cyrilzakka/clinical-trials huggingface dataset:
Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)

A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens.

The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL
* Age ≥ 18 years.
* Adequate bone marrow function i.e. absolute neutrophile count of \> 1000/µl and thrombocytes \> 75,000/µl.
* Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
* Total bilirubin ≤ 2,5 x ULN
* Creatinine clearance ≥ 50 ml/min
* Female subjects of childbearing potential† must: Understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
* Male subjects must agree to use condoms and agree not to donate semen

Exclusion Criteria:

* Prior history of malignancies, other than PTCL, unless the subject has been free of the disease for ≥ 3 years
* Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
* Prior treatment with a HDAC inhibitor
* Prior treatment with Lenalidomide (patients previously treated with Thalidomide may be enrolled)
* Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)
A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) The rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.

Although peripheral nerve blocks are known to provide superior postoperative analgesia. Continuous peripheral nerve block (CPNB) are not used to the extent they deserve. This is predominantly due to variable success rates. Furthermore, the existing techniques for placing catheters for CPNBs are technically complicated and time consuming.4,5 Major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (LA) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. We have developed a new catheter for CPNBs to address and overcome these limitations.

Hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. Furthermore, in-plane ultrasound (US) visualization during the entire procedure and during readjustment should be possible. The new catheter should also provide a simple and rapid technique with few components. Initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age at Visit X.
2. ASA classification ≤ II
3. Written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study.

Exclusion Criteria:

1. BMI ≥ 30
2. Previous or ongoing surgery, pain or other disability of investigated region.
3. Prescriptive drugs other than anti-contraceptive.
4. Sensory or neurologic deficits in the investigated region
5. Allergy to LA
6. Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study.-
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.

Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).

Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.

Eligibility Criteria:
Inclusion Criteria:

* post-menopausal insomnia

Exclusion Criteria:

* unstable medical conditions
Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation

The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.

Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* women 16 years of age and older
* intrauterine pregnancy \> 14 weeks gestation
* desires termination of pregnancy
* desires IUD for contraception
* ability to give informed consent
* no contraindication for D+E

Exclusion Criteria:

* unable to give informed consent
* less than 16 years of age
* congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* acute pelvic inflammatory disease (PID)
* known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
* untreated acute cervicitis or vaginitis, until infection treated/controlled
* confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
* acute liver disease or liver tumor (benign or malignant)
* woman or partner currently with multiple sexual partners
* history of Wilson's disease
* hypersensitivity to any component of Copper T IUD
Feasibility and Acceptability of HCV Treatment in Pregnancy

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use

Participant Duration: Approximately 1 year.

Aims:

Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.

Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.

Pregnant adults over the age of 18 with a history of either past or current drug use who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who consent to participate in the study will be treated with glecaprevir-pibrentasvir.

All consented individuals will participate in four (4) in-person study visits. At the first in-person study visit, patients will receive information about hepatitis C virus treatment, complete testing for HIV and HBV and be assessed for cirrhosis. Patients who meet study criteria will initiate HCV treatment with glecaprevir-pibrentasvir. Patients will return for a second in-person study visit while on HCV treatment (between day 14-56) at which time they will complete a questionnaire about medication adherence and have HCV RNA testing performed. A third in-person study visit will occur at completion of HCV treatment at which time patients will again complete a questionnaire about medication adherence, and have HCV RNA testing performed. The final study visit will occur 4 weeks after completion of HCV treatment at which time patients will have HCV RNA testing performed. All labs that are included as part of the study are standard of care labs for all pregnant women, and are standard of care during HCV treatment (HCV RNA, CBC and CMP).

Additional information about the clinical course of infection (including HCV RNA testing obtained at the time of labor and delivery), and maternal and fetal outcomes will be abstracted from the medical record at 1 year post study enrollment.

All participants will be followed longitudinally in the medical record to ascertain maternal and fetal outcomes and HCV re-infections for up to 1 year post study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.

Exclusion Criteria:

-
Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age

SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the coronavirus family identified in China in December 2019. This pathology can present multiple clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms called "Acute Respiratory Distress Syndrome". The elderly population is more at risk for this infection due to the senescence of the immune system, co-morbidities and poly medications. They also often present a greater state of fragility.

This study aims to report the epidemiology of the first 50 patients over 90 years of age hospitalized within the CHU Brugmann hospital.


Eligibility Criteria:
Inclusion Criteria:

* Be over 90 years of age on the date of admission to CHU Brugmann Hospital
* Have a SARS Cov2 infection proven by antigen or RT-PCR on smear and / or typical imaging regardless of the clinical manifestation
* Have been hospitalized at CHU Brugmann between 03/01/2020 and 05/10/2020

Exclusion Criteria:

None
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults

Primary objective

* The tolerability and safety of SAR443809 Secondary
* The PK parameters of SAR443809
* The PD activity of SAR443809
* The immunogenicity of SAR443809

Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.

Eligibility Criteria:
Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. The investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. The findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. The predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.


Eligibility Criteria:
Inclusion Criteria:

(1) a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale \< 3 at any joints), (5) able to follow examiners' commands and study instructions (Montreal Cognitive Assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project.

Exclusion Criteria:

(1) acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.
PVRI GoDeep Global Deep Phenotyping Meta-Registry for Pulmonary Hypertension

PVRI-GoDeep is a PH Meta-Registry, run under the umbrella of the Pulmonary Vascular Research Institute (PVRI). It merges anonymized PH patient related data from various local registries around the world run under the responsibility of PVRI members. It will be operated under the auspices of the University of Giessen/Giessen PH center. Combining deep phenotyping with worldwide outreach, PVRI-GoDeep aims to offer insights into specific geographical and ethnical profiles of PH, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of PH patients.

PVRI-GoDeep is a PH Meta-Registry, run under the umbrella of the Pulmonary Vascular Research Institute (PVRI). It merges anonymized PH patient related data from various local registries around the world run under the responsibility of PVRI members. It will be operated under the auspices of the University of Giessen/Giessen PH center.

Combining deep phenotyping with worldwide outreach, PVRI-GoDeep aims to offer insights into specific geographical and ethnical profiles of PH, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of PH patients.

The data provided by PVRI-GoDeep will support academia to perform scientific projects in the field of PH. Pharmaceutical / commercial companies will be charged fee for access to PVRI-GoDeep data and / or analysis, thereby creating revenues exclusively devoted to support the PVRI mission and the registries entering their data into PVRI-GoDeep. All requests from academia or commercial companies are to be decided by the PVRI-GoDeep consortium, serving as Use and Access Committee.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Pulmonary Hypertension

Exclusion Criteria:

* none
Umbilical Cord Blood Therapy for Global Developmental Delay

This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic umbilical cord blood therapy for children with global developmental delay.

Global developmental delay is defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.

Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.

Eligibility Criteria:
Inclusion Criteria:

* Global developmental delay
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Uncontrolled persistent epilepsy
* Not eligible according to the principal investigator
Virtual Reality on the IMC

The goal of this substudy (main study NCT04498585) is to determine the feasibility of applying virtual reality stimulation to patients in the intermediate care unit. Patients on this ward are generally more awake and alert than patients in the intensive care unit, thereby they are able to provide feedback about their experience. As the intermediate care unit is not without stress, examining the physiological parameters (e.g., heart rate, respiration rate, blood pressure, etc.) could also provide telling information as to the calming effect of virtual reality. The movements of these patients are also recorded using accelerometers which will provide valuable information about the characteristics of the movements that patients make while confined to their beds. These movements can act as a reference for further investigation into movements related to delirium which is a secondary outcome measure of the main study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged ≥18 years
* No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
* German or French speaking
* Estimated length of stay (from time of study inclusion) \>24 hours

Exclusion Criteria:

* Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
* Patients with epilepsy
* Patients with Covid-19
Home-based Vision Therapy

Post-concussive vision symptoms affect many Veterans who have experienced traumatic brain injury (TBI). One common issue is trouble with near vision, a problem that may persist long after the acute injury. Double vision or difficulty focusing on close objects can affect reading and depth perception. Poor reading can interfere with academic or work performance, and loss of near focusing can affect jobs that require fine motor tasks like machining and electrical work. Even having trouble using a smartphone can have a substantial impact on both work and social function. Near vision impairment after TBI is not well understood, and treatments are limited. The goal of this project is to investigate novel virtual-reality assessments and training games to improve the near vision diagnosis and home-based rehabilitation. Restoring normal near vision function could have a large impact on the fulfillment of Veterans' educational, career, and overall life goals.


Eligibility Criteria:
Inclusion Criteria:

* U.S. Military Veteran
* Place of residence within driving distance of Cleveland, OH
* Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable)
* Best-corrected visual acuity 20/25 or better in each eye
* Convergence insufficiency (VR-NPC \< 32 deg)

Exclusion Criteria:

* Neurological condition other than TBI that would affect convergence
* History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Biological Markers of Treatment Response to Repetitive Transcranial Magnetic Stimulation for Depression

The main objective of this study is to determine whether biological stress markers (Oxidized Phosphatidylcholines and Oxylipins) in the blood can be used to predict the efficacy of rTMS in the treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may be used to determine which patients will benefit from rTMS treatment. A second objective of this study is to measure any changes in stress markers that occur across the course of rTMS therapy.

250 patients who have been prescribed repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of major depressive disorder will be recruited for this study. Prior to undergoing rTMS, patients will give a small blood sample. An additional blood sample will be given upon completion of rTMS treatment. 60 healthy control individuals will also be recruited to provide a one-time blood sample for comparison. Control individuals will not receive rTMS treatment.

Blood samples will be analysed for levels of Oxidized Phosphatidylcholines and Oxylipins. The investigators wish to determine whether there is a difference in the pre-treatment levels of stress markers between individuals who ultimately respond to rTMS and those who do not. Additionally, the investigators wish to determine whether there is a change in stress markers as a result of rTMS treatment.

Eligibility Criteria:
Patient Inclusion Criteria:

* Patients with a major depressive episode
* Not actively receiving psychotherapy

Patient Exclusion Criteria:

* History of a psychotic episode
* History of neurological illness
* Head injury
* Active alcohol or substance abuse
* History of a seizure disorder
* Pregnant

Control Subject Exclusion Criteria:

* History of depression or psychiatric illness
* History of a psychotic episode
* History of neurological illness
* Head injury
* Active alcohol or substance abuse
* History of a seizure disorder
* Pregnant