cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction

Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.


Eligibility Criteria:
Inclusion Criteria:

* First ST Elevation Myocardial Infarction
* Primary Percutaneous Coronary Intervention (TIMI 3)
* Single vessel coronary artery disease
* Age over 18 years
* Informed Consent dated and signed
* Written and spoken French
* Beneficiary of social security insurance

Exclusion Criteria:

* No Primary Percutaneous Coronary Intervention
* TIMI 0-2 after Primary Percutaneous Coronary Intervention
* Significant two or three-vessel coronary artery disease (\> 70% stenosis in at least one of the other two coronary arteries)
* Past history of myocardial infarction before STEMI
* Mechanical complication (ischaemic mitral regurgitation, interventricular septal defect, cardiac tamponade) or clinical signs of heart failure
* Pregnant and / or lactating
* Age under 18 years or guardianship
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI

Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Associating liver partition and portal vein ligation (ALPPS) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation. Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT. Meanwhile, part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure, even in patients with sufficient FLR volume. In other words, this volumetric increase may not reflect the increase of liver function. And the laboratory parameters can only partly reflect the global liver function but not the regional liver function. Therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe. The Gd-EOB-DTPA-enhanced liver MRI, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination. Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS.

The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team (MDT). The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE (Relative enhancement of the liver)=（SI20min-SIunenhanced）/ SIunenhanced and other related indexes were calculated. SI referred to signal intensity. SI20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). The relationship between the indexes and postoperative liver failure as well as other complications were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* future liver remnant volume \<30%;
* indocyanine green clearance (ICG) rate \<20% at 15 minutes;
* Child A liver function, serum platelet count \> 50×109/L;
* good general condition.

Exclusion Criteria:

* complete right portal vein thrombosis;
* serum platelet count \< 50×109/L;
* clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.
Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis

This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis.

This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis. Radiation therapy uses pulsed low dose rate high energy X rays to kill tumor cells and make less side effects than conventional 3-dimensional conformal radiation therapy. Palliative radiation therapy may help gastric cancer patients with peritoneal metastasis live more comfortably.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically-confirmed gastric adenocarcinoma
* Patients must have metastasis tumor located within peritoneal cavity
* Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
* Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
* Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, or other therapies
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 in the irradiated field
* Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
* Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3
* Absolute neutrophil count (ANC) \>=1,000/ul
* Platelets (PLT) \>=75,000/ul
* Subjects must sign a written informed consent and Health Insurance Probability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures of assessments and must be willing to comply with treatment and follow-up

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
* A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
* Scleroderma or active connective tissue disease
* Active inflammatory bowel disease
* Serious, active infections requiring treatment with intravenous (IV) antibiotics
* Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
Impact of Combined Aerobic and Resistance Exercise on Autonomic Function and Cardiopulmonary Endurance in Obese College Students

This study explores the potential link between aerobic exercise combined with resistance training and improvements in cardiopulmonary function in obese individuals, focusing particularly on the influence of autonomic nerve function. By examining the effects of combined exercise on obese college students, this research aims to elucidate the critical role that autonomic nerve function improvement plays in enhancing cardiopulmonary function in this demographic.

The study primarily utilized a combined exercise regimen of aerobic and resistance exercises, conducted three times a week over a period of 16 weeks. One session was held during class hours, with the remaining two sessions scheduled during free time in the university gym. Aerobic exercises included the use of treadmills and elliptical machines, with intensity maintained at 60%-70% of the maximum heart rate (calculated as 220 minus age), for a total of 40 minutes per session (5 minutes of warm-up, 30 minutes of main exercise, and 5 minutes of cool-down). Heart rate monitors were used to ensure the intensity was maintained; resistance exercises involved gym equipment and bodyweight exercises, including the use of a pec deck machine, lat pull-downs, chest presses, bicep curls, tricep extensions, leg curls, and leg presses. The intensity of resistance exercises was set at about 65%-70% of one repetition maximum (1RM), with each session consisting of three sets of 6-8 repetitions and lasting for 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Obese college students aged 18-22 were recruited from a university in Beijing to participate in a public elective course on exercise for weight loss and slimming at the Capital University of Physical Education and Sport (CUPES). The inclusion criteria included a BMI of ≥28 kg/m\^2, no history of chronic diseases such as cardiovascular or metabolic diseases, no psychiatric conditions (e.g., depression, anxiety disorder, obsessive-compulsive disorder), and no physical disabilities or movement disorders (such as bone and joint diseases).

Exclusion Criteria:

* The exclusion criteria include individuals with diseases that may affect training (such as cardiovascular diseases, respiratory diseases, and musculoskeletal disorders), as well as those diagnosed with mental disorders (such as depression, anxiety, obsessive-compulsive disorder, etc.).
Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted zinc fortification programs.

The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to young children. The following specific steps will be completed:

1. Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
2. A two-week feeding trial will be implemented to assess the change in plasma zinc concentration among young children who receive: a) the zinc-fortified cereal porridge and a liquid vitamin preparation between meals; b) a non-zinc-fortified cereal porridge and a liquid vitamin preparation between meals \[negative control group\]; or c) a non-zinc-fortified cereal porridge and a zinc-containing liquid vitamin preparation between meals \[positive control group\].

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy

Exclusion Criteria:

* severe malnutrition
* severe anemia
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device

This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.

Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.

Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:

* The collection of platelets and plasma in Japan, Europe and the US (BK960005), 1996.
* The collection of mononuclear cells (MNCs) in the US (BK000047), 2002.
* The collection of a concurrent red blood cell (cRBC) product collected in ACD-A anticoagulant and stored in ADSOL® Preservation Solution (BK000039), 2002.

Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
2. A physician's prescription for TPE for various non-emergent conditions.
3. Test and Control TPE procedures that would be expected to be completed within approximately five weeks.

Exclusion Criteria:

1. Patients under 18 years old.
2. Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
3. Patients with altered mental status that would prohibit the giving and understanding of informed consent.
4. Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
* an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
* The expected survival time is more than 1 year
* signed Patient informed consent form

Exclusion Criteria:

* Serum creatinine clearance rate less than 30ml/min in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* In-stent restenosis in the blow-knee popliteal artery
* target lesion can't be cross by the guide wire
* the stenosis rate of proximal outflow more than 30% with or without intervention
* the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
* stenosis or occlusion of distal outflow for below-the-ankle artery.
* expected major amputations at the index limb before intervention
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the same time
* pregnancy and lactating woman
* untreatable bleeding diatheses
ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction

Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . In clinical work, in patients have poor ST-segment decline, the investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of myocardial scar.

The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to provide convenient, cheap and widely used test method for patients who cannot tolerate CMR-LGE.

42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured on the baseline and 24 hours after PCI. The study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (LGE- CMR), with transmural myocardial scar (\>75%) or non-transmural myocardial scar (\<75%).


Eligibility Criteria:
Inclusion Criteria:

1. Single-branch coronary artery stenosis or occlusion
2. Restoration of coronary perfusion to TIMI flow grade 3 after PCI

Exclusion Criteria:

1. A prior history of the acute coronary syndrome
2. Coronary revascularization
3. Severe chronic kidney disease
4. Intracardiac pacing leads or other implants precluding CMR-LGE
5. Hemodynamic instability
6. Known claustrophobia
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer

RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.

PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.

OBJECTIVES:

* Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.
* Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary hepatocellular carcinoma (HCC)
* Completely resected disease with clear margins
* No residual disease by postoperative CT scan
* No metastatic disease

PATIENT CHARACTERISTICS:

Age:

* 17 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 1,500/mm\^3
* Platelet count greater than 50,000/mm\^3

Hepatic:

* Bilirubin less than 2.92 mg/dL
* PT less than 4 seconds over control

Renal:

* Creatinine less than 2.26 mg/dL

Other:

* No contraindication to contrast or radioactive iodine
* No uncontrolled thyrotoxicosis
* No other prior or concurrent malignancy
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics
* Recovered from prior surgery

Other

* No other prior treatment for HCC
Liponovo Tissue Product in Healthy Volunteers

The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of Liponovo tissue product. The safety of the Liponovo tissue product is to be studied in 40 healthy volunteers. Liponovo tissue product is injected into superficial part of the subcutis with one injection to standardized area. The amount of the injection is 4,5 ml. As the control method same sized area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 years or more)
* Healthy skin in the studied area (dorsal forearm, proximal third)
* Able and willing to give informed consent
* Reasonably accessible to the study clinic and compliant to follow-up visits

Exclusion Criteria:

* known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
* hematologic or other bleeding disorder
* use of antitrombotic/ anticoagulation medicine
* autoimmune disease
* immunosupressive disease or medication
* cancer or neoplastic disease
* connective tissue disease
* diabetes type 1 or 2 or other metabolic diseases
* smoking
* pregnancy or nursing
* sunbathing during last 7 days
* a skin disease that is or has been symptomatic in the studied area
* test subjects with previous fat or hyaluronic acid filling under the same area
* those who withhold consent
* Use of following medications:
* Histamine receptor-blockers \<7 days before study initiation
* Topical corticosteroids in test area \<7 days before study initiation
* Topical calsineurin inhibitors \<7days before study initiation
* Longterm (\>10days before study initiation) systemic prednisolon \>10mg/d
* Omalitsumabi \< 4weeks before study initiation
* Doksepin \< 7 days before study initiation
Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female at least 12 years of age and older.
* 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).
* Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
* 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, gramnegative folliculitis, dermatitis, eczema.
* 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.
* Subjects with a facial beard or mustache that could interfere with the study assessments.
* Evidence or history of cosmetic-related acne.
* Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.