cyrilzakka/clinical-trials huggingface dataset:
Effects of Facemask on Cardiorespiratory Performance

The purpose of the study is to explore whether using a surgical facemask impacts performance in response exercise below vs. above the ventilatory threshold (VT). The investigatores also aim to explore the impact of sexual dimorphism in the physiological response to exercise performed within these specific intensities. Finally, the onvestigators intend to examine whether the effects of wearing a facemask affect physiological recovery at cessation of exercise

Tests will be carried out during the afternoon period (between 13.00 and 16.00 h), in a laboratory with an environmental temperature between 22 and 24 ºC and a relative humidity between 44 and 56%.

Each participant will be tested on 3 non-consecutive days. On the first day, a Graded Exercise Testin (GXT) will be performed, to measure VO2max and to enable the individualization of intensities according to the VT of each participant. (Silva et al., 2011). Then, in a randomized (computer generated algorithm) counterbalanced manner, all participants performed resting and standardized cycle-ergometer submaximal protocols on two different conditions (with and without facemask), within a 1-week period. On the first visit, body mass measurements will be taken, to the nearest 0.01 kg, on a digital scale (BG 42, Breuer GmbH, Söflinger, Germany) with the participants wearing light-weight clothes and no shoes. Measurements of standing height will be limited to the first visit and taken to the nearest 0.5 cm using a stadiometer. Body Mass index (BMI) will be calculated by dividing the participants' mass in kilograms by the square of their height in meters. Then, after a brief warm-up period, each participant will perform a maximal cycle-ergometer test consisting of a ramp protocol to volitional exhaustion.

One of our purposes is to determine the impact of exercising with a facemask on physiological recovery. For this reason, measurements, within each submaximal testing session (with and without a facemask), will be taken using a standardized timeline designed to allow measuring recovery postsubmaximal exercise and compare it with a resting baseline time point. Specifically, testing will begin with a 10-min resting period in the seated position (baseline). Subsequently, participants will exercise either without (control) or with (experimental) a surgical facemask at an intensity below the VT and recover for another 10 min. Then, each participant will exercise at an intensity above the VT until volitional exhaustion and this will be followed by 10 min of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 18 to 30 years old adults

Exclusion Criteria:

* Potential participants, with body mass index (BMI) \> 24.9 kg.m2 will be excluded. Additional exclusionary criteria will include active smoking status, known metabolic disease, cardiovascular disease, respiratory disorders including asthma; and any orthopedic issues that would limit exercise performance.
Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia

Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Minimum inhibitory concentration (MIC) data will be interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine predictors of mortality for S. maltophilia isolates.

Stenotrophomonas maltophilia is an aerobic, non-fermenting, Gram-negative bacillus recognized by the World Health Organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. The Investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* S. maltophilia isolated on respiratory or blood culture

Exclusion Criteria:

* Those that do not meet the inclusion criteria outlined in Section 4.1.
Mindfulness Training for Head Start Parents

A training module has been developed for parents to effectively address stressors and demands of parenting and promote positive and supportive parent-child interactions. The purpose of this study is to implement the parent training program and evaluate the effectiveness of the program. Depending on the results, investigators expect core aspects of this module to be adaptable and modified or extended for parents of older children in the future to meet the needs of families across the stages of childhood development.

Parents of children enrolled in the Head Start program will be recruited to take part in a training module to learn and practice mindfulness techniques. Recruited participants will be randomly assigned to an intervention group or a wait-list control group. Parents in the intervention group will attend the training, which involves 6 weekly, group sessions. Data will be collected from both the intervention and wait-list control groups 1-3 weeks prior to the intervention period and 1-3 weeks following the end of the intervention period. This data will be collected through self-report questionnaires, in-home observations, hair sample from parents, an activity tracker for parents, and records on developmental assessments and attendance of the target child from Head Start. The wait-list control group will be offered a training after measures are completed. Intervention group participants may be invited to take part in focus groups after the training is complete. At these focus groups, they will engage in a discussion of their experiences and opinions about the class. Some participants may be invited to individual interviews to share their experiences and aid further revision of the program.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children ages 0 - 5 who are enrolled in Head Start

Exclusion Criteria:

* None
Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation

The purpose of this study was to test whether a brief motivational intervention is associated with enrollment in cardiac rehabilitation.

Cardiac rehabilitation programs help reduce morbidity and mortality following a cardiac event, but only a subset of referred patients chooses to participate. An intervention based on principles of motivational interviewing may help resolve individuals' ambivalence about cardiac rehabilitation. The primary aim is to evaluate the efficacy of a brief motivational intervention (MI) for enhancing intention to enroll in cardiac rehabilitation compared to a usual care (UC) control condition among patients referred to cardiac rehabilitation. It is hypothesized that patients in the MI condition will report greater intention to enroll in cardiac rehabilitation compared to patients in UC. A small-scale feasibility trial will include patients (n = 100) with acute coronary syndrome who are referred to a standard 12-week exercise-based cardiac rehabilitation program in Calgary, Canada. Patients will be randomly assigned to MI or UC. The primary outcome will be self-reported intention to attend cardiac rehabilitation. Secondary outcomes will include beliefs about cardiac rehabilitation, exercise self-efficacy, perceived barriers, and cardiac rehabilitation enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Referred to and eligible for outpatient, exercise-based cardiac rehabilitation; confirmed acute coronary syndrome; English-speaking; able to complete study prior to first scheduled cardiac rehabilitation appointment

Exclusion Criteria:

* Cognitive or hearing impairment that would interfere with study participation
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels

This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
* Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
* Body mass index (BMI) of \>39 kg/m2.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Patients with peripheral neuropathy.
* Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.
Topical Alprostadil for Female Sexual Arousal Disorder

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary. The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 21-60 who have undergone a hysterectomy
* Have a primary diagnosis of female sexual arousal disorder
* Be willing to comply with all study requirements and visit schedules

Exclusion Criteria:

* Known allergy to alprostadil or product excipients
* Have a genital inflammatory or infectious condition or STD
* Have a significant medical condition that would interfere with the study
* Have received an investigational drug within the prior 30 days
The Role of Matrix Metalloproteinase 2 and 9 Enzymes in Developing Chronic Thromboembolic Pulmonary Hypertension

Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery.Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension

Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery. Only 4% of patients with acute pulmonary embolism develop chronic thromboembolic pulmonary hypertension and acute pulmonary embolism or deep vein thrombosis is reported in the anamnesis of 75% of those with chronic thromboembolic disease. Therefore, the etiology of the disease is not clear. Altought many studies are done, especially the role of inflamation is emhasised underlie the disease.

Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension.

Matrix metalloprotinase enzymes are known to play a role in atherosclerosis. This research will investigate whether there is atherosclerosis together with inflamattion in the background of chronic thromboembolic hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Despite 3 months of anticoagulation therapy
* mean pulmonary arterial pressure \> 20 mmHg
* pulmonary vasculary resistance \> 3 wood
* pulmonary capillary wedge pressure \< 15 mmHg
* perfusion defect in ventilation perfusion scintigraphy
* pulmonary angiography or computed tomography angiography showing pulmonary artery occlusive lesions

Exclusion Criteria:

* Patients undergoing pulmonary thromboendarterectomy concomitant coronary bypass, carotid endarterectomy, aortic valve, ascending aorta, mitral valve, tricuspid valve, pulmonary valve surgery
* Patients who have undergone surgical or percutaneous procedures due to atherosclerotic disease
An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of MFOLFOX6 + Bevacizumab Versus MFOLFOX6 + Panitumumab Therapy in Patients with Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion Criteria:

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study
Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.

To assess the efficacy of Taurolock-hep500™ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .

In this study,investigators will recruit 60 patients with ESRD on regular hemodialysis from hemodialysis units in Ain-Shams university Hospitals, Patients will be recruited to study at the time of catheter insertion.

They will be randomized into 2 groups. Group 1; 30 Patients will receive unfractionated heparin (5000i.u/ml) after hemodialysis sessions (control group).

Group 2; 30 Patients will receive Taurolock-hep500™ after hemodialysis sessions. All patients will be subjected to;

1. Full history including history of ESRD and dialysis initiation.
2. Clinical examination. Aseptic technique will be used in handling with catheters including (sterile gloves, antiseptic solution in dealing with covers and caps topical antibiotics spray and ointment) catheter will be instilled by 10 ml of normal saline in both opening followed by either taurolock hep 500™ or unfractionated heparin 5000 iu/ml.

Patients will be followed up for one month and will be monitored for clinical symptoms and signs of catheter related bacteremia (fever ,rigors, hypotension, sweating ) on the hemodialysis sessions . Also catheter performance will be assessed using the following parameters;

1. Blood flow rate measured by hemodialysis machine blood pump in (ml/min).
2. Dialysis quality by URR( urea reduction ratio) is a dimensionless number used to quantify dialysis treatment adequacy by calculating difference between urea level before and after hemodialysis session (average of 4 sessions , 1 per each week).
3. CBC ,markers of inflammation (CRP) baseline and at time of appearance of symptoms and signs of bacteremia in both groups in addition to (IL6) measured by Elisa technique baseline and at time of appearance of symptoms and signs .

Eligibility Criteria:
Inclusion Criteria:

1. Patients on regular hemodialysis 3sessions/wk.
2. Recent catheter insertion at beginning of the study.
3. Both males and females.
4. Age group ≥ 18 ys.

Exclusion Criteria:

1. Patients with intercurrent infections.
2. Patients with sepsis.
3. Patients receiving drugs affecting immune system like immunosuppressive drugs.
4. Patients on antibiotics.
Sleep and Circadian Mechanisms in Hypertension

This study is a mechanistic clinical trial designed to investigate the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN).

This study is a mechanistic clinical trial designed to study the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN). Investigators will study participants with dipping and non-dipping hypertension. All participants will partake in all experiments. First, investigators will assess sleep in the participants' home environment using unattended polysomnography. Participants will then complete a 5-day overnight forced desynchrony laboratory protocol to uncover circadian rhythms (Constant Routine). The second experiment is a randomized crossover protocol. Two trials (Overnight Sleep and Rested Wakefulness) will be completed in randomized order to separate the effects of sleep on non-dipping blood pressure while assessing nighttime cardiovascular mechanisms. Finally, investigators will pilot test if 2 weeks of sleep regularization impacts 24-hour BP.

Eligibility Criteria:
Inclusion Criteria:

* Ages 25-64
* BMI 18.5-42kg/m2
* Hypertension (average resting blood pressure between 130/80 mmHg and 160/100 mmHg)

Exclusion Criteria:

* Over 5 pack-years of smoking;
* Prior shift work within 12 months prior to the study;
* Travel greater than three time zones for at least 3 months;
* History of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction;
* Acute or chronic diseases (except hypertension) that may affect outcome measures;
* History of psychological conditions;
* Sleep disorders, like severe sleep apnea, insomnia, etc.;
* Prescription medications (Contraceptives and anti-hypertensive medications are permissible);
* History of Illicit drug use and alcohol dependency;
* 30 days free of cannabis use prior to the study;
* Pregnancy;
* Upper cut-off of 160/100 mmHg for BP
Vela China Study: in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population

Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow up for evaluate the safety and utility of VelaTM XL thulium laser.

This study aimed to evaluate the safety and utility of VelaTM XL thulium laser in cutting and hemostasis for gastrointestinal epithelial neoplasia in Chinese population.

Vela China study will enroll at least 60 patients. Follow up points are 72 ±3 hours post procedure, 7±2 days post procedure, 14 days(±2 days) post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent to participate in the study and comply with the study procedures.
* Diagnosed as gastrointestinal epithelial neoplasia and admitted to hospital for gastrointestinal ESD procedure.
* EUS and/or CT are performed to confirm the absence of regional lymph node or distant metastasis.

Exclusion Criteria:

* Endoscopic techniques or treatment are contraindicated.
* Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
* Based on doctor's evaluation, the patient's medical condition doesn't fit for this study.
UARK 2009-32 Compassionate Use Study of Carfilzomib

This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.

The protocol has been designed for relapsing or refractory multiple myeloma patients. A maximum of 30 patients may be treated on this protocol.

Since this is a compassionate use study of an investigational agent, the size is determined by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment and accrual number will be limited to N=30.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated
* Serum creatinine \< 3.0 mg/dL OR calculated creatinine clearance \>15 mL/min calculated or measured clearance is ≥15 mL/min
* ANC \> 1000/mm3 (may be supported with growth factors)
* Platelet count \> 30,000/mm3 (may receive transfusion)
* Female participant of child-bearing potential has agreed to use dual methods of contraception for the duration of the study
* Male participant has agreed to use a barrier method of contraception if sexually active with a female of child-bearing potential
* Patients must have signed and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

* Active infection requiring systemic treatment
* Requires concomitant use of approved or investigative anticancer therapeutic treatment with activity against multiple myeloma, other than dexamethasone
* Concomitant use of other investigative agents (e.g., antibiotics or antiemetics)
* Pregnant or breast-feeding