-mediated immunity against multiple tumor antigens.

The vaccine will be prepared from the subject's own blood, obtained during leukapheresis. From leukapheresed blood, monocyte-derived DCs and malignant lymphocytes will be isolated. The DCs will then be loaded with lymphocyte-derived tumor antigens. Formulations and release criteria must be met before vaccine can be administered.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of Sezary syndrome
* Must be willing to discontinue concomitant medications for CTCL, including: \*Oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency, \*PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \*Electron Beam - for the duration of the study, \*Chemotherapeutic agents - 30 day washout, \*Bexarotene capsules or other oral biologics - 3 week washout, \*Topical nitrogen mustard - 2 week washout, \*Extracorporeal photopheresis - 4 week washout and for the duration of the study.
* Must be at least 18 years of age and must be able to understand the written informed consent.
* Subjects must have no evidence of active infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.

Exclusion Criteria:

* Subjects with autoimmune disease, HIV, and/or hepatitis
* Subjects who are pregnant or lactating