cyrilzakka/clinical-trials huggingface dataset:
Tele-Collaborative Outreach to Rural Patients with Chronic Pain

This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.

The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies.

Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups: 1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.

Eligibility Criteria:
Inclusion Criteria:

* U.S. Veteran
* Rural Residence based on Rural Urban Commuting Area codes
* High Impact Chronic pain, determined through a phone screening
* Access to landline or cell phone
* English Speaking

Exclusion Criteria:

* Cognitive impairment that would impact participation in the study
* Plans to move in the next 3 months
* Surgery in the past 3 months
* In long-term inpatient or hospice care
* Terminal illness (defined as life expectancy of less than 12 months)
* Active participation in another pain intervention study
Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study

The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).

The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected.

The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration:

* R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone)
* R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab - methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin)
* R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients treated in the centre during the period considered
* Age\>=18 years
* Histological diagnosis of PMBCL
* Signature of "Informed Consent" to participate in the study (if applicable)
* Treatment according to local practice
* Diagnosis between 01 January 2007 and 31 December 2019

Exclusion Criteria:

- The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis.
Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes

Participants will ask to answer questionnaire related to general characteristic, lifestyle, dietary pattern and undergo physical examination and measurement of body composition. The subjects will be divided into 2 groups: healthy control and intervention. The intervention group was divided into 3 subgroups: the fermented vegetable (kimchi) group, the kimchi supplemented with polyphenol (Vitexin) group, or the kimchi supplemented with probiotic (Lactobacillus rhamnosus) group. The intervention group will be instructed to consume 1 pack of kimchi per day (50 g/pack) with lunch for 2 months.

The subjects will be divided into 2 groups: healthy control and intervention. The intervention group was divided into 3 subgroups: the fermented vegetable (kimchi) group, the kimchi supplemented with polyphenol (Vitexin) group, or the kimchi supplemented with probiotic (Lactobacillus rhamnosus) group. The intervention group will be instructed to consume 1 pack of kimchi per day (50 g/pack) with lunch for 2 months. During the study, participants will be strongly encouraged to avoid consuming prebiotics or probiotic supplements, as well as foods such as yogurt, sour milk, fermented vegetables, and fermented fruits, especially 2 weeks before the blood and fecal examination. Compliance will be assessed by monitoring product side effects through follow-up phone calls every week to check on participants' symptoms and assessing the number of sachets or packs they actually consume.

Eligibility Criteria:
Inclusion Criteria: for the intervention group

* age 35-50 years, BMI of ≥23 kg/m2, presence or absence of metabolic syndrome (not treated by medication) according to the National Cholesterol Education Program (NCEP ATPIII 2007), in collaboration with the International Diabetes Federation (IDF) and the World Health Organization (WHO), metabolic syndrome

Exclusion Criteria:for the intervention group

* participants declined or withdrew, history of taking antibiotics in the 12 weeks prior to the project, history of using prebiotics or probiotic supplements on a regular basis, history of eating foods in these groups regularly, including yogurt, sour milk, fermented vegetables, and fermented fruits, history of taking drugs or weight loss products in the previous 6 months, history of diarrhea or constipation regularly, history of cure for ulcerative colitis, history of underlying disease that requires continuous medication, history of taking laxatives regularly, history of severe gastrointestinal disease, and history of illnesses such as thyroid disease, cancer, autoimmune diseases, kidney disease and hypertension etc.
Pulsed Radiofrquency Targeting Mid Cervical Medial Branches Versus GON for Cervicogenic Headache

To detect the Clinical efficacy of pulsed radiofrequency treatment targeting the mid cervical medial branches versus greater occipital nerve for cervicogenic headache

Cervicogenic headache (CHA) is one of the secondary headache disorders. The prevalence of CHA was estimated to be \~4.1%, and most of the patients affected by CHA report un-resolved, recurrent throbbing pain.

it has been treated with many treatment modalities, such as the administration of medi-cines, physiotherapy, transcutaneous electrical nerve stimulation, and interventional pro-cedures. However, these treatments do not result in long-term relief for many patients and need to be repeated Pulsed radiofrequency treatment (PRF) is one of the modalities used to treat CHA

. CHA has been known to originate from the convergence of the 3 upper cervical and tri-geminal afferents, and therefore, many physicians have performed PRF targeting the upper cervical structures (occipital nerve, C2 dorsal root ganglion).

However, this results in only short-term pain relief in the posterior head, and it can lead to some complications, such as vascular and nerve injuries. Because of these limitations, we will attempt PRF targeting the mid-cervical medial branches

Eligibility Criteria:
Inclusion Criteria:

1. medically stable outpatients with confirmed diagnosis of cervicogenic headache according to International Headache society
2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
3. Men or women older than 18years of age .
4. clear written informed consent from each participant in the trial.

Exclusion Criteria: 1)pregnants, breastfeeding, or willing to be pregnant during the study.

2)presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study 3)participation in any other type of medical research that may interfere with the interpretation of the study.

4)patients with haemocoagulation disorders, local infection or those who refused to consent
Transitional Care Interventions for Patients With Cirrhosis Post-TIPS

The investigators conducted a randomized controlled trial to describe if multidisciplinary and patient-centered transitional care interventions for patients with cirrhosis post-TIPS can improve compliance behavior and reduce complications post-TIPS after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diagnosis of cirrhosis;
* Child-Pugh Score \<10;
* Informed Consent.

Exclusion Criteria:

* Age \<18 years;
* Right ventricular failure;
* Severe systemic infection;
* Hepatocellular carcinoma (HCC);
* Terminal disease; and
* Failure to provide written consent to participate in the study.
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).

Antithrombotic agents such as ticagrelor can increase the risk of surgical bleeding in patients undergoing CT surgery if there is not adequate washout time of the drug. Patients who require urgent surgery may not be able to wait for the recommended washout time (up to 7 days). The intraoperative use of the DrugSorb-ATR device to remove active ticagrelor may help reduce the risk of postoperative surgical bleeding in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older, with documented full, written informed consent
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

Exclusion Criteria:

1. CT surgery occurring 3 days or greater following ticagrelor discontinuation
2. Heart-lung transplant procedures
3. Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
4. Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis \[HITT\], perioperative platelet count \< 50,000u/L, hemophilia, and international normalized ratio \[INR\] \>1.5)
5. Prohibited concomitant antithrombotic medications as defined in the study protocol
6. Acute sickle cell crisis
7. Known allergy to device components
8. Active (untreated) systemic infection
9. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
10. Women with positive pregnancy test during current admission or who are breast-feeding
11. Life expectancy \<30 days
12. Inability to comply with requirements of the study protocol
13. Treatment with investigational drug or device within 30 days of current surgery
14. Previous enrollment in this trial
Pediatric Medication Therapy Management Trial

The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical complexity and polypharmacy.

Patients and their parents who meet the study eligibility requirements will be invited to participate in the study. After being informed about the study and potential risks, all patients and their parents giving written informed consent (and assent, when appropriate) will be randomized in a 1:1 ratio to usual care or to the Pediatric Medication Therapy Management (pMTM) intervention.

Eligibility Criteria:
Inclusion Criteria:

* 2-18 years old
* ≥1 complex chronic condition (CCC)
* ≥5 current medications (including prescription, as needed, and over-the-counter medications)
* Receives primary care at Children's Hospital Colorado

Exclusion Criteria:

* Non-English speaking
* Sibling or family member already enrolled in this study
CBT as an Adjunct to SRIs in the Treatment of BDD

The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment

In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).

Eligibility Criteria:
Inclusion Criteria:

* Age 16-65
* A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic type)
* Ability to communicate meaningfully with the investigators
* Competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months
* Parental consent, if under 18 years old
* For phase two: must be on a stable therapeutic dose of one of the following SRI medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline.

Exclusion Criteria:

* current or lifetime diagnosis of any DSM_IV psychotic disorder not attributable to delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder,
* current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse,
* recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization,
* need for inpatient or partial hospital treatment,
* use of any medication prescribed for the treatment of BDD other than SRIs, including tricyclic antidepressants, buspirone, or neuroleptics,
* presence of any significant and/or unstable medical condition,
* females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of multiple sclerosis (MS).
* Expanded Disability Status Score 0 - 6.5.
* One or more relapse of MS in previous 12 months.
* Currently not taking any medications for MS (apart from those used to treat symptoms).

Exclusion criteria:

* Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
* Subjects who cannot have MRI scans.
* Women who are pregnant, breast feeding or planning to become pregnant during the study.
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 9 years of age and older.
2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
6. Subjects with 2 or fewer facial nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
4. Subjects with a facial beard or mustache that could interfere with the study assessments.
5. Subjects with more than 2 facial nodules.
6. Evidence or history of cosmetic-related acne.
Adherence Enhancement for Renal Transplant Patients

Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.


Eligibility Criteria:
Inclusion Criteria:

* Persons \> 21 years of age
* first time recipient of a solitary kidney transplant
* prescribed at least 3 medications for immunosuppression and hypertension
* previous history of non-adherence
* functioning kidney transplant
* ability to speak, hear and understand English
* able to use medication delivery device and self administer medications
* able to operate blood pressure monitor
* comfortable using cell phone
* no other diagnosis that might shorten lifespan
* transplant physician's assent that the patient can participate

Exclusion Criteria:

* failure to meet all inclusion criteria
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98

RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.

PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.

OBJECTIVES:

Primary

* Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.

Secondary

* Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years.
* Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy.
* Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy.
* Assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains.
* Assess the relationship between cognitive function and psychological distress, fatigue, and quality of life.

OUTLINE: This is a longitudinal, multicenter study.

Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year\* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant hormonal therapy).

NOTE: \*Patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled in protocol IBCSG-1-98

  * Must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole)
* No breast cancer recurrence or second malignancy
* Patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol IBCSG-1-98 are not eligible
* Hormone receptor status

  * Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent hormone replacement therapy
Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

The aim of this study to investigate and compare cardiorespiratory fitness (CRF) parameters of prediabetic, type 2 diabetic and healthy individuals. CRF assessed with cardiopulmonary exercise test (CPET) which is gold standard measure of CRF. Pulmonary functions, inflammation, disease specific parameters such as HbA1c, fasting plasma glucose etc affect CRF in prediabetic and type 2 diabetics.All parameters examine in this study.

This study will be participated with Type 2 diabetic,prediabetic and healthy patients. Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise capacity, physical activity level, quality of life, cardiorespiratory fitness levels will assess and record. Pulmonary function test will be assesed with CPET system, respiratory muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated using six minute walking test, incremental shuttle walk test. And cardiorespiratory fitness will assess CPET system. Physical activity level will be evaluated trial accelerometer and International Physical Activity Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Cooperation,
* No assistance for Ambulation,
* Body Mass Index\<40
* Diagnose of prediabetes/type 2 diabetes and health

Exclusion Criteria:

* Any cardiac problems,
* Uncontrolled hypertension,
* Any neurologic disease,
* Uncontrolled diabetes,
* Any orthopedic disease impairs walking, balance
* Any respiratory disease affects cardiorespiratory fitness