cyrilzakka/clinical-trials huggingface dataset:
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin

The purpose of this study is to assess steroid induced skin atrophy by sonography.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, 25 to 40 years old inclusive.
2. Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

1. Clinical skin atrophy, telangiectasia or striae on volar arms.
2. Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
3. Fitzpatrick skin type IV - VI.
4. History or current evidence of infection, eczema or other relevant skin disease.
Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* ms diagnosis verified
* age \> 18 years
* central pain symptoms for more than 3 months
* central pain diagnosis confirmed by neurological examination
* adequate anticonceptive treatment for women with child bearing potential
* informed consent
* baseline pain of more than 4 on numeric rating scale

Exclusion Criteria:

* other cause of pain
* previous allergic reaction towards levetiracetam
* known adverse drug reaction on levetiracetam
* pregnancy
* severe disease
* inability to follow study protocol
* treatment with antidepressants, other anticonvulsants or opioids
Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.


Eligibility Criteria:
Inclusion Criteria:

* Men between 20 and 30 years
* Body Mass Index between 18 kg/m² and 25 kg/m²
* Normal clinical examination
* Normal biological variables
* Normal electrocardiogram and echocardiography
* Written, voluntary informed consent
* Non smoker since at least a year

Non-inclusion Criteria:

* Any history of significant allergy
* Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function
* Medication during the study
* Alcohol consumption more than 30g/day or drug addiction
* Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
* Exclusion period mentioned on the Healthy Volunteers National list
* Persons deprived of freedom or under guardianship
Suprascapular Notch Cross-sectional Area Measured by Ultrasonography

Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.

Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.

In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.

Eligibility Criteria:
Inclusion Criteria:

* chronic shoulder pain
* 35-65 years
* who agreed to participate in the study

Exclusion Criteria:

* . Lymphoproliferative diseases and other neoplasms
* .Uncontrolled arterial hypertension
* Metabolic syndrome
* Uncontrolled diabetes mