cyrilzakka/clinical-trials huggingface dataset:
Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas

To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell


Eligibility Criteria:
Inclusion Criteria:

* The subjects are voluntary and sign the informed consent form;
* ECOG score 0 to 2;
* The expected survival time ≥3 months;
* Patients with cutaneous T-cell lymphoma confirmed by histopathology, with measurable lesions, with or without systemic lymph node involvement; clinical stage IB-IVA;
* The patients previously receive at least once of systemic therapy (including systemic electron beam irradiation or chemotherapy, stem cell transplantation) and do not achieve remission (including remission period shorter than 30 days after the treatment;
* An interval of at least four weeks after the target tumor was treated with chemotherapy, radiotherapy, biological therapy, stem cell transplantation or other study drugs;
* Subjects at childbearing age agree to take effective contraceptive measures during the study; blood pregnancy test result is negative (except infertility due to menopause or operation);
* Laboratory tests (blood routine, liver and kidney function) meet the following requirements:

  1. ANC≥ 1.5×109/L; b) PLT ≥ 75×109/L; c) Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ; e) TBIL ≤ 1.5x ULN; f) AST or ALT ≤2.5 x ULN.

Exclusion Criteria:

* Pregnant or lactating women;
* An allergic history to anthracyclines or liposome drugs;
* Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
* Patients who once used mitoxantrone injection;
* Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose\> 360mg/m2, or epirubicin with the total cumulative dose \> 600mg/m2;
* Left ventricular ejection fraction is \< 50% or \< the lower limit of normal; clinically significant QT interval prolongation (\>450ms in male, \>470ms in female); a past history of cardiac disease caused by anthracyclines; a history of severe heart disease;
* Concomitant treatment as other anticancer drugs are needed;
* With internal organ involvement (including bone marrow, central nervous system;
* Clinically active infection that can significantly affect the clinical trial;
* Within 6 weeks after organ transplantation or major organ surgery;
* Those who are inappropriate to be enrolled as evaluated by the researchers.
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).


Eligibility Criteria:
Inclusion Criteria:

* Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
* Suspected bacterial infection at time of surgery in at least 1 ear.
* Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
* Legally Authorized Representative (LAR) must read and sign the informed consent.
* Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
* Middle ear pathology in either ear other than otitis media.
* Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
* Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
* Other protocol-specified exclusion criteria may apply.
Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

Exclusion Criteria:

* Levin tube or gastrostomy tube in situ
* Decline to participate
rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

Based on the individualized positioning technology of diffusion tensor imaging (DTI), the purpose of this study is to explore a new stimulation target and protocol for the treatment of bipolar disorder in remission through the repetitive transcranial magnetic stimulation(rTMS) and transcranial alternating current stimulation（tACS）under neuronavigation，verify whether there is abnormal functional connectivity and structural connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission, which will contribute to further understand the relevant neural pathway and mechanism.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 14-45 years old, regardless of gender\] 2.Meet DSM-V diagnostic criteria for bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points; 4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire PDQ≥17 points; 6.Han nationality, right-handed; 7.More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy;
6. ECT or rTMS or tACS treatment was performed within six months.
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients

Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the heart muscle called myocardial stunning. This may occur for many reasons, including removal of fluid during dialysis or low blood pressure. Initial ischemia and subsequent white blood cell infiltration into the injured myocardium play a critical role in the degree of myocardial ischemia reperfusion injury.

In this study an additional man made membrane (selective cytopheretic device) and tubing will be added to the dialysis circuit. The device shifts the circulating white blood cells pool to a less inflammatory phenotype. Researchers believe the selective cytopheretic device will alter the phenotype of circulating white blood cells which play a role in myocardial stunning.

The purpose of this study is to evaluate whether the selective cytopheretic device will reduce myocardial stunning events in hemodialysis patients. It will also report the rate of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease (Chronic Kidney Disease Stage 5)
* Receiving hemodialysis 3 times/week for over 3 months
* Baseline blood pressure before hemodialysis has been ≥ 100/50 over preceding 4 weeks
* Recurrent weight gain between hemodialysis sessions

Exclusion Criteria:

* Any active inflammatory condition (e.g., gout, systemic lupus erythematosus flare, hepatitis B or C infection, allograft rejection, subcutaneous injection of illicit drugs, "skin popping")
* Treatment with immunosuppressive therapy within 30 days of study
* Blood levels within a specified range
* Woman who is pregnant, breast feeding a child, or is trying to become pregnant
* Heart weakness or failure
Open Versus Arthroscopic Release for Lateral Patellar Compression Syndrome: Comparative Study

Chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "Lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as knee flexion progresses. Eighty patients were involved in this study, and it was divided into 2 random groups; Group A (40 patients)(odd number) were treated with open release after diagnostic arthroscopy and Group B (40 patients)(even number) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy. All patients were followed by Lysholm knee scaling score before surgery and two weeks , six weeks then 6 months after surgery.

This study was done by two orthopedic surgeons working in three hospitals from March 2016 to April 2018, Eighty patients were involved in this study, and it was divided into 2 matched groups; Group A (40 patients) were treated with open release after diagnostic arthroscopy and Group B (40 patients) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI ( figure 1)and diagnostic arthroscopy. All patients were followed by Lysol knee scaling score before surgery , two weeks , six weeks then 6 months after surgery. The two groups are matched related to age and gender. 52 patients are females and age ranged from 21-48 years.

Exclusion criteria are 1. Smoking 2.Patellar instability 3. D.M 4. Knee osteoarthritis 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity

Eligibility Criteria:
Inclusion Criteria:

* All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy.

