cyrilzakka/clinical-trials huggingface dataset:
Gut Health Response to Dietary Fiber

Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.

Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.

Eligibility Criteria:
Inclusion Criteria:

1.Weight

* BMI between 23 - 29
* having obtained his/her informed consent
* willing and able to exclusively consume enteral diets for two 14 day periods
* willing and able to collect stool samples as instructed

Exclusion Criteria:

* any disease
* use of medication except for contraceptive medication and certain OTC medications not affecting laxation
* smoking
* excessive exercise (\> 2 hours per week)
* consumption of more than 20 grams of dietary fiber daily
* pregnancy or lactation
* use of laxatives
* use of antibiotics in past 6 months
* use of pre or probiotics supplements in the past 2 months
* use of probiotic foods in the past month
* subjects who cannot be expected to comply with the study procedures
* currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* known allergy or sensitivity to formula ingredients
Anodal Transcranial Direct Current Stimulation and Cognition in Stroke

Pervious literature shows the effects of tDCS and RehaCom on cognition in chronic stage of stroke and only short-term effects were seen, but detailed evidence-based study on cognition in subacute and acute stages of stroke is spare and there is limited number of studies are available on effects of tDCS in cognition in both acute and subacute stages of stroke. Some polite studies were done in acute stage of stroke and only short-term effects of tDCS were evaluated along with other outcome measures including upper and lower limb motor recovery, balance and improving activity of daily living. The long-term effects of transcranial direct stimulation only for the improvement of cognition in subacute stage of stroke are yet to be seen. This study will help us in evaluating the long-term effects of aTDCS and RehaCom cognitive therapy on cognition in subacute stage of stroke.

Previous literature showed that, the brain has a capacity to recover the loss that comes after brain damage within subacute stage, as in this stage there is high excitation-inhibition phenomena in neural circuit, this excitation-inhibition spectacles may reflect to upsurge the activity of neurotransmitter concentration within cortex that put subtle effect for developing neural plasticity.

More innovative therapies are used worldwide in patient's cognitive rehabilitation after stroke, for cognitive training including physical movement, paper-and-pencil activities, manipulatives training programs or other aids such as playing cards or a combination of multiple training, along with transcranial direct current stimulation (tDCS) and RehaCom cognitive therapy which shows significant effects with (p \< 0.05) in acute and chronic stages of stroke. Most of the studies used a different type of therapy in therapeutic protocols for other functional improvement including motor recovery exercises for both upper and lower limb balance training, postural stability exercises, manipulative training programs with significant improvement (p \< 0.05) in real time (tDCS)

Eligibility Criteria:
Inclusion Criteria:

* First ischemic stroke of frontal cortex
* Subacute stroke
* Age 40-60 years of both genders
* Individual with 10 years formal education
* MMSE score between 19 and 24
* MoCA score is minimum10
* FIM score between 84 and 99
* Beck depression inventory ranged between 0 and 10

Exclusion Criteria:

* Hearing and Visual loss/ deficit
* Recurrent CVA
* Neurological condition affects the cognition
* Receiving the drugs affect the cognition like anti-depressant, anti-epileptics etc
* Wound at skull
* Presence of shunt
* Brain tumors
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus

Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients
* acute coronary syndrome
* patients underwent to primary PCI
* naïve for platelet P2Y12 receptor inhibition therapy

Exclusion Criteria:

* history of bleeding diathesis
* chronic oral anticoagulation treatment
* contraindications to antiplatelet therapy
* PCI or coronary artery bypass grafting (CABG) \< 3 months
* hemodynamic instability
* platelet count \< 100,000/μl
* hematocrit \< 30%
* creatinine clearance \< 25 ml/min
* Patients with a history of stroke
* contraindication for prasugrel administration
* patients weighing \< 60 kg
* patients treated with morphine
* \> 75 years of age.
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, 40-90 years of age, inclusive.
* Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
* Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

* Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Results of Coronary Angiography Rafter CABG: Comparison Between No-touch and Conventional Vein Graft

Coronary artery disease is one of the biggest health issue worldwide: It is estimated that cardiovascular diseases cause around 45% of all death in Sweden and in the West World. The treatment, in a large part of the patients, implicates a so called bypass-operation, that consists in to connect new vascular conduits (grafts) beyond the narrowed coronary vessels to improve the blood supply to the heart. One of the graft that is commonly used is the saphenous vein from the leg. The disadvantage of the saphenous vein graft is the predisposition to early obstruction. The international literature shows the following grades of occlusion: 15% in the first year and 40% after 10 years.

At the Cardio-Thoracic Clinic of the University hospital of Örebro has been developed a new method to harvest the saphenous vein together with the surrounding fat-tissue. This technique, called no-touch technique, has the advantage to reduce the damages to the vein during the harvesting, showing a substantially reduced risk for future occlusion (5% after 18 months and 10% after 8,5 years).

2020-05-20 2020-11-16 Project created in: FoU Region Örebro län Resultat av Koronarangiografi hos patienter som tidigare CABG opererats Project number : 274418 Created by: Gabriele Ferrari, 2020-05-20 Last revised by: Gabriele Ferrari, 2020-11-16 Ongoing The aim of the PhD project is to evaluate the results of the no-touch technique in compare to the conventional technique for the venous graft harvesting. The focus of the study is to analyze all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). One will compare the patency rate, the rate of MACE (major adverse cardiac events) and the quality of life in the two groups (no-touch vs. conventional). This study is the first and the only one in the world that will examine the long-term angiographic results of the no-touch technique in patients that had angina pectoris after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Angina after CABG requiring diagnostic coronary angiography
* CABG operation between 1992 and June 30th 2020
* Coronary angiography between 2006 and June 30th 2020

Exclusion Criteria:

* Coronary angiography within 30 days from the CABG operation date
Cardiometabolic Effects of Rapid Glucose Excursion

The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated

BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also glycaemic variability is currently particularly regarded as a risk factor for cardiovascular and microvascular complications. Intermittent blood sugar excursions with pronounced fluctuations between high and low values instead of constant, even increased blood sugar exposure, have been shown to be more harmful in several studies.

AIM: The aim of this study is to determine the effect of rapid glucose excursion versus continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.

METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic biomarkers will be analysed serially to analyse the effects of glucose excursions.

PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic complications, but there is currently a lack of conclusive evidence. The causes and mechanisms of these negative influences on the cardiovascular system due to high glucose variability have not been sufficiently investigated and are therefore not fully understood so far. To date, however, there have been no studies with acutely altered glucose concentrations in healthy volunteers that have investigated the effects on traditional as well as recently identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the therapeutic strategy in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or older with no disease history
* written informed consent

Exclusion Criteria:

* receiving any medication
* probands who suffer from infectious disease
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level

Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level

86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification

Eligibility Criteria:
Inclusion Criteria:

* Diabetics and non-diabetic patients undergo cataract surgery
* Age between 50-60 years old
* Corrected distance visual acuity\<0.4
* Gender: both genders.

Exclusion Criteria:

* Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity).
* corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery
Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder

The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.

DOV 21,947 is an investigational drug that is being developed for the treatment of depression. The purpose of this study is to evaluate the safety and effectiveness of a flexible dosing schedule of DOV 21,947 (25 mg twice daily for two weeks, then 50 mg twice daily for four weeks as compared to placebo) in the treatment of major depressive disorder. Information about any side effects that may occur will also be collected.

