cyrilzakka/clinical-trials huggingface dataset:
Bone Marrow Cells in Myocardial Infarction

This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.

This is a randomized, double-blinded study, where patients treated with thrombolytic therapy for acute myocardial infarction are randomized to receive bone-marrow derived stem cells or sham-infusion at the time percutaneous coronary intervention of the target vessel. The end-points are many arrhythmia risk variables, suchs as heart rate variability, T-wave alternans and many ECG variables as well as systolic and diastolic left ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

* Indication for rescue PCI, severe clinical heart failure, age \<18 years
The iCARE Feasibility Study

Conducting assessment lower limb muscle strength, power and joint range of movement as well as inertial measurement unit (IMU) data capture during periods of walking and activities of daily living (sit to stand, stand to sit, climbing stairs) in participants over the age of 65. Assessing to see if there is any correlation between prospective follow up for incidence of fall events and patterns observed in the IMU data of the subject and to assess if the IMU data observed that results in higher or lower incidence of falls is related to any particular pattern in lower limb muscle strength, power and joint range of movement data.

Research Question:

• What is the feasibility of conducting a large scale study to identify modifiable musculoskeletal factors, increasing the risk of falls in older adults; that can be detected in mobility data collected from a wearable device worn during activities of daily living?

Primary aim:

• To collect feasibility data on study processes, resource and management.

Secondary aims:

* Assess the preliminary efficacy of 'Wearable technology' in predicting falls risk in older adults during activities of daily living.
* Assess the preliminary efficacy of identifying musculoskeletal factors predisposing to mobility issues that are associated with or protective against falls.
* Assess the preliminary efficacy of specifically treating these musculoskeletal factors compared with traditional care?

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65 years of age
* Able to give informed consent
* Able to mobilise independently or with mobility aid (walking stick, Zimmer frame etc.)

Exclusion Criteria:

* Patients under the age of 65.
* Patients who are bedbound or wheelchair bound.
* Patients with cognitive impairment and are unable to give informed consent.
* Significant medical co-morbidities that make participation in the study unsafe.
Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia

Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.

Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of \> 10 days. Patients are randomized according to a 1:1 ratio to receive either the usual empirical strategy (antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical strategy (administration of antifungals is limited to patients with pneumonia, septic shock, sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or positive galactomannan antigenemia). The antifungals administered are deoxycholate amphotericin B or liposome amphotericin B, according to the creatinin clearance. This strategy is applied during the first 14 days of persistent fever, then the therapy is left at the discretion of the investigator. The primary endpoint is survival at neutrophil recovery, or, in case of persistent neutropenia, at day 60 at the latest. Secondary objectives are the incidence of invasive fungal infections (IFI), IFI-free survival, number of febrile days, and renal function at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Malignant Hemopathy
* Induction or consolidation phase of chemotherapy, with expected neutropenia (\< 500/mm3) during at least 10 days
* Hospitalisation during aplasia

Exclusion Criteria:

* allogeneic haematopoietic stem cell transplants
* Previous fungal infection according to EORTC-MSG criteria
* Active fungal infection according to EORTC-MSG criteria
* Previous anaphylactic intolerance to polyenes
* known aspergillosis infection
* Sepsis
* Pneumopathy
BRAIN - Home Intervention Trial

We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. The trial will evaluate the effect of a resource-intensive early intervention (EI) program on the outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. The control group will receive enhanced health counseling (HC).

The overall goal will be to implement and evaluate an EI program for infants following birth asphyxia, which is sustainable in developing countries. The challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. Because there are limited data on normative development and EI programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. A final aim will be to address individual variation in EI effects that could be due to child and/or family characteristics.

A randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either EI or enhanced health education counseling (HC). The trial will randomize infants to a home-based parent-provided early developmental intervention (EI) with frequent home interaction between parents and parent trainers vs. HC. A group of infants without birth asphyxia or other major perinatal complications also will be randomized. Children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).


Eligibility Criteria:
Inclusion Criteria:

* birth asphyxia
* birth weight of at least 1,500g
* neurological examination consistent with normal, Stage I or II on the Ellis scale (Ellis, et al. 2000)
* willing to participate in an intervention program for 36 months.

Exclusion Criteria:

-
Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.

Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed lung cancer
4. Failed from first line Chemo-immunotherapy.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.
9. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

1. Subjects who have received any of the following treatments must be excluded:

   * Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
2. Presence of spinal cord compression or meningeal metastasis.
3. History of other malignant tumors within 2 years.
4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
8. Heart-related diseases or abnormalities
9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
11. Live vaccine was given 2 weeks before the first medication.
12. Women who are breastfeeding or pregnant.
13. Hypersensitivity to the test drug and the ingredients.
14. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.

Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology

Eligibility Criteria:
Inclusion Criteria:

* Males or females, of legal age of consent
* Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
* Dry eye symptoms are defined as

  1. has dry eye symptom everyday for more than 3 months
  2. has foreign body sensation frequently
  3. use tear substitutes more than 3 times per day
* Tear test shaw abnormalities at least 1 of 2 of following:

  1. Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
  2. Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following:

2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye

* Patent punctum

Exclusion Criteria:

* Age \< 18 years old
* Patients with Steven Johnson syndrome without dry eye
* Patients used oral cyclosporine or anticholinergic drug within past 2 months
* Patients with HIV or immunocompromise status
* Patients with active ocular infections and patients with a history of herpes keratitis
* Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
* Female patients are pregnant or nursing
Postural Control in Breast Hypertrophy

Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor alterations and impairment in body balance due to postural misalignment. The investigators conducted this study to evaluate the postural control with different sensorial information condition in women with breast hypertrophy.

Up to the moment, changes caused by breast hypertrophy are described based on the alteration of body mass distribution leading to an impact of psychological and physical aspects. However, the investigators hypothesize that due to alterations in postural alignment, sensoriomotor inputs are also impaired and postural or motor control are ultimately compromised.

Eligibility Criteria:
Inclusion Criteria:

* For the breast hypertrophy group, the women had to be in attendance in the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital.

Exclusion Criteria:

* For both groups:

  * rheumatic, neurological, respiratory and vestibular conditions due to possible balance alterations
EmpowHer is a Gender-specific Teen Pregnancy Prevention Curriculum for Middle School-aged Girls.

Alternatives For Girls (AFG's) EmpowHer curriculum is a program for pre-and early middle school girls (ages 10-15). The curriculum is gender-specific (girls), youth-co-led, and innovative (using online platforms and digitized presentation of material that targets minority/high-risk African American and Latina girls). EmpowHer addresses four adulthood preparation subjects (APS), such as parent-child communication, healthy relationships, adolescent development, and healthy life skills, and is implemented as an after-school program.


Eligibility Criteria:
Inclusion Criteria:

Females in 6th - 8th grade who are 10 -15 years of age at the start of the study and residing in Detroit or Out Wayne County at the time of enrollment will be eligible to participate in the study.

Exclusion Criteria:

Participants who are currently utilizing other services from Alternatives For Girls (AFG) will not be eligible to participate and will be wait-listed until they are no longer receiving other services from AFG (i.e., after-school programs, summer day camps, mentoring, youth leadership programs, and shelter services). These services are unrelated to the study/sexual health education and do not include EmpowHer or Sassy Science. If siblings were to be enrolled, one would be randomly assigned, and the rest would be allowed to participate in the same group as the study sibling but not counted in the evaluation. This is to prevent possible contamination between conditions.
Tenofovir Disoproxil Fumarate vs. Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response to Entecavir

Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic hepatitis B patients. However, about 20% of patients showed partial virologic response after 2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients). Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there is no cross resistance between the two drugs. Therefore it is assumed that tenofovir would be effective in the treatment of chronic hepatitis B patients who shows partial virologic response (detectable HBV DNA by real time PCR after 12 months of treatment) despite treatment with entecavir. In this study, we will compare the efficacy of switching to tenofovir with continuing entecavir in patients who shows partial virologic response to entecavir.

The number of patients needed was calculated using PASS 2008. We hypothesized that two-thirds (65%) of the patients receiving TDF, and one-fifth (20%) of the patients receiving ETV, would achieve virologic response. We also assumed a 15% drop-out rate; thus, 22 patients were needed in each group to achieve 80% power to demonstrate a difference between the groups with a 5% level of significance.