Exclusion Criteria:

1. Smoking
2. Patellar instability
3. D.M 4. Knee osteoarthritis

5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients

This study is an open phase II clinical study, which consists of part a and Part B. Part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable HCC to And pk/pd characteristics, and determine the treatment plan of Part B. Part B will evaluate absk-011 combined with atilizumab Anti Fgf19 overexpression in advanced stage or non resectable patients who have not received systemic therapy or only received first-line systemic therapy before In addition to the safety and tolerability of HCC subjects, the antitumor activity of the combination will be further evaluated.

During part a, all subjects will receive continuous oral administration of absk-011 once a day (QD) or twice a day (bid) with an initial dose of 180 mg, and intravenous infusion (IV) of 1200 mg of atilizumab every 21 days (q3w). After the first subject (sentinel subject) in each dose cohort completed the first combined medication, follow-up subjects were administered at least 7 days later.

Part B will include subjects with advanced unresectable HCC who have not previously received systemic therapy or only received first-line systemic therapy and whose Fgf19 expression is positive. No more than 70% of the enrolled subjects have only received first-line systemic therapy

Eligibility Criteria:
Inclusion Criteria:

1. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. Subjects should be able and willing to follow the study follow-up and study procedures in the protocol.
2. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old.
3. part a: subjects with advanced or unresectable HCC who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child Pugh score is 5-6.

Part b: subjects with advanced or unresectable HCC who must be confirmed histologically or cytologically, are not suitable for curative surgery and / or local regional treatment, and have not previously received systematic treatment or only received first-line systematic treatment-

Exclusion Criteria:

1. history of autoimmune diseases
2. have a history of the second primary malignant tumor other than HCC within 5 years before screening,
3. have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels.
4. meningeal metastasis or central nervous system (CNS) metastasis -
Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers

The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.

There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

* ≥Age 18 years (no upper age limit)
* Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment.
* Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill
* Ability to read English (required for CGA)
* Curative treatment intent as defined by their radiation oncologist
* Negative serum pregnancy test in women of childbearing potential

Exclusion Criteria:

* \< Age 18 years
* Incurable cancer as defined by their radiation oncologist
* Planned radiation for palliative intent only
* Inability to complete the I-ADL section of the CGA
* Prior radiation to areas targeted by radiotherapy within this study
* Other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of:
* Localized squamous cell carcinoma of the skin
* Basal-cell carcinoma of the skin
* Other malignancies requiring locally ablative therapy only
Nutrition Protocol and Premature Infants' Growth

Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes.

This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.


Eligibility Criteria:
Inclusion Criteria:

* All surviving infants born between 26 and 32 weeks gestation in our Level III NICU

Exclusion Criteria:

* Death
* Any congenital malformation
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors

Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.


Eligibility Criteria:
Inclusion Criteria:

* 6-30 years of age
* 2 years from the completion of therapy for cancer
* free of active disease

Exclusion Criteria:

* \<6 or \> 30 years of age
* current cancer treatment or inside of 2 years post treatment
* Active disease/infection
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

To determine response rate, median time to tumor progression, qualitative and quantitative toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions.

Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2 additional courses those who achieve partial response or stabilization, continue therapy until progression.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Microscopically confirmed diagnosis of KS associated with HIV for which systematic therapy is medically indicated by the presence of at least one of the following:

A. \>= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C. Symptomatic lymphedema (pain).

* Minimum of 5 clearly measurably cutaneous lesions by physical exam or measurable disease by X-ray, CT or MRI.
* Failed at least one systemic chemotherapy regimen.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Less than 2 weeks since major surgery.
* Serious uncontrolled infection. NOTE:
* Must be ruled out by thorough work-up in patients with unexplained fevers, night sweats, or involuntary weight loss of more than 10% normal weight.
* Leukopenia.
* Thrombocytopenia.

Patients with the following prior conditions are excluded:

* History of angina or myocardial infarction within the past 6 months.
* Second degree or third degree atrioventricular block without a pacemaker.
* Congestive heart failure (poorly controlled).
* History of prior malignancy except:

Completely excised in situ, carcinoma of the cervix or nonmelanomatous skin cancer.

Curatively treated other malignancy with no evidence of disease for at least 5 years.

Prior Medication:

Excluded:

Prior taxane therapy.

Required:

* At least one systemic chemotherapy regimen that failed to maintain significant benefit. NOTE:
* Intralesional chemotherapy regimens are not considered as prior chemotherapy.
* At least 2 weeks since last dose of prior systemic chemotherapy.
PMCF Study to Examine the Debridement Pad Cutimed DebriClean

Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice

60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product.

Per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older with full legal competence
* Signed informed consent
* Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
* Superficial wound
* Minimum 30 % of the wound is covered by debris, necrosis or slough
* Wound size \> 4 cm²

Exclusion Criteria:

* Subjects not willing to participate or to attend the scheduled study visit
* Known sensitivity or allergy to the product components
* Severe pain or hyperaesthesia in the wound area
* Patients who are pregnant or lactating
* Drug abuse or alcohol abuse
* Patients who participate in any other clinical study investigating drugs or medical devices
Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47

The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.

A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.

This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy adults ≥ 18 to \</= 65
* female subjects: post-menopausal or practicing reliable methods of contraception during the study

Exclusion Criteria:

* History of autoimmune diseases and malignancies.
* History of severe hypersensitivity reactions and anaphylaxis.
* Immunodeficiency due to immunosuppressive therapy.
* Infection with HIV, Hepatitis B or Hepatitis C.
* Pregnancy, lactation
* Vulnerable subjects