cyrilzakka/clinical-trials huggingface dataset:
Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study

The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

The secondary objectives of this study are:

A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60.

B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient presents with a severe cognitive disorder
* The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2
* The patient has heminegligence with a bells test \> 6 on the left.
* The patient presents with limited amplitude in the paretic upper limb (shoulder abduction \<60°, elbow flexion \> 30° or dorsal wrist flexion \<20°).
* Imbalanced/uncontrolled epilepsy
Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Signed and dated written informed consent.
* History of dry eye syndrome for at least 3 months
* Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
* OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
* Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
* No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Intake of parasympathomimetic or anti-psychotic drugs
* Wearing of contact lenses
* Glaucoma
* Treatment with corticosteroids in the 4 weeks preceding the study
* Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
* Ocular infection or clinically significant inflammation
* Ocular surgery in the 3 months preceding the study
* Sjögren's syndrome
* Stevens-Johnson syndrome
* History of allergic conjunctivitis
* Ametropia \>= 6 Dpt
* Pregnancy, planned pregnancy or lactating
* Known hypersensitivity to any component of the study medication.
* Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
* Inability to understand the study procedures
Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients in stable condition ( without exacerbation min 1 months ago)
* Over 40 years
* History of at least 10 py

Exclusion Criteria:

* acute exacerbation of COPD
* active malignancy
* autoimmune disease
* acute myocardial infarction
* diabetes mellitus with late complications
* congestive heart failure
* women of childbearing potential
Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy

The study will be carried out with volunteer patients who are diagnosed with Bell's Palsy and comply with the study criteria.The aim of the study is to compare the home PNF exercise program with video-based telerehabilitation and the conventional training program in terms of outcome measures in patients with Bell's Palsy lesions.

With the telerehabilitation program, it is aimed that patients can easily adapt to home exercise programs and be followed up remotely. In this way, the most effective treatment of the disease will provide the patient with both motor function gain and psychosocial gain. This study was planned to examine the effectiveness of telerehabilitation in patients with Bell's Palsy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 - 65 years
* Being diagnosed with Bell's Palsy by a specialist physician
* Having a lower motor neuron lesion
* Non-traumatic cases
* Not having any other neurological deficits
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Bilateral involvement
* Having an operation for facial palsy
* Having an upper motor neuron lesion
* Neurological problems that would preclude evaluation and/or treatment.
Effect of Cranial Osteopathy on Visual Function

It is the purpose of this study to attempt to determine if there is an immediate, measurable change in visual function as a direct result following a session of cranial osteopathic manipulation.


Eligibility Criteria:
Inclusion Criteria:

* Free of active ocular or systemic disease
* Refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
* Normal best-corrected visual acuity at 20/40 or better
* Normal amplitude of accommodation
* Willing to undergo cranial osteopathic manipulation

Exclusion Criteria:

* Pregnancy
* History of previous closed head trauma or brain injury
* Students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry
* Prior cranial manipulative treatment/craniosacral therapy
Alternative and Integrative Therapy for Lumbar Disk Herniation

The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* LBP with sciatica,
* A numeral rating scale (NRS) leg pain intensity of 5 or higher
* Onset within 1 year;
* Lumbar Disk Heriation confirmed by MRI;
* Written consent to attend 6 months of integrative CAM treatment and following assessment visits.

Exclusion Criteria:

* Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol
* Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)
* History of spinal surgery, vertebral dislocation, fracture, or cancer;
The Bucharest Early Intervention Project

The purpose of this study is to determine the long term effects of early intervention (placement into foster care) on physical, cognitive, social and brain development and psychiatric symptomatology in previously institutionalized children.

The Bucharest Early Intervention Project (BEIP) was a randomized controlled trial of foster care as an intervention for children abandoned at or around the time of birth and placed in one of six institutions for young children in Bucharest, Romania (Zeanah et al., 2003). The PI (Nelson) and Co-PIs (Zeanah and Fox) conducted this study beginning in the fall of 2000 from baseline assessments and implementation of the intervention in the spring of 2001.

The BEIP began with comprehensive assessments of 136 institutionalized children and their caregiving environments prior to randomization. Half the children were randomly assigned to high-quality foster care and the other half to remain in institutional care. The average age at foster care placement was 22 months (range=6-31 months). All children were initially seen prior to randomization and again for follow-up assessments at 30 months, 42 months 54 months, 8 years, 12 year and 16 years of age. The development of children in foster care was compared to the development of children in institutions and to a group of never institutionalized children (community controls). These children, now young adults are being assessed at age 21 years.

