cyrilzakka/clinical-trials huggingface dataset:
Dermoscopic Findings of Small Plaque Parapsoriasis and Patch Stage Mycosis Fungoides and Histopathological Correlation

Dermoscopic findings of small plaque parapsoriasis and patch stage mycosis fungoides (MF),histopathological correlation of the dermoscopic findings, and using these findings to differentiate two diseases by demonstrating the difference in diagnostic success of dermatologists

Limited number of studies have been conducted on the dermoscopic findings of mycosis fungoides (MF) and small plaque parapsoriasis for the differentiation of these two diseases. Therefore, prospective studies involving a large number of patients and which can reach high magnification levels with videodermoscopy are needed to determine the criteria for discrimination. In our study, dermoscopic demonstration of vascularity will be achieved through videodermoscopy and capillaroscopy from the lesional skin, resulting in high magnification levels (x200).

In terms of histopathology and dermoscopy correlation, skin punch biopsy will be taken for diagnostic purposes. Videodermoscopy and lesional capillaroscopy will be performed to the same site of the lesion where punch biopsy will be taken. As a result patients who had the diagnosis of mycosis fungoides or parapsoriasis will be included to our study. After histopathological features are evaluated by pathologists, dermoscopic correlations will be examined for each lesion.

30 patients with clinical and histopathological diagnosis of mycosis fungoides, and 30 patients with clinical and histopathological diagnosis of small plaque parapsoriasis, who applied to the dermatology clinic of our hospital between february 2022 and june 2022 are included in the study. Patients did not use systemic treatment for 4 weeks and topical treatments in the last 2 weeks were included to the study.

Patient's demographical data, clinical data, videodermoscopy findings such as vascular structure (vascularity (shape, clustered, uniform, non-clustered) presence of scale ( diffuse or in patches or grooves, etc.), orange structural areas or specific clues will be evaluated. If vascularity is detected at x200 magnification in patients undergoing lesional capillaroscopy, characterization of vascularity (point, clustered, uniform, etc.) will be made.

After dermoscopic criteria are determined, the individuals whose dermatology education range from 1 to 15 years will be randomized and divided into two groups, and the correct diagnosis rates will be measured, with one group only clinical and the other group clinical and dermoscopy images together.

Eligibility Criteria:
Inclusion Criteria:

* Patient who have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
* over the age of 18
* who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
* patient who have patch lesions on their body

Exclusion Criteria:

* Patient who do not have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
* under the age of 18
* who have received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
* patient who does not have patch lesions on their body
Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients

PURPOSE

The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.

In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).


Eligibility Criteria:
Inclusion Criteria: (Healthy)

* HbA1 \< 6 %
* Normal haemoglobin levels
* Informed content

Inclusion Criteria: (T2DM)

* T2DM \> 5 years
* Normal haemoglobin levels
* Informed content

Exclusion Criteria: (T2DM)

* Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues
* Obesity (BMI \> 30)
* Age \> 70 years
* Gastrointestinal disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 12h
* Gastrointestinal surgery

Exclusion Criteria: (Healthy)

* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Age \> 70 years
* Gastrointestinal disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 12h
* Gastrointestinal surgery
Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by programming the pacing output to a sub-threshold level for ineffective pacing.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* implanted ICD
* occurrence of pacemaker-induced VT

Exclusion Criteria:

* documentation of pause-related syncope
* AV block
* sick-sinus syndrome
* younger than 18 years
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female.
* Age 18 64 years (both inclusive) at the time of signing the informed consent.
* Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.
* Body mass index between 18.5-29.9 kilograms per square meter (kg/m\^2) (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Platelet count greater than (\>) 400\*10\^9/ Liter (L) at visit 1
* Absolute neutrophil count less than or equal to (≤) 1.5\*10\^9/L at visit 1
* Female who is:

  1. pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or
  2. of childbearing potential and not using highly effective contraceptive method and whose male partner is not using effective contraception, from screening until 6 months after the last dose of trial product
* Male of reproductive age with female partner of childbearing potential who does not agree to use condoms and whose female partner of childbearing potential is not using a highly effective contraceptive measure (or adequate contraceptive measure as required by local regulation or practice) from signing the informed consent form (ICF) until 6 months after the last dose.
Smokers' Quitline for Asian Language Speakers

The study tested the effects of telephone counseling for smokers from three Asian language speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the efficacy of a culturally appropriate counseling protocol for smokers calling the California Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether intervention effects varied by cognitive and behavioral predictors of cessation success, 4) examine whether family involvement plays a role in quitting success, and 5) assess differences in counseling effect across the three ethnic groups.

Asian Americans are among the least studied groups in smoking research, which has created a knowledge gap in understanding their behavior and in developing methods to help them quit. No efficacy data have been reported for telephone counseling of smokers who prefer to use Asian languages, although telephone intervention holds promise for these groups because of its convenience and its potential to reach large numbers of smokers. In this two-arm design subjects are stratified by language (Chinese, Korean, and Vietnamese) and randomized to telephone counseling (plus materials) or self-help materials only, which serves as the control. The study is significant in several ways. First, it provides timely information on a cessation approach for a traditionally under-served population (Asian language speakers). Second, effective telephone counseling can be widely applied because of the proliferation of quitlines with centralized services in recent years. Third, by targeting Asian language speakers this study addresses the issue of ethnic disparities, which has been identified by many (including the NCI Bypass Budget) as a research priority.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old,
* daily smoker,
* ready to quit within one month,
* first time caller,
* valid phone number,
* valid address,
* California (CA) resident,
* gave consent to participate in study and evaluation,
* called the Chinese, Korean or Vietnamese line

Exclusion Criteria:

* used other form of tobacco,
* major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)
Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand

This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.

PRIMARY OBJECTIVE:

I. To investigate pathological alterations in cartilage and joints in breast cancer patients on aromatase inhibitor (AI)s with and without pain and in healthy control patients.

OUTLINE:

Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI of about 60 minutes.

After completion of study, a subset of patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
2. Breast cancer patients with either natural or chemically induced menopause with stage 1-3 hormone receptor-positive breast cancers and on AI for at least one year OR healthy postmenopausal women

   Breast cancer patients on aromatase inhibitors (AI) may fall into one of the three following groups:
   * Patients with knee pain with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) \>= 5, but no or minimal hand/wrist pain
   * Patients with self-reported moderate or severe hand/wrist pain but no or only mild knee pain (WOMAC =\< 7)
   * Patients with no or minimal hand/wrist or knee pain (WOMAC =\< 7)
3. Age \<= 70 years old
4. Ability to read and complete quality of life surveys in English (or have a family member or friend available to translate and assist in completing surveys)

Exclusion Criteria:

1. History of prior traumatic injury at knee joint or severe degenerative joint disease or osteoarthritis defined as having a history of prior joint replacement or moderate to severe knee pain prior to initiation of AI
2. History of claustrophobia
3. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data, including prior history of implanted devices with ferromagnetic objects
Does Five Session CAT Consultancy Lead to Improved Outcomes?

Five session CAT (Cognitive Analytic Therapy) consultancy was developed for patients whom services 'struggle to help', such as those with diagnoses of personality disorder. Five session CAT consultancy works with both patients and care coordinators, utilising key elements of CAT including reciprocal roles and reformulation to inform care planning and case management. The proposed study expands on the existing evidence base by utilising a comparator; a treatment as usual condition. The proposed mixed methods feasibility study will compare outcomes for both patients and care coordinators to assess the effectiveness of the intervention compared to controls in a community mental health team.


Eligibility Criteria:
Inclusion Criteria:

1. they are indicated as unsuitable for individual therapy,
2. there is a poor or challenging relationship between the patient and the care coordinator(s)
3. the care coordinator(s) feels a sense of 'stuckness' with the case
4. the patient is chaotic

Exclusion Criteria:

1. actively psychotic
2. severely misusing substances
3. have poor appointment attendance
4. indicating that they are actively suicidal and unwilling to commit to trying to stay safe.
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings ("CDE-EHR-PC" Study), Phase 2

This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements (CDEs) in primary care settings. The study will be conducted at three adult primary care clinics, in two large health systems. Each phase will include deliverables essential to move to the next phase, and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. Based on progress during earlier phases, the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4.

Phase 2 prepares for implementation of the screening and CDS tools as part of routine clinical practice. A key component of this phase is tailoring the screening and CDS tools through an iterative process of usability testing and adaptation of their design. In the KTA framework, this phase corresponds to the 'select, tailor, and implement interventions' step. Simultaneously, investigators will plan for implementation in one clinic of the MSHS system by identifying clinical champions, educating clinic leadership and staff, and conducting a workflow analysis to identify barriers and facilitators of implementation.


Eligibility Criteria:
Inclusion Criteria:

* English speaking adult individuals aged 18 years or older, and employee at a Wave 1 clinic.
* Clinical implementation leaders Clinical implementation leaders are practicing PCPs who provide feedback to the research team and support their colleagues on implementing screening, using the CDS, and carrying out clinical interventions and referrals to address unhealthy substance use. One or two primary care providers will be identified from each clinic site to advise the research team on implementation and to serve as a resource for their colleagues.

Exclusion Criteria:

* Inability to provide informed consent.
Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery

The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs.

The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks


Eligibility Criteria:
Inclusion Criteria:

* Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
* Able to co-operate with the docking system for the femtosecond laser
* Clear corneal media
* 40 years of age or older
* Willing and able to return for scheduled follow-up examinations

Exclusion Criteria:

* Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
* Maximum K-value that exceeds 58.D
* Minimal K-value of less than 37.D
* Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
* Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
* Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
* Known sensitivity to planned concomitant medications
* History of lens or zonular instability
* Keratoconus or keratectasia
* Immune compromised or diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study Pl.
* Anterior chamber depth (ACD) \< 1.5 mm or ACD \> 4.8 mm as measured from the corneal endothelium.
* Extensive corneal scarring, pterygium
* Developmental disability or cognitive impairment (would preclude adequate comprehension of the IC form and/or the ability to record the study measurements)
* Concurrent participation in another ophthalmological clinical study
Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.


Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* KPS \>=70
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately

This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect how much Avibactam and Ceftazidime enters the blood. Part B investigates how much Avibactam (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately or together intravenously.

A Phase I, 2-Part, Open-Label, Pharmacokinetic and Drug-Drug Interaction Study of CAZ104 (Avibactam and Ceftazidime in Healthy Subjects)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and female subjects aged 18 to 50 years with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. Female subjects must have a negative pregnancy test at screening and on admi
* Male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the IP (investigational product).
* Have a body mass index (BMI) between 19 and 30 kg/m2
* As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to avibactam, ceftazidime, and/or excipients
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP Prolonged QTcF (\>450 ms) or shortened QTcF (\<350 ms) or a family history of long QT syndrome