cyrilzakka/clinical-trials huggingface dataset:
Development of Biomarker for Development of Non-Alcoholic Steatohepatitis (NASH) in Children

The purpose of this study is to document how often specific genotypes known to be associated with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and investigate whether these genotypes are associated with increased susceptibility to NASH.

NASH is a clinico-pathological entity characterized by the development of histological changes of inflammation and fibrosis in the liver that are nearly identical to those induced by excessive alcohol intake, but in the absence of alcohol abuse. Nonalcoholic steatohepatitis occurs commonly children with additional comorbidities such as obesity and diabetes mellitus. Paralleling the increasing prevalence of obesity and type 2 diabetes in the pediatric population, nonalcoholic fatty liver disease (NAFLD) and especially its more severe histological form NASH, is expected to become one of the most common causes of end-stage liver disease in both children and young adults.

Although no genome wide association studies have been conducted in association with NASH to date, individual candidate gene investigations have identified several genes associated with increase susceptibility to NASH in adults including the microsomal triglyceride transfer protein (MTP) which regulates the incorporation of triglycerides into apolipoprotein B and a key enzyme for the assembly and secretion of VLDL from hepatocytes, the manganese superoxide dismutase (MnSOD) gene which catalyzes the conversion of two molecules of superoxide anion, a highly unstable ROS, into hydrogen peroxide and oxygen more stable ROS, and lastly, phosphatidylethanolamine N-methyltransferase (PEMT) which is required for hepatic secretion of triacylglycerol in very low density lipoproteins (VLDL).

We propose the following aim:

Aim 1: To document the frequency of specific genotypes, previously identified to be associated with adult-onset NASH, in a purely pediatric cohort.

Aim 2: To investigate whether these genotypes are associated with increased susceptibility to NASH and increased occurrence of fibrosis in the cohort of pediatric subjects. Our hypothesis would be:

A significantly higher proportion of the polymorphisms would exist in those subjects with NASH compared to controls.

Aim 3: To investigate the presence of other polymorphisms or other biomarker that are indicative of pediatric NASH. Such that our secondary hypothesis would be:

Specific polymorphisms or biomarkers will be identified that will indicate a higher probability of NASH.

Eligibility Criteria:
Inclusion Criteria:

* All subjects aged 2-18 with biopsy proven NAFLD and/or NASH undergoing a blood draw and willing to consent to this study will qualify for inclusion in this protocol.

Exclusion Criteria:

* other causes of chronic liver disease or other chronic diseases, specifically autoimmune disorders, immunodeficiencies, or individuals with congenital/genetic disorders
* chronic viral hepatitis, Wilson's disease, or alpha -1- antitrypsin deficiency
* acute life threatening illness or conditions
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis

Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess the outcomes after TACE in patients with branch PVT regarding Child classification, radiological response and 1 year survival.

Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed HCC,
* Child class A and
* Portal vein branch tumoral thrombus (proved by imaging)
* written informed consent

Exclusion Criteria:

* patients with Child class B and C,
* main Portal vein thrombosis,
* previous management for HCC,
* Arterio-portal shunt
* refused to be enrolled
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject at least 18 years of age
* Subject is able to provide written informed consent and comply with the requirements of this study protocol
* Subjects have AKN class I or II (less than 6.5 cm in width)
* Subjects who are women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 6 months after the last dose of study. Acceptable methods of birth control include:

  * intrauterine device (IUD) oral;
  * transdermal;
  * implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study);
  * tubal ligation;
  * abstinence;
  * barrier methods with spermicide.
* If not of child-bearing potential, subjects must have:

  * a sterile or vasectomized partner;
  * have had a hysterectomy;
  * a bilateral oophorectomy or be clinically diagnosed infertile;
  * or be in a menopausal state for at least a year.
  * Subject is judged to be in good general health as determined by the principal investigator.

Exclusion Criteria:

* unable to understand and provide written consent
* Have received prior intralesional steroids for AKN within the past 6 months
* Are using topical steroids or topical medications on their scalp within 4 weeks
* Have used Duobrii on the scalp for AKN or other scalp disorders
* Subject is pregnant or breastfeeding
* Use of prior systemic medication for AKN or acne (doxycycline or isotretinoin) or hair loss in the last 6 months
* Currently using topical minoxidil or prior use within the past 3 months
* Have a history of other or other active scalp/hair disease or other forms of or other forms of alopecia
* Are on systemic steroids or other immunosuppressants
* Have a history of auto-immune disease, thyroid disorder, or hypersensitivity to steroids.
Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer

This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.

PRIMARY OBJECTIVES:

I. Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.

II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.

ARM II: Patients receive standard care plus attention comprising two telephone contacts.

After completion of study, patients are followed up at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic or ovarian cancer
* Confirmed stage III or IV disease
* Patients who are within one year from initial diagnosis
* Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations
* Ability to read and/or understand the study protocol requirements, and provide written informed consent
Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury

The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.

Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).

Eligibility Criteria:
Inclusion Criteria:

* Male, Female, age 18-65, all ethnic groups
* Spinal Cord Injury, traumatic and non-traumatic
* C1-T12 neurological level
* ASIA class A-D
* Chronic injury \> 6 months from the injury
* Visible motor response to FES stimulation (visible muscle contraction evoked with electrical stimulation)
* Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
* Subjects are able to comply with procedures and follow-up

Exclusion Criteria:

* Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
* History of inability to tolerate electrical stimulation
* Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability
* Uncontrolled hypertension (resting systolic BP \> 160mmHg or diastolic BP \>100mmHg consistently)
* Presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps
* Unstable long bone fractures of the lower extremities
* Presence of stage III or greater skin ulcerations that would preclude application of stimulating pads
* Malignancy
* History of epileptic seizures
* Women who are pregnant
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
* Fractures less than 6 months
A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation

A retrospective chart review of patients receiving concurrent chemoradiotherapy for oropharynx cancer was performed to compare clinical data for patients treated prior to the initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The variables studied included; rate of hospitalization, dose completion and dose reductions. The results revealed an overall improvement in all variables for those patients seen in the weekly NP clinic.

To further analyze this data a randomized, prospective study is proposed to validate the findings of the retrospective study. It is predicted that a weekly NP led clinic will decrease costly hospitalizations, increase patient treatment completion and improve overall patient quality of life and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of stage III or IV HNC
* Are initiating concurrent chemotherapy and radiation
* Are able and willing to sign informed consent
* Ages 18 years or older
* ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (The ECOG score attempt to quantify cancer patients' general well-being and activities of daily life)
* Able to read and complete the required survey

Exclusion Criteria:

* Cannot provided informed consent
* Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment.
* Have a history of prior cancer within past 5 years (excluding non-melanoma skin cancer)
* Are unwilling or unable to complete the required QOL (Quality of Life) survey
Airway Alkalinization and Nasal Colonization

The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization

16 subjects per group will be randomized to receive study drug or saline followed by a wash out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab will be done at baseline and after both study treatment and saline treatment for assessment of airway colonization.

Eligibility Criteria:
Healthy subjects:

Inclusion Criteria:

* 16 subjects, aged 16-80, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained fom subject.

Exclusion Criteria:

* Pregnant or lactating
* Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to screening, smoked in the last 6 months.

CF subjects:

Inclusion Criteria:

* FEV1% \>35%, O2 saturation \>90% on room air, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained from subject.

Exclusion Criteria:

* Same as for healthy subjects.
The Urinary Incontinence Treatment Study

Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

Investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit.

Eligibility Criteria:
Inclusion Criteria:

* Women, age 70 years or older
* Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)
* Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
* Willing and able to undergo an extensive physical function evaluation

Exclusion Criteria:

* Prior surgical intervention for urinary incontinence within the past 12 months
* Hysterectomy within 12 months
* Diagnosis of:
* Pelvic Organ Prolapse beyond the hymenal ring
* Urogenital Fistula
* Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)
* Incomplete Bladder Emptying/Urinary Retention with PVR \>150 ml (measured by bladder scan)
* Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound
* Having significant cognitive impairment or dementia
* Unsafe to exercise (severe cardiopulmonary disease)
* Unable/unwilling to provide informed consent
* Determined otherwise ineligible by the principal investigator
3D011-08 Monotherapy in Subjects With Advanced Solid Tumors

The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors.

