cyrilzakka/clinical-trials huggingface dataset:
Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for remote monitoring by their care team. Patients will be approached for a semi-structured interview to understand the barriers and facilitators to ePRO use.

This is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission Eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be enrolled in the study. Patients will complete symptom surveys via email or telephone. Concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. Patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using ePRO. Interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Able and willing to complete a web-based or telephonic symptom survey
* Planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days.

Exclusion Criteria:

* Not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively)
* Inability to read and speak English
* Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair)
* Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
* Dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
* Current incarceration
* Pregnancy
Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide

Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated response and long term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, at least 18 years of age
* History of histologically confirmed NHL as assessed per medical record review.
* At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
* Recommended to start lenalidomide.
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
* Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic cervical dystonia
* TWSTRS severity score ≥ 15
* At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
* Written informed consent prior to collect the data

Exclusion Criteria:

* Contraindications to any BoNT-A preparations
* Secondary cervical dystonia
* Subject already been included in the study
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

The investigators hope to learn the following:

* If heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury.
* The difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia.
* A better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.

Eligibility Criteria:
Inclusion Criteria:

Pediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study.

Group 1 will consist of patients with ≥30% TBSA burn injury. Group 2 will consist of patients with \<30% TBSA burn injury who develop a cardiac abnormality.

Exclusion Criteria:

Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.
Effects of Bran Size on Glycemic Responses

This study investigated the effects of bran's particle size on glycemic responses

This study aimed at 1. to determine the GI and GL of three breads and 2. to investigate the effects of bran's particle size on postprandial glycemic response in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, non-diabetic men and women, individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol or drug dependency
Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping

The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-10 years
* Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
* No general danger signs or severe malaria present
* Haemoglobin ≥70 g/L
* History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
* No other cause of fever is detectable
* No severe malnutrition
* Guardian/patient has understood the procedures of the study and willing to participate

Exclusion Criteria:

* Not able to drink or breastfeed
* Vomiting everything
* Recent history of convulsions
* Lethargic or unconscious
* Unable to sit or stand (as appropriate for age)
* History of allergy to test drugs
* History of intake of any drugs other than paracetamol and aspirin within 3 days
* Symptoms/signs of severe malaria
Gaze and Gait Training With rTMS

The purpose of this study is to evaluate the feasibility of combining repetitive transcranial magnetic stimulation (rTMS), gaze and gait training to improve walking and balance in people with or without mild cognitive impairment.

The study plan is to recruit a total of 15 cognitively impaired and 15 healthy adults. The study will involve two visits. Each study visit will involve:

* Real rTMS or sham rTMS that last about 60 minutes
* Gaze stabilization exercise via a virtual reality headset for about 1-hour
* Target stepping on a treadmill for about 1-hour

Researchers will compare changes in gaze and gait following training sessions with real rTMS and sham rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years
* Capable of providing informed consent and complying to the experimental procedures

Exclusion Criteria:

* Significant gait difficulty requiring ambulatory aids
* Presence of implanted device such as a neurostimulator, cochlear implant or pacemaker
* History of epilepsy
* History of hearing issues
Is Real-time CGM Superior to Flash Glucose Monitoring

The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* patients with T1D naive to rtCGM and isCGM
* Type 1 diabetes for \>2 years
* ≥ 18 years old
* CSII or MDI
* GOLD score \< 4, no history of severe hypoglycemia within last 6 month
* written informed consent prior to starting study related activity

Exclusion Criteria:

* severe noncompliance
* severe diabetic retinopathy and/or macular edema
* lactation, pregnancy, intending to become pregnant during study
* condition likely to require MRI
* use of acetaminophen-containing medication
* unwillingness to use the study device for \>70% of time
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and non-childbearing females 18-55 years old

Exclusion Criteria:

* Use of an investigational drug and/or treatment within 30 days prior to enrollment.
* Positive HIV, Hepatitis B or Hepatitis C test result
* Tobacco user
* History of GI disease or disorder
* History of positive fecal occult blood test (FOBT)
* Body Mass Index (BMI) \> 30 or \< 18, or body weight \< 50 kg
* Prior abdominal or pelvic surgery
Pilot Trial to Assess the Feasibility of Implementing Objective Parameters in Patients Affected by Knee Osteoarthritis

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis.

