cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Intradialysis: Last vs. First Part of the Session

The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.

The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.

Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.

The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria:

* Recent cardiac events (less than 3 months)
* Unable to exercise
Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects

Eligibility Criteria:
Inclusion Criteria:

* right handedness
* German native speaker
* cerebrovascular stroke in left hemisphere (\>6 months)
* mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
* residual anomia in naming test (\>75 correct responses)

Exclusion Criteria:

* other current or previous neurological or psychiatric diseases
* alcohol or drug abuse
* MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
Effect of Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain

the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females

: Menstrual low back pain is a prevalent condition among women. Menstrual low back pain occurrence is affected by hormonal changes. Menstrual low back pain incidence more than 40% to 50% during the menstrual phase (days 1-6) of the menstrual cycle, while the range of prevalence was 45 to 95%. It has a high prevalence among females, especially females aged 20 to 25 years old. Hormonal changes might play an important role in the formation of Menstrual low back pain and is the main cause of feeling of pain during menstrual cycle. kinesio taping and myofascial release technique play an important role in the treatment of Menstrual low back pain. this trial has two groups; one will receive kinesio taping three days and the second will receive myofascial release technique for12 sessions through 3 consecutive menstrual cycle

Eligibility Criteria:
Inclusion Criteria:

1. Healthy young virgin females suffering from menstrual low back pain diagnosed by the gynecologist.
2. Their ages will be ranged from 18-25 years\&#39; old
3. Their body mass index will be ranged from 20-25 kg/m2.
4. All females have regular menstruation
5. Their pain intensity is scored as \&gt; 4 on VAS just before or during the first 3 days of the menstruation

   -

Exclusion Criteria:

Females will be excluded from the study if they have:

1. Any orthopedic problems such as trauma at lower spine, congenital malformation at spine and scoliosis.
2. Any gynecological problem such as irregular menstrual cycle, secondary dysmenorrhea due to endometriosis, ovarian cyst, uterine fibroid and congenital malformation or pelvic inflammation.
3. Athletic females
4. Allergy to kinesio taping.

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Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with limited therapeutic options and notably absent FDA approved therapy with any WM indication. Therefore, there is a need to identify new therapeutic agents for WM patients both in the upfront and relapsed/refractory setting. The purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory WM.

Perifosine is a drug that in particular inhibits Akt thought to be important for initiation and progression of malignancies, specifically in lymphomas. In laboratory experiments of WM and lymphoma cell lines, perifosine has shown to have cytotoxic and anti-proliferative activity as a single agent. This drug has been used in clinical research studies of other types of cancers including soft tissue sarcomas, head and neck cancers and prostate cancer. This study uses a two-stage design to evaluate efficacy of perifosine based on overall response (OR). The null and alternative OR rates are 20% and 40%. If 4 or more patients enrolled in the stage one cohort (n=17 patients) achieve OR than accrual will proceed to stage two (n=20 patients). If fewer than 10 ORs are observed then the regimen will be considered ineffective.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must have received prior therapy for their WM and have relapsed or refractory WM. Any number of prior therapies is acceptable
* Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the ULN and over 10% of lymphoplasmacytic cells in bone marrow
* ECOG Performance Status 0,1, or 2
* Laboratory values as described in the protocol
* Life expectancy of greater than 12 weeks

Exclusion Criteria:

* Uncontrolled infection
* Other active malignancies
* CNS involvement
* Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration.
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
* Pregnant or nursing women
* Known to be HIV positive
* Radiation therapy less than 2 weeks prior to registration
Examining Early Palliative Care in Newly Diagnosed Cancer Patients

To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.

The investigators overall goal is to understand the impact of initiation of early palliative care in an oncology population in a low-resource setting in order to provide guidance for future public health policies surrounding the provision of palliative care in Ethiopia. Hypothesis: The investigators hypothesize that initiation of palliative care in this low-resource setting is a cost-reducing intervention that will improve patient-reported outcomes and quality of life. Preliminary data: This research will focus on adult patients with oncologic diagnoses as preliminary research in this setting revealed that this patient population had the highest depression and anxiety scores, the lowest palliative outcome scores, and reported the highest costs of medical care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.

