cyrilzakka/clinical-trials huggingface dataset:
Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline.

Cognitive decline after stroke is a common sequela and is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, evidence about the effects of combined exercise-cognitive trainings on physiological biomarkers, cognitive and physical functions in stroke patients with cognitive decline is still less. The present study aim to investigate the effects of sequential combination of exercise-cognitive trainings on cognitive, physical, and daily function. In addition, the physiological mechanism of the combination training on cognitive function by several biomarkers including the brain-derived neurotrophic factor (BDNF), antioxidative marker, HbA1c, and plasma lipid level will be investigated. This study is a single-blind randomized controlled trial. Participants will be randomly assigned to SEQ group in which sequentially perform physical exercise and cognitive training or to CI group of control intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. MMSE score ≥ 19,MoCA\<26,able to follow the study instruction
3. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
4. Adequate cardiopulmonary function to perform aerobic exercise
5. Able to walk with or without assistive devices

Exclusion Criteria:

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial
Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).

The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.

1. Four cycles of R-CHOP chemotherapy for the induction treatment \[Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)\]

   If patients with CCI \<1
   * Rituximab: 375 mg/m2, day 1 every 3 weeks.
   * Conventional dose of CHOP chemotherapy repeat every 3 weeks.

   If patients with CCI ≥1
   * Rituximab: 375 mg/m2, day 1 every 3 weeks.
   * 75% of conventional CHOP repeat every 3 weeks.
2. Rituximab augmentation

   * Rituximab: 375 mg/m2, every week x 4 times.
   * Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed CD20 positive DLBCL
2. Age ≥ 70
3. Ann Arbor stage II, III and IV
4. No prior chemotherapy or radiotherapy for DLBCL
5. Performance status (Eastern Cooperative Oncology Group) ≤ 2
6. At least one or more bidimensionally measurable lesion(s)

   * ≥ 2 cm by conventional computerized tomography (CT)
   * ≥ 1 cm by spiral CT
   * skin lesion (photographs should be taken) ≥ 2 cm
   * measurable lesion by physical examination ≥ 2 cm
7. Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
8. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
9. Adequate liver functions:
10. Adequate bone marrow functions:

    hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
11. Life expectancy more than 6 months
12. Informed consent

Exclusion Criteria:

1. Other subtypes of non-Hodgkin's lymphoma
2. Patients who transformed follicular lymphoma or other indolent lymphoma
3. Primary Central Nervous System (CNS) DLBCL
4. CNS involvement by lymphoma or any evidence of spinal cord compression.
5. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
6. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
8. Other serious illness or medical conditions
Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery

Reduction of intra-operative blood loss

Spine surgery is usually performed using a posterior approach with the patient in the prone position, but on the other hand this position causes venous engorgement in the back and increases bleeding with the risk of interruption of surgery and increases the need for blood transfusion. The prone position also produces undesirable haemodynamic changes resulting from compression of large vessels and decreased venous return to the heart.

Deep neuromuscular blockade has been shown to improve surgical conditions compared with moderate neuromuscular blockade in various surgical procedures specially different laparoscopic procedures to optimize surgical field conditions. In spine surgery, although many other factors such as the body habitus of the patient and the surgical equipment are important, an improvement in surgical field conditions can be achieved through reducing muscle tension in the back, and also reducing intra-abdominal and thoracic pressure. This goal may be attainable by using deep neuromuscular blockade. Better operating conditions offer the surgeon easier access to the surgical field with less damage. However, the effect of deep neuromuscular blockade on surgical bleeding in spinal surgery in the prone position has been yet under evaluation.

The investigators hypothesise that deep, compared with moderate, neuromuscular blockade would cause less surgical bleeding in spinal surgery in the prone position. The investigators aim to evaluate the effects and superiority of deep neuromuscular blockade on surgical bleeding in patients undergoing posterior lumbar interbody fusion surgery in the prone position.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 65 years.
* American Society of Anesthesiologists physical status classification (ASA) I - III
* Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level).

Exclusion Criteria:

* Urgent or emergency case or re-operation.
* History of pre-operative anticoagulant medication or an indication for peri-operative anticoagulant medication.
* ASA classification more than III.
* Age less than 16 years.
* Reduced left and right ventricular function (ejection fraction \<40%).
* Previous respiratory disease or a diagnosed neuromuscular disorder.
* Pre-operative dysrhythmia.
* Allergy to neuromuscular blocking agents.
* Family history of malignant hyperthermia.
* Decreased renal function (serum creatinine level more than twice the normal range, urine output \<0.5 ml kg/h, glomerular filtration ratio \<60 ml/ h).
REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access

This will be a multi-center, multi-national, investigator-initiated and lead, retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access.

This will be a multi-center, multi-national, investigator initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of the dysfunctional vascular access.

There are no limitations on the type of covered stent use, the reason, or the length of the treatment area. The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area.

The criteria for inclusion, the outcome measures and the variables that should be recorded are listed below.

There is also no limitation if data has been previously published in another study, however data as part of an ongoing study, or of a study in press cannot be submitted.

Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions. Thus, study will focus on primary patency and safety. Nevertheless, centers should provide data regarding circuit survival (thrombosis, abandonment, surgical revision, patient's death). Terms and definitions of outcome measures are provided below.

Study's final follow-up date is March 31st, 2021. Patient should have a minimum follow-up of 6 months to be included in the study at that timepoint, unless circuit is no longer in use (thrombosis, abandonment, surgical revision, patient's death).

If a scientific committee's approval is needed for the data collection, it is the center's responsibility to acquire it. If this is waived due to the nature of the study, this should also be stated.

A large number of data will be recorded so hopefully, a lot of meaningful evidence will come up from this effort. As seen below, situations out of those allowed in the instructions for use for covered stents are included (ruptures, pseudoaneurysms, cannulation zone placement etc).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<80 years
* Patient on Dialysis with an Arteriovenous Fistula (AVF) or Graft (AVG)
* Clinical Signs of Vascular Access Dysfunction or presence of a Pseudoaneurysm or Intraprocedural Vessel Rupture
* Use of Covered Stent(s) for treatment
* Minimum follow-up: 6 months

Exclusion Criteria:

* \>1 treatment areas included per procedure
* Covered Stent not available in the market any more
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults

This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion criteria:

* Patient must be diagnosed with ADHD.

Exclusion Criteria:

* Patient has a current or past history of seizure disorder, brain injury, anorexia nervosa or bulimia.
* Patient has a current diagnosis of Major Depressive Disorder (MDD).
* Patient has a current primary diagnosis of, or received treatment for, Panic Disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD) or Acute Stress Disorder within the previous 12 months.
* Patient has a lifetime diagnosis of bipolar disorder, schizophrenia or other psychotic disorders.
* Patient has a positive urine test at screening for presence of illicit drugs or alcohol abuse during the past 12 months.
Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

The purpose of this study is to evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff.

To evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff and to evaluate, at the end of the rehabilitation period, the range of motion, the function gained and the quality of life comparatively in the two groups of patients treated with Transcutaneous Electrical Stimulation or Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy.

Eligibility Criteria:
Inclusion Criteria:

* subjects after surgery for rotator cuff injury of traumatic and / or degenerative

Exclusion Criteria:

* concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5

Abstract Background: Vitamin D affects a wide variety of functions in the body including regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population drastically reduce sun exposure, known to encourage production of Vitamin D. Countless research has analyzed preterm as well as term neonates born to mothers with vitamin D deficiency, with regard to weight, height, and bone mineral density at birth. However, there is a paucity of information about healthy infants' vitamin D levels and its' correlation to these parameters during the first few years of life. Objectives: The purpose of the proposed study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end of the first year of life with growth rates and bone mineral density in the same children at the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12 months of age (when routine blood tests are normally drawn for these infants) and bone mineral density will be measured using Quantitative Ultrasound. Infants will be divided into 2 groups: those with those with normal 25(OH)D levels (\>15ng/ml), and those with 25(OH)D deficiency (\<15ng/ml). Group 1- normal levels will receive no intervention. Infants with 25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for one year, or Group 3- those receiving the placebo. Height, weight, and head circumference growth curves will be recorded every two months until 2 years of age. Quantitative ultrasound, growth charts and blood tests including 25(OH)D, serum calcium and phosphate levels, Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12 months will be repeated at 2 years of age. At that time children from Group 1 (no supplementation) will be divided into three: Group 1a- normal 25(OH)D levels will continue with no intervention, Group 1b \<15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c \<15ng/ml will receive a placebo until age three. Groups 2 and 3 will continue their previous treatment until age three. All aforementioned tests will be repeated at age 3, when treatment will stop, and the same tests will be repeated at age 5.


Eligibility Criteria:
Inclusion Criteria:

Infants between 9-12 months old in Tipat Chalav and Kupat Holim Clalit in Beitar Illit undergoing a blood draw for CBC at one year of age.

Exclusion Criteria:

Parents that refuse to participate in this study, infants with any diagnosed chronic disease, and preterm infants less than 34 weeks.
Follow up of Nasolacrimal Intubation in Adults

For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard treatment, with a success rate of 80-90% according to literature. Another available treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.

In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was performed in our medical center on a few hundred patients with mild epiphora.

Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is close in it's efficacy to the Dacryocystorhinostomy procedure.

Under normal conditions, the amount of tears excreted from lacrimal glands to the eye is equal to the amount drained through the tear duct. Epiphora in adults usually involves a blockage of the lacrimal sac or the nasolacrimal duct. Epiphora causes tearing in patients, which can be treated sympthomatically in a conservative way (antibiotic treatment, probing of the tear duct, pressure irrigation of the tear duct) or therapeutic in an invasive way. The invasive treatment includes one of the following:

1. Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear drainage.
2. Nasolacrimal intubation - inserting a silicone tube through the tear duct. The tube is usually removed after 3-6 months.

Currently, there are only a few reports regarding the efficacy of nasolacrimal intubation, all with a small number of research subjects. Also, these reports have stratified the patients according to the location of the tear duct blockage, and didn't take into account the severity of the blockage (ie the severity of symptoms) prior to performing the intubation.

In our research, we would like to find the efficacy of nasolacrimal intubation which was performed in our medical center on a few hundred patients with mild epiphora, and to compare in with the efficacy of the Dacryocystorhinostomy - which is 80-90% according to literature.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild epiphora.
* Underwent nasolacrimal intubation during 01/2000 - 12/2007.

Exclusion Criteria:

* Purulent excretions from nasolacrimal duct on day of admission or intubation.
* Nasolacrimal intubation in the past.
* Dacryocystorhinostomy in the past.
Chronic Complaints After Small Umbilical Hernia Repair

There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* primary elective open non-mesh sutured umbilical or epigastric hernia repair

Exclusion Criteria:

* mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age \< 18 years, pregnancy
Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine

Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Primary tumors of the spine are exceedingly rare and therefore the literature has been limited to case series of limited size and significant heterogeneity. These tumors comprise 11% of all Primary Musculoskeletal Tumors and 4.2% of all spine tumors. Of all primary spine tumors only 6% are malignant, but it is the malignant tumors that present the greatest therapeutic challenges. Through this multi-center retrospective cohort study performed at 13 spine oncology referral, data on at least 2.000 patients with specific primary benign and malignant spine tumors will be collected. This will provide power to determine the influence of many previously hypothesized variables on outcome.

The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. These data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.

Eligibility Criteria:
Inclusion Criteria:

* Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically.
* At least one follow-up detectable in the medical charts

Exclusion Criteria:

* metastatic tumor of the spine
* primary spinal cord tumor
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED.

Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
* Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose
* Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose.
* Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
* Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
* Must not have a history of inflammatory bowel disease
* Female TED participants who must not be pregnant or breastfeeding

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.