cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

This study is expected to contribute to the body of knowledge on the benefits of individuals with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.

The hypotheses for this study are:

1. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.
2. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a change in perceptions of the impact of spasticity on their lives.

The purpose of this study is to determine if there is a change in spasticity and perceptions of the impact of spasticity in individuals with multiple sclerosis who transition from interferon to glatiramer acetate (Copaxone®).•

* Potential participants meeting the criteria will be identified by Shared Solutions and informed of the study. Interested individuals will contact the investigator either by email or telephone. Enrollment will continue until there are 110 participants starting glatiramer acetate (Copaxone®).
* Potential participants will be informed of the details of the study, eligibility will be confirmed, and participant's questions answered.
* The two study instruments and the sociodemographic questionnaire will be emailed or mailed via UPS along with an information letter. May be returned either via email, fax or UPS mail.
* At month 6 for each participant, the study instruments and sociodemographic questionnaire will be sent a second time and returned to the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Stopped interferon (beta-1a or beta-1b) within the past 30 days
* About to start or started glatiramer acetate (Copaxone®) within the past 21 days.
* At least 18 years of age
* Has spasticity at the beginning of the study
* Able to ambulate with unilateral support or without support
* Understands, speaks and reads English

Exclusion Criteria:

* Severe Gait Disability or Total Gait Disability
Acute Effects of High Intensity Training in Pregnancy on Fetal Well-being and Blood Flow Distribution

Pregnant women are recommended to be physically active ≥150 min/week, but \<15% of Norwegian women attain this goal. Several well-designed studies on lifestyle interventions focusing primarily on exercise training in overweight/obese pregnant women have reported disappointing outcomes with regard to maternal glycemic control, gestational weight gain and infant outcomes. Low adherence to the training program was found to be a problem; the participants did not enjoy the exercise program and had difficulties scheduling time to exercise. Pregnant women also report that they are not sure what exercises are safe during pregnancy.

High intensity interval training (HIT), defined as short periods of intense activity separated by low-intensity breaks, has proved to induce superior improvements in insulin sensitivity and fitness compared with continuous moderate intensity training in individuals at increased risk for cardiometabolic diseases. Even short-term (6 weeks) HIT with brief (15-60 sec) work-bouts and a total time commitment of \<45 min per week, improves insulin sensitivity similar to that attained after 6 months of traditional endurance training.

HIT is feasible and enjoyable for individuals with low fitness level and with obesity.

HIT is therefore a highly potent intervention that elicits important changes in a range of clinically relevant health outcomes in reproductive-aged women.

This study will investigate fetal responses to a single bout of HIT. Preliminary data of the investigators suggest that HIT does not negatively influence fetal heart rate. Others have reported that uterine and umbilical blood flow are not changed during or following acute exercise. However, no previous study has determined the acute effect of HIT on uterine blood flow and there are no studies investigating the fetal blood flow distribution in response to exercise. Since the relative distribution of blood to the fetal liver is associated with newborn adiposity, fetal blood flow distribution in response to exercise can provide insight about the effect of maternal exercise on offspring health.


Eligibility Criteria:
Inclusion Criteria:

* pregnant, gestational week 22-36
* singleton fetus
* no known diseases
* capable of cycling on an ergometer bike

Exclusion Criteria:

* hypertension
* gestational diabetes mellitus
* any contraindication to exercise training
Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

This study is an examination of the influence of cooling components of WS-3, WS-23, and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.

The investigators will examine the influence of cooling components of WS-3, WS-23 (synthetic coolants) and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults. Participants will rate the flavor intensity, coolness, sweetness, and irritation/harshness, bitterness experienced using validated rating scales. 66 adult participants (18+ years of age) who are current e-cigarette users will participate in 3 laboratory sessions. Participants will receive 3 e-cigarette that contain cooling flavors and nicotine (59mg/ml nicotine salt) during the sessions. Participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in combination three WS-3 conditions (no WS-3, low WS-3, high WS-3) and two WS-23 conditions (low WS-23, high WS-23). All participants will be exposed to all fifteen conditions across 3 lab sessions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read and write
* Some current e-cigarette use
* Willing to abstain from tobacco/nicotine use 2 hours prior to sessions

Exclusion Criteria:

* Current use of non-prescription substances besides nicotine, marijuana, alcohol
* Any significant current medical or psychiatric condition
* Known hypersensitivity to propylene glycol
* Pregnant or lactating females
* Uncontrolled asthma
* Nut/e-liquid flavorant allergy
* Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms
To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks

The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

This will be a bioanalytical assay method cross-validation study using blood samples donated by up to 100 liver and 100 kidney transplant patients. Subjects who will be attending a routine outpatient follow-up visit will be asked to provide 3 whole blood venepuncture samples (each sample = 3 mL blood) and 3 finger prick DBS blood samples at predose and at 1 and 3 hours postdose. All subjects will be discharged from the study and clinical site at 3 hours postdose. Subjects will derive no benefit from the blood collection procedures and will be paid a predetermined stipend for participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Stable adult transplant recipients aged ≥ 18 years maintained on a once daily Advagraf® based immunosuppressive regimen for the prophylaxis of kidney or liver allograft rejection.

Exclusion Criteria:

* Subjects who are still participating in another clinical study (e.g. attending follow up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.
Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar (SFT).


