cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.


Eligibility Criteria:
Key Inclusion Criteria:

* Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:

  * High risk acute myeloid leukemia (AML) in complete remission
  * Very high risk pediatric AML; patients \<21 years eligible with \<25% blasts in marrow after failed chemotherapy
  * High risk acute lymphocytic leukemia (ALL) in complete remission
  * Chronic myelogenous leukemia (CML), excluding refractory blast crisis
  * Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
  * Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
  * Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
  * Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission (chemotherapy refractory large cell NHL not eligible)
  * Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in complete or partial remission, or after progression if stage I/II \<1 year (chemotherapy refractory high-grade NHL not eligible)
  * Multiple myeloma beyond 2nd partial remission
* Preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
* Adequate organ function

Key Exclusion Criteria:

* Symptomatic underlying pulmonary disease or requiring oxygen
* Active infection
* HIV positive
* Pregnant or nursing
Neuromuscular Stimulation Versus Intermittent Compression for Venous Thromboembolism Prophylaxis in Critical Care

In this prospective, randomised, open-label, parallel group, feasibility trial; the investigators will objectively assess whether it is feasible to apply the Geko device to critically ill adults for the prevention of venous thromboembolism (VTE) compared to usual care with intermittent pneumatic compression devices (IPCs).

VTE is a common problem amongst patients in critical care. Current measures include intermittent pneumatic compression devices, used to aid the venous return of blood from the lower limbs. These devices are contraindicated and/or poorly tolerated by some patients. Neuromuscular stimulation of the lower leg muscles might offer a better tolerated and more physiological alternative to IPCs.

In this feasibility trial the investigators will randomly allocate 40 patients to receive either the Geko device (n=20) or IPCs (n=20) as principal means of mechanical VTE prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years.
* Intact healthy skin at the proposed site of gekoTM device application.
* Within 24 hours of their admission to critical care
* Expected to remain in critical care until the day after tomorrow

Exclusion Criteria:

* Use of any concurrent neuro-modulation drug or device (e.g. neuromuscular blocking agents).
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* Inability to palpate the fibula head in order to apply geko device effectively
* Inability to obtain valid written consent from the participant or their designated legal representative
Effectiveness of a Church-Based Program at Increasing Physical Activity and Healthy Dietary Habits in African Americans

Obese African Americans are at risk for diseases such as diabetes, cancer, and heart disease. Church-based interventions have the potential to positively influence the health habits and behaviors of a large percentage of African Americans. The purpose of this study is to evaluate the effectiveness of a church-based program that emphasizes increased physical activity and healthy dietary habits among members of predominately African American churches in South Carolina.

Many obesity-related diseases, including diabetes, cancer, and heart disease, occur more frequently in ethnic minorities than in Caucasians. African Americans have an extremely high church attendance rate, making church-based interventions a viable method to reach a wide audience and positively influence health habits and behaviors. The most effective way to prevent or reverse the effects of obesity is through weight loss, which can be accomplished by increasing physical activity and following a low fat and low sodium diet that emphasizes fruits, vegetables, and whole grains. Few programs have been developed that have specifically examined the effects of a church-based physical activity and dietary intervention. This study will encourage church leaders to assist in the development of a health promotion program that will incorporate the church's social, cultural, and policy influences. The purpose of the study is to evaluate the effectiveness of the intervention on increasing physical activity, improving blood pressure levels, and promoting healthy dietary habits among church members. The importance of pastor support and participation will be evaluated, and the results from this study may be used to develop additional church-based interventions across a larger geographic area.

In Year 1 of this 5-year study, representatives from the Palmetto Conference of the African Methodist Episcopal (AME) Church and three state universities in South Carolina will participate in monthly planning sessions to develop the intervention. Local health committees and church pastors and cooks will be trained to implement the program. The 18-month intervention will occur in three waves; where at least 60 churches will be randomly assigned to participate in either the immediate intervention or delayed intervention. The program will emphasize increased physical activity and the adaptation of a healthy diet that includes low fat and low sodium foods, fruits, vegetables, and whole grains. At baseline and Month 18, blood pressure will be measured, and physical activity levels and fruit and vegetable intake will be assessed for some church members. Additionally, throughout the study, some participants will wear an accelerometer, which is a small device that measures physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Member of a church in the Palmetto Conference of the 7th Episcopal District of the AME Church
* Attends church services or events at least once per month

Exclusion Criteria:

* Planning to move in the 18 months following study entry
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused

This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.

PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.

Participants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* History of a discrete episode of assault in childhood or adulthood
* Meets criteria for post-traumatic stress disorder

Exclusion Criteria:

* Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence
* Psychosis
* Mental retardation
* Suicidal or parasuicidal
* Currently addicted to drugs
* Illiterate
* Currently in an abusive relationship
* Currently being stalked
An Observational Study of Patients With Autoimmune Disease

TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .


Eligibility Criteria:
Disease Cohort

Inclusion Criteria:

- Adult patients at the time of enrollment with a diagnosis autoimmune disease by select ICD-10 codes in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* Adult patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign the informed consent.
* Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
* Subject is male or non-pregnant female and 18 years or older at the time of surgery.
* Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following:

  * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis
  * Failed previous shoulder joint replacement

Exclusion Criteria:

* Subject has an active or suspected latent infection in or about the shoulder joint.
* Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
* Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
* Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
* Subject has concomitant disease(s) which may significantly affect the clinical outcome.
* Subject has traumatic or pathologic fracture of the proximal humerus
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study

The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.

