cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 12 years old.
* Subjects must be in good general health as confirmed by medical history and physical examination.
* Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
* Clear diagnosis of facial acne vulgaris for at least 3 months.
* Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
* Disease must be stable or slowly worsening for more than one week prior to entering the study.
* Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.

Exclusion Criteria:

* Females who are pregnant, attempting to conceive, or breastfeeding.
* Subjects with known hypersensitivity to study drug.
* Subjects with very severe acne (PGA score of 5)
* Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
* Subjects with a current active skin malignancy or infection.
* Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
* Subjects who have received systemic antibiotics within 2 weeks.
* Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
* Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
* Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
* Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
* Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Exercise Training and Metabolic Flexibility in Prediabetes

The purpose of the study is to determine if a 6-week exercise training program promotes exercise-induced metabolic flexibility, that is, the ability to switch fuel sources for energy, in older prediabetic adults.

This is an investigator initiated single group intervention trial. All participants will receive a 6-week exercise training program with testing occurring before and following the training program. Participants will be provided with 3 days of a high fat diet prior to each of the three testing sessions at the Clinical Research Unit. All who agree to participate will undergo the same intervention.

The goal of this proposal is to study the impact of a 6-week moderate intensity walking training program on exercise induced lipid metabolic flexibility in older adults with prediabetes. Study Investigators will seek to determine if exercise induced lipid oxidation following a high fat diet is increased in trained individuals relative to their baseline.

Eligibility Criteria:
Inclusion Criteria:

* ≥60 years of age
* Sedentary prior to the start of the training program (self-reported: less than 30 minutes of exercise for no more than 1 day a week)
* Prediabetes (measured at first screening: HbA1c = 5.7-6.5%)
* Must be able to pick-up and consume study provided foods
* Willingness to provide informed consent and participate in the intervention
* Must obtain transportation to visits and intervention training sessions
* No contraindications for involvement in a moderate exercise training program or exercise testing procedures by self-report

Exclusion Criteria:

* Self-reported diagnosis of a metabolic or chronic disease such as cardiovascular disease, diabetes, Chronic Obstructive Pulmonary Disease, or movement disorders such as Parkinson's disease, Ataxia, Huntington's Disease
* Current or recent (\<12 months) treatment for cancer
* Body Mass Index \<18.5 or \>/30.0 kg/m2
* Tobacco users
* Febrile or chronic infection within study period
* Aversion to testing procedures
* Hypertension, hyperthyroidism, hypothyroidism
* Unwilling to abstain from ingesting caffeine during study testing periods
* Unwilling to withhold medications that affect metabolic rate during testing periods
* Physically active (\>30 minutes per day on more than 1 day per week)
* ECGs that indicate cardiac injury or contraindications to treadmill testing
* Allergic or intolerant to any study-provided foods
Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.

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Exclusion Criteria:

1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
3. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
4. Patients with another active systemic malignancy in the past year.

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Low-dose Ketamine for Acute Pain in the Emergency Department

This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.

The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.

Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.

Its use in the ED may probably play a role in maximizing analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and give informed consent
* Comfortable with the experimental protocol as outlined to them by the research team
* Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
* Acute pain, pain duration \< 7days
* Deemed by treating ED attending physician to require IV opioid analgesia

Exclusion Criteria:

* Neurologic, respiratory, or hemodynamic compromise
* Pregnancy or breastfeeding
* Known or suspected allergy to ketamine or morphine
* Known Renal (Cr\>2.0) or Liver Failure
* Unstable psychiatric disease (as per treating physician)
* History of stroke
* History of cardiac disease or coronary artery disease
* History of chronic respiratory disease
Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.


Eligibility Criteria:
Inclusion Criteria:

* Receiving 3 or more nephrotoxic medications on the same day OR
* Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Exclusion Criteria:

* Currently being treated for a urinary tract infection
* Presence of an acute kidney injury prior to enrollment
A Phase I Study of QLS12010 Capsules in Healthy Adults

The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants. This study consists of three parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B, which consists of three multiple ascending doses (MAD) cohorts of QLS12010 Capsules. Part C is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-45 (inclusive),
* Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive),

Exclusion Criteria:

* Participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervous system, psychiatric system, cardiovascular system, blood and lymphatic system, immune system, respiratory system, digestive system, urinary system, metabolic and skeletal system disorders,
* The 12-lead ECG at screening shows QTcF (QT corrected using Fridericia's formula) \> 450 ms. If QTcF is \> 450 ms, the 12-lead ECG should be repeated 2 more times (at least 3 min apart), and the mean of the 3 measurements will be used to determine whether the participant meets the inclusion criteria,
* Participants who smoke more than 5 cigarettes per day on average within 6 months before screening or are currently using e-cigarettes,
* Participants who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening or have a positive breath alcohol test at screening,
* Participants who have donated more than 400 mL of blood within 3 months or more than 200 mL of blood within 4 weeks before screening, or plan to donate blood during the study,
* Participants who have received any strong inhibitor or inducer of CYP3A4within 4 weeks before screening,
* Participants who have received any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer).
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS.
2. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate \< 50% tubulointerstitial fibrosis.
3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
4. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.

