cyrilzakka/clinical-trials huggingface dataset:
Placebo Effect in the Treatment of Atopic Dermatitis

The study is initiated in the indication of atopic dermatitis to study the impact of placebo in the treatment of pruritus. Classical conditioning and expectation via instructions/anticipation maintain the effect of placebo.


Eligibility Criteria:
Inclusion Criteria:

* SCORAD-Score \< 50 points
* basic experimental pruritus \>= 3 points on a numeric rating scale
* no acute eczema on their forearms
* no systemic treatments for skin diseases for at least four weeks
* no topical treatment on their arms for at least two weeks

Exclusion Criteria:

* intake of antihistamines
* pregnancy and lactation
* serious dysfunctions of the liver, kidneys or thyroid
* prostatic hyperplasia
* patients with tumors, major cardiovascular diseases, immunosuppression
* glaucoma
Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers

Expression of hypoxia-inducible factor-α in oral precancers and cancers

Expression of hypoxia-inducible factor-α in oral precancers and cancers

Eligibility Criteria:
Inclusion Criteria:

* oral cancer specimens

Exclusion Criteria:

* not oral cancer specimens
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome

RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning problems experienced by girls with Turner's syndrome.

PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental and social functioning in girls who have Turner's syndrome.

PROTOCOL OUTLINE: Participants are evaluated for cognitive and social function at entry and 4 years following entry. Assessments include the Wechsler Intelligence Scale for Children-Revised, a child behavior checklist, the Children's Self-Concept Scale, and visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks.

Patients (and parents) undergo X-chromosome analysis; brain magnetic imaging is optional.

Controls are matched using school selection and telephone interviews.

A study duration of 12 years is estimated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Girls aged 8 and 12 years with Turner's syndrome-compatible karyotype
* Age-matched girls without Turner's syndrome entered as controls
* Concurrent registration on Thomas Jefferson University growth study required of subjects with Turner's syndrome
A Novel Method for Enhancement of Standard Rest Electrocardiograms (ECG) Provides New Parameters for Early Detection of Coronary Artery Disease (CAD)

The investigators aim to determine whether a new method of enhancing and improving ECG acquisition, analysis and display is effective. The investigators will perform superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal alignment to the peak R wave and voltage alignment to an improved baseline at the T-P segment.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine coronary angiogram

Exclusion Criteria:

* Patients with significant irregular heart rhythm
* Patients with heart failure
Impact of Various Diets on Surgical Complications

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (IM) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by European Society for Clinical Nutrition and Metabolism (ESPEN) in 2006 recommended to use IM for 7-14 days preoperatively in all patients undergoing major surgeries. Some authors questioned IM by showing no benefit of IM over standard enteral nutrition. Other authors observed similar results.The debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. One year later, ESPEN changed its surgical recommendations and advised to use IM preoperatively in malnourished and perioperatively in well-nourished patients. American recommendations remained unchanged and, according to them, it is advised to use IM preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option.

To address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted.

Eligibility Criteria:
Inclusion Criteria:

* no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) \< 18),
* good general status (Karnofsky Performance Index \> 80,
* Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
* no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease \[COPD\], coronary aortic bypass graft \[CABG\], etc.),
* no history of known allergies or drug intolerance to analyzed substances.

Exclusion Criteria:

* Patients malnourished or with metastatic disease,
* pregnant,
* in poor general status (Karnofsky \<80, Eastern Cooperative Oncology Group (ECOG) \> 1),
* recent history of severe heart, lung, kidney or liver failure,
* history of allergies or drug intolerance
A Study of Hemodynamic Cardiopulmonary Exercise for CHD

The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.


Eligibility Criteria:
Inclusion Criteria:

* Congenital Heart Disease Diagnosis
* Undergoing Clinically indicated Cardiac Cath

Exclusion Criteria:

* Unable to consent
* Pregnancy
Intervention to Reduce Infectious Complications of Peritoneal Dialysis

Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.

Peritoneal infections (PI) have been a very relevant representative of peritoneal dialysis (PD) for decades. PI is a very serious complication of PD and is a source of concern because of its high incidence. Each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode.

The risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training).

It is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis.

Patient education is very important and can affect the success of the technique and clinical results. Therapeutic education has been considered a key factor in PD outcomes.

The PD nurse is responsible for training the patient and/or caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home.

This is a pragmatic, retrospective-prospective (ambispective) study of educational intervention for patients with stage V advanced chronic kidney disease and those with cardiorenal syndrome starting a peritoneal dialysis program.

A retrospective control group with patients starting PD before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study and they will be implemented a new educational intervention based on a systematic review that has been carried out with the most recent evidence.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Medically stable
* Who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included

Exclusion Criteria:

* Patients with psychiatric, psychological disorders and social (language barrier included)
* Who do not have a formal/informal caregiver
* Those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention
Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with Durvalumab and Lenvatinib in Patients with Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.

   Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
2. Disease recurrence \> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \> 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion.
3. WHO/ECOG PS of 0 or 1
4. There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria

Exclusion Criteria:

1. Patients who have received systemic treatment in the past.
2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
3. Patients with severe and uncorrectable coagulation dysfunction.
4. Patients with active hepatitis or severe infection who cannot be treated simultaneously.
5. Patients with cachexia or multiple organ failure.
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.


Eligibility Criteria:
Inclusion Criteria:

1. Have signed the informed consent
2. Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
3. ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
4. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
5. Patients have received at least one faricimab treatment (the first dose) in the study eye

Exclusion Criteria:

1. Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
2. Active ocular inflammation or suspected / active ocular infection in either eye
3. Received any other anti-VEGF treatment after faricimab
4. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
5. Any participation in any other clinical trials currently
6. Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection
High Flow Nasal Cannula After Esophagectomy

This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.


Eligibility Criteria:
Inclusion Criteria:

* elective esophagectomy for cancer
* METS≥4
* AGE 18-85
* Written informed consent

Exclusion Criteria:

* ASA\>3
* COPD≥ III stage according to GOLD criteria
* FEV1\<50%
* EF\<30%
* NYHA\>2
* BMI\<17 or \>35 Kg/m2
* CKD with eGFR\<60 mL/min
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease

The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea (HU), at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. AYA have adopted text messaging and smartphone apps at a fast pace, including those who have SCD.Existing evidence indicates that mobile health (mHealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in AYA, including SCD. The specific aim for this study is to test the feasibility and acceptability of the MED-Go app as an mHealth behavioral intervention to improve HU adherence among AYA with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-21 years old
* Any sickle cell disease genotype
* On steady state of hydroxyurea for 2 months
* Own of have access to a smartphone during the study period

Exclusion Criteria:

* Recent hospitalizations within the past 7 days
Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

This is multiple baseline study including up to three participants with a primary diagnosis of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic stimulation study intervention.

Study assessments will be conducted at pre-baseline, weekly during baseline assessment (until a stable baseline is established, but not less than 2, 4, and 6 weeks for patients respectively), weekly during treatment, and at post-treatment. Magnetic resonance imaging (MRI) will be competed at pre-baseline, pre-treatment, and post-treatment. Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation using the Neurostar Therapy System for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC). Neuronavigation will direct coil placement over the DLPFC based upon structural MRI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hoarding disorder as primary disorder
* Clinical Global Impression Score \> 3
* Saving Inventory-Revised score \> 39

Exclusion Criteria:

* Any contraindication for participation in magnetic resonance imaging or transcranial magnetic stimulation
* Severe and/or unstable medical or psychiatric condition that require immediate medical attention
* Diagnosed with current major depressive episode
* Currently taking psychiatric medication
Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

The population of type 1 diabetes patients with cardiovascular disease is increasing and this study aims to explore the electrocardiographic changes that are associated with spontaneous hypoglycemia in this type of population. More precisely, this study will investigate if these modifications are of the same nature as those already observed in different populations (patients with type 2 diabetes) to see the pro-arrhythmogenic impact of hypoglycemia in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years old;
* Be able to give informed consent;
* Diagnosis of type 1 diabetes for ≥ 6 months;
* Treated with intensive insulin therapy (multiple injections of insulin or insulin pump)

AND EITHER

* A history of CV disease defined as: 1) Established diagnosis of atherosclerotic coronary artery disease (example: previous history of infarction); 2) Previous cerebral Vascular Stroke or Transient Ischemic Accident; 3) Anterior revascularization of the coronary arteries, carotid artery or peripheral arteries; 4) At least one coronary stenosis, carotid artery or lower extremity arteries \> 50%; 5) History of symptomatic coronary heart disease confirmed with hospitalization or a positive stress test result or by any cardiac imaging result, or unstable angina with changes observed at the ECG; 6) Asymptomatic cardiac ischemia confirmed by a nuclear imaging test, an exercise test, a dobutamine stress echo; 7) NYHA II-III class chronic heart failure; 8) Amputation of limb or foot due to circulatory insufficiency.
* Or more than 20 years duration of T1D and at least 2 of the following risk factors or associated condition: 1) Chronic renal failure eGFR \<60 ml / min / 1.73 m2); 2) Presence of micro or macro-albuminuria (albumin / creatinine ratio \> 2); 3) Hypertension or treatment for hypertension; 4) Hyperlipidemia or treatment for hypolipemia; 5) Abdominal obesity (Waist circumference\> 94 cm for men and \> 80 cm for women); 6) Smoking ; 7) Significant retinopathy (pre-proliferative, proliferating, laser or intravitreous injection); 8) Body mass index \> 30 kg /m2; 9) Erectile dysfunction; 10) Left ventricular hypertrophy; 11) Positive family history of early MCAS (H \< 55 years old and F \< 65 years old)

Exclusion Criteria:

* Definitive criteria: 1) QRS \> 120 ms on the baseline ECG; 2) Presence of atrial fibrillation at inclusion; 3) Current intake of any drug that may prolong QT according to the judgment of the investigator and the update of the list available on www.professionsante.com.
* Transient criteria (the patient can be included once the anomaly is corrected): 1) Hypokalemia (\< 3.5 mmol/L); 2) Hypocalcemia (ionized calcium \< 1.10 mmol/L); 3) Hypomagnesemia (\< 0.7 mmol/L)
Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing.

Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.

Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Have been diagnosed with insulin-requiring diabetes
3. Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
4. Insert sensors on their own and wear 2 systems simultaneously;
5. Use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;
6. Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
7. Have an intravenous catheter inserted for 4 blood draws per hour
8. Willing to perform SMBG during home use with the meter provided;
9. Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
10. Speak, read, and write English;
11. Willing and able to be compliant with provisions laid out in this protocol.

Exclusion Criteria:

1. Have extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Allergy to medical-grade adhesives;
3. Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
4. Dialysis treatment;
5. Hematocrit that is outside the range of 30-55% at screening visit;