cyrilzakka/clinical-trials huggingface dataset:
Bowel Function After Minimally Invasive Hysterectomy

Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic NSAID use and anatomic manipulation.

There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.

The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.

Following enrollment subjects will be randomized into the intervention/treatment arm and control arm. All subjects will be asked to complete a baseline demographic form and three questionnaires (PAC-SYM, PAC- QOL, Wexner Constipation score). Additional demographic information will be obtained from chart review. This information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation.

Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.

Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).

At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
* Able to understand the consenting process and willing to participate in study

Exclusion Criteria:

* Planned laparotomy
* Emergent surgery
* Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
* Planned bowel surgery
* Presence of colostomy
* Inability to consent
* Medical problems as follows:
* CKD (Cr: \> 1.2 mg/dL)
* IDDM
* Cardiac disease
* Gastric ulcers
* Difficulty swallowing or esophageal stricture
* Persistent nausea or vomiting
* Signs or symptoms of a small bowel obstruction
Malabsorption as a Cause of Iron Treatment Failure in Infants

Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.


Eligibility Criteria:
Inclusion Criteria:

* All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.

Exclusion Criteria:

* Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.
Studies in Porphyria I: Characterization of Enzyme Defects

OBJECTIVES: I. Characterize enzyme defects in patients with known or suspected porphyria and their family members.

II. Determine whether selected patients are eligible for other porphyria research protocols.

III. Provide blood, urine, and fecal samples from well characterized patients and their family members to investigators studying the nature of specific mutations in genes for heme biosynthetic pathway enzymes.

PROTOCOL OUTLINE: All patients are evaluated for porphyria type and factors contributing to the clinical expression of their particular form of the disease. Testing includes erythrocyte porphobilinogen deaminase, erythrocyte protoporphyrin, plasma porphyrins, and urinary and fecal porphyrins and precursors.

Selected patients are entered into other porphyrin research protocols in this and other institutions, including analysis of DNA to identify specific mutations in genes for heme biosynthetic pathway enzymes.

Eligibility Criteria:
* Suspected or confirmed porphyria
* Adults, children, and family members eligible
a Cohort Study (Gut Microbiota and HCC)

To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.

This is a prospective, observational cohort study. Patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. During the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, gender unlimited
2. Diagnosed as HCC through pathological or clinical examination
3. BCLC Phase B or C
4. Previously without systematic treatment
5. Irremovable
6. Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment
7. ≥ 1 measurable lesion (RECIST V1.1)
8. ECOG PS 0-1
9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
2. Active, known or suspected autoimmune diseases
3. Known history of primary immunodeficiency
4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
5. Pregnant or lactating female patients
6. Uncontrolled concurrent diseases
7. Currently conducting clinical trials for other drugs
8. Other patients deemed unsuitable for inclusion by researchers
Switching From One Type of Anti-rejection Drug (Tacrolimus or Cyclosporine) to Another (Sirolimus) Approximately 90-180 Days After Liver Transplantation

Sirolimus can be safely switched as early as 90 days after liver transplantation with excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated the switch.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (18 years or older) patients undergoing liver transplantation at Thomas Jefferson University Hospital.
2. Diagnosed with at least one of the following CNI side effects 90-180 days post transplantation:

   1. CNI renal toxicity. Any liver transplant recipient who has elevated creatinine level (greater than 1.4 mg/dl) and impaired creatinine clearance (MDRD) of 40-60 ml/minute or decreased by 15% compared to baseline in the setting of having a therapeutic CNI level, without suspicion of acute or chronic allograft rejection.
   2. Hepatic fibrosis on biopsy. Any patient who has fibrosis seen on liver biopsy with LFT's 2 times the upper normal limit.
   3. CNI neurologic toxicity. Any patient who has significant neurological side effects from CNIs. This will include the following: seizures not secondary to an epileptogenic focus or any metabolic derangement; alteration of speech ranging from aphasia to slurred speech; inability to be awake and alert.
   4. Post transplant diabetes. Any patient who has developed diabetes after transplant and in whom CNIs are thought to be contributing to poor glycemic control.
3. Signed informed consent at approximately 90 -180 days post transplantation.

