cyrilzakka/clinical-trials huggingface dataset:
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma

The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ECOG 0,1,2,3
* Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy
* Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
* Subjects with relapsed PCNSL and are able to receive biopsy

Exclusion Criteria:

* Subjects that are not DLBCL type pathologically
* Intraocular PCNSL without evidence of brain disease
* Subjects who cannot undergo MRI assessments
* Relapsed PCNSL patients who cannot undergo biopsy
* Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
* Subjects with other malignancy
* Subjects with history of any inflammatory CNS diseases
* Subjects with an active, known, or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply
A Randomized Double-Blind Placebo Controlled Trial to Determine the Status of Post Knee Chondroplasty Patients Administered Theramine Versus Placebo in Addition to Post Surgery Analgesics

The purpose of this study will be to show the patient response to analgesics taken post surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The data collected will be used to show that patients have a shorter and lower post operative pain measurement and the time to discontinuation of analgesics is less in the active comparator group.

No other decription

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed knee pain requiring chondroplasty knee arthroscopic surgery.
* Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent.
* If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-consultants), treatment must be stable for at least three (3) months prior to study.
* For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study.
* Must be willing to commit to all clinical visits during study-related procedures.
* Require use of narcotics for pain relief.

Exclusion Criteria:

* Patients with significant neurologic impairment, as diagnosed on screening physical examination.
* Patients not fluent in English.
* Patients currently involved in a Workman's Compensation case related to this procedure.
* Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening.
* History of substance abuse.
* History of malignancy, other than basal or squamous cell of the skin within the last 5 years.
* Tibial plateau fracture within 6 months prior to surgery.
Cell Therapy in HFpEF

The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome.

The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.

In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the immunomagnetic positive selection of the CD34+ cells.

Eligibility Criteria:
Inclusion Criteria:

* Preserved left ventricular systolic function on echocardiography (LVEF\>50%)
* Evidence of diastolic dysfunction by echocardiography (E/e'\>15)
* Symptoms of heart failure
* NT-proBNP levels \>300 pg/ml
* absence of permanent atrial fibrillation

Exclusion Criteria:

* acute multi-organ failure
* history of any malignant disease within 5 years
* diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
* pregnancy
The Benefits of Vibrating Floors for Deaf Children

In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via vibrations. One such tactile tool used by speech therapists is the vibrating floor, which enables the child to feel sounds through the vibrations perceived by his or her body. Although used in many institutions, there is very little scientific evidence to date of the effectiveness of using the vibrating floor with deaf children.


Eligibility Criteria:
Inclusion Criteria:

* Deaf children whose project is to develop oral French language skills
* Deaf children with cochlear implants or hearing aids
* Children with previous experience of the vibrating floor

Exclusion Criteria:

* intellectual disability
* impairment
Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial

To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema

Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B \& C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT

Eligibility Criteria:
Inclusion Criteria:

Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.

Exclusion Criteria:

Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-72 years of age
* Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators

Exclusion Criteria:

* Planned concomitant glenoid labral repair
* Previous open shoulder surgery
* Neurological deficit or other disability involving the surgical extremity
* Anyone with a documented allergy to bupivicaine
* Subjects that are not mentally competent to give consent
* Pregnant women
* Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication
Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

* Immediate unaided high and low contrast visual performance
* Its impact on quality of life.

Phacoemulsification procedure

* Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)
* Anaesthesia: topical
* Incision: temporal clear corneal 2.2 mm single plane
* CCC and hydrodissection, sculpting and division using step by step chop in situ and lateral separation, I/A.
* Single-piece AcrySof IOL (SN60WF) in the bag

SICS procedure

* Anaesthesia: peribulbar
* Incision: superior scleral tunnel 6.5 to 7 mm
* CCC and hydrodissection
* Nuclear expression: blumenthal technique using anterior chamber maintainer, manual cortical clean-up
* Single-piece PMMA (MZ60BD) in the bag

Eligibility Criteria:
Inclusion Criteria:

* Prospective subjects should be diagnosed with senile cataract. Subject must require extraction of cataract in one eye followed by implantation of an AcrySof (SN60WF) or PMMA (MZ60BD) posterior chamber intraocular lens.
* Pupil dilation equal or greater to 7 mm after mydriasis.
* Patients undergoing cataract surgery for the first eye.
* Visual prognosis equal or greater to 6/12.

Exclusion Criteria:

* Patients with history of ocular pathology, glaucoma, uveitis, high myopia, PEX, or corneal pathology.
* Patients with traumatic, subluxated and posterior polar cataract.
* Patients who had previously ocular surgery in the past 6 months prior to the screening visit.
* Patients with diabetic retinopathy.
* Patients who are not suitable for follow-up visits.
* Patients with Fuchs' Dystrophy, Macular Degeneration, Ocular Surface Disease that will interfere with normal recovery.
* Any patients with significant intra-operative complications will be removed from the overall analysis of the results. All patient data should still be recorded, even if from the "excluded" patient group.
Danhong Injection in the Treatment of Chronic Stable Angina

The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients


Eligibility Criteria:
Inclusion Criteria:

* Female or male inpatients.
* Age: 18 - 70 years.
* Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in angina ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5.
* Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

* Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
* Woman who disagree with contraception during treatment period
* Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
* Patients who were angina-free during the run-in period without taking any drug.
* Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
* Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
* Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
* Patients with history of hematopoietic system diseases.
* Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
* Patients who is participating in other trials or has been participated in other trials in recent 3 months.
* Patients with history of allergy or suspected allergic to the drug.
* Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
* Patients with mental disorder.
* Patients who were unable to participate in the study as judged by investigator.
* Patients who were family members or relatives of the research center staffs.
Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing

This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study.

The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.

This clinical trial is conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.

Statistical method: analysis will be performed using R software version 4.0.2. or higher. All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk). All efficacy evaluation will be done on the Per Protocol Set.

The categorical variables are summarized by frequency and percentage for each response category (N, %). The continuous variables are summarized using means, medians, minimum, maximum, and standard deviations for the data collected at each visit.

Sample size determination: A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91% at a risk alpha of 0.05 and assuming a common standard deviation of ±2.7 days. Twenty-five (25) subjects will be included in the study to take into account possible dropouts.

Eligibility Criteria:
Inclusion Criteria:

* phototype II and III on the Fitzpatrick scale
* subjects with normal clinical examination and medical history compatible with the study

Exclusion Criteria:

* subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology
* subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study
* subject who has taken systemic treatment for more than 5 days in the month prior to inclusion
Safety of Hib Vaccine (Bio Farma)

The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 - 40 years old)
* Provision of written informed consent
* Good health according to the clinical investigator
* Willingness and ability to adhere to the regimen of the study

Exclusion Criteria:

* Known not enrolled in other study
* Pregnancy or lactation
* Known or suspected allergy to any of the vaccine component (by medical history)
* History of unusual reaction to any previous vaccination
* Known or suspected immune deficiency, or use of medication that may influence the immune system
* Prior respiratory infection
* Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
* Acute febrile illness (temperature \> 37.5 Celsius)
* Present evidence of serious diseases demanding medical treatment
* Any significant congenital or chronic disorder
Post-Market Clinical Investigation of the IotaSOFT Insertion System

The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject

available iotaSOFT Insertion System when used per intended use for insertion of a cochlear implant electrode array in subjects 12 years and older. The purpose of the study is to collect additional safety data in retrospective and prospective subjects. The primary object of the study is to demonstrate post-market safe use of the commercially available iotaSOFT Insertion System. The secondary objective of the study is to define procedural characteristics including device deficiencies, electrode array insertion speed, rate of tip fold-over, and objective measures of cochlear implant functionality to demonstrate effective use of the commercially available iotaSOFT Insertion System.

Eligibility Criteria:
Inclusion Criteria:

1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:

   1. Advanced Bionics HiFocus SlimJ
   2. Cochlear Slim Straight
   3. MED-EL Flex 24 and 28
2. Age 12 years or older at the time of CI surgery.
3. Willingness to participate in the study and able to comply with the follow-up visit requirements.

Exclusion Criteria:

1. Prior cochlear implantation in the ear to be implanted.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
3. Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
4. Deafness due to lesions of the acoustic nerve or central auditory pathway.
5. Diagnosis of auditory neuropathy.
6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
7. Absence of cochlear development.
8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
10. Non-native English speakers who are unable to read, understand and/or speak English for completion of required procedures
11. Planned or current participation in a clinical study of an investigational device or drug.
12. Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56
Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be enrolled in LifeScan Patient Registry.
* Participants must have read the Information sheet and signed an informedconsent form \>prior to study participation.
* Participants must be 16 years or older.
* Participants must be diagnosed with Diabetes

Exclusion Criteria:

\> Participants not enrolled in the LifeScan Patient Registry
Left Ventricular Aneurysms in Children

Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.

Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.

We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":

Mostly occur after:

Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract

We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:

* Procedures including the dates performed
* Medications
* Physical Exam Findings
* Weight
* Gestational Age
* Outcome

Eligibility Criteria:
Inclusion Criteria:

* aneurysms between 6.30.2002 and 6.30.2004

Exclusion Criteria:

* those children who do no meet inclusion criteria