cyrilzakka/clinical-trials huggingface dataset:
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with mild to moderate open angle Glaucoma.
2. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
3. IOP \< or = to 36 mmHG while on one to four ocular hypotensive medications
4. Shaffer grade of \> or = III in all four quadrants
5. Able and willing to comply with the Protocol and follow up visits for 12 months

Exclusion Criteria:

1. Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
2. History of iStent or iStent inject within 180 days of the screening visit
3. History of ECP or Micropulse laser
4. Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
5. Prior canaloplasty (ab interno and ab externo)
6. Prior goniotomy or trabeculotomy
7. History of Hydrus microstent or suprachoroidal stent
8. History of cataract surgery within 6 months of screening
9. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
PK and PD Study of NPI-001 and Cysteamine Bitartrate

Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.

This study will examine the safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients, aged ≥ 10 years. The ability of NPI-001 to reduce cystine will be assessed and compared with cysteamine.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, any race, ≥ 10 years of age.
2. Diagnosis of nephropathic cystinosis and able to cease cysteamine therapy for 2 days.
3. Females will be nonpregnant and nonlactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol.
4. Able to comprehend and willing to sign an informed consent /assent form and to abide by the study restrictions (travel as necessary, clinical phase 1 unit or similar for up to 3 days).

Exclusion Criteria:

1. Have undergone kidney transplantation.
2. Are receiving dialysis treatment.
3. History of significant hypersensitivity to NAC or any ingredient of NPI-001 oral solution.
4. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the 30 days prior to Day 1.
5. Inability to provide blood samples, including difficulty with venous access.
6. Subjects who, in the opinion of the Investigator and/or Sponsor (or designee), should not participate in this study.
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)

* Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
* Both acute and long-term toxicity are equal in both treatment arms.

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

1. To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
2. To evaluate acute and long-term toxicity in both treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* High risk acute lymphoblastic leukemia
* Not eligible for bone marrow transplantation
* Age 1-18
* Written informed consent has been obtained

Exclusion Criteria:

* Persistent NCI grade 3-4 neurotoxicity from previous treatments
* Bilineage ALL
* Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia)
* Previous cancer
* Known intolerance to NOPHO ALL 2008 anticancer agents
* Sexually active females will use safe contraceptives
* Previous treatment with intrathecal liposomal cytarabine
Impact of Focused Echocardiography in Management of Patients in Pediatric Intensive Care Units

Echocardiography is currently considered a key tool for the hemodynamic assessment in Intensive Care Units (ICU), able to identify causes of hemodynamic instability and to quickly guide therapy . Some of its advantages are being a noninvasive method, risk-free, capable of being performed serially and in real time, and analyzed along with clinical data by intensivists. Several studies have demonstrated the positive effect of the use of echocardiography in the management of critically ill patients, changing their treatment in 30%-60% of cases after the test is performed . Echocardiography has been used as an adjunct in predicting patient outcomes. Relevant and easily obtain-able information about hemodynamics is required for effective therapeutic manipulation of circulation in critically ill children ,Hemodynamic monitoring of critically ill infants and children noninvasively using echocardiography has been evaluated comprehensively Echocardiography is an influential procedure that allows direct visualization of the heart, guiding patients' hemodynamic condition at the bedside. This hemodynamic estimate informs physicians to guide therapeutic approaches like volume resuscitation, initiation, discontinuation, alteration of vasopressor therapy and referral for specialist rapidly if cardiac or surgical attempt is necessary Management of critically ill pediatric patients is a demanding task that requires proper prioritization and judicious time management. Multi-system affection with overlap of symptoms often complicates the clinical picture. Hemodynamic assessment has recently taken top priority in the management of critically ill patients, Echocardiography is an integral component of the clinical service in the pediatric intensive care unit (PICU). It is considered a handy bedside imaging modality, and an accurate diagnostic tool that explores a crucial body system. Indications of bedside echocardiography in TINEC (training in intensive care and neonatal echocardiography) include assessing cardiac function, pulmonary hypertension, severe pericardial effusion, and tamponade. Consequently, it serves as a guide for interventions in critically ill pediatric patients and management .


Eligibility Criteria:
Inclusion Criteria:

* All critically ill patients admitted to pediatric intensive care units aged from 1 month Up to 18 years old.

Exclusion Criteria:

* non crtical ill patients
Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle.

No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints. Correlation is made to ultrafiltrated volume (UFV).


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for hemodialysis
* signed Informed Consent Form

Exclusion Criteria:

* acute intercurrent disease,
* subjects with known hypersensitivity to plasters (adhesive or gel).
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled for a cardiac catheterization procedure
* Adult patients over the age of 21
* Acceptable baseline echocardiographic images in the supine position
* If a female of child-bearing potential, must have a negative pregnancy test
* Provide written informed consent

Exclusion Criteria:

* Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome
* Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary
* Patients with anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts where Definity could traverse as a bolus
* Patients with known hypersensitivity to Definity
* Females who are pregnant or nursing
Effects of Online Yoga on the Quality of Life of Breast Cancer Patients

This study investigates the effects of two different online yoga interventions on the health-related quality of life in breast cancer patients. Qualitative and quantitative data will be collected.

