cyrilzakka/clinical-trials huggingface dataset:
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.

PRIMARY OBJECTIVES:

I. To obtain results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days.

SECONDARY OBJECTIVES:

I. To achieve a response (cytoreduction or at least partial response) greater that than expected for comparable refractory patient populations with other salvage regimens.

OUTLINE:

A patient receives a drug intervention based on the results of a high throughput sensitivity assay. This assay best matches a drug to the patient's disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria (except acute promyelocytic leukemia), acute leukemias of ambiguous lineage by WHO criteria, or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO classification who have failed 2 inductions at initial diagnosis or failed \>= 2 salvage regimens for relapsed acute myeloid leukemia (AML)
* Patients who have had a 1st remission for \>= 1 year must have received cytotoxic chemotherapy as a salvage regimen
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
* Expectation that we can obtain about 100 million blasts from blood and/or marrow (for example, circulating blast count of 5,000 or greater)
* Bilirubin =\< 1.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum pyruvate glutamate transaminase (SPGT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN, unless elevation in thought to be due to hepatic infiltration by the hematologic malignancy
* Alkaline phosphatase =\< 2.5 X ULN
* Serum creatinine =\< 2.0 mg/dL
* Stable or improving on appropriate antimicrobial therapy for infection, without ongoing fever
* Informed consent
* Willing to use contraception

Exclusion Criteria:

* No other concomitant treatment for leukemia
* No other active cancer that requires systemic chemotherapy or radiation
* Significant organ compromise that will increase risk of toxicity or mortality
* Pregnancy or lactation
Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy

To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide clinical spectrum that encompasses generalized to focal and multifocal forms not only leads to an impaired quality of life, but also to an increased morbidity and mortality . Till now there is no available effective therapy for the treatment of diabetic peripheral neuropathy (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides necessary growth factors that promote wound healing/growth, angiogenesis, and axon regeneration .

Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Method : Prospective double blinded randomized controlled trial was conducted . All included patients had type 2 DM selected from Endocrinology unit Department of Internal medicine, Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were double blindly divided into two groups, Group I underwent PRP preineural injection under ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control group) . Blood glucose was strictly controlled in both groups . Patients were followed every month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means ± standard deviation or frequencies. Independent Student's t test was done for comparison between groups

Eligibility Criteria:
Inclusion Criteria:

* Diabetic peripheral neuropathy of at least 5 years duration of symptoms

Exclusion Criteria:

* hereditary neuropathies , entrapment neuropathies , connective tissue diseases , vertebral diseases , thyroid disorders and end organ failure
Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts

The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein derivative (PPD) antigen immunotherapy alone for multiple common warts

Common warts are benign skin lesions caused by the human papillomavirus (HPV). The dorsal surface of the hands and fingers are the main predilection sites. Cryotherapy is frequently used to eradicate common warts via necrotic destruction of HPV-infected keratinocytes or by inducing of an effective cell-mediated immune response. However, the cure rates of cryotherapy are only around (44-47%) .

Intralesional antigen immunotherapy represents a promising therapeutic approach for the treatment of different types of warts, particularly if multiple and/or recalcitrant.

The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein n immunotherapy alone for multiple common warts.

Although intralesional immunotherapy - compared to conventional therapeutic methods - has been generally along with better outcome, lower incidence of side effects and less recurrence, it is not still approved as a standard method of treatment in patients with wart , because the majority of available studies are open-labeled and randomized, placebo-controlled trials are very scarce.

The immune system plays an important role in the spontaneous resolution of warts. The immune mechanisms against HPV include the development of cell-mediated immune response with activation of T helper1 (Th1) lymphocytes resulting in long-term immunity . Stimulation of the immune system would clear warts in other locations, eliminating the need for the local treatment for each individual wart .

Multiple studies support the use of intralesional PPD injection as an effective and valuable treatment option due to its systemic effect, especially for patients with multiple warts, with the benefit of clearance of both treated and distant warts.

Eligibility Criteria:
Inclusion Criteria:

1. A dults older than 18 years
2. multiple (\>3 warts) common warts .
3. not currently using other treatments for a wart .
4. not had relapsed at least once after treatment with any of the tissue-destructive modalities.
5. Positive tuberculin skin test.

Exclusion Criteria:

* Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.

Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients, 18-50 years of age
* History of either recreational and/or occupational exposure to noise
* Voluntarily consent to participate in the study
* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
* Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria:

* Current use or within 60 days prior to study of excluded ototoxic medications
* History of autoimmune inner ear disease
* History of middle ear or inner ear surgery
* Current conductive hearing loss or middle ear effusion
* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
* Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
* Participation in another investigational drug or device study within 90 days prior to study enrollment
* Female patients who are pregnant or breastfeeding
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV). Infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. Enrollment in Cohorts 2 and 3 will proceed following Data Monitoring Committee (DMC) review of cumulative safety and tolerability data from preceding cohorts. Following completion of DMC review of safety and tolerability data for the cohorts enrolled in Part 1, additional infants will be enrolled and randomized equally to receive either PCV20 or AFX3772 at different dose levels approved for evaluation in Part 2.


