cyrilzakka/clinical-trials huggingface dataset:
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical diagnosis of moderate to severe melasma
* Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
* Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.

Exclusion Criteria:

* Subjects with diagnosis of dermal melasma
* Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
* Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
* Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
* Subjects with a history of hypertrophic scarring or a history of keloids
* Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study
Connecting Low-Income Adults to Primary Care After Inpatient Discharge

Healthcare systems and insurers have tried to reduce costs by improving the care and coordination provided to patients with high healthcare spending. Often termed, "hotspotting", these interventions seek to lower costs by reducing care provided in fragmented, high-cost settings, including the emergency department and inpatient settings, by addressing the social determinants of health and improving patients' access to lower-cost, ambulatory settings. Vanderbilt University Medical Center (VUMC), in collaboration with Tennessee's Medicaid agency (TennCare), is piloting a program to reduce costs and improve the quality of care provided to high-risk TennCare enrollees by referring them from inpatient settings to VUMC primary care services. This study seeks to evaluate this pilot by comparing outcomes between Medicaid patients referred to VUMC primary care services and similar Medicaid patients not referred to VUMC primary care services using data from surveys and administrative sources, including electronic health records and health insurance claims.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Currently enrolled in Tennessee's Medicaid Program (TennCare)
* Presenting in VUMC's inpatient setting
* Reporting no active relationship with a primary care doctor
* Lives in Davidson County, Tennessee, or a surrounding county

Exclusion Criteria:

* Patients discharged to a setting other than the community (e.g. to a Skilled Nursing Facility)
Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

This is a Phase 1, open-label, non-randomized, mass balance study in patients with histologically or cytologically confirmed advanced solid tumors. Approximately 6 patients will be enrolled. The study will consist of 2 parts: a mass balance part (Part I) and a rucaparib treatment part (Part II).

Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. If the cumulative recovery of radioactivity exceeds 90% of the administered dose or if radioactivity in urine and feces is \< 1% of the administered dose over a 24 hour period on two consecutive days, as determined by quick counts.

In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumor
* Part II only: Have a known deleterious BRCA1/2 mutation (germline or somatic) as determined by a local or central laboratory
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate bone marrow, renal, and liver function

Exclusion Criteria:

* Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or angiogenesis inhibitors within 14 days prior to Day 1
* Participation in a trial involving administration of \[14C\]-labeled compound(s) within the last 6 months prior to Day 1
* Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months prior to Screening
* Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
* Untreated or symptomatic central nervous system (CNS) metastases
* Evidence or history of bleeding disorder
* Participation in another investigational drug trial within 14 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1
* Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1, unless mild in severity and approved by the Investigator and Sponsor's/designated medical representative
* Active second malignancy
Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori

The increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori) with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the eradication rate, and the secondary outcome was the incidence of adverse events.

Background: Helicobacter pylori(H.pylori)infection is a common bacterial infection that causes chronic gastritis, peptic ulcer, MALT lymphoma, gastric cancer, and other gastrointestinal diseases. and has been classified as a group 1 biologic carcinogen with a prevalence of about 50% population in china. In recent years, with the massive use of antibiotics, poor patient compliance, and irregular drug use, the side effects associated with drugs have increased and have led to the development of antibiotic-resistant bacteria and a gradual increase in refractory H.pylori infections, researchers have been searching for a safe, effective and simple treatment for H. pylori.

Methods: The patient come from the department of Gastroenterology, Xiangya Third Hospital, Central South University. After obtaining informed consent, patients is randomly divided into a study group and a control group. The study group (n=100) is divided into two stages of treatment, starting with Saccharomyces boulardii monnotherapy for 14 days, Patients who are still positive on reexamination after 4 weeks of stopping the drug continue with bismuth quadruple therapy. As for the control group (n=100), patients is observed for 4 weeks without any gastric drugs as well as antibiotics, and those who were still positive on retest after 4 weeks continued with bismuth quadruple therapy. We observe the eradication rate of patients and the occurrence of adverse effects during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 65 years, of either sex
2. patients with a diagnosis of Hp infection
3. patients who have failed treatment for Hp infection
4. not taking acid-suppressing medications (PPI or H2 blockers) within the last 2 weeks
5. who have not used antibiotics and/or bismuth within the last 4 weeks
6. understand and are willing to participate in this clinical trial and provide a signed informed consent form.

Exclusion Criteria:

1. those with a history of drug allergy
2. those with severe cardiac, hepatic, pulmonary, and renal insufficiencies
3. those with a recent history of gastrointestinal hemorrhage, obstruction, perforation, tumors, and other serious organic diseases of the gastrointestinal tract
4. those with mental illness, psychological disorders that cannot be expressed normally
5. those who are pregnant, lactating, or planning to have children in the near future during the study period.
6. those who are not suitable for clinical trials and those who cannot cooperate
Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients

The purpose of this study is to learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing.

Following severe burn injury in human patients the mitochondrial fat oxygenation capacity is decreased in muscle. This is associated with a corresponding progression in the severity of the resistance to the action of insulin on glucose disposal and protein synthesis and breakdown in muscle, regenerating wound and liver.

Fatty acids or their active intracellular products ( e.g. Diacylglycerol, acyl- Coenzyme A(CoA) or acylcarnitine) are the direct inhibitors of insulin action, rather than tissue triglycerides(TG) itself. In other words, impaired mitochondrial fatty acid oxygenation is the mechanism that causes altered lipid metabolism that ultimately contributes to insulin resistance.

Accumulation of active fatty acid products, such as Diacylglycerol, acyl-CoA or acylcarnitine esters in muscle cells is due to the rate of uptake of plasma free fatty acids(FFA) exceeding the rate of oxygenation within muscle due principally to a reduced capacity of mitochondria to oxidize fatty acids.

Decreasing insulin sensitivity in muscle is related to impaired insulin signaling. This will be reflected by increased activity of protein kinase C (PKC). Because PKC is thought to exert its regulatory effect primarily on either tyrosine kinase activity on the insulin receptor or downstream kinase insulin receptor substrate (IRS) phosphorylation, these elements of the insulin signaling cascade will be decreased. In turn, elements of insulin signaling related to the response of muscle glucose (PI3 Kinase) and protein (P70S6k)metabolism will be reduced. The investigators propose that increased tissue PKC activity will be associated with increased tissue concentration of Diacylglycerol, acyl-CoA or acylcarnitine. The investigators hypothesize that the treatment of patients with the peroxisome proliferator-activated receptor (PPAR) alpha antagonist fenofibrate will improve mitochondrial capacity to oxidize fatty acids. Insulin sensitivity in muscle, skin and liver in terms of both glucose and protein metabolism will be improved by fenofibrate treatment.

Eligibility Criteria:
Inclusion Criteria:

* ≥40% Burn
* ages 4-20years
* body weight ≥10kg

Exclusion Criteria:

* \<40% burn
* ages \<4-\>20 years
* body weight \<10kg
* Respiratory insufficiency
* Multiple fractures
* History of cancer in last 5 years
* Bilirubin\>3mg/dL
* Serum Creatinine\>3mg/dL after fluid resuscitation
* Glutamyl-Oxaloacetic Transaminase(GOT) \>40 Units/L
* Glutamyl-Pyruvate Transminase(GPT) \>51 Units/L
* Associated head injuries requiring therapy
* Associated injuries to the chest or abdomen requiring surgery
* Receipt of any experimental drug other than the ones supplied within two months of study
* Any metal in body including rods, cardiac defibrillators, pacemaker, etc
* Orthopedic casting which would prevent placement in MRI
* Hepatitis
* Abnormal EKG
* Electrical burns
A Combination Treatment Reduces Acne Severity and PIHP

Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.\[1\] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.\[2, 3\] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.


Eligibility Criteria:
Inclusion Criteria:

* adult
* mild to moderate acne
* presence of postinflammatory hyperpigmentation lesions
* phototype IV to VI

Exclusion Criteria:

* less than 18 years
* severe acne
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Subjects with non-Hodgkin's lymphoma (NHL) who are considered to be suitable candidates for autologous PBPC transplantation per institution guidelines - ECOG 0-2 inclusive - ANC greater than 1.5 x 10\^9/L; PLT greater than 100 x 10\^9/L Exclusion Criteria: - More than one line (regimen) of previous chemotherapy treatment and more than 2 cycles of any premobilisation salvage chemotherapy prior to enrolment. Patients were also to be excluded from the study if they had received any salvage chemotherapy containing the following agents: procarbazine, nitrogen mustard, nitrosoureas (including BCNU), melphalan and fludarabine. - Previous bone marrow or PBPC transplant - Greater than 20% bone marrow involvement of the disease at time of screening, as demonstrated by biopsy - Prior total nodal irradiation or any radiotherapy in the past 4 weeks - Serum creatinine greater than 1.5 x upper limit of institutional normal range - Total serum bilirubin greater than 2 x upper limit of institutional normal range - Current diagnosis of splenomegaly not related to lymphoma - History of prior malignancy, except for lymphoma, curatively treated basal cell carcinoma, squamous cell carcinoma, in-situ cervical carcinoma or a surgically cured malignancy - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Significant non-malignant disease, including documented HIV infection, uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive heart failure (greater than NY Heart Association Class II), poorly controlled diabetes, coronary angioplasty within 6 months, uncontrolled atrial or ventricular cardiac arrhythmias, or active hepatitis C - Haematopoietic growth factors administered within 1 week of study entry. If growth factor support was given during previous chemotherapy cycles, WBC less than 15.0 x 10\^9/L was required at enrolment - Treatment with Interferon® during the last 3 months - Known hypersensitivity to E. coli-derived pharmaceutical products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase) - Subject had previously been randomised into this study
Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial

The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.


Eligibility Criteria:
Inclusion Criteria:

* peptic ulcer diseae
* two test positive rapid urease test, culture, histology

Exclusion Criteria:

* lactating or pregnant
* previous stomach surgery
* severe underlying disease
Parenting Intervention and Metabolic Syndrome

This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.

In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.

Eligibility Criteria:
Inclusion Criteria: 5th graders -

Exclusion Criteria: None

-
"Point of Care" Ultrasound and Renal Colic

The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.

Currently, two imaging techniques are recommended during an episode of renal colic:

1. Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
2. The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.

The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.

In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.

The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted in ER for suspicion of simple renal colic
* Signed informed consent

Exclusion Criteria:

* protected adults (tutorship or guardianship)
* fever ≥ 38.5°C
* chronic endstage kidney failure (Glomerular filtration rate \< 30%)
* Solitary kidney
* Urinary tract catheter or percutaneous nephrectomy
* Pregnancy
* traumatic back pain
* Renal colic diagnosis in the past three months
Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.

Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage 3 or more pelvic organ prolapse

Exclusion Criteria:

* Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy