cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease

rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or late-stage RHD patient, however, whether mitral valve repair surgery is superior to replacement or other evolving interventional device remains controversial, this study aims to investigate the results of repair surgery compared with replacement or other treatment strategy from international multicenters.


Eligibility Criteria:
Inclusion Criteria:

* 1、rheumatic heart disease 2、mitral valve disease 3、combined with other heart valve disease(aortic valve, tricuspid valve, pulmonary valve) 4、patients underwent initial mitral valve surgery or intervention

Exclusion Criteria:

* 1、congenital heart disease degenerative heart valve disease 2、isolated aortic valve or tricuspid valve, pulmonary valve disease( doesn't affect mitral valve ) 3、patients received more than 1 time mitral valve operation
Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.

Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.

Primary Objective:

Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.

Secondary Objectives:

Signs and Symptoms Evaluated:

* Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye.
* Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.
* Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation.
* Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep).
* Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).

Safety Assessment:

- Compare the incidence of adverse events (AEs) related to the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Ability to voluntarily provide signed informed consent.
* Able and willing to comply with the scheduled visits, treatment plan, and other study procedures.
* Be of legal age.
* Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form \[ICF\]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
* A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.

Exclusion Criteria:

* Pregnant women, breastfeeding women, or those planning to become pregnant during the study period.
* Having participated in another clinical research study ≤ 30 days prior to the screening visit.
* Having previously participated in this study.
* Having only one functional eye.
* A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF.
* Current user of soft or hard contact lenses. They may be included if they suspend use during the study, and they must be lens-free for 15 days prior to inclusion.
* Known hypersensitivity to the components of the investigational products.
Adenotonsillectomy Postoperative Parental Teaching Tool

The study will involve parents filling out a survey before \& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. The parents randomized to the video arms will watch the video while their child is in the OR and then either take the post survey immediately after or wait to take the survey until just prior to discharge. Parents not in the video arms of the study will also be asked to complete a survey pre and post standard pain management teaching.


Eligibility Criteria:
Inclusion Criteria:

* Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.

Exclusion Criteria:

* Non-english speaking families that require an interpreter.
* Any parent/family/caregiver that declines to be part of the study.
Efficacy of Human Placental Graft in Diabetic Foot Ulcers

To determine the efficacy of full-thickness placental allograft in chronic wound healing

To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* 18-80 years old
* Diagnosis of Type 1 or 2 Diabetes Mellitus
* Foot ulcers \>1cm2 and \<25cm2 for 4 weeks or more prior to enrollment
* Able to give consent to participate
* Compliance with all aspects of protocol and follow-up

Exclusion Criteria:

* Male and female patients younger than 18 years old
* Male or female patients older than 80 years old
* Smoking, and any additional health risk factors contraindicated with Revita use
* Involvement in any other ongoing studies
Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

* Pregnant or breast feeding women; coincidental loiasis
Hydraderm for Androgenic Alopecia

The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on scalp health and hair growth.


Eligibility Criteria:
Inclusion Criteria:

* Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization
* Participants who have androgenetic alopecia
* Healthy men and women, ages 18 - 65 years of age
* Participants who understand the study and can follow study instructions and are willing to attend the required study visits
* Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
* Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
* Participants who agree to use the same shampoo for the duration of the study

Exclusion Criteria:

* Participants who have not had a change to hair loss treatment for 4 months prior to study enrollment
* Participants who have an active or known skin inflammation or infection within the treatment area.
* Participants who have an active or known acute skin allergies
* Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area
* Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
* Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
* Immunosuppression
* Participants who are HIV+ / Hepatitis B + / Hepatitis C+
* Participants who have been diagnosed or have a known history of any hematopathology disorders
* Participants who have been diagnosed or have a known history of haemostasis disorders
* Participants who have been diagnosed or have a known history of an autoimmune diseases
* Participants who are undergoing chemotherapy
* Participants with a history of any skin cancer on the scalp
* Participants who have had skin biopsy or procedure on scalp in last month
* Participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area
* Non-English speakers
Post-operative CT Follow up After Nellix Endoprosthesis Implantation

Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.

Rationale:

In patients with abdominal aortic aneurysms the Nellix Endoprosthesis aims to reduce post-operative complications and subsequent re-intervention rates. Using two stents covered with two polymer filled endobags used for sealing and excluding the aneurysm sac. Preliminary results show promising results in reducing these complications. The new endoprosthesis is not only different in treatment but also in follow up imaging. To date it is unknown how the stent, polymer filled endobags and aneurysm appear in CT imaging in short and long term follow up.

Objective:

To assess and describe the normal computed tomography (CT) appearance at 30 days and 1 year after implantation of the Nellix Endoprosthesis.

Study population:

Approximately a total of 100 patients who underwent endovascular aneurysm repair using Nellix endoprosthesis in three different hospitals. The population is comprised of approximately fifty patients from Rijnstate Ziekenhuis Arnhem and twenty-five each from St. Antonius Nieuwegein and St. Elisabeth Tilburg.

Design and methods:

The study is designed as a multicenter retrospective cohort. Using CT-scans from regular follow up dates (30 days and 1 year) imaging will be retrospectively assessed using medical imaging software. Main study endpoints are defined as followed:

1. Changes in the infrarenal neck morphology (below the renal arteries)
2. Changes in the thrombus in the aneurysm sac
3. Changes in the aneurysm wall and geometry
4. Changes in the cobalt-chromium stent and their lumen
5. Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files.

Nature and extent of the burden and risk associated with participation, benefit and group relatedness:

The study will not bring an extra burden or risk for patients participating. Patients are encouraged to participate to improve insight for patients with the same disease and might improve health care in the future for this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis

Exclusion Criteria:

* No specific exclusion criteria
Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System

Using color Doppler ultrasound to screen people with breast masses. For the patients who show only a single mass on either side of the breast in color Doppler ultrasound, computer tomography photoacoustic breast imaging will be performed. By comparing the two modalities, the blood vessel imaging performance of the computer tomography photoacoustic breast imaging system developed by Union Photoacoustic technologies Co., Ltd is evaluated.

The evaluation index of this experiment is the percentage of blood vessel pixels in the same region of interest (Region Of Interest, ROI) to the total area of the ROI.

Screening of people with breast tumors, through breast color Doppler ultrasound examination, the results showed that there is only a single tumor on either side of the breast. The computer tomography photoacoustic breast imaging system was used to perform breast examination again. By comparing ultrasound and photoacoustic vascular imaging, the vascular imaging of the computer tomography photoacoustic breast imaging system developed by Union Photoacoustic technologies Co., Ltd was evaluated.

This test does not evaluate the diagnosis or treatment performance of two imaging modalities. It only compares the vascular imaging of two different imaging systems. Therefore, the evaluation index of this experiment is the percentage of blood vessel pixel number in the same region of interest (ROI) to the total pixel number in ROI. By comparing the percentages of blood vessel pixel number to the total pixel number in the same ROI in ultrasound and computerized tomography photoacoustic breast imaging system, the vascular imaging of the computerized tomography photoacoustic breast imaging system is evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects aged ≥18 years old;
2. Those who have undergone breast color Doppler ultrasound examination in this hospital, and the results show that there is only a single tumor on either side of the breast;
3. Able to comply with the research procedures specified in this program;
4. Those who have fully understood the study before the experiment, volunteered to participate in the study and signed a written informed consent.

Exclusion Criteria:

1. Those with incomplete skin (such as scratches, open wounds, ulcers, etc.) in the assessment side breast area;
2. Those who have a history of surgery in the assessment side breast area;
3. Those with persistent or active breast and/or axillary infection on the assessment side;
4. Those who have a history of mental illness and cannot cooperate to complete the trial at present;
5. Subjects deemed unsuitable by the investigator to participate in this study.
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.

A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.

Eligibility Criteria:
Inclusion Criteria:

* Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
* Stuttering severity must be notable for \> 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.

Exclusion Criteria:

* Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.
A Cohort Study on Early Stages of Heart Failure

The main goal of this observational study is to learn about the epidemiological characteristics of heart failure among elder population in Beicai community in Shanghai and construct a community-based database and biobank. The main question it aims to answer is:

What is the prevalence and prognosis of different stages of heart failure among elder population in community in Shanghai? And what are the influencing factors? What are the best screening strategies and hierarchical management strategies among different stages of heart failure patients in community? Participants are the elderly people aged 60 years or older in Beicai community in China. The follow-up will be programmed every 2 years.