Exclusion Criteria:

1. Invasive/surgical therapy within 2 weeks of the 90-180 day post transplantation conversion. (e.g. patients with T-tubes would not be eligible for the study because the T-tube removal will coincide with the conversion date).
2. Open surgical wound at 90-180 days post transplantation.
3. Acute cellular rejection during the first 90-180 days post transplantation.
4. Re-transplants or multiple-organ transplants.
5. Active infection.
6. Pregnancy.
7. Malignancy within 3 years prior to liver transplantation (except adequately treated basal cell carcinoma). Patients with HCC prior to transplant will not be excluded.
8. Total cholesterol \>300 mg/dl on medical treatment or triglycerides \>150 mg/dl at 90-180 days post transplantation.
9. White blood cell count \<3,000/mm3 or platelet count \<100,000/mm3 at 90-180 days post transplantation.
10. Ascites.
11. Patients on chemotherapy.
12. Urine protein/creatinine ration \> 0.5
Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).

The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.

Eligibility Criteria:
Inclusion Criteria:

* Must be female sex and at least 18 years of age.
* Must be willing and able to complete all procedures and follow-up visits indicated in the protocol.
* Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.
* Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for \> 3 months.

Exclusion Criteria:

* Currently suffering from active urogenital infection.
* Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions).
* Having concomitant pelvic floor or cystoscopic procedure.
* Has had prior surgical SUI treatment.
* Has had prior radiation therapy or brachy therapy.
* Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions.
* Is pregnant or planning to become pregnant during the study duration.
* Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures.
* Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.
Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women

The purpose of this small preliminary study is to determine whether it is feasible to recruit women smokers who have just delivered a baby and are not breastfeeding into a study that would test whether starting bupropion, a smoking cessation medication, after a baby's birth helps a postpartum woman to stop smoking.

Purpose: A pilot randomized double-blind placebo-controlled trial is testing the feasibility of conducting a full-scale trial of the efficacy of bupropion SR vs. placebo in non-breastfeeding postpartum women who smoked \>1 cigarette in the last month of pregnancy and want to stop smoking. The study will estimate achievable enrollment and retention rates; estimate the effect size of the drug on tobacco abstinence; assess the tolerability of bupropion in postpartum women; and allow refinement of recruitment, retention, intervention, and assessment protocols.

Research Design: Pilot double-blind placebo-controlled randomized clinical trial.

Study Population: 40 postpartum women aged 18 years or older who smoked \> 1 cigarette in the last month of pregnancy, want to stop smoking, and are not breastfeeding. Subjects will be recruited postpartum while hospitalized after delivery.

Intervention: Bupropion SR (or matching placebo) for 8 weeks, starting immediately post-delivery. The dose is 150 mg qd for one week then 150 mg bid for 7 weeks. All subjects will receive behavioral counseling delivered face-to-face during the post-delivery hospitalization and by telephone 4 times over 8 weeks.

Outcome Measures: (assessed at 2, 4, 8, and 12 weeks postpartum):

1. Study eligibility, recruitment, and retention rates (primary outcome).
2. Tobacco abstinence (7-day point prevalence nonsmoking by self-report and confirmed by saliva cotinine at 2 weeks, 8 weeks (end of drug treatment), and 12 weeks postpartum.
3. Postpartum weight loss and symptoms of depression and anxiety.
4. Tolerability of postpartum bupropion, assessed by medication adherence and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

Postpartum women who:

* Smoked \>1 cigarette in last month of pregnancy
* Deliver a baby at Brigham and Women's Hospital in Boston, MA
* Do not breastfeed or plan to breastfeed.
* Want to attempt to stop smoking

Exclusion Criteria:

* Age \<18 years;
* Current use of bupropion or antidepressant;
* Current major depression or other severe psychiatric illness (e.g., schizophrenia, mania);
* Contraindication to use of bupropion;
* Illegal substance use in past 6 months;
* \>1 drink/day of alcohol during pregnancy;
* Newborn with major congenital anomaly or \<25 weeks' gestation;
* Inability to speak or read English;
* No telephone.
Effect Of 8-Week Online Fitness Intervention Health Related Fitness

The purpose of this study is to investigate the effectiveness of 8-week online delivered exercise program on actual and perceived physical fitness components.

Physical fitness is one of the leading concepts of health and well-being at all stages of life. In certain context, individuals tend to engage in prolonged sedentary behaviors, and these contexts are considered sedentary-promoting environments. These environments also detrimental on physical fitness and health. University students and office workers who predominantly engage in sedentary behaviors, such as prolonged sitting and computer-based work, have consistently shown associations with various aspects of diminished physical fitness. The online intervention protocols might be a good alternative for increasing fitness level for those who live or work in highly sedentary settings. Hence, the purpose of this study is to investigate the effectiveness of 8-week online delivered exercise program on actual and perceived physical fitness components. Specifically, body composition measured by DXA, upper body muscular strength, and flexibility are the main focus of this study. Moreover, physical self-perception is also a focus of this study.

Eligibility Criteria:
Inclusion Criteria:

* Working or studying at the university,
* Do not have any health problems that would prevent from participating in exercise,
* Not participating any another exercise/training program during the research process,
* Voluntarily participation
* Being suitable for exercise participation according to Physical Activity Readiness Questionnaire (PARQ) test results

Exclusion Criteria:

* Presence of any significant health conditions that may pose a risk during exercise (e.g., heart conditions, severe respiratory disorders, uncontrolled hypertension).
* A history of musculoskeletal injuries or conditions that would limit participation in physical fitness activities.
* Current or recent participation in another exercise or fitness program.
* Inability to provide informed consent or unwillingness to participate voluntarily.
* Any medical condition that contraindicates exercise or physical activity as determined by a healthcare professional.
* Pregnancy or postpartum period, depending on the specific requirements and goals of the intervention.
* Age restrictions (younger than 18).
* Cognitive impairments that would hinder the ability to understand and follow exercise instructions.
Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" \[LTIA\]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older)
* Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care
* Attending anesthesiologist plans to place an intra-arterial catheter for routine care
* Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient

Exclusion Criteria:

* Minors (17 years or younger)
* Parturient (pregnant women)
* Cognitively impaired
* Unable to sign informed consent form
* Prisoner
* Prior esophageal surgery
* Moderate to severe aortic regurgitation
* Mechanical cardiac support (e.g., intra-aortic balloon pump)
* Severe, persistent arrhythmias
Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients

This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic.


Eligibility Criteria:
Inclusion Criteria:

All of the hypertensive patients in both diastolic dysfunction and control groups were either newly diagnosed or were aware of hypertension without using any pharmacotherapy.

-

Exclusion Criteria:

Individuals already under treatment for hypertension were not include.

-
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.


Eligibility Criteria:
Inclusion Criteria:

* Participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage IIB-IV cutaneous melanoma who have undergone complete resection
* Initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage IIb-IV melanoma, between January 1, 2015 and 6 months prior to data collection
* For the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage IIb-IV melanoma within 12 weeks following index resection
* Aged \<18 years at the time of nivolumab/ipilimumab treatment initiation
* At least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months)

Exclusion Criteria:

* Prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
* Receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach

The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Emergency surgery for trauma
* ASA 1 and 2 patients
* Full stomach (antral area \> 550 mm²)
* Adult patients

Exclusion Criteria:

* No contraindication to erythromycin
* Extreme emergency surgery (time frame \< 90 min between arrival in the service and the start of the surgery)
* gastroparesis or pathology associated with gastroparesis
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

* shortening the length and reducing the symptoms of human rhinovirus infection (also known as the common cold),
* controlling asthma symptoms, and
* lowering the risk of asthma symptoms worsening in subjects with asthma.

Subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to enrolment. If a subject develops symptoms of human rhinovirus (HRV) infection they will visit the site for assessment. Symptomatic subjects meeting all eligibility criteria will be invited to enroll.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18-70 years
* Diagnosis of asthma consistent with Global Initiative for Asthma (GINA) steps 1 to 3
* Presumptive human rhinovirus infection

Exclusion Criteria:

* Current severe asthma exacerbation
* Severe asthma, GINA steps 4 or higher
* Uncontrolled or clinically significant medical condition, disease or event which could impact subject safety and/or study evaluations and/or compliance to the protocol
* Current smoker, ex-smoker of \<1 year, or history of smoking \>/=10 pack years.
Virtual Reality for Pediatric Palliative Care Team

Is virtual reality a useful and usable tool to improve the psychological well-being of PPC operators? study primary obtv: assessment of occupational psychological well-being (divided into stress, depression, anxiety and risk of burnout) in the population of health professionals working in pediatric palliative care; verify if the virtual reality tool leads to an improvement change at the level of the investigated items (feasibility study). The treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment At time zero (T0), the participants will be administered, shortly before the application of virtual reality, the Mini-Z survey 2.0 questionnaires (the single item burnout question), Depression Anxiety Stress Scales 21 (DASS-21), and a demographic questionnaire (gender, age, profession, shift work, years of work in PPCs). At the end of the compilation, two vision treatments will follow, which will take place three to four days apart.

At time T1 (second week) and time T2 (third week) the DASS-21 will initially be administered followed by two weekly treatments with a visor. At the end (T3) the compilation of both tests (Mini-Z survey 2.0-the single item burnout question and the DASS-21) will be repeated following the last two applications of the viewer.


Eligibility Criteria:
Inclusion Criteria:

* work within the pediatric hospice of Padua
* Absence of neurological pathologies
* personnel who actively engage in membership/participation during all 4 weeks of the project

Exclusion Criteria:

* Subject do not sign written consent