cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies

An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies

This is an open, multi-center, randomized trial comparing the clinical outcomes of haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies. This study is indicated for patients with hematological malignancies including acute leukemias and MDS who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 88 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.

Eligibility Criteria:
Patient Inclusion Criteria:

* Patient age 13-78 years
* Absence of a suitable HLA identical related or unrelated hematopoietic stem cell donor
* Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50
* Presence of both HLA haploidentical young non-first-degree (age ≤ 40) and older first-degree (age \>50) donors

Eligible diagnoses:

AML（excluding APL） with at least one of the following:

* median- or high- risk according to the WHO prognostic stratification system
* failure to achieve CR after 2 cycles of induction chemotherapy
* AML arising from MDS or a myeloproliferative disorder, or secondary AML
* patients in CR2 or beyond

Mixed-phenotype acute leukemia (MPAL) in morphological remission Acute lymphoblastic leukemia (T or B) in morphological remission

MDS with at least one of the following:

* IPSS score of INT-2 or greater
* IPSS score of INT-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions

  * A first allo-HCT
  * Adequate end-organ function
  * ECOG performance status \< 2
  * No other contraindications for HSCT
  * Signature of the informed consent

Patient Exclusion Criteria

* Availability of suitable HLA identical related or unrelated hematopoietic stem cell donors
* Availability of suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50
* Not the first allo-HCT
* Presence of uncontrolled bacterial, viral, or fungal infection
* Patients with severe heart, lung, liver and kidney insufficiency
* HIV-positive patients
* Women of childbearing potential who are pregnant (β-HCG+) or breast feeding
* Patients with a psychiatric history
* ECOG performance status ≥ 3
* Patients with malignancies other than the primary disease
* Refusal to sign the informed consent

Donor Inclusion Criteria:

* The donor and recipient must be HLA haploidentical
* Meets institutional selection criteria and medically fit to donate
* Lack of recipient anti-donor HLA antibody

Donor Exclusion Criteria:

* The donor and recipient are HLA identical
* Has not donated blood products to recipient
A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test

The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.

The study will assess the IdeS efficacy in creating a negative crossmatch test (XM) in patients who exhibit donor specific antibodies (DSA) and have a positive crossmatch test to their available live or deceased donors. The first 3 patients in this study will receive a kidney from a deceased donor. The study will primarily examine the efficacy of IdeS in creating a negative XM. The first 3 patients will receive one dose of 0.25 mg/kg BW IdeS on study day 0. If it is considered safe and negative crossmatch test is not achieved after the first dose, an additional IdeS infusion can be given within 2 days of the first infusion. The dose schedule may be increased to 0.5 mg/kg BW given once or twice after the first 3 patients have been tested. The decision to escalate the dose will be done after evaluation of safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. The breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation.
* Patients with a live or deceased donor with a positive crossmatch test.

Exclusion Criteria:

* Previous treatment with IdeS
* Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment
* Lactating or pregnant females
* Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception
* HIV-positive patients
* Patients with clinical signs of HBV or HCV infection
* Patients with active tuberculosis
* A significantly abnormal general serum screening lab result according to the investigator's judgement. Hgb cannot be \< 6.0 g/dL
* Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
* Individuals deemed unable to comply with the protocol
* Patients with clinical signs of CMV or EBV infection
* Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions
* Patients should not have received investigational drugs within 4 half-lives (or similar)
* Known allergy/sensitivity to IdeS infusions
* Patients who have a live donor and test positive for ImmunoCap anti-IdeS IgE
Management of Cardiovascular Risk Factors

This practical experience should report a retrospective collection of data regarding cardiovascular risk factors of cardiovascular diseases. The goal is an evaluation of the development of the risk profile of cardiovascular patients with simultaneous treatment of hypertension and hyperlipidemia


Eligibility Criteria:
Inclusion Criteria:

* Patients received a anti-hypertension treatment in addition to cholesterol lowering treatment during the observation period
* Patients received a cholesterol lowering treatment in addition to hypertension treatment during the observation period
* Patients received during the observation time new cholesterol lowering and hypertension treatment

Exclusion Criteria:

* Patients received during the observation time only cholesterol lowering or only anti-hypertension treatment
Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment

The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.

An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.

MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.


Eligibility Criteria:
Inclusion Criteria:

1. Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.
2. Males or females ≥ 18 years of age at the time of signing the ICD (if informed consent is applicable)
3. Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available
4. Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:

A. Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.

Exclusion Criteria:

* no exclusion criteria.
Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery

This is a prospective study looking at the effects of dexmedetomidine on pacemaker function in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The use of dexmedetomidine will be left up to the discretion of the treating physicians. The study will involve only the collection of data regarding the amplitude required to capture and specific demographics and intraoperative features including cross clamp time, time on CPB, and vasoactive agents that were and are being administered. In addition to these data, it will be noted whether dexmedetomdine was used or not and whether it is being administered on arrival to the CTICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients with temporary surface pacemaker leads following surgery for congenital heart disease.

Exclusion Criteria:

* Patients with single ventricle anatomy
* Patients receiving epinephrine
* Infants less than 6 months of age
Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM

The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer

To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men aged ≥40 years and life expectancy of ≥10 years.
* Serum prostate-specific antigen (PSA) ≤15 ng/mL.
* Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
* Radiological stage T1-T2 N0 Mx/M0 disease.
* A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.

