cyrilzakka/clinical-trials huggingface dataset:
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.

The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

Rationale for Omegaven® Treatment

Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

References

1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24.
2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-18 years of age
* Patients will be PN-dependent and expected to continue PN for at least 30 days
* Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
* Direct bilirubin \> 2.0 mg/dl
* Signed patient informed consent
* Signed patient assent where applicable.

Exclusion Criteria:

* Pregnancy
* Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
* Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
* The patient is allergic to eggs/shellfish
* The patient has a severe hemorrhagic disorder
* The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
* The parent or guardian or child unwilling to provide consent or assent.
Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.

OBJECTIVES:

* Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies.
* Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1. Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of an advanced metastatic malignancy for which no curative therapy exists

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 2.0 mg/dL

Pulmonary:

* Corrected DLCO at least 60% expected

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Prior short-infusion gemcitabine allowed

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Prokinetic Effect of Selected Nutraceuticals

Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects.

This Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Pulmonary TB patients (both genders)
* Age group 18-65 years
* Symptoms criteria (Rome IV)

Exclusion Criteria:

* Patients ˃ 18 years and ˂ 65 years.
* Patients registered with extra pulmonary disease
Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data

Laboratory study on healthy volunteers to acquire spectral video data from the tongue and fingers as well as photoplethysmographic data from the forehead, fingers, and earlobes to evaluate and optimize algorithms for imaging photoplethysmography (iPPG) and multispectral imaging (MSI)


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers \>= 18 years old

Exclusion Criteria:

* pregnant and nursing women
* persons unable to consent
* persons with tattoos or diseases on the tongue, finger, ear, or forehead
* narcoleptics
* epileptics
* persons with arterial hypertension, peripheral arterial disease, anemia, Raynaud syndrome, autoimmune vasculitides, Takayasu arteritis, venous insuffiencies, microangiopathy, diabetic vasculopathy, scleroderma
Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histological or cytological diagnosis of AOC
* Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy
* Measurable disease defined by RECIST criteria
* ECOG Performance Status of 0, 1, or 2
* Life expectancy \> 3 months
* Adequate bone marrow, Renal, Hepatic reserve:

  * absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
  * platelet count ≥ 100,000 cells/μL
  * hemoglobin ≥ 9 g/dL
  * Total bilirubin ≤ 1.5 X ULN
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
  * Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
  * Serum creatinine \< 1.5mg/dL or calculated creatinine clearance \> 60mL/min
* Signed a written informed consent

Exclusion Criteria:

* Active infection
* Symptomatic brain lesion
* Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases
* Prior anticancer therapy within 4 weeks before enroll
* Active pregnancy test and Pregnant or nursing women
* Participation in any investigational drug study within 28 days prior to study entry
Distribution of Regional Lung Function by Vibration Response Imaging

Assessment of regional contribution of different areas of the lung to its integrated function is often required, such as prior to lung resection in the presence of tumor or emphysema. This assessment is derived from the proportion of zonal radionuclear perfusion or ventilation. The investigators hypothesized that lung VRI may provide an alternative approach to assess regional lung function.

Patients diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation presented in stable clinical condition and were evaluated by lung sound recordings and quantitative V/Q lung scintigraphy. Regional signals (percentage of lung sounds) for left and right lungs were compared with the corresponding regional count percentages of each radionuclide scan, by V/Q scan regions of interest.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read and understand the Informed Consent Form and he/she will provide written Informed Consent.
* Male or female in the age range of 18-85 years.
* The patient will undergo V/Q scan (up to ONE WEEK from the VRI recording)
* The patient presented for evaluation of COPD.
* Body Mass Index \>21.

Exclusion Criteria:

* Unstable clinical status such as fever, acute shortness of breath, cough, hemoptysis, cheat pain, or acute chest illness.
* Chest wall deformation;
* Spine deformation (including severe scoliosis);
* Hirsutism;
* Potentially contagious skin lesion on the back;
* Skin lesion that would interfere with sensor placement;
* Any additional chronic lung disease of any findings such as past tuberculosis, visualized on CXR.

  8. Previous resection lung surgery and history of lung tumor; 9. Cardiac pacemaker or implantable defibrillator
A Quality of Life Study in Patients With Migraines

The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.

