cyrilzakka/clinical-trials huggingface dataset:
Barriers to Care in Patients With Rectal Bleeding in Nigeria

This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.

Patients who had rectal bleeding are invited to electronic media and print media will be invited for free medical consultation. Consented patients will complete a purposely design questionnaire for the study to assess the knowledge, attitude and practice of patient with rectal bleeding as regard the possibility of occurrence of colorectal cancer.

General practitioners in three cities will be contacted to assess their screening strategy for patients with rectal bleeding

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with rectal bleeding that persisted for up to one month

Exclusion Criteria:

* Patient that has the cause of rectal bleeding already determined before presentation
Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma

The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed cholangiocarcinoma.
2. Documented disease progression following at least one previous systemic cancer therapy
3. Tumor assessment for FGF/FGFR gene alteration status.
4. Have measurable disease according to RECIST v1.1
5. ECOG Performance Status ≤ 2
6. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Previously received selective FGFR inhibitor therapy.
2. History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
3. Have any of the following eye diseases/conditions: 1) history of retinal pigment epithelial detachment (RPED); 2) history of laser treatment or intraocular injection for macular degeneration; 3) history of dry or wet age-related macular degeneration; 4) history of retinal vein occlusion (RVO); 5) history of retinal degenerative diseases; 6) history of chorioretinal lesions..
4. Received CYP3A4 and/or CYP2C8 strong inhibitors or CYP3A4 strong inducers within 14 days prior to the first dose and subject who need to continue using these drugs.
Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).


Eligibility Criteria:
Inclusion Criteria:

* IBS according to Rome III criteria. Accepted sub-types include IBS-M, IBS-D and IBS-U
* Age 18-65 years
* Willing to use rye bread daily during the study periods

Exclusion Criteria:

* IBS-C (constipation dominant)
* Celiac disease
* IBD
* Major gastrointestinal operations like bowel gastric resection
* Non-treated hypo- or hyperthyroidism
* Alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol
* Regular (almost daily) use of NSAIDs, antibiotics or lactulose
* Linaclotide and other prescription medicines targeted specifically to IBS
* Pregnancy and lactation
* Follows currently strict low-FODMAP diet
Preventing Age-Related Weight Gain in the Workplace With Daily Weighing

To examine the effectiveness of daily weighing to prevent age-related weight gain.

Cornell employee's were recruited for a two-year weight gain prevention study. Height and weights were taken in our metabolic center. They were randomized into two group. The experimental group was given an internet based scale and asked to weigh themselves every morning immediately after rising. The other group was asked to return at the end of the study when they height and weight will again be measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-diabetic

Exclusion Criteria:

* History of eating disorders
Assessment of Sleep Quality and Mental Health After Using Meditation

This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems.

Participants selected for this clinical trial will be randomized into two groups: group 1 (intervention), with 87 participants undergoing 30 minutes of Shabad Kriya meditation before going to sleep, and group 2 (control), with 87 participants who will perform 30 minutes of relaxing reading before going to sleep. In addition, participants will complete the demographic data form; a sleep quality diary; and the scales: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PBS), Five Facets of Mindfulness (FFMQ), Daily Spiritual Experiences (DSES), Functional Assessment of Chronic Illness Therapy - Wellness Scale Spiritual (FACIT- 12), Duke Religiosity Index (DUREL), Quality of Life - Brief Mode (WHOQOL-Bref) and the Depression, Anxiety and Stress Scale (DASS 21). The study is open to the general community, and those interested are screened through the "Insomnia Severity Index" and questionnaires about health conditions. For conducting and guiding the intervention and completing the research instruments, online meetings will be held with the participants. The sleep quality diary will be completed for fourteen days before the start of the intervention (Baseline). Data collection will be carried out with online Google Forms questionnaires, sent through links in digital media, such as messages or emails, or made available in printed form. The main outcome measure will be sleep efficiency calculated using data from the sleep diary. Data from participants with ISI greater than or equal to 10 will be compared before and after the intervention. Additionally, data analysis of participants with ISI above or greater than 8 will be performed. At the end of the eighth week of the intervention (Shabad Kriya meditation or Relaxing reading), as well as one month after the end of the intervention, and three months after the end of the intervention, the participants will again fill in the questionnaires described above, for statistical comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of insomnia (Insomnia Severity Index between 8-28)

Exclusion Criteria:

* Major medical or psychiatric problems
* Who has used sleeping pills or sleep-disrupting medications in the last 30 days prior to participating in the study
* Who will need to use sleeping pills or sleep-disrupting medications during the study
An RCT of an Online Training for Vulnerable Patients to Use an Online Patient Portal Website

Online patient portals are becoming ubiquitous in the US. Previous research has documented substantial usability barriers, especially among patients with limited health literacy. This pilot randomized pilot trial had the goal of determining the effectiveness of an in-person training with a scalable online video-based training program to increase portal use among patients in a safety net healthcare setting.

The intervention in this study was a patient portal training curriculum with simple instructions and 11 how-to videos for accessing features of an online patient portal. Using a deeply participatory approach, this curriculum was created in consultation with a patient advisory board from the San Francisco Health Network, a local Medicaid health plan. From June until October 2016, 93 patients with 1 or more chronic diseases were randomized to receive either: 1) an in-person tutorial with a trained research assistant versus 2) a link to view the videos on their own. The primary outcome was portal log-in (yes/no) between 3 and 6 months post-training, assessed through a portal administrative dashboard within the EHR. Secondary outcome included baseline and follow-up survey measures on participants' perceptions of the portal use and their care, as well as views of the web-based lessons.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking as portal is only available in English
* diagnosed with at least one chronic condition

Exclusion Criteria:

* cognitive impairment
* visual impairment
* severe mental health conditions
* any circumstances that would make participation in the study difficult
* no previous email use
* self-reported usage of MYSFHEALTH
Epidural Calcitonin in Lower Limb Amputation

A prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

Eligibility Criteria:
Inclusion Criteria:

* prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders
* physical status American Society of Anaesthesiologist (ASA) I and II
* will undergo lower limb amputation

Exclusion Criteria:

* history of pituitary gland dysfunction
* cardiac disease
* chronic obstructive respiratory disease
* contraindications to performing an epidural block such as:

  * coagulation abnormalities
  * spinal deformities, and
* patients allergic to local anesthetics and or calcitonin will be excluded from the study
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.


Eligibility Criteria:
Inclusion Criteria:

1. Part 1 only, patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures.
2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

Exclusion Criteria:

1. At the time of randomization, patients who require intensive care unit (ICU) admission or patients with severe respiratory insufficiency who require mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
2. Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion.
3. Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.
A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.


Eligibility Criteria:
Inclusion Criteria:

* On stable daily doses of a statin for 45 days prior to receiving study treatment.
* Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

Exclusion Criteria:

* History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
* Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%).
MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes

Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 85 years of age
* Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
* Able to give informed consent and follow 2-step command.
* English Speaking

Exclusion Criteria:

* Unable to stand from chair without physical assistance from another person (able to use assistive device).
* History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
* Chronic lasting symptoms (\> 6 months) of severe COVID-19 (i.e., hospitalization)
* History of head trauma or concussion within the past 6 months
* Comorbid neurological disorder
* Peripheral vascular disease
* Myocardial infarction or arrhythmia in the previous year
* Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
* Pregnant or breastfeeding.
* Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
Two-channel IV-PCA With Dexmedetomidine

Dexmedetomidine was administered in the 'selector' channel and fentanyl in the 'basic \& bolus' channel of dual channel intravenous patient-controlled analgesia (IV-PCA) and the amount of opioid consumption was compared. In addition, intensity of pain, postoperative nausea/vomiting, and postoperative delirium was evaluated.

Bellomic® (Cebika, Uiwang-si, Gyeonggi-do, South Korea), a new IV-PCA device consisting of two separate drug pump channels, can be used in various ways and is expanding its scope of use. Unlike conventional IV-PCA devices, which have been used to mix and administer all drugs in one channel, the device can inject drugs separately in two channels. One channel (Selector \& Bolus) allows the patient to control whether to take additional bolus medication by pressing the button with adjustable continuous infusion, while the other channel (Continuous) allows constant rate continuous infusion.

Dexmedetomidine is a selective alpha-2 agonist, which is widely used in intensive care unit management, surgery, and various procedures because it has the advantage of less respiratory suppression along with sedation/anesthesia and pain effects. It has been previously reported that postoperative pain, morphine usage, and nausea/vomiting can be reduced when used during/after surgery in addition to general anesthetic drugs. However, in terms of major abdominal surgery, there is no research related to the use of dexmedetomidine after surgery, even though a large amount of opioid agents are required due to severe acute pain.

Thus, the investigators planned a randomized controlled trial to investigate the effectiveness dexmedetomidine using dual-chamber IV-PCA.

Eligibility Criteria:
Inclusion Criteria:

* Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
* Aged ≥ 20 years old

Exclusion Criteria:

* Body mass index ≥35 kg/m2
* American Society of Anesthesiologists physical status \> 3
* Severe cardiovascular disorder
* Severe liver or renal dysfunction
* Preoperative dyspnea
* Contraindication to dexmedetomidine (preoperative severe bradycardia (Heart rate \<50), atrioventricular block, allergy to dexmedetomidine)
* Preoperative use of opioid, anticonvulsant, antidepressant
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries

The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.

The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy children
* Children with at least one carious cavitated or non-cavitated lesion
* Must be able to spit
* Must be able to collaborate during clinical intervention

Exclusion Criteria:

* Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions
* Children who underwent antibiotic treatment during the course of this clinical trial
* Children with developmental disabilities
* Children with no clinical signs dental caries
Effect of Resistance Training in Patients on the Waiting List for Heart Transplant

The present longitudinal, randomized, and blinded clinical trial aims to:

* Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx).
* Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training.

The protocol will have a total duration of 12 weeks.

Heart failure (HF) presents a significant challenge to contemporary healthcare systems. As HF progresses, heart transplantation (HTx) becomes the primary treatment option to enhance survival rates. Patients awaiting HTx often endure extended hospitalizations and rely on continuous inotropic support. This scenario exacerbates bed rest and potentially worsening functional capacity. Resistance training has shown promise in mitigating the detrimental effects of immobility, however, limited research has explored its impact on HF patients on the HTx waiting list.

Objectives:

* To evaluate the effects of resistance training on functional capacity, quality of life, and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list.
* To assess the associations between Fried's frailty phenotype and functional capacity responses to resistance training, hemodynamic behavior during the protocol, and the incidence of adverse events during the protocol implementation.

Methods:

A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study. Participants will be randomly assigned to one of two groups: the resistance training group (TG) and the control group (CG). Assessments will occur at three time points: baseline (T0), at 6 weeks (T1), and at 12 weeks (T2) of resistance training. Clinical parameters will be evaluated, including the six-minute walk test and the Short Physical Performance Battery. Peripheral muscle strength will be measured using a dynamometer, and inspiratory muscle strength will be assessed through maximum inspiratory pressure. Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12. Additionally, cardiac biomarkers, such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples, will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients included in heart transplant list ≤1 month
* hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg.
* dobutamine dose ≤ 10 mcg/kg/min

Exclusion Criteria:

* heart failure of arrhythmogenic and/or restrictive etiology
* presence of uncontrolled acute arrhythmias
* cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out
Relationship Between Oral Findings and Salivary Factors in Sars-Cov-2 Patients

Two hundred individuals will be formed according to the study and control groups: Group-1: coronavirus 2 (Covid-19) (+) patients (n=100) and Group-2: Healthy individuals (in which the volunteers will be included due to group-1) (n=100). Oral examinations including DMFT scores, salivary flow rate, visible gingival index scores and radiographs (OPG) will be performed on both groups on the 1st appointment. Oral swap samples will be collected with sterile swap brushes (Six sample for each person) on the 1st, 7th and 30th days to evaluate the salivary immunoglobulins (Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)) and cytokine (IL-1, IL-6, IL-10) levels. Blood samples will be collected to validate the oral swap test results.

Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) is the virus responsible for coronavirus disease 2019 (COVID-19) which also affects all systems of the body including the oral environment. Recent studies have demonstrated the association between oral health status and systemic diseases. including systemic infections and respiratory diseases. Aim of this study is to analyze the immunoglobulin and cytokine levels of SARS-CoV-2 patients and correlate the oral health status of these patients. Our hypotheses are, 1) Covid-19 affects individuals with low oral hygiene (high DMFT score) more severely, 2) Oral cytokine levels will increase similarly to blood levels in patients with Covid-19, 3) Oral immunoglobulin levels in patients with Covid-19 decreased similarly to those in blood. Oral examination of 100 Covid (+) patients which were hospitalized due to acute respiratory failure will be performed in the dental department of each faculty hospital. Decay-Missing-Filled Tooth (DMFT) scores, visible gingival plaque index (Löe-Silness), Bleeding on Probing (BoP) scores, and orthopantomographs (OPG) will be collected for each participant. Oral swap specimens will be collected (6 sample for each person) to evaluate the levels of salivary immunoglobulins (IgA, IgG, IgM) and cytokines (IL-1, IL-6, IL-10) on 1st, 7th, and 30th days. ELISA test will be performed for immunological analysis with ready-made kits (SunRed Biotech. Co, Shanghai, China). Full blood analyses will be performed to validate and correlate the actual cytokine and immunoglobulin levels.

Eligibility Criteria:
Inclusion Criteria:

* Covid (+) patients,
* Patients who were hospitalized due to Acute Respiratory Deficiency,
* Conscious patients in ICU (intensive care unit) or IDMC (Infectious Diseases and Microbiology Clinic).

Exclusion Criteria:

* Patients with Cancer,
* Patients with Autoimmune System diseases,
* Pregnant women,
* Patients with Immune Deficiency diseases (Acquired immune deficiency syndrome - AIDS, Autoimmune lymphoproliferative syndrome - ALPS , Chronic granulomatous disease - CGD, etc.).