cyrilzakka/clinical-trials huggingface dataset:
Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.

PRIMARY OBJECTIVES:

I. To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms.

ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.

ARM IB (Active Journaling): Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA.

ARM II (Lumosity only): Participants complete Lumosity cognitive exercises as in Arm IA.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of breast cancer
* Received chemotherapy treatment for breast cancer diagnosis
* Chemotherapy-free for at least one year

Exclusion Criteria:

* History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
* Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
* Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
* Pregnancy
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

- Subject must have successfully enrolled and completed M11-290 study

Exclusion Criteria:

- Subject considered by the investigator, for any reason, to be an unsuitable candidate
Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)

160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.

In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help.

160 patients who received a primary total hip arthroplasty (THA) were included and randomized to receive specific RS or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. The goal of the study was to prospectively randomized evaluate the effect of RS on hip-related muscular strength, endurance and postural stability on patients who underwent THA.

Eligibility Criteria:
Inclusion Criteria:

* non-complicated THA
* written informed consent

Exclusion Criteria:

* complicated THA
* partial weight-bearing after surgery
* cardial comorbidities
Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan

This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase (MGMT) methylation status, will be correlated with the disease clinical data and with the disease response

This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan.

The MGMT methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) The MGMT methylation analysis will be performed extracting from fresh tumor sample, the DNA on the basis of the standard protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmed diagnosis of Ewing Sarcoma
2. Chemotherapic treatment with temozolomide and irinotecan
3. Written informed consent prior to any study related activities

Exclusion Criteria:

1. Lack of written informed consent for the study
2. Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment
Biomarkers to Predict Gain From Therapy in Motor Stroke

The aim is to determine predictors of treatment response, i.e gain from rehabilitation training, in post stroke upper limb deficits. The investigators will like to answer the following question: "What is this patient's potential for recovery, given his profile?" The investigators propose to conduct a longitudinal physiopathological study on the stroke patients with motor deficits who entered the rehab center of Pitié Salpêtrière hospital. The investigators will benefit from the organization, which is already in place (clinical asssessments and training) to add MRI, TMS and EEG recordings, as well as genotype analysis before the training offered in the rehabilitation unit. The investigators will repeat these assessments after the training (immeadiately and 6 weeks after).

The protocol is based on 10 visits. The three main one are V1, V9 and V10. V1, V9 and V10 are the assessments visits with clinical scores, MRI TMS and EEG recordings. These are made before the training (V1), immediately after the 6 weeks of training (V9) and 6 weeks after (V10) V5 is a visit where the investigators will clinically assess the patients at three weeks of the training.

The other visits (V2, V3, V4, V6, V7, V8) consist in recording an EEG while patients are under training each week during six weeks.

Eligibility Criteria:
Inclusion Criteria:

(i) First-ever stroke patients (ii) Upper limb motor impairment (Fugl Meyer scale) (iii) post stroke delay between 7 and 42 days (iv) affiliated to french health care (v) Suitable for task based oriented training in the rehab center

Exclusion Criteria:

(i) age \< 18 or \> 85 years (ii) Hemianopia (iii) contra-indications to MRI or TMS assessments (iv) life threatening conditions (v) patients under legal protection (vi) pregnancy
Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty

Continuous administration of local anesthetics to the distal adductor canal could spread into the popliteal fossa and contribute to analgesic effects on posterior knee pain. Periarticular local anesthetic infiltration is a component of multimodal joint pathways and the posterior knee capsule was among the tissues routinely infiltrated. It is expected that there will be overlapping effects of distal adductor canal block and periarticular injection. Therefore, we aim to compare the postoperative pain in the group that received only continuous distal adductor canal block and the group that received both continuous distal adductor canal block and periarticular injection. Sixty-six patients scheduled for total knee arthroplasty will be randomly divided into the two groups. In group 1, the adductor canal catheter is inserted 2cm above the adductor hiatus. In group 2, the adductor canal catheter is inserted where the nerve block performed in group 1 and periarticular injection are performed intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. Severe psychiatric illness
Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias

Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT \[rehabIlitation prograM for sPAstiC aTaxias\]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide.


Eligibility Criteria:
Inclusion Criteria:

* have a confirmed genetic diagnosis of ARSACS or SPG7
* be able to maintain standing position and to transfert
* be authorized by their treating neurologist
* speak French or English
* be able to give informed consent.

Exclusion Criteria:

* have active participation in a rehabilitation program (self-reported information)
* have another condition causing physical limitations
* be uncomfortable in a swimming pool
* be pregnant.
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.

Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.

Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.

Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.

Eligibility Criteria:
Inclusion Criteria:

* Born and reside in Bilal Colony, Karachi Pakistan during the study
* Parent or guardian willing to provide informed consent
* Parent or guardian willing to permit home visits
* Predominantly breastfed at study start

Exclusion Criteria:

* Malnutrition at time of weaning
* Medical condition that would affect response to LGG
Effect of a New Infant Cereal on Weight Gain

The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.

Eligibility Criteria:
Inclusion Criteria:

* Lactating babies
* 6 months of age
* Informed consent signed by parents

Exclusion Criteria:

* Malformations, diseases or conditions that may alter development and/or nutritional status
* Born very and extremely preterm (\<32 weeks of gestational age)
Caffeine and Training Intensity Quantification

The goal of this clinical trial is to learn about the effects of caffeine on exercise physiology and the subsequent quantification of athlete training zones in trained cyclists. The main questions that it aims to answer are:

* What are the effects of low and moderate doses of caffeine on exercise physiology.
* How do the effects of caffeine on exercise physiology affect the calculation of training zones.
* Do the effects of caffeine on exercise physiology differ between men and women.

