cyrilzakka/clinical-trials huggingface dataset:
Dietary Impact on Continuous Glucose Monitoring

Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims:

SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor.

SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response.

SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults, ages 14-22 years

Exclusion Criteria:

* Previous diagnosis of type 1 or 2 diabetes
* Previous diagnosis of hyperlipidemia or other metabolic disease
* Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
* Allergies to milk.
* Inability to participant in the maximal exercise test on the treadmill.
* Individuals not having android or IOS phones
* Individuals who cannot speak and/or write in English.
The Effect of Tear Supplements on Contact Lens Comfort

The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).

Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of contact lens associated discomfort

Exclusion Criteria:

* Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

PRIMARY OBJECTIVES:

I. To identify participant-level factors affecting recruitment of potentially eligible participants in AIDS Malignancy Clinical Trials Consortium (AMC) studies at core and affiliated sites.

SECONDARY OBJECTIVES:

I. To describe the socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites.

II. To characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial.

III. To identify the perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial.

IV. To better understand how potential study volunteers learn about AMC clinical trials and by what means are they referred to a particular study.

OUTLINE:

Participants complete the Improving Participation in AMC Clinical Trials (IMPACTS) survey comprising questions about socio-demographic information and clinical trial participation.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected participants
* Cancer or anal dysplasia diagnosis
* Offered informed consent on an AMC interventional clinical trial
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Inability to provide informed consent
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients

Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI treatment, partial symptom reduction is substantial. Investigations into the effectiveness of alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as paying attention in a particular way (on purpose, in the present moment and nonjudgmentally), promotes awareness and attention to internal experience and has been shown to reduce symptoms of anxiety and depression. A number of controlled studies have found Mindfulness-Based Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice, in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are allocated to the wait list, they will be randomly assigned to receive either 10 weeks of group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to the MBCT treatment group, compared to those in the wait list control group, will see greater reductions in self-reported measures of OCD symptom severity and improvement in other measures of mindfulness, mood and level of functioning. The results of this pilot study, if successful, will provide evidence towards another route by which patients can improve their OCD while waiting for clinic services or consultation. Results will also lend more evidence as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will inform further investigations into the potential addition of mindfulness techniques to standard care.


Eligibility Criteria:
Inclusion Criteria:

* Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
* Primary Diagnosis of OCD
* Ability to communicate in written and spoken English

Exclusion Criteria:

* Those with active substance abuse/dependence within 3 months
* Suspected organic pathology
* Recent suicide attempt/active suicidality
* Current self-injurious behaviour
* Active bipolar or psychotic disorder
* Previous completion of an MBCT course (≥ 8 weeks)
* Previous completion of an OCD-specific course of CBT (≥ 8 weeks)
* Previous completion of a general course of CBT (≥ 8 weeks) in the past 3 years
Substudy : Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading cause of death by 2030. COPD is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. Although most patients eventually recover, repeated episodes of exacerbations may accelerate COPD progression. Exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength.

The overall objective of this substudy is to elucidate how an acute COPD exacerbation may affect limb muscles.

Focusing our attention during exacerbations, a period of aggravated systemic inflammation, should be more rewarding in terms of understanding the link between inflammation burst and muscle disease in COPD. We have recently acquired experimental data supporting a role for the ubiquitin proteasome pathway in the worsening of limb muscle structure and function during an acute exacerbation, providing a solid framework for this investigation. The overall objective of this proposal is to substantiate these preliminary findings and elucidate how systemic inflammation during acute COPD exacerbation may affect limb muscles. Ultimately, our research could open new therapeutic avenues to minimize the systemic consequences of an acute exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* male and female
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* between 50 and 75 years old
* experiencing an acute exacerbation of COPD (24-48 hours, before treatment)

Exclusion Criteria:

* all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
* hormonal dysregulation
* inferior limb pathology
* neuromuscular pathology
* history of tobacco or alcool abuse
* oxygen dependent
A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers.

The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2), inclusive.
* Have a negative test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator.
* History of severe allergic, anaphylactic, or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, and diagnostic agents to be administered during the study.
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -1.
* Any immunization or vaccination given within 10 days prior to Day 1 and for 10 days after Day 1.
* Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
* Prior exposure to the study treatment or previous participation in this study or previous studies with aducanumab.
* Mini mental state examination (MMSE) score of \<27 at screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

Exclusion Criteria:

* Patients younger than 6 months or older than 8 years
* Previously failed sedation
* Weight greater than 25 kg
* Weight less than 5 kg
* BMI above 30
* Diagnosis of ADHD
* Any patient deemed inappropriate for nurse administered sedation
* Patients with any cardiac disease
* Obstructive sleep apnea
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Key Inclusion Criteria:

1. Adult patients (≥ 18 years)
2. Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
3. Brain metastases from NSCLC, which:

   have radiologically-progressed after WBRT or are present without prior WBRT
4. At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.
5. Patients must be neurologically stable, defined as being on stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose of GRN1005 (Cycle 1, Day 1).
6. Karnofsky Performance Score (KPS) ≥ 80%
7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005 (with the exception of local radiation therapy for palliation to extra-cranial sites, i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE v4.0 Grade 1.0.

Key Exclusion Criteria:

1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy
2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
3. Known intra-cranial hemorrhage
4. Known leptomeningeal disease
Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors

Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.


Eligibility Criteria:
Inclusion Criteria:

* Single
* Male
* Ages 21-30
* Engagement in unprotected intercourse with a woman at least once in the past year -
* Consumed alcohol at least 2 times per week in the past 30 days
* Had sex with a woman at least 2 times in the past 30 days

Exclusion Criteria:

* A history of alcohol problems
* A medical condition and/or medications which contraindicate alcohol consumption
* In a relationship that is monogamous and has lasted longer than 6 months
Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or high body mass index . Difficult visualization of the pelvic anatomy along with the limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes and increase the risks of injuries during surgery. A down to up approach via transanal total mesorectal excision (TaTME) technique may overcome these problems

This clinical trial will be conducted at general surgery department of Assiut University Hospital .

.

Eligibility Criteria:
Inclusion Criteria:

* • rectal cancer histologically proven through biopsy

  * tumours located at least 3 cm from anorectal ring;
  * local spread restricted to the rectal wall
  * adequate preoperative sphincter function and continence;
  * absence of distant metastases.
  * Suitable for elective surgical resection

Exclusion Criteria:

* • T4 tumours not responding to neoadjuvant chemo- radiotherapy

  * Patients under 18 years of age
  * Pregnancy
  * Previous rectal surgery (except local excision, endoscopic mucosal resection (EMR) or polypectomy)
  * Patients with acute intestinal obstruction
  * Multiple colorectal tumours
  * Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), Crohn's disease or ulcerative colitis
  * Planned synchronous abdominal organ resections
  * Preoperative evidence for distant metastases through imaging of the thorax and abdomen
  * Absolute contraindications to general anaesthesia,
  * presence of fecal incontinence,
  * undifferentiated tumors .
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use

The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking females
* greater than or equal to 18 years old
* scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.

Exclusion Criteria:

* less than 18 years of age
* non-English speaking patients
* unscheduled urogynecologic surgeries
* patients expected to undergo a simple reconstructive surgery with same-day discharge,
* history of chronic pain
* chronic Lyrica or Celebrex use
* psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks
* current liver disease
* kidney disease (defined as GFR \<60)
* malignancy
* sulfa allergy