Eligibility Criteria:
Inclusion Criteria:

• Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.

Exclusion Criteria:

* Had prior administration of any pneumococcal vaccine.
* Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
* Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
* Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
* Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
* Has received immunoglobulins.
* Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
* Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.
Duration of Use of Highly Effective Reversible Contraception

To assess the proportion of women who use HERC for ≥2 years of duration


Eligibility Criteria:
Inclusion Criteria:

-Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012
Topical Antibiotics and Intravitreous Injections

Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.


Eligibility Criteria:
Inclusion Criteria:

* intravitreous injection

Exclusion Criteria:

* antibiotic use
A Study of KW-6356 in Subjects With Early Parkinson's Disease

The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
* Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
* MDS-UPDRS part III score of ≥ 15

Exclusion Criteria:

* Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
* Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period.
* Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more.
* Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS).
* Either of the following criteria consecutively at screening and enrollment;

  * Resting Pulse \> 100 bpm
  * Resting systolic blood pressure \> 140 mmHg, or diastolic blood pressure \> 90 mmHg
* Significant dementia or a Mini-Mental State Examination (MMSE) score of ≤ 23.
* Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
* Anyone otherwise considered unsuitable for the study by the investigator or sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic renal cell carcinoma with a component of clear cell subtype.
* Prior first line systemic therapy
* At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors \[RECIST 1.1\].
* Adequate hematology, liver and kidney functions
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1.
* Life expectancy of ≥12 weeks.
* Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
* Negative pregnancy test
* Adequate recovery time from prior systemic therapy, surgery or radiation
* Willing and able subjects who have signed consent

Exclusion Criteria:

* More than one prior systemic therapy regimen
* Major bowel-penetrating surgery \<4 weeks
* Active gastro intestinal bleed in past 3 months
* Active peptic ulcer disease in the past 6 months
* Current or anticipated use of potent CYP3A4/5 inhibitors
* Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
* Requirement for therapeutic warfarin or high dose steroids
* Symptomatic or untreated brain metastases
* A serious uncontrolled medical disorder or active infection
* Pregnant or breastfeeding females
* History of another active malignancy
* Dementia
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
* Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.


Eligibility Criteria:
Inclusion Criteria:

1. Participants are 12-18 years of age
2. Participants live with a family (some families may contain only one parent)
3. Family members fluently speak and read English and have access to a computer with internet
4. Participants meet DSM-5 criteria for AN (both subtypes)
5. EBW above 75%
6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
7. Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

Exclusion Criteria:

Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published studies related to CPAP treatment in this patient group. The investigators aim was to assess the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and to recognize and overcome possible difficulties in CPAP initiation and acceptance by these patients.

Recently published studies report a high incidence of obstructive sleep apnea (OSA) in patients with IPF. Underlying, and usually under-diagnosed OSA in these patients may be a reason for impaired sleep quality and may consequently have a negative influence on their daily activities and overall quality of life. In addition, underlying OSA may have a negative influence on the already impaired IPF-related morbidity and mortality. The absence of any effective treatment for IPF so far indicates that the recognition and treatment of generally under-diagnosed OSA in IPF patients should be a primary goal. Therefore, our primary aim in this study was to assess the results of effective CPAP therapy in terms of sleep quality and overall quality of life in IPF patients with moderate to severe OSA. The investigators used generally accepted instruments to assess quality of sleep and overall life. In addition, the investigators tried to determine and overcome the reasons for poor CPAP compliance in these patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with apnoea-hypopnoea index \>15/h
* Newly diagnosed IPF

Exclusion Criteria:

* Congestive heart failure
* Chronic renal failure
Autohypnosis and Cancerology

Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient.

Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy.

In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy.

The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management.

The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.


Eligibility Criteria:
Inclusion Criteria:

* Age superior or equal to 18 years old
* Colorectal or breast cancer history, treated by surgery and that should undergo an adjuvant chemotherapy

  * In the case of breast cancer, adjuvant chemotherapy must involve anthracyclines
* ECOG performance score \< 3
* Patient must be affiliated or beneficiary of social security or any similar regime

Exclusion Criteria:

* Patients already included in another interventional clinical research protocol
* Patients unable to proceed to hypnosis treatment due to their speech limitations (poor comprehension and expression of french, deafness, mental illness)
* Patients protected by French law from clinical inclusion ( pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation...)