Participants will complete four trials on a cycle ergometer as follows:

* Trial 1: participants will complete two incremental tests to determine the power outputs required to elicit 50-80% of maximal oxygen consumption for trials 2-4.
* Trials 2-4: participants will consume (in a randomized order) either a low (2 mg/kg) dose of caffeine, a moderate (5 mg/kg) dose of caffeine, or a placebo (maltodextrin), 45 minutes prior to to completing an incremental cycling test from 50-80% of maximal oxygen uptake.

Measures of heart rate, oxygen uptake, blood lactate, and perceived exertion will be recorded throughout all trials.

Researchers will compare the effects of exercise intensity, caffeine dose, and sex to see if they affect exercise physiology and training zone quantification.


Eligibility Criteria:
Inclusion Criteria:

* To be considered for inclusion in the study, participants must be regular cyclists, between 18 and 45 years of age, capable of completing a 20 km cycling time trial at a minimum speed of 30 km/h for men and 28 km/h for women (arbitrary inclusion criteria to ensure a sufficient standard of athlete). Female participants must have a regular menstrual cycle and not be taking oral contraceptives.

Exclusion Criteria:

-
Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury

The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU patients with SARS-CoV-2 requiring advanced respiratory support. As this is one of the first studies of nebulised heparin in COVID 19 lung disease the investigators will assess safety as a co-primary outcome.


Eligibility Criteria:
Inclusion Criteria:

To be eligible, a patient must satisfy all these inclusion criteria:

1. Confirmed or suspected COVID-19. Note, if 'suspected', results must be pending or testing intended
2. Ability to obtain informed consent/assent to participate in study
3. Age 18 years or older
4. Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 hours
5. D-dimers \> 200 ng/ml
6. PaO2 to FIO2 ratio less than or equal to 300
7. Acute opacities on chest imaging affecting at least one lung quadrant. Note 'Acute opacities' do not include effusions, lobar/lung collapse or nodules
8. Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.

Exclusion criteria

To be eligible, a patient must have none of these exclusion criteria:

1. Enrolled in another clinical trial that is unapproved for co-enrolment
2. Heparin allergy or heparin-induced thrombocytopaenia
3. APTT \> 100 seconds
4. Platelet count \< 50 x 109 per L
5. Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning
6. Uncontrolled bleeding
7. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded)
8. Receiving or about to commence ECMO or HFOV
9. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome
10. Usually receives home oxygen
11. Dependent on others for personal care due to physical or cognitive decline (pre-morbid status)
12. Death is imminent or inevitable within 24 hours
13. The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
14. Clinician objection.
15. The use or anticipated use of nebulised tobramycin during this clinical episode
16. Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here
17. Relapse in clinical condition in patient that had fully weaned from advanced respiratory support
18. Any systemic anticoagulation other than prophylactic anticoagulation
A STEP for Patients Prior to Undergoing TAVR: A Pilot Study

The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).

TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a very high procedural success rate (\>95%), mortality rates after TAVR at 1- and 2-year follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study by Green, et al. frailty status was independently associated with increased 1-year mortality (OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired mobility and malnutrition were significantly associated with a longer hospital length of stay (5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per patient). Given the phenotype of frailty is characterized by reductions in muscle mass, strength, endurance and activity level, a STEP is ideally suited to counteract these impairments. This pilot study aims to establish whether a STEP can safely improve the frailty score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.

This single-center pilot study will be conducted in partnership between Heart Care Midwest (HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical support. The study will be funded by an operational research grant from OSF SFMC.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled to undergo first-time elective TAVR

Exclusion Criteria:

* Vulnerable populations including prisoners, pregnant females and patients less than 18 years age.
* Patients with history of unstable angina, myocardial infarction, or decompensated heart failure in the week prior to screening
* Patients with physical limitations (i.e. debilitating stroke, amputation, unable to complete initial screening frailty profile)
* Patients with advanced dementia or cognitive deficits (i.e. unable to follow instructions of initial screening frailty profile)
* Exercise-induced arrhythmias
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from the patient and legally acceptable representative, if required
* Informed consent obtained from the caregiver
* Males and and females between 55-90 years
* Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration
* Brain imaging consistent with Alzheimer's disease
* Mini-mental state examination score 12-21
* Treated with donepezil, rivastigmine or galantamine
* At least mild level of behavioral symptoms

Exclusion Criteria:

* Other types of dementias
* Modified Hachinski Ischemia Score \> 4
* Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months
* Changes in antidepressant dosing within 2 months
* Use of other psychotropic agents
* Myocardial infarction within the past 2 years
* Malignancy within the past 5 years
* Suicidal ideation, risk of suicide
* History of alcoholism or drug abuse within 5 years
* Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness
* Specific findings in brain imaging
* Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension
* Blood donation or participation in a drug study within 60 days
* Previous AD immunotherapy treatment
* Patient cannot complete the computerised cognitive training
* Patients who reside in a skilled nursing facility
* Patients who are not able to swallow capsules