• to assess the feasibility of implementing ultrasonography and Range of motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing HA.

The secondary objectives of the trial are:

* to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional).
* to evaluate the enrollment range in one month.

The explorative objectives of the trial are:

• Preliminary data on efficacy of the tested product

Eligibility Criteria:
Inclusion Criteria:

* Any gender and age from 50 to 70 years
* Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination (1). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.
* Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint (2).
* Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.

Exclusion Criteria:

* Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
* Treatment with oral corticosteroids within 4 weeks before screening.
* Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.
* Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
* HA-containing nutritional supplements or cosmetics during the month before the study.
* Previous surgical treatment of knee joint(s) or its necessity; complication(s) necessary for hospitalization and surgical treatment.
* Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).
* Subjects following an energy-restricted diet for weight loss.
* Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.
* Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Participation in an interventional clinical study in the previous 30 days.
* Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RMS in accordance with the revised McDonald criteria
* Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
* Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
* For sexually active female participants of reproductive potential, use of reliable means of contraception

Exclusion Criteria:

* Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
* Known presence of other neurologic disorders
* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
2. Patient's age is ≥18 years
3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) identified by CT or MRI
2. Rapidly improving symptoms at the discretion of the investigator
3. Pre-stroke mRS score of ≥ 4 (indicating previous disability)
4. Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
5. Contra indication to imaging with contrast agents
6. Any terminal illness such that patient would not be expected to survive more than 1 year
7. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
8. Pregnant women
Laser Spot Treatment of Perioral Rhytids

Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. To date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone.

This study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half.

To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.

Cohort Study, with Split Face treatment

Methods:

Patients will be evaluated in the office for possible inclusion. Those who agree to partipate will receive preoperative photos.

On the day of the procedure patients will have a topical anesthestic applied for 30 minutes, then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin and debris. After that, patients will have reapplication of a topical anesthetic for an additional 10 minutes. They will then undergo a 50 um peel to one side of the face and a patient tailored spot treatment of perioral wrinkles to the other side of the face. The depth of this may vary from 100 to 400um.

Patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a short survey and have medical photography done. Patients will return at 3 and 6 month follow-up for additional photography and surveys. These visits will typically take 10 to 20 minutes.

Preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for post-operative changes and improvements.

Eligibility Criteria:
Inclusion Criteria:

Patient who are electively presenting to the plastic surgery department for evaluation and treatment of facial aging and elect/seek to have laser treatment will be asked to voluntarily participate in the study.

Fitzpatrick type 1-4 skin

Exclusion Criteria:

1 Patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection

2 History of Photosensitvity

3 Use of photosenstive medications

4 History of keloid or hypertrophic scarring

5 Use of Isotretinoin in the previous year

6 Previous resurfacing procedure (laser or chemical peel) within the previous 6 months
Magnetic Resonance Imaging and Spectroscopy of the Prostate

Past studies have shown that MRI is useful for staging prostate cancer. This study will use magnetic resonance spectroscopic imaging (MRSI) to obtain more information. MRSIs with MRIs help doctors locate prostate cancer and determine the extent of tumor before deciding on treatment. This study looks at structural and chemical properties of prostates in prostate cancer patients before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* prostate cancer patients willing to undergo a MRI and MRSI exam

Exclusion Criteria:

* patients with prostate cancer and bone or lymph node metastasis
* patients who can not have an MRI exam
Investigations on the Effect of Kale on the Lipid Status

This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* total cholesterol \> 200 mg/dl

Exclusion Criteria:

* LDL cholesterol \< 130 mg/dl
* medication to lower blood lipids
* genetically based hypercholesterolemia