cyrilzakka/clinical-trials huggingface dataset:
Wool Clothing for the Management of Childhood Atopic Dermatitis

The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis over two consecutive six-week periods.

The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.

The study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.

The primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.

Secondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit
* has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
* is capable of returning for review having had education through the Royal Children's Hospital eczema workshop

Exclusion Criteria:

* known reactions to wool products
* is unable to attend visits
* has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months
Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.

A 12 week randomized double-blind, placebo-controlled trial was conducted in patients with T2DM to evaluate the effect of green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids, anthropometric variables, arterial stiffness and inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

- Patients with type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* Smoking patients
* Ischemic heart disease
* Use of anti-inflammatory or antioxidant drugs
* Previously diagnosed liver or thyroid disease
Setrox JS Master Study

The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".


Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Available for follow-up visits on a regular basis at the investigational site
* Contractual capability and ability to consent
* Age ≥18 years

Exclusion Criteria:

* Meet one or more of the contraindications for pacemaker therapy
* Permanent atrial fibrillation
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker
* Pregnant and breast-feeding women
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.

Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.


Eligibility Criteria:
Inclusion Criteria:

* HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment.

Exclusion Criteria:

-
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis

In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better for maintaining remission in sarcoidosis.

The population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone).

The present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients will be randomized in the 2 groups in a 1:1 ratio.

The screening visit takes place between 60 days and until the baseline visit. The investigator will first check that the patient meets the inclusion criteria and does not present exclusion criteria. Before enrolment and randomization, all patients will receive comprehensive information and provide written consent.

Visit schedule:

* Baseline visit
* Follow-up Visits In the REMAIN arm: visits will be performed each 4-8 weeks depending on the infliximab interval. In the STOP arm, visits will be performed every 8 weeks, and in case of relapse (until M12+/- 2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Age superior or equal to 18 years
* Clinical and radiological presentation consistent with sarcoidosis
* Presence of non-caseating granulomas in at least one organ
* Exclusion or other causes of granulomas
* Infliximab treatment for at least 6 months
* Steroid dosage \< or equal to 10 mg/day for at least 6 months
* No activity of the disease (ePOST score 0) for at least 6 months
* Normal ACE (angiotensin converting enzyme) and serum calcemia level
* Signed informed consent
* Affiliated to the National French social security system
* As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Positive IGRA (Interferon Gamma Release Assays) test without previous antituberculous antibiotherapy
* Active infection
* Patients with moderate to severe heart failure (NYHA class III/ IV)
* Severe liver function disorders
* Alcoholism
* Severe kidney function disorders
* Pre-existing blood dyscrasias
* History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
* Concurrent vaccination with live vaccines during therapy
* Inability to understand information about protocol
* Adult subject under legal protection or unable ton consent
* Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
* Concomitant participation to another biomedical research (only Category 1 trial according to the french law)
AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States and Europe. Although selected patients with oligometastatic CRC undergo systemic therapy and surgery/local ablative therapy in curative intent, the treatment approach for the majority of metastatic CRC (mCRC) patients remains palliative with a median overall survival (OS) ranging between 9-38 months depending on various prognostic and predictive factors. Particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. The aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mCRC who have already received at least two lines of therapy.

This registry aims at retrospectively and prospectively evaluating the treatment landscape and clinical outcome of mCRC ≥3L in a collective attempt by including multiple oncologic centers in Austria.

Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. Imaging studies ≥3L will be centrally collected in a virtual "imaging-bank" and tumor tissue samples of deceased patients will be stored in a central "bio-bank". Additionally, further biomaterial (e.g. ctDNA samples or DNA from DPYD genotyping) may be requested from the centres in case of specific research questions. The patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which have already been recorded in the patients' medical charts, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patients' medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Data will be collected from all sites willing to participate.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years with tissue-based diagnosis of mCRC
* ≥ 2 prior lines of palliative systemic therapy including 5-FU, irinotecan, oxaliplatin, anti-VEGF, anti-EGFR (in case of RAS/BRAF wildtype), anti-PD1- therapy (in case of MSI/MMRd) . (Exception: Patients who have received mFOLFOXIRI +/- anti-VEGF or anti- EGFR- 1L therapy or patients with ineligibility to receive 5-FU, oxaliplatin or irinotecan can be included after 1st line.)

Exclusion Criteria:

* Due to the non-interventional design of this registry, there are no specific exclusion criteria
Improving Physical and Psychosocial Well-being of African American Older Adults

The proposed research effort will:

The purpose of this study is as follows:

1. Test the feasibility and acceptability of an eight-week community-based exercise program among AA older adults living in rural areas.
2. Determine whether participation in physical exercise through a community-based exercise program in comparison with an attentional control group: a) improves physical well-being b) improves psychosocial well-being

Among the aging population, African Americans (AA) experience depression and other chronic diseases such as diabetes, hypertension, and cardiovascular disease at a higher rate compared to non-minorities; moreover, those living in rural areas are less likely to seek treatment due to various factors including lack of accessibility, affordability, and acceptability of health care services. Fortunately, non-pharmacologic and cost-effective interventions such as physical activity can yield physical, psychosocial, and cognitive benefits for older adults. The purpose of the proposed research effort is to test the feasibility of, and effect of a community-based physical exercise program among community-dwelling older adults living in rural areas on the physical and psychosocial well-being. The research effort will be a randomized controlled trial. Fifty African American older adults will be recruited from community centers. A total of 50 participants will be recruited. These adults will be randomly assigned to either the intervention or control group, with each group containing 25 participants. The intervention will occur over a period of eight week. The exercise program will be offered three times a week, with each session lasting one hour. Study measures will be collected prior to the start of the exercise program, after the fourth session, after the last session, and at one-month follow-up. The primary outcome measures for the feasibility study will include enrollment rate, randomization rate, retention rate, and data completion rate. Additionally, the investigators will examine whether there is improvement I both physical and psychosocial measures. All statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) version 22.

Eligibility Criteria:
Inclusion Criteria:

1. At least 65 years of age
2. Identifying as AA
3. community dwelling and living in a rural community.
4. Sedentary life style (engaging in less than two hours of structured physical exercises whether independently or in a group setting every week)
5. Identify as having altered psychosocial health by scoring at least a 10 on the Patient Health Questionnaire (PHQ-9), which is indicative of moderate depressive symptoms (Kroenke, Spitzer, \& Williams, 2001).

Exclusion Criteria:

1. cognitive impairment as defined by the St. Louis University Mental Status Exam
Biomarkers of Bone Resorption in Metastatic Prostate Cancer

Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* prostate cancer with bone metastases
* hormone sensitive

Exclusion Criteria:

* inadequate renal function
* ongoing dental problems
* previous bisphosphonate therapy
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians

The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaska Native people within a primary care setting.

The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaska Native peoples within a primary care setting. Diabetes is disproportionately prevalent among low-socioeconomic status and racial/ethnic minority populations in the US. The high prevalence of psychosocial stressors such as depression, discrimination, and exposure to trauma among these populations contributes to the high prevalence of diabetes and interferes with successful completion of lifestyle interventions. The investigators hypothesize that a DPP that directly addresses these psychosocial stressors will be superior to the standard DPP in addressing this disparity in diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Urban of Indigenous Ancestry from the Americas (North, Central and South America)
* Men and women
* BMI Between 30-55
* Not diagnosed with Type II Diabetes
* At least one of the following criterion

  1. Triglycerides: 150mg/dL or higher
  2. Reduced HDL: \<40mg/dL (men); \<50mg/dL (women)
  3. Blood pressure: \>130/80 or current treatment with antihypertensives
  4. Fasting glucose: \>100mg/dL

Exclusion Criteria:

* Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
* On greater than 10 prescription medications.
* Psychiatric disorders requiring atypical antipsychotics or multiple medications;
* Inappropriate for moderate exercise according to the Revised Physical Activity Readiness Questionnaire;
* Pregnant, planning to become pregnant, or lactating;
* Family household member already enrolled in the study;
* Already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;
* Resident of a long term care facility;
* Lack of spoken English by patient or a household member \> 18 y who can serve as interpreter;
* Plans to move during the study period (9 months post-randomization);
* Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Appraising Clinical Trial Experiences of Patients With Insomnia

Medical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future insomnia patients during clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of insomnia.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results.
* Pregnant or lactating woman
Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle

A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)


Eligibility Criteria:
Inclusion Criteria:

1. Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
2. Subject weighing \<100 kg and body mass index (BMI) \<32 kg/m2.
3. Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
4. Able and willing to comply with the requirements of the protocol.
5. Able to understand and sign written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
2. History of:

   a. Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 \< iii. any known complications of diabetes (PVD, Nephropathy \[CR\>1.3\], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP).

   c. Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT2. g. Fracture (past or present) of MT1 or MT2.
3. Aseptic necrosis or any deformity of MT2 head.
4. Aseptic necrosis of the MT1 head
5. Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
6. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
7. ASA grade above 2
danceSing Care Evaluation: Testing the Effectiveness

This pilot randomised controlled trial aims to compare the effectiveness of a 12-week music and movement intervention in older adults in care homes compared to a waitlist control group.

The main questions it aims to answer are:

* Do salivary cortisol and DHEAS levels improve after the intervention, compared to the waitlist control group?
* Do feelings of anxiety and depression improve after the intervention, compared to the waitlist control group?
* Does the quality of life improve after the intervention, compared to the waitlist control group?
* Does physical function improve after the intervention, compared to the waitlist control group?

Participants will engage in music and movement sessions three times per week for 12 weeks. Researchers will compare the intervention group to the waitlist control group to see if any effects occur.


Eligibility Criteria:
Inclusion Criteria:

* residents in care homes ≥ 65 years,
* able to complete 12 weeks of a movement and music program,
* having the capacity to give informed consent as assessed by care staff and confirmed in discussion about the project with the research team using the British Psychological Society capacity checklist

Exclusion Criteria:

* currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study,
* pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made,
* inability to adequately understand written/spoken English to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).