The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study.

The participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Eligibility Criteria:
Inclusion Criteria:

* Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study

Exclusion Criteria:

* There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis

Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.

Rituximab is an anti-CD20 monoclonal antibody which is effective in RA. The dose indicated in the marketing authorisation is 1000 mg twice per cycle. However, rituximab is associated with adverse events, and more specifically the risk of infection, which seems to be dose-dependent. The dose of 1000 mg once a cycle has been evaluated and is non-inferior for maintenance treatment. Lower doses than 1000 mg once could also be sufficient, but there is a lack of predictive criteria to guide clinicians in their search for the minimal effective dose for a given patient.

In our center, a PK-PD model including several parameters (body surface area, serum IgG concentration, residual rituximab concentrations and CD4+ T-cell count) has enabled to quantify part of the concentration-effect relationship of rituximab in this indication and at standard dose (1000 mg twice at 15-day intervals). On the basis of this model, a model for predicting clinical response has been developed.with reliable prediction of clinical response.

The aim of this study is to apply this model to patients receiving low-dose rituximab (1000 mg once per cycle) and to evaluate the prediction of clinical response to low-dose rituximab using this model.

Correlation and coefficient of determination between DAS28-CRP observed 6 months after a second low-dose cycle and DAS-28 predicted by a PK-PD model taking into account gender, body surface area, IgG concentration, rituximab concentration and CD4 T-cell count.

Eligibility Criteria:
Inclusion Criteria:

. Age ≥ 18 years

* Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
* Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
* In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
* If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.

Exclusion Criteria:

* Other associated targeted disease-modifying therapy
* Sjögren's syndrome or other associated inflammatory rheumatism
* Fibromyalgia or other pathology having an impact on the assessment of disease activity
* Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
* Opposition to data processing
* No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).
Impact of Dialysis Modality on Hepcidin and Iron Metabolism

* Dialysis modality may influence the oxidative stress and proinflammatory cytokines in ESRD patients.
* Dialysis modality may affect hepcidin
* Dialysis modality may influence iron and ESA requirements.

It has been considered that PD patients tended to be less anemic and require lower ESA dose than HD patients. In addition, it was also known that the level of oxidative stress and inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD patients may be associated with lower hepcidin level due to lower inflammatory state compared with HD patients.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 years or older
* Dialysis treatment was expected over 3 months
* In HD patients, regular hemodialysis 4 h a session more than two times a week
* In PD patients, over 2 exchange with more than 1.5 L solution

Exclusion Criteria:

* Poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite medication requiring hospitalization or interruption of ESA treatment
* Significant acute or chronic bleeding such as overt gastrointestinal bleeding within the previous 3 months
* Active malignant disease (except non-melanoma skin cancer and patients with malignant disease who have been disease-free for at least the 5 previous years are eligible)
* Acute infection
* Hemolysis
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Megaloblastic anemia
* Platelet count \>500 x 109/L or \<100 x 109/L
* Pure red call aplasia
* Epileptic seizure during previous 3 months
* Women of childbearing potential without effective contraception
* Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol
* Planned elective surgery during the study period except for cataract surgery or laser photocoagulation
* Life expectancy less than 12 month
Clinical Performance of Therapeutic Use of BTX for Bruxism

The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.

The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.

This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.

The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to trigger points (TrPs). 0.05 ml was injected into each TrP.

The level of statistical significance was set at p \< 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).

Eligibility Criteria:
Inclusion Criteria:

* Patients who self-reported having awake bruxism and recovered completely following BTX injections during the period ranging between 2009 and 2015. It includes patients who had previously occlusal splints and who should stop their use once the BTX injections were started.

Exclusion Criteria:

* Patients suffering from temporomandibular disorders or having a contraindication to BTX injection.
Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis

The purpose of this study is to present a descriptive analysis of demographic and clinical characteristics of the participants, as well as of the treatment patterns for multiple myeloma (MM) in Brazil.

Participants with a diagnosis of MM will be observed in this retrospective study. Data collected for the study will include identification, demographic, baseline data on MM, additional baseline laboratory, initial treatment for MM, subsequent treatment for MM, and outcome.

The study will enroll approximately 1000 participants.

This multi-center trial will be conducted in five geographic regions of Brazil. For each participant, data collection will comprise the longest possible period of time since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation (initiation defined as the initiation visit for the first site).

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent, for participants who are alive and not lost to follow-up (for participants already deceased or lost follow up, informed consent should have been waived by the corresponding ethics review board \[ERB\]).
2. Documented diagnosis of MM by the responsible physician between January 1, 2008, and December 31, 2016.
3. Absence of any plasma-cell disorder other than MM.
4. Absence of any immunoglobulin-related disorder other than MM.
MODULA Modul 5 BEAT-HF

Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What proportion of patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia?

How many patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with CRT-therapy within 12 months after implantation of a CRT-device.

Eligibility Criteria:
Inclusion Criteria:

* patient under CRT-D or CRT-P therapy

Exclusion Criteria:

* patients with permanent Atrial Fibrillation