Detailed Description: This study was initiated on February 24, 2022, at Fudan Cancer Hospital. However, noparticipants were screened or enrolled after the initiation. Due to strategic development adjustments, thecompany terminated the study on September 11. 2023.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors(part 1 dose escalation); Histologically confirmed locally advanced or metastatic hepatocellular carcinoma (cohort 1),advanced renal cell carcinoma (cohort 2), and metastatic castration-resistant prostate cancer (cohort 3) for which not amenable to local therapy.(part 2 dose expansion).
2. Cohort 1 and 2: at least one measurable lesion (according to RECIST 1.1 criteria);Cohort 3: at least one measurable or unmeasurable lesion (according to RECIST 1.1 criteria).
3. Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds(part 1 dose escalation). Cohort 1 (advanced hepatocellular carcinoma)and Cohort 2 (advanced renal cell carcinoma): Subjects had disease progression after received previous first-line of systemic treatment, or subjects are intolerant of or have refused to receive first-line of systemic treatment.

   Cohort 3 (metastatic castration-resistant prostate cancer) : Patients who had failed or had refused prior abiraterone and/or docetaxel chemotherapy.(part 2 dose expansion)
4. ECOG Performance Status ≤ 2(part 1 dose escalation).≤ 1.(part 2 dose expansion)
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Investigational products or devices in other clinical trials or received antibody drug therapy within 4 weeks before the first dose,or chemotherapy, targeted therapies,or radiotherapy within 2 weeks before the first dose.
2. Participants need to continue using medications known to have a significant risk of causing QTc prolongation or a CYP3A4 strong inhibitor or strong inducer.
3. Participants who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1.
4. Participants with diseases at risk of bleeding within 3 months prior to enrollment
5. Participants with concomitant medical conditions requiring anticoagulant therapy at a therapeutic dose
6. History or current condition of uncontrolled cardiovascular disease.
7. Participants with gastrointestinal disease associated with a risk of perforation or fistula formation
Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy

The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous patients

Exclusion Criteria:

* Parous patients, menopausal status, cervical pathology, and previous cervical surgery
The Effectiveness Of Auricular Acupressure On Body Weight Parameters On Patients With Schizophrenia

The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.


Eligibility Criteria:
Inclusion Criteria:

1. ICD:295,living in chronic ward for more than 2 month
2. Body Mass Index (BMI) \>or=24
3. Age between 20 to 60
4. Psychotic status stable and can communicate

Exclusion Criteria:

1. Unstable psychotic status
2. Participants who have endocrine disease
3. Participants who have cardiac disease
4. Participants who have immunological disease
5. Participants who have liver or renal function impairment
6. Pregnant woman or in milking stage
7. Cerebrovascular accident (CVA) stroke and disability
8. Participant who attends weight control programs in recent 3 months
9. Any conditions that clinical doctors refuse to let join in this study
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has an ankle fracture
* Patient speaks English
* Patient weighs between 100 and 250 pounds
* Patient lives in close enough proximity to the hospital to return for all appointments (\~100 miles)

Exclusion Criteria:

* Patient is younger than 18 years of age
* Patient has multiple fractures that would alter weight bearing protocol
* Patient does not speak English
* Patient weighs less than 100 pounds or more than 250 pounds
* Patient does not live in close enough proximity to the hospital to return for all appointments (\~\>100 miles)
* Patient has a traumatic brain injury that would make it so they cannot consent
* Patient has diabetes
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).


Eligibility Criteria:
Inclusion Criteria:

* Infection with HCV
* Must have participated in a prior Gilead HCV study
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Eligible patients include those in the following

  * received placebo or Peg-IFN+RBV in a control arm
  * previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:

    * Sofosbuvir+RBV
    * Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic use of systemically administered immunosuppressive agents
* Active drug abuse
* Use of any prohibited concomitant medications