Exclusion Criteria:

1. Diagnosis of collapsing FSGS.
2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
3. Organ transplant.
4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
5. Body mass index (BMI) greater than 45 kg/m2.
6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer

This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through colonscopy compared with chemotherapy alone in patients presenting with advanced rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.

Exclusion Criteria:

* 1.Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer
Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. The advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years.

For NEC patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. Traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. However, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. Retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. It also has the advantage of avoiding a second operation for enterostomy closure. Nonetheless, prospective studies comparing the two approaches are lacking.

The proposed study will fill up the following knowledge gap on what the best surgical option for NEC at laparotomy is. The findings will help guide our practice for NEC patients in the future in order to provide them with the best possible and evidence-based care.

In this study, the investigators hypothesize that neonates with major NEC undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities.

Aim of the study is to compare the short term and medium term outcomes of NEC patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.


Eligibility Criteria:
Inclusion Criteria:

* All neonates with confirmed NEC and require surgical intervention will be included

Exclusion Criteria:

1. Neonates found to have NEC totalis and deemed unsalvageable;
2. Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses;
3. Neonates found to be extremely unstable cardiovascularly intra-operatively and can only withstand excision of gangrenous bowels, but will not allow anastomosis or stoma creation;
4. Parents who do not agree to participate in the study
5. Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).
Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma. Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age, male or female.
* Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
* ECOG performance status 0 to 2.
* Adequate bone marrow reserve.
* Absolute neutrophil count \> 1x10\^9/L.
* Total bilirubin \<3 times the upper limit of the normal range.
* Life expectancy ≥ 12 weeks.
* Signed written informed consent form.

Exclusion Criteria:

* Prior malignant disease other than pancreatic cancer.
* Patients suitable for surgical or locoregional therapies.
* Patients who have prior anticancer therapy for pancreatic cancer.
* Patients unable to swallow oral medications.
* Any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
* Active clinically serious infections (\> grade 2 NCI / CTC Adverse Event version 3.0).
* History of allergy to platinum compounds.
* Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
* Patients who have severe bone marrow failure.
* Patients undergoing renal dialysis.
* History of HIV infection.
* Seizure disorder requiring medication (such as steroids or anti-epileptics).
* Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
Diagnostic Role of Renal Biopsy in Patients With Fabry Disease

This is a retrospective, single-centre, non-pharmacological observational study carried out for scientific and health protection purposes. It provides for the systematic collection of information from the medical records of patients with a genetic diagnosis of Fabry Disease referred to the single centre of Renal Genetic Diseases of the IRCCS Azienda Ospedaliero-Universitaria di Bologna.

These patients were considered eligible for the biopsy procedure if:

* presence of a clinical picture compatible with a classical phenotype
* presence of laboratory (microalbuminuria, proteinuria, GFR reduction by various methods) or instrumental (renal ecostructural features) pathological alterations suggestive of Fabry disease
* presence of VUS
* presence of an abnormal course of nephropathy or doubtful overlapping pathology.

Patients with ESRD were excluded.

The main objective of the study is to evaluate the diagnostic capacity, currently undocumented in the literature, of renal biopsy in patients with Anderson-Fabry disease, afferent to the Sant'Orsola-Malpighi General Hospital's Single Centre for Renal Genetic Diseases.

As secondary objectives we intend to assess whether the renal damage associated with Fabry disease, evidenced by histological features obtained by biopsy, manifests differently in subgroups of patients defined by:

* Gender
* CKD stage
* genetic mutations Individual pathological lesions are assessed using the Scoring System devised by the International Study Group of Fabry Nephropathy (ISGFN).

All patients with a definite diagnosis of Fabry's disease who have been admitted to the IRCCS Azienda Ospedaliero-Universitaria di Bologna's single centre for Renal Genetic Diseases from 01/01/2012 to 31/12/2020 are eligible. Based on the number of patients afferent to the genetic kidney disease outpatient clinic, approximately 80 patients will be enrolled. The comparison will be performed on the basis of variables that are associated with Fabry disease in the literature, such as enzyme activity assessment, Lyso-GB3 assay, renal function parameters, enzyme therapy, genetic mutations and cardiac markers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age with a diagnosis of Fabry disease defined based on the 2017 guidelines.
* Obtaining written Informed Consent

Exclusion Criteria:

* None
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age,
* TRQ of at least 17 or above,
* Able to pay for the treatment,
* Not using any other treatment for tinnitus,
* Access to computer and internet,
* Compliant patient

Exclusion Criteria:

* Hearing PTA \> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
* Not willing to follow the protocol