Exclusion Criteria:

* Patients who have not been diagnosed with cancer.
* Patients with diagnoses made more than 4 weeks ago, who are non-ambulatory, or are already receiving palliative care, are ineligible to participate in the study.
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Men 50 years or older, women 60 years or older
* Low to normal levels of low density lipoprotein (LDL) cholesterol (\< 130mg/dL)
* Elevated levels of C-Reactive Protein (CRP) \> 2.0 mg/L

Exclusion Criteria:

* History of cardiovascular or cerebrovascular events
* Active liver disease
* Diabetes mellitus
* Uncontrolled hypertension or hypothyroidism
* History of certain malignancies
* Chronic inflammatory conditions
* History of alcohol or drug abuse
Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease

This randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.

Between 80-90% of people with associated metabolic fatty liver disease present with obesity and diabetes mellitus.

Alpha-lipoic acid is a cofactor of mitochondrial enzymes that has been considered an antioxidant since its reduced form, dihydrolipoate, reacts with reactive oxygen species and thus protects the cell membrane. Alpha-lipoic acid administration has been shown to have beneficial effects on adipokine levels and metabolic disorders such as diabetes and obesity, both of which are present in patients with MAFLD. It has been shown that the administration of 1200 mg of alpha-lipoic acid in patients with fatty liver decreases insulin resistance, serum leptin, increases the concentration of adiponectin.

Given the metabolic effects of alpha-lipoic acid, it is hypothesized that administration of this formulation may be beneficial for people with metabolic associated fatty liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects treated at the Instituto de Investigaciones Médico Biológicas de la Universidad Veracruzana with a diagnosis of Fatty Liver Disease
* Agree to voluntarily participate in the study and sign informed consent.
* Patients with evidence of hepatic steatosis who are overweight or obese
* Patients with evidence of hepatic steatosis with diabetes mellitus and overweight or obesity.
* Patients with evidence of steatosis plus metabolic risk abnormalities will be included (waist circumference \>102 in men, 88 cm in women, blood pressure \>130/85 mmHg or specific treatment, triglycerides \>150 mg/dL or specific treatment, HDL cholesterol \< 40 mg/dL in men, \<50 mg/dL in women or specific treatment, HOMA-IR \>2.5, CRP \>2 mg/L or prediabetes defined by fasting glucose detection 100 to 125 mg/dL, postload glucose 2 hours 140 to 199 mg/dL or HbA1c between 5.7 to 6.4%)
* Accept not to start any diet program during the study period.
* Agree not to change your current exercise plan during the study period

Exclusion Criteria:

* Patients meeting diagnostic criteria for Fatty Liver Disease with normal weight
* Patients with terminal illness, cancer, renal disease in renal replacement therapy
* Pregnant women
* Patients with inability to understand or follow the study protocol
* Sensitivity to the components of the formula.
Determination of Lysine Requirements in Pregnancy

Amino acids are building blocks of protein in our body. It is important that pregnant women eat adequate amount of protein/amino acids to ensure healthy growth and development of the fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and not much in plant foods such as wheat. Currently , it is not known how much lysine is needed to eat during pregnancy.

Current Dietary Reference Intake recommendations for amino acid requirements are based on non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators knowledge, there is no scientific information regarding the amount of lysine needed at different stages of pregnancy.

The investigators hypothesize that current recommendations for lysine intake in pregnant women are underestimated. The investigators also hypothesize that the lysine requirements will be greater during the later stages of pregnancy, compared to early stages.