The primary efficacy end point will be analyzed on a per-protocol basis, including only those patients who had completed the treatment schedule of study. In contrast, the intention-to-treat analysis will include all randomized subjects, even those dropped-out from the study before 12 months, as cases of treatment failure.

Eligibility Criteria:
Inclusion Criteria:

1. CHB patients (positive HBsAg more than 6 months)
2. Age 19 years old
3. HBeAg positive or negative patients
4. Patients receiving entecavir 0.5 mg more than 12 months
5. Detectable HBV DNA by real time PCR (HBV \> 60 IU/mL)
6. Compensated liver function (Child-Pugh-Turcotte score ≤7, prothrombin time 3 sec above ULN or INR ≤1.5, serum albumin \>3 g/dL, total bilirubin \<2.5 mg/dL, no history of variceal bleeding, diuretics or ascites requiring paracentesis, hepatic encephalopathy)

Exclusion Criteria:

1. History of treatment with nucleotide analogue other than 0.5 mg of ETV
2. Serum creatinine level \> 1.5 mg/dL or creatinine clearance \< 50 mL/min
3. Absolute neutrophil count ≤ 1000 cell/mL
4. Hemoglobin level ≤ 10 g/dL in men or ≤ 9 g/dL in women
5. Antiviral resistance mutations on rtT184, rtS202, or rtM250 + rtM204V/I
6. A positive antibody test for human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
7. Pregnancy or lactation
8. HCC (in cases where alfa-fetoprotein levels were over 100 ng/mL, abdominal computed tomography or magnetic resonance image was performed to exclude HCC)
9. Untreated malignancy other than HCC.
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.

The objective of this multi-center, open label, single arm, investigator initiated exploratory pilot study is to evaluation of safety and efficacy of transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices), in treating hypertrophic obstructive cardiomyopathy(HOCM).

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 20 years or older
* NYHA(New York Heart Association) Class Ⅱ to Ⅳ in spite of optimal medical treatment. (For optimal medical treatment, β-blocker or diuretic such as calcium antagonists should be given for at least 3 months.)
* Patients with left ventricular effusion gradient (LVOT) greater than (1) 30 mmHg at rest or (2) at least 50 mmHg at physiological exercise/dobutamine administration/balsalva manuver. (The pressure difference due to the left ventricle drain must be the proximal mitral valve-septal contact by the systolic motion of mitral valve (SAM).)
* Patients who voluntarily decide to participate in this clinical trial and provide written informed consent.
* Patients who are able to understand and follow instructions and participate for the entire duration of the clinical trial.

Exclusion Criteria:

* Target area wall thickness ≤15mm
* LV ejection fraction ≤40%
* Subjects who have unsuitable septal vein and coronary sinus anatomy by cardiac CT or venogram
* Conduction disturbance; LBBB or RBBB
* Advanced AV block without permanent pacemaker
* Subjects who have experience in performing vascular stent procedures (PCI) or CABG on coronary arteries close to the coronary sinus within 3 months.
* Severe pulmonary HTN ≥70mmHg
* Patients who have cardiogenic shock and those who have an expected life expectancy of 12 months or less.
* Patients with other valve diseases (companion disease) that require surgical treatment (in this case, Systolic motion of the mitral valve (SAM) caused by systolic myocardia is not considered a companion disease).
* Patients who are pregnant, or lactating, or plan pregnacy during the clinical trials
* Patients who are participated in other clinical trials within 1 month of enrollment
* Patients who are deemed not to be eligible in this study by physician's discretion
Validation of a New Method of Limb Volumetry

Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3D laser scanner.

Water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. The most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured.

Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3D reconstruction.

Its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. This approach will ultimately provide data that will used for designing personalized limb compression ortheses.

In each subject and patient, limb volume will be measured once by water - displacement (WD) and twice by 3D laser scanning (3D), by 2 independent operators, in random order. In a subgroup of patients, measurements will be repeated in the morning and evening, twice a year (during winter and during summer) to estimate the nycthemeral and seasonal effects.

Measurements will be performed in healthy subjects and in patients with chronic venous insufficiency or lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Either healthy adult or - Adult and chronic venous insufficiency C1s, C3, or C5 (CEAP classification) or - Primary lymphedema (between 10-90 years old)

Exclusion Criteria:

* No consent form