Heart failure is a serious manifestation or advanced stage of various heart diseases with high mortality and re-hospitalization rates, and early diagnosis of heart failure is important to improve patient survival. Currently, the prevalence of preclinical heart failure (heart failure stage B) is lacking in China, and the rate of progression of heart failure from stage A/B to symptomatic heart failure (heart failure stage C) and end-stage heart failure (heart failure stage D) and the factors influencing the heart failure development are unknown.

The study is an ongoing prospective community-based study. After enrollment, a questionnaire, physical examination, laboratory examination and imaging examination will be administered to each participant at baseline and every 2 years in the follow-up. The laboratory and imaging examination include: blood/urine sample and biochemical measurements, electrocardiogram, echocardiograph, etc. In the follow-up, the incidence of cardiovascular disease, heart failure, other CV events and mortality will be recorded. Whether at baseline or follow-up, if the investigators find that patients are unclear about their disease status, the investigators will notify them by phone and record their subsequent medical behavior and results.

In this study, a community-based database and biobank will be established for early screening and long-term prognosis of heart failure in elderly population. Through the analysis of the data, the epidemiological characteristics of early stage of heart failure in elderly population in Shanghai can be identified and a multivariable model predicting heart failure in early stage will be constructed. Furtherly，the investigators will explore the referral criteria and hierarchical management strategies for heart failure through the cooperation between community hospitals and comprehensive hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥60 years
2. Cooperate in participating in research and sign informed consent forms

Exclusion Criteria:

1. End stage heart failure patients
2. Refusal to participate in this study
3. Patients who are not suitable to participate in this study by Researchers\&#39;s evaluation
Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies

Previous experience with antibody therapy in both NHL and CLL warrants further exploration of new antibody treatments for these diseases.

Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1 is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders.

This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one prior standard treatment. All patients will receive hLL1 administered intravenously once daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per statistical plan) in order to determine the maximum tolerated dose (MTD) for this administration schedule.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia
* Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA test required if received prior humanized antibody treatment)
* Patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved
* Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived)
* Measurable disease as defined by a tumor mass \> 1.5 cm in one dimension or WBC \> 5,000 (CLL patients)
* Age \> 18 years
* Patient has KPS \> 50%
* Absolute granulocyte count \> 1000 cells/mm3
* Platelet count \> 50,000 cells/mm3
* Creatinine \< 2.0 x ULN
* Total bilirubin \< 2.0 x ULN
* Patient agrees to use birth control if of reproductive potential
* Patient has signed IRB-approved informed consent

Exclusion Criteria:

* Known central nervous system (CNS) involvement by lymphoma
* Known HIV disease
* Patient is pregnant or nursing
* Patient is receiving other investigational drugs
* Known serum human anti-human antibodies (HAHA)
* Estimated life expectancy of \< 3 months
Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease

The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.

DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:

* Number/severity of exacerbations or hospitalisation since last clinic visit
* Compliance and side effects
* Blood sample
* Plasma levels of theophylline
* Sputum (induced)
* MMRC
* SGRQ
* Forced spirometry + inspiratory capacity

  - At the beginning and at the end of the study
* 6MWT
* BMI
* BODE


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Ability to understand study procedures and to comply with them for the entire length of the study.
* Any gender. No contraception is required neither pregnancy expected in the range of age
* Age \> 45 years
* Smoking history \> 10 pack-years (current or ex-smokers)
* Clinical diagnosis of COPD
* Presence of severe airflow obstruction on forced spirometry (FEV1/FVC \< 0.7 and post-BD FEV1 \< 50% of reference value) staged as GOLD III or IV
* Diagnosis of COPD exacerbation on discharge.

Exclusion Criteria:

* Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
* Cancer
* Heart failure
* Pregnancy, or risk of pregnancy
* Other inflammatory diseases
* Previous treatment with theophylline
* For drug studies: allergy/sensitivity to study drugs or their ingredients.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies

Mediastinal lymph nodes enlargement with short axis diameter \>15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age
* Mediastinal and/or hilar lymphadenopathies \> 20 mm on an injected chest CT scan
* Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
* Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max \> 3)
* No contraindication for general anesthesia
* French-speaking Patient
* -Signed informed consent

Exclusion Criteria:

* Patient not covered by the French social security system
* Patient with legal protection
* Pregnant or breastfeeding patient (if applicable)
* Patient under guardianship or curatorship
* Patient deprived of liberty