The purpose of this study is to determine lysine requirements in healthy pregnant women 19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Maternal age 19-40y
* Early stage of pregnancy(15-18 weeks) and late stage of pregnancy(33-36 weeks)
* In good health (free of chronic/acute illness, full range of physical mobility)
* Healthy pre-pregnancy body mass index

Exclusion Criteria:

* Subjects outside the age range of 19-40y
* Women pregnant with more than one child
* Body mass Index less than 18.5kg/m2 or greater than 25 kg/m2
* less than 18 months between current pregnancy and last pregnancy
* History of spontaneous abortion,pre-term birth, preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy related jaundice
* Existing metabolic disease
* Substance dependance (i.e. alcohol, cigarette, illicit drugs)
* Allergic to eggs and egg protein
* Severe nausea and vomiting during pregnancy
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or greater
* History of ≥ 2 episodes of recurrent CDI. CDI is defined as the presence of diarrhea ( Bristol 6 or 7 for 48 hours and a confirmatory test for CDI). Preferred testing will be a two-step method using GDH/EIA toxin, though PCR will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months
* Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis)
* Undergoing FMT via colonoscopy for CDI as part of standard medical care

Exclusion Criteria:

* Unable or unwilling to undergo a colonoscopy
* Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
* Anticipated immediate or upcoming surgery within 30 days
* Need for continued non-anti-CDI antibiotic therapy
* History of total proctocolectomy
* Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
* Patients who are unable to give informed consent
* Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
* Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
* Life expectancy \< 6 months
* Unable to adhere to protocol requirements
* Patient who have received an FMT in the past year
* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
* Patient who is diagnosed with NYHA class 3 or 4 Heart Failure
* Lab value of WBC \<3.0 x 103/mm3 , Platelets \<100 x 103/mm3 , ALT or AST \> 1.5 x institutional ULN
* EBV or CMV negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)
Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.

Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Isolated coronary artery bypass indication
* Left ventricular ejection fraction greater than 50 %
* Absence of preoperative pulmonary dysfunction

Exclusion Criteria:

* Intra and postoperative circulatory shock
* Postoperative pulmonary dysfunction
Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19

Ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well

150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs

Eligibility Criteria:
Inclusion Criteria:

* early covid19 pateints

Exclusion Criteria:

* children and pregnant women
Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient

Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients.

* Variability and complexity of resting tidal breathing
* Oscillatory resistance and reactance of airways Tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics.

The relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study.

After baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003 for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects aged 40-75 years Documented COPD in stable condition FEV1 between 30 % and 70 % predicted (post bronchodilator) Significant dyspnea with a mMRC dyspnea scale

Exclusion Criteria:

* History or current diagnosis of asthma or ACO (asthma-COPD overlap syndrome)
* Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
* Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters
* Severe renal impairment eGFR \< 30
* Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
* Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
Perceptions of Hospital Care At Home for Patients with Cancer: a Qualitative Study of Cancer Providers, Patients and Caregivers.

The objective of this qualitative research study is to assess the knowledge, attitudes and beliefs of cancer care providers, patients with cancer and caregivers regarding hospital care at home. We aim to conduct qualitative interviews to inform implementation of future on oncology hospital care at home programs

Interviews and focus groups will be conducted in English only using an interview guide (attached). The interview guide was based on the Consolidated Framework for Implementation Research (CFIR)8 to provide a broad understanding of the potential barriers and enablers of implementing a hospital care at home program. In summary, interviews will begin with an overview of the qualitative research study followed by verification of a completed demographic questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Cancer Care Providers

   * Cancer care providers of any specialty, including but not limited to oncologists, surgeons, hospitalists, emergency medicine physicians, nurses (including nurse practitioners), physician assistants, and any other member of the cancer care team (eg social workers or physical therapists)
   * Employed by the University of Texas MD Anderson Cancer Center
2. Patients

   * Adults ages 18 and over
   * Currently undergoing or completed cancer treatment within the last 5 years at MD Anderson
   * Able to speak and read in English
3. Caregivers

   * Adults ages 18 and over
   * Self-identifies as a caregiver of an individual over 18 who is currently undergoing cancer treatment or completed cancer treatment within the last 5 years at MD Anderson
   * Able to speak and read in English

Exclusion:

None