In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:

* Intervention group 1 will receive an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study mainly includes physical and relaxation exercises.
* Intervention group 2 will receive a meditative yoga intervention online including physical and meditation exercises and also ideologically neutral explanations of the ethical aspects of yoga.
* Group 3 consists of a waiting list control group, combined with the offer to participate in a yoga intervention after 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of non-metastatic breast cancer (TNM stage I-III) up to 5 years after diagnosis
* Primary therapy completed for at least 3 months
* Limitation of the quality of life due to the cancer (indication of at least 4 out of 10 points on the numerical analogue scale)
* Willingness to participate in the study and signed informed consent.

Exclusion Criteria:

* Current or planned chemotherapy, radiation or surgery
* Severe physical or psychopharmacologically treated psychiatric comorbidity due to which a patient is unable to participate in the study
* Pregnancy/breastfeeding
* Participation in other clinical trials with behavioral, psychological, or complementary medicine interventions
* Immobility or limitation for gymnastic exercise due to orthopedic, neurologic, or other medical cause
* regular meditation practice \>2x/month
* regular yoga practice \>2x/month
Bone and Body Comp: A Sub Study of the SECOND-LINE Study

The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis are also common in HIV-infected patients. There appears to be some association between ART and bone loss, but this is poorly understood and requires further research. The SECOND-LINE study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently standard of care. This study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used in second line therapy result in more or less bone loss than use of other classes of anti-HIV drugs such as protease inhibitors or N(t)RTI combinations.

It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).


Eligibility Criteria:
Second-Line main study identifier: NCT00931463

Inclusion Criteria:

1. HIV-1 positive by licensed diagnostic test
2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for ≥ 24 weeks
4. No change in antiretroviral therapy within 12 weeks prior to screening
5. Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (≥7 days apart) HIV RNA results of \> 500 copies/mL
6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
7. Able to provide written informed consent

Exclusion Criteria:

1. The following laboratory variables:

   * absolute neutrophil count (ANC) \< 500 cells/µL
   * hemoglobin \< 7.0 g/dL
   * platelet count \< 50,000 cells/µL
   * ALT \> 5 x ULN
2. Pregnant or nursing mothers
3. Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
4. Use of immunomodulators within 30 days prior to screening
5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
6. Intercurrent illness requiring hospitalisation
7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
8. Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
9. Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients

The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical care

Exclusion Criteria:

* Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication
* Other protocol-defined inclusion/exclusion criteria may apply
Optical Assessment on Brain Death Via a Oxygen Supply Procedure

This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

Brain death is an irreversible loss of all brain functions, and the assessment is crucial for organ supply for transplantation. The noninvasive, sensitive, universally available and timely ancillary method to assess brain death has not been established. This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment. The concentration changes ratios of oxyhemoglobin to deoxyhemoglobin (Δ\[HbO2\]/Δ\[Hb\]) in the cerebral cortex of brain-dead patients were significantly higher than those of healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had brain death or serious brain trauma.
* Healthy people who are interested in optical assessment of hemodynamic parameters

Exclusion Criteria:

* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan of surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.

  * AIDS, Active Hepatitis, Tuberculosis, Syphilis
  * Patients who regularly take anticoagulants, antiplatelet drugs
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* History of persistent bronchial asthma for at least 6 months
* FEV1 50-90% of predicted

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* History of life-threatening asthma
* Premature birth
* Current smoking
* Smoking history with either equal or more than 10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
PaCIFiC-CUP Classifies Cancer of Unknown Primary

This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.


Eligibility Criteria:
Inclusion Criteria:

1. The patient specimens were obtained from the Sun Yat-sen University Cancer Center and affiliated cooperating centers, with written consent from the patients authorizing the use of the specimens for research purposes.
2. Following standard assessments (medical history, physical examination, complete blood count, biochemistry, computed tomography scans of the neck, chest, abdomen, and pelvis, targeted evaluations of all symptomatic areas, pathology, and immunohistochemistry), the diagnosis was determined as a primary site unknown tumor (including adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, sarcoma, etc).
3. The diagnosis was confirmed at the participating institution and the patient had received systemic therapy.
4. Complete clinical, pathological, and follow-up data for the patients can be obtained.
5. ECOG performance status score: 0-2 points.

Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Tumor tissue sample size is too small (tumor tissue accounts for \<70% in the biopsy or slice tissue).
3. Organ transplant or history of non-autologous (allogeneic) bone marrow or stem cell transplantation.
4. History of previous tumors, with the current condition being a recurrent tumor.
5. Hematological malignancies (excluding lymphoma).
6. Other diseases that may severely impact patient survival, such as severe cardiovascular or cerebrovascular diseases, sepsis, severe trauma or burns, etc.
Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.

This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.

After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks.

At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.

Eligibility Criteria:
Inclusion Criteria:

* Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
* Patient on \>5 mg prednisone for pulmonary indications
* FVC \<85% predicted
* Prednisone dose not reduced in prior 3 months
* Deterioration of pulmonary disease over the past year
* Decrease in FVC \>5%
* Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).

Exclusion Criteria:

adrenal insufficiency (Addison's disease)

* Scleroderma
* a fungal infection
* herpes infection of the eyes
* osteoporosis
* a stomach ulcer
* congestive heart failure
* high blood pressure
* recent surgery
* if you are allergic to pork proteins
* Do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin.
* Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab) in prior six months
* Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
* Patients requiring therapy for pulmonary hypertension
* Females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening.
* Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days)
* Any other condition that the investigator feels would pose a significant hazard to the patient if Acthar Gel therapy is initiated.