The efficacy evaluation will be based on the change in the total MADRS and HAMD-17 scores from randomization to week 9 .The secondary objective is to determine if DOV 21,947 improves the quality of life for patients with MDD as compared to placebo

Eligibility Criteria:
Inclusion Criteria:

1. Males or females between 18 and 65 years of age (inclusive).
2. Either outpatients or inpatients diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, see Appendix 3) and MINI International Neuropsychiatric Interview (MINI).
3. Patients with recurrent depressive episode of at least 2 months in duration. Patients must have previously responded (significant clinical improvement judged by the Principal Investigator) to at least one antidepressant treatment.
4. HAMD-17 total score \* 22 with a severity score of at least 2 on Item 1 at the Placebo Run-In Visit and the Baseline/Day 1 Visit.
5. HAMD-17 score reduction ≤ 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit.
6. HAM-A total score \< 17 at the Screening Visit.

Exclusion Criteria:

1. Patients with a HAMD-17 total score reduction of more than 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit (placebo responders).
2. Patients with a medical history of MDD that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (MAO) inhibitor.
3. Patients who are known to be antidepressant treatment-resistant. Patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., TCA, SSRI, SNRI, MAO-I, etc). Failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the Principal Investigator's discretion.
4. Patients with a medical history of MDD who consistently did not respond significantly to electroconvulsive shock therapy (ECT) or had ECT within a year prior to the Screening Visit regardless of outcome.
5. Patients with psychotic depression
A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors

This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed malignant solid tumor.
* Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.
* Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Patients must have normal organ and marrow function

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2.
* Known history of allergic reactions to carboplatin or cremophor-paclitaxel.
* Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of seizure disorder.
* Hepatitis B surface antigen (HBsAg) positive, Hepatitis C virus (HCV) antibody positive or Human immunodeficiency virus (HIV)-positive patients.
Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience

Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. This project tests the hypothesis that rates of medical errors and adverse events (primary outcome), hospital experience, communication, and shared understanding will improve following implementation of Patient and Family Centered I-PASS, as compared with current practice.

We conducted an intervention study on pediatric inpatient units in seven North American hospitals. Each site was assigned to one of 3 staggered waves of implementation and data collection. The Patient and Family Centered I-PASS intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation. We measured errors and adverse events (AEs) via an established systematic surveillance methodology, family experience via pre-discharge surveys, and communication processes via direct observations.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the pediatric inpatient study units of participating hospitals
* Parents/caregivers of patients less than 18 years of age who speak English, Chinese, Arabic, Russian, or Spanish
* Nurses working on these units
* Residents working on these units
* Medical students working on these units

Exclusion Criteria:

* Parents/caregivers who do not speak a study language (decided based on the 5 most commonly spoken languages across study sites; study languages include: English, Chinese, Arabic, Russian, Spanish)
* Parents/caregivers of patients greater than 18 years of age
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.

This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be decided by the Investigators based on the locally approved label. The patients will be treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up for 3 years. The objectives of this study are to record safety and efficacy information on the treatment combination in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority
* Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
* Patient willing and able to give written Informed Consent
* Patient capable of complying with study data collection procedures

Exclusion Criteria:

* Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
Topical Nitrates for Myofascial Trigger Points

The purpose of this study is to determine whether a topical nitroglycerine patch applied daily over a trapezius trigger point can improve patients' symptoms.

If there is improvement, this open label study will help determine the degree of improvement and contribute to the design of a larger double blind placebo controlled trial.

We would consider moving forward to a large randomized trial if:

* The intervention is acceptable to patients (\>= 70%) and
* Compliance is satisfactory (\>=80%) and
* We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the VAS.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include age between 19 and 65 years old, myofascial pain lasting at least 6 months, and a myofascial trigger point point in the trapezius muscle.

Exclusion Criteria:

* Our exclusion criteria include symptomatic disc herniation, symptomatic cervical osteoarthritis, systemic infection, malignancy, collapsed vertebra, thoracic outlet syndrome, temporomandibular joint dysfunction, collagen-vascular disease, or brachial plexopathy. Patients with ongoing litigation regarding their symptoms are not eligible for this study. Also excluded are patients with underlying cardiac disease, hypotension, or medical conditions that may not allow them to tolerate the use of vasodilators, and those who use phosphodiesterase inhibitors.