A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Have the diagnosis of migraine
* Have had no change in migraine medication(s) 30 days prior to study
* Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit
* Capable of completing self-reporting questionnaires
* Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

* Presence of a clinically significant comorbidity of an unstable or progressive nature
* Presence of major depression
* Participation in an investigational drug study within the past 30 days
* Inability to communicate well with site study personnel
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* patients with differentiated thyroid cancer
* recently underwent total thyroidectomy (within 6 months)
* pathological criteria

  1. T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)
  2. T3N0 : Tumor size \<=2cm with microscopic extension (less than strap muscle)
  3. T1-3N1a : 3 or less micrometastatic lymph node

Exclusion Criteria:

* differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer
* gross extension (strap muscle or more)
* thyroid cancer with distant metastasis
* previous remote history of thyroid cancer surgery
* history of cervical external beam radiation therapy
* previous history of comorbid cancer within 5 years
* renal insufficiency (Ccr \<30ml/min)
* women with pregnancy or breast feeding
Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery for hernia repair.

Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric population. Multimodal anesthesia consisting of systemic narcotics, surgical wound infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based studies have demonstrated that blind abdominal wall injections are done with poor accuracy. Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may improve analgesic efficacy and patient comfort in the post-operative period when compared to blind landmark based nerve blockade. There has been increasing utilization of the TAP block in the adult population due to the described ability to provide effective blockade of the thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized prospective evaluation of the analgesic efficacy comparing surgeon performed ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female;
* The subject is of any racial and ethnic groups;
* The subject is age 12 months to 10 years (inclusive);
* The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
* The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
* The subject is American Society of Anesthesiologists (ASA) patient classification I-II
* The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

* Additional surgical procedures are being performed concurrently;
* The subject is ASA classification \> II;
* The subject has pre-existing allergies to local anesthetics;
* The subject receives midazolam as a premedication;
* The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
* The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.
Acylcarnitine Profile After Intensive Care

The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.

In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population.

Carnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders.

In this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Group short stayers: ICU length of stay of 2 days
* Group long stayers: ICU length of stay of at least 7 days

Exclusion criteria: patient refusal
Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men

Objectives

1. To evaluate the acceptability and feasibility of "standard HIV prevention package" among Thai men who have sex with men (MSM)
2. To conduct a pilot study to demonstrate the acceptability and feasibility of internet-based social networking, asymptomatic sexually transmitted infection diagnosis and treatment and pre-exposure prophylaxis strategies as "potential HIV prevention methods" among Thai MSM
3. To use mathematical modeling to identify the most effective HIV prevention package optimized for Thai MSM

Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC), age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.

Study design and methodology:

We will conduct a pilot study among 100 MSM participants who will be enrolled from the TRC-AC and will be followed up for 12 months. Participants will be followed at baseline, months 1 and 3, and then every 3 months. Interventions in the "standard HIV prevention package" to be provided at every clinic visit include anti-HIV testing, risk reduction counseling, provisions of free condoms and lubricants and diagnosis and treatment of symptomatic sexually transmitted infections (STI). All participants will also have access to non-occupational post-exposure prophylaxis (nPEP) without charge as part of the standard HIV prevention package. In addition, we will test for acceptability and feasibility of the "potential HIV prevention methods" which include:

1) Internet-based social networking to distribute and stimulate discussion of HIV prevention information (2) Asymptomatic STI diagnosis and treatment for every participant at baseline visit and every 6 months (3) Oral and topical pre-exposure prophylaxis (PrEP) strategies using placebo tablet and gel.

The meta-analysis of various behavioral and biomedical HIV prevention studies among MSM will be done in parallel with the pilot study in order to gather information for mathematical modeling and finally to inform the design of a larger study. Data acquired from the pilot study will be used for mathematical modeling of HIV transmission among MSM. The output from the modeling will directly inform HIV preventative interventions to be evaluated empirically among MSM in Thailand.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or older
2. Have documented negative HIV EIA or CMIA test at screening
3. Live in or near Bangkok
4. Have a history of anal sex with men
5. Understand the study and sign informed consent form.

Exclusion Criteria:

1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent
2. Persons with history of urinary tract stone
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question\[s\] it aims to answer are:

* Safety of the maximum tolerable dose of AXT107
* Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring visits through 9 months post single injection.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator
* Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator
* BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)
* BCVA of 34 ETDRS letters or better (20/200 or better Snellen equivalent) in the non-study eye at Baseline (Day 0)
* Able and willing to give signed informed consent and follow study instructions
* Has been/is a prior partial responder to an anti-VEGF agent

Exclusion Criteria:

* Previously treated patients who are non-responders to anti-VEGF as determined by the Investigator
* Any prior use of Brolucizumab; use of Aflibercept within 8 weeks or use of Ranibizumab or Bevacizumab within 6 weeks from Baseline (Day 0) in the study eye
* Any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract)
* Any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of AMD (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy)
* Other causes of CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the Investigator
* Chronic uveitis or ongoing clinically significant infection or inflammation (e.g., keratitis, scleritis) in either eye