Exclusion Criteria:

* Previous radiation therapy to the pelvis.
* Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
* Use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
* Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
* Inability to tolerate a transrectal ultrasound (TRUS).
* Known allergy to latex or gadolinium (Gd).
* Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, thermal or microwave therapy to treat cancer of the prostate.
* Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc. likely to contribute significant artifact to images).
A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

It was hypothesized that 200 participating doctors would provide the survey with sufficient statistical precision to meet the objectives, with each participating doctor recruiting up to 6 patients. An initial sample of 1000 doctors should be contacted (letter, phone).

These 1000 doctors will initially be chosen at random from a file held by Pfizer of doctors who have agreed to take part in a Pfizer survey.

These doctors will be experienced and qualified in the treatment and management of patients with non-metastatic, surgically-treated breast cancer (medical oncologists, gynaecologists, and medical oncologists/ radiation oncologists). They are practicing in general hospitals, teaching hospitals, CRLCC cancer centres and private clinics treating patients with breast cancer.

Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on December 3, 2010. There were no safety concerns involved in the decision to stop enrollment.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal patients, defined as: natural menopause for at least 1 year, surgical ovariectomy, chemotherapy-induced amenorrhoea for at least 2 years.

Patients who have had surgical treatment for histologically confirmed breast cancer that was nonmetastatic at the time of the initial diagnosis.

Patients whose tumour was hormone receptor positive (HR+, ER+ and/or PR+). Patients initiated on Aromasin at least 2 months before inclusion but not more than 1 year.

Exclusion Criteria:

Patients for whom Aromasin treatment is contraindicated. Presence of metastasis or a contralateral tumour. Another adjuvant endocrine therapy. Another concomitant antineoplastic treatment (except for Herceptin®). Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Effect of Various Treatment Modalities on Dendritic Vial Ulcer

Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections\]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK.

In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK.


Eligibility Criteria:
Inclusion Criteria:

patients with epithelial viral ulcers

-

Exclusion Criteria:

* patients with stromal keratitis patients with corneal opacity
Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).

A population-based registry in Catalonia of patients with acute spontaneous Intracerebral Hemorrhage, to investigate whether type of center and time from onset to admission is associated with functional outcome and mortality.

Introduction. Recent studies show that there are potentially beneficial therapeutic measures for the patient with acute intracerebral hemorrhage (ICH), which should be applied urgently and that some would only be available in tertiary stroke centers (TSC). However, the transportation criteria for ICH patients are not well defined.

Objectives: Design and implementation of a registry (HIC-CAT) of patients with HIC in the healthcare network of public hospitals in Catalonia, which does not modify the current logistics but collects data related to patients and TSC, interhospital transfers and non-TSC centers. The registry will allow us to evaluate the hypothesis that: 1) Patient care in TSC decreases the probability of death or dependence in patients with spontaneous ICH compared to non-TSC; and 2) The shorter the time until admission to a TSC, the better the survival and functional outcome. This will be due to the application of diagnostic, therapeutic and structural measures at the TSC. In addition, organ donation will be more frequent in a TSC.

Methods: Observational, prospective, multicentre, population study of 2500 consecutive patients with spontaneous ICH of less than 24 hours from the onset of symptoms and Rankin scale score 0-3. We will collect times, clinical and radiological variables, vital and functional outcome at 3 months follow-up. Number of organ donations. Primary variable: Functional outcome at 3 months (Rankin 0-3). Statistics: Multivariate analysis with logistic regression, propensity matching scores.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of spontaneous intracerebral hemorrhage who is diagnosed in any of the participant hospitals

Exclusion Criteria:

* Traumatic intracerebral hemorrhage
* \>24 hours from onset to admission
* Prior Rankin scale score \>3
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 to 55 years old
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Body Mass Index (BMI) 18 to 32 kg/m2
* Willing and able to give informed consent
* Additional inclusion criteria apply

Inclusion Criteria for Ulcerative Colitis (UC) subjects:

* Subject has a history of UC
* Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days
* Additional inclusion criteria apply

Exclusion Criteria:

* Is positive for hepatitis A, B or C, HIV or tuberculosis
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)
* Additional exclusion criteria apply

Exclusion Criteria for Healthy Subjects:

* Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.
* Additional exclusion criteria apply
Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques)

EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a variety of clinical trials. This study examines the effect of a six session EFT protocol on the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M). Subjects in the experimental group receive EFT coaching supplemental to, and supportive of, the "usual care" treatment provided by their primary care provider. Subjects in the wait list control group receive usual care for a month, with pre and posttests, after which they also receive the EFT coaching protocol. Subjects are followed at three month intervals to determine if gains are maintained, and whether the symptom reductions are similar to those observed in other trials of EFT.


Eligibility Criteria:
Inclusion Criteria:

* Military Service
* The ability to follow instructions, complete written forms, and provide informed consent.
* Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
* Between 18 and 90 years old

Exclusion Criteria:

* Participants with a score of more than 3 on questions 34 and 35 of the Symptom Assessment-45 Questionnaire (SA-45) will receive phone/skype sessions, not office visits