cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

The primary aim of the study is to assess mortality and cardiovascular events potentially linked to cortisol excess in patients with adrenal incidentalomas stratified by cortisol values following the 1-mg overnight dexamethasone test.

The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* adrenal incidentaloma (≥ 1cm) detected by cross-sectional imaging between January 1, 1996 and December 31, 2015
* imaging characteristics suggestive for an adrenal adenoma or excluded malignancy by follow-up imaging
* availability of a 1 mg dexamethasone test result
* follow-up data on living status and occurrence of cardiovascular events
* follow-up duration of at least 36 months.

Exclusion Criteria:

* proven pheochromocytoma, primary hyperaldosteronism or adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome
* clinical features suggestive for overt Cushing's syndrome; urinary free cortisol (UFC) ≥ 2-fold higher than the upper limit of normal of the local assay
* any active malignancy (including adrenocortical cancer) at the time of primary diagnosis
Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema

Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as Avastin on retinal ischemia in the setting of diabetic macular edema.

The major causes of vision loss in diabetic retinopathy are diabetic macular edema (DME) characterized by thickening of the macula due to abnormal leakage of the retinal vasculature. Ischaemic changes and microvascular pathologies have long been hypothesized to play a role in the development of DME. In diabetic retinopathy, ischaemia stimulates the production of vascular endothelial growth factor (VEGF), which can lead to the breakdown of blood-retinal barriers, and may cause DME through an increase in retinal vessel permeability. DME is best evaluated by optical coherence tomography (OCT) while retinal ischemia is determined by Fluorescein angiography. With the avaiability of ultra wide field fluorescein angiography, the investigators can now accurately measure the degree of ischemia in peripheral retina. Thus, this study will provide us data on the degree of retinal ischemia in nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) cases as well as the measurable change that occurs in retinal ischemia after intra vitreal injection of bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic patients at age \>18year with DME
2. Scheduled for Avastin therapy
3. Adequate media to obtain OCT and UWFA

Exclusion Criteria:

1. Macular pathology of any etiology
2. Preexisting systemic disease causing retinal ischemia
3. Previous laser or anti-VEGF treatment in past 3 months
4. Previous retina surgery in past 2 months
5. Allergy to fluorescein dye
6. Psychiatric disorder, Alzheimer disease and Dementia or any other disorder precluding follow-up or continuation of the study.
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 19 and younger than 70 years
* Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
* Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum
* No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks
* At lease 20% of target great toe nail affected

Exclusion Criteria:

* Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance)
* Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis
* Patients with greater than 6 toenails affected
* Over 90% of target great toe affected
* Evidence of fingernail fungal infection
* Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection
* Patients with known history of HIV or hepatitis B or C infection
* Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease
* Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
Information Needs After Surgery for Colorectal Cancer

Aim The overall aim was to investigate information needs after surgery for colorectal cancer and factors explaining information needs, both from the patients' perspective and the next of kin's.

Sample Inclusion criteria are patients over 18 years of age that have gone through a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live.

Instruments In study I, 100 patients filled in four different instruments 1-2 weeks after discharge to measure: QOL, information needs, sense of coherence and performance status.

QLQ-C30 and QLQ-CR38 were used to measure QOL. INFO26 were used to measure received information. The SOC - Sense of Coherence was used to measure sense of coherence. And finally the scale for ECOG Performance Status was used to measure the level of physical performance status.

In study II the same patients filled in the same instruments a second time, 5-7 week after discharge.

Information about marital status, occupation, diagnosis and prognosis were taken from the medical record.

Interviews In study III 16 patients both filled in the instruments in study I and II, and were interviewed to gain a deeper understanding of their information needs. The interviews were semi structured and will be analysed with content analysis.

In study IV the next of kin to patients in study III were interviewed about their own information needs in connection to discharge.

The interviews were performed twice for each person, 1-2 weeks after discharge and a second time, 5-7 week after discharge.

Data sampling The data were collected consecutively, and every third patient living together with their next of kin were asked to participate in the interviews.

Eligibility Criteria:
Inclusion Criteria:

* adult over 18 years of age
* surgery for colorectal cancer in one of the three hospitals in the study
* speak and read Swedish
* be able to understand the instructions written in the questionnaires

Exclusion Criteria:

* receiving a stoma
* don't want to participate
* not completed at least half of the items in both questionnaires
An International Randomized Study to Compare SPIES Versus WLI

This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as short and long-term follow up.

This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where CIS is scored as flat lesion). Patients randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB, whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB. WLI is chosen as control, since it is considered the gold standard for detecting bladder tumors. Short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period. Perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of SPIES.

Eligibility Criteria:
Inclusion Criteria:

* Has signed informed consent
* Is scheduled for treatment of a primary or recurrent NMIBC
* Is aged 18 years or older
* Has or has had no tumors in the upper urinary tract
* Has had no previous irradiation of the pelvis

Exclusion Criteria:

* Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
* Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
* Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
* Conditions associated with a risk of poor protocol compliance
* Has had instillation therapy in the six months prior to the screening visit
Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, SOFA Score in Critical Illness

The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study.

The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study. Both groups will be given standard nutrition with target energy of 20 kcal/kg bodyweight(BW)/day and ratio of nitrogen:non-protein calorie 1:70 and neuromuscular electrical stimulation 30 minutes per day.

Eligibility Criteria:
Inclusion Criteria:

* new admission to intensive care unit (ICU) in first 24 hours
* aged 18-65 years
* SOFA score \>= 4

Exclusion Criteria:

* pregnant
* ultrasound examination cannot be performed under these circumstances: deformities, open wounded, prosthetics on right leg, amputated above right patella
* body mass index \<16 kg/m2
* chronic kidney disease stage 3-5
* diabetes mellitus uncontrolled blood glucose (BG) (BG \>200 mg/dL)
* neuromuscular diseases with musculus quadriceps femoris dextra paralysis
* autoimmune diseases
* referral from another ICU
Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty

Background:

In the early phase after a total knee arthroplasty (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central nervous system (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. Early-commenced, progressive strength training of the knee extensors of the operated leg therefore seems rational. However, the concern is that this type of early-commenced, intense physical rehabilitation exacerbates post-operative symptoms, such as knee joint pain.

The investigators have recently reported that early-commenced physical rehabilitation, including progressive strength training of the knee extensors of the operated leg seems feasible after TKA. The classic exercise-physiology literature emphasizes loading and repetitions performed to contraction failure - among others - as important variables for muscle hypertrophy and strength gains. It is currently not known how loading and repetitions performed to contraction failure during knee extensions with the operated leg, influences post-operative knee joint pain in patients with TKA.

Purpose and hypothesis:

The purpose of this study is to investigate how loading and repetitions to contraction failure influence knee joint pain during knee extensions with the operated leg early after TKA.

The hypothesis is that knee pain increases with increasing loading and fatigue.

Methods:

Fifteen patients with a unilateral TKA, operated between 1 to 2 weeks prior to the first investigation, will be included. The participants are investigated twice. During the first investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a load that can be lifted exactly 10 times) will be determined for unilateral (operated leg) knee extension. At the second investigation, at least 72 hours later, the patients will perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a randomized order, estimated from their 10 RM test at the first investigation. Time under tension (contraction velocity) and range of knee joint motion for each repetition will be controlled for. During the concentric phase of each repetition, the patients rate their knee joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a short break, the patients perform 1 set of knee extension with a relative loading of 10 RM until of contraction failure. As for the loading effect described above, they rate their knee joint pain during the concentric phase of each repetition.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary TKA
* Between the age of 18 to 80 years
* Understand and speak Danish
* Informed consent
* 1 to 2 weeks after TKA

Exclusion Criteria:

* Disease/Musculoskeletal disorder, which requires special rehabilitation modality
* Alcohol and drug abuse
* Lack of wish to participate or unwillingness to sign an informed consent
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS-C/D)

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy (capecitabine or vinorelbine) in patients with HER-2 positive stage I breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Females 18-70 years old;
* Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the lymph node is negative (N0);
* If a patient is HR negative(ER/PR\<10%), the longest diameter of invasive cancer could not exceed 2cm; while if a patient is HR positive(ER and/or PR ≥10%）,the longest diameter of invasive cancer is greater than 1cm and no more than 2cm;
* The pathological type of immunohistochemistry must meet the following conditions: HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;
* For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled;
* Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST)

  ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula);
* LVEF\>50%;
* The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

* Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;
* Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;
* Has metastic (Stage 4) breast cancer;
* Pregnant or breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
* Patients participating in other clinical trials at the same time;
* Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
* Has severe or uncontrolled infection;
* Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
* The researchers considered patients to be unsuitable for the study.
CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.


Eligibility Criteria:
Key Inclusion Criteria:

* Signed Informed Consent Form
* Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma (HGBL); and transformed follicular lymphoma
* Patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal antibody therapy
* Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed suitable for CAR-T and Glofitamab treatment by the investigator
* Presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter \> 4 cm; (3) TP53 mutation
* ECOG Performance Status of 0, 1, or 2
* Life expectancy ≥12 weeks
* Adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function

Key Exclusion Criteria:

* Hypersensitivity to any study drug or excipient
* History of allogeneic stem cell transplantation
* Patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B surface antigen or core antibody); patients who test positive for HCV RNA (HCV testing only for patients who test positive for HCV antibody)
* Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc
* History of HIV infection
* Presence or concurrence of other malignancies within the past 2 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors
* Previous anti-CD19 CAR-T therapy is not allowed
* Pregnant or lactating women
* Other uncontrollable medical condition that may interfere the participation of the study
First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers

This First-In-Human trial will be conducted in healthy male subjects to explore the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of M6495.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Body Mass Index (BMI) of greater than or equal to (\>=) 18.5 and less than or equal to (=\<) 29.9 Kilogram per square meter (kg/m\^2), and a body weight between 50 and 100 kg at screening.
* Subjects must agree to use effective method(s) of contraception during the trial.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Subjects who have recently participated in other clinical trials.
* Donated blood, have a significant medical condition, history of drug hypersensitivity, consumption of large amounts of xanthine-containing foods or beverages, recent or ongoing concomitant medication, hypertension, tachycardia and significant findings on electrocardiogram
* Positive drug screening test, positive test for Hepatitis B or C or human immune deficiency virus (HIV), or have been kept in detention
* Other protocol defined exclusion criteria could apply.
Effects of Pain Neuroscience Education in Fibromyalgia

Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.

Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years.
* Willing and able to participate
* Diagnosis of Fibromyalgia

Exclusion Criteria:

* Systemic diseases
* Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position

Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. The aim of this study is to determine the diagnostic accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old with endotracheal intubation
* Having normal airway anatomy

Exclusion Criteria:

* Age below 18 years old
* Neck deformities,
* Presence in history of neck radiation,
* Cervical spine immobility/instability
* Unstable vital signs
* Unwilling to participate or denial of informed consent