Eligibility Criteria:
Inclusion Criteria

Women will be enrolled in this study who:

* Are willing to give consent and comply with evaluation and treatment schedule;
* Are 21 to 60 years of age (inclusive), post menopausal, or otherwise no longer expect to bear children, e.g., previous tubal ligation;
* Are a candidate for surgical weight loss intervention (meets ASMBS and NIH criteria);
* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations;
* Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial;
* Are American Society of Anesthesiologists (ASA) Class I, II, or III); and
* Have a negative pregnancy test (for women of childbearing potential).

Exclusion Criteria

Subjects will be excluded from the study for any of the following:

* Previous pelvic surgery other than transverse C-sections and/or tubal ligation;
* Enlarged uterus;
* Evidence of pelvic malignancy on a screening ultrasound;
* Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit;
* Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
* Unable or unwilling to attend follow-up visits and examinations;
* Planned or predicted concurrent surgical procedure;
* Any medical condition which precludes compliance with the study;
* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
* Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma;
* Use of prescription or over the counter weight reduction medications or supplements, participation in weight-loss programs, or change in smoking habits within 8 weeks of the Screening Visit and for the duration of study participation;
* Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial (unless previously approved by the investigator and Sponsor); or
* Any condition which precludes compliance with the study (investigator discretion).
Denver Garden Environment and Microbiome Study Disease

An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.

The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:

Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.

Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.

Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.

Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.

Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.

Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent in English or Spanish
* Aged 18 or over
* Currently on the wait list for a new garden
* Not have gardened in the past 2 gardening seasons

Exclusion Criteria:

* Is not able to complete the study requirements in Spanish or English
* Aged 17 or younger
* Has gardened in the past 2 gardening seasons
Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver

The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.

Our data will investigate if preemptive administration of pregabalin will have a role in reducing postoperative pain after radiofrequency ablation (RFA) of liver cancer.

Eligibility Criteria:
Inclusion Criteria:

* HCC patients, Child A, B, scheduled for Radiofrequency ablation of HCC.

Exclusion Criteria:

* Encephalopathy, Renal impairment
Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis

It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis
* Stable clinical condition (no exacerbation in last 4 weeks)

Exclusion Criteria:

* Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
* Subjects previously involved in exercise training or physiotherapy programs
Cardiac Outcome Measures in Children With Muscular Dystrophy

The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

The research study will include 50 participants aged 8 to 18 years old (before 18th birthday) with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies.

Participants will be seen in one of five Cooperative International Neuromuscular Research Group (CINRG) centers located in the United States.

All study assessments will be completed in the same day and include reviewing past medical and surgical history, collecting vital signs, collecting cardiac measures through echocardiographic tests.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 8 and 18 years old
* Confirmed diagnosis of muscular dystrophy (DMD, BMD, or LGMD 2C-2F and 2I)

Exclusion Criteria:

* Investigator assessment of inability to comply with protocol
* History of a congenital cardiac defect or other cardiac disease unrelated to muscular dystrophy
Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02

This study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (WLC). The researchers will compare how well the artificial intelligence tool and WLC perform in detecting bladder cancer through a controlled, organized testing process.

This clinical investigation aims to confirm that an artificial intelligence model utilizing a Convolutional Neural Network (CNN) can achieve sensitivity in detecting bladder cancer that is non-inferior to traditional white light cystoscopy (WLC) in a randomized controlled trial. The investigational artificial intelligence device leverages the advanced capabilities of CNNs, a type of deep learning model designed to analyze visual imagery with high precision.

Eligibility Criteria:
Inclusion Criteria:

* Men and women adults, age \>18 years old

Suspicion of primary or recurrent bladder cancer

Willingness to sign the Informed Consent Form (ICF) for the CI

Ability to comprehend the oral and written Patient Information Leaflet (PIL)

Exclusion Criteria:

* Not able or willing to sign the Informed Consent Form
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.

Objectives:

1. Primary:

   * Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2)
   * Waiting time for colonoscopic procedure and quality of bowel preparation
2. Secondary:

   * Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)

Eligibility Criteria:
Inclusion Criteria:

1. All adult patient referred for colonoscopy to AIG
2. Age 18 - 75 years old

Exclusion Criteria:

1. Acute GI bleeding.
2. Patient of bowel preparation regime other than excepted for the study.
3. Renal insufficiency.
4. Dementia.
5. Symptomatic heart failure.
6. Recent Myocardial Infarction.
7. Patients with ileus.
8. Suspected bowel obstruction.
9. Prior alimentary tract surgery.
10. Significant gastroparesis.
11. Gastric outlet obstruction.
12. Toxic colitis or megacolon.
13. Pregnant or lactating patients.
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection.

Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups.

Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.


Eligibility Criteria:
Inclusion Criteria:

* be aged ≥ 18 years (of either gender)
* have provided written informed consent prior to participation in the study
* undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).

Exclusion Criteria:

* rethoracotomy
* presence of pleural adhesions
* Neuropathy
* be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue \[lung or parts of lymph nodes\] for biological research may occur in the same patients)
Serial Assessment of Body Fat Accrual in Very Preterm Infants

Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.

Infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). Infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

* Gastrointestinal or neurologic malformations
* Terminal illness requiring limited or withheld support