Eligibility Criteria:
Inclusion Criteria for assessment at age 21 years:

* previously institutionalized and community children that took part in previous BEIP assessments
* target recruitment age is +/- 6 mos of 21st birthday

Exclusion Criteria for assessment at age 21 years:

* open or closed head injury within the past 12 months
* viral or bacterial meningitis within the past 12 months
Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.

Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester.

In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of IDA estimated to be 2.4 to even 4 times higher.

Expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. Moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal Hgb and ferritin concentrations.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. The purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.

Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancy.
* Hemoglobin ≥ 10.5 gm/d l. at booking visit

Exclusion Criteria:

* Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation
* Thalassemia minor (alpha or beta).
* Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).
* Anemia from chronic illness.
* Any use of multi-vitamin supplements containing iron.
* Any chronic blood loss. e.g: hemorrhoids.
* Autoimmune disorders.
Serratus Plane Block for Rib Fractures

Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.

Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.

Eligibility Criteria:
Inclusion Criteria:

* 2 o more ipsilateral rib fractures
* Trauma within 24h from hospital admission
* Informed consent

Exclusion Criteria:

* Chest drain
* head trauma
* bilateral rib fractures
* Intensive care admission
Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

This is an open-label, monotherapy, Phase II Study clinical study. The objective is to evaluate the efficacy, safety, and pharmacokinetics of Tazemetostat in the treatment of patients with relapsed/refractory follicular lymphoma. It is planned to enroll 39 Chinese patients in 2 cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
2. Age ≥18 years;
3. Patients with histologically confirmed R/R FL (Grades 1, 2, 3a)
4. Patients must have one measurable lesion
5. Life expectancy ≥ 12 weeks;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
7. Adequate bone marrow function, renal function and hepatic function:
8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive:
9. Female patients of childbearing potential must agree to adopt dual contraceptive method

Exclusion Criteria:

1. Previous use of Tazemetostat or other EZH2 inhibitors;
2. Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater;
3. Previous bone marrow malignancies,
4. Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;
Effects of MDMA on Emotional and Social Memories

The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.

Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of positive, negative, social, and neutral memories. The study will use a between subjects design with three groups (N = 20 per group). Two of the groups will be randomly assigned to receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The third group will receive placebo only (PLC). All three groups will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and other capsules will contain placebo.

Participants will participate in two sessions: a viewing session during which they will view emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which there will be a surprise memory test with two components (verbally cued recollection and picture recognition). On all sessions subjects will also complete mood questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy males and females, aged 18-40 years.

Exclusion Criteria:

1. any current medical condition requiring medication or abnormal electrocardiogram
2. current or past medical condition considered to be a contraindication for the study conditions
3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
4. less than high school education
5. lack of fluency in English
6. night shift work
7. pregnancy, lactation, or plans to become pregnant
8. use of hormonal contraception
DCI COVID-19 Surveillance Project

This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19 infection and antibody response in an in-center dialysis population. The investigators hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and antibodies response to infection (potential immunity) in a dialysis center population within a high-prevalence region can provide foundational information to guide approaches toward prevention of COVID-19 related illness in a susceptible population. Participants will be given a questionnaire initially and monthly over the study period to find out whether they have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the study period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive in-center chronic dialysis (\>3 months) at DCI Henry Avenue
* Patients who are able to consent for study

Exclusion Criteria:

* Patients receiving transient hemodialysis at DCI or receiving hemodialysis for Acute Renal Failure
* Patients who are unable to consent
* Patients who are receiving other forms of dialysis therapy (e.g. home hemodialysis, peritoneal dialysis)
* Patients whose life expectancy is \<12 months
* Patients who are planning to leave the dialysis center within 12 months
Senior Elastic Band (SEB) on Institutional Elders

The goals of this research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term SEB exercises.

A three-year, longitudinal, triangulation research method will be used. The study purpose of the first year is to develop a safe and appropriate SEB program for the elderly residents in long term care facilities using Delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. In the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the SEB exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. Through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in Kaohsiung will be recruited and randomly assigned based on the resided facilities to a SEB experimental group or a waiting-list control group. The subjects in the experimental group will receive the SEB interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. All subjects will receive one pre-test and two post-tests three months apart during the study. In the third year, the elderly participants will continue practicing the SEB guided by a VCD for another nine months, and the compliance of the participants toward regular SEB exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.

Eligibility Criteria:
Inclusion Criteria:

* elderly residents aged 65 and over
* Mandarin or Taiwanese speakers
* have been living in the facility for at least 3 months
* able to stand alone without assistive devices
* cognitively alert and able to verbally state their name, address, and answer questions.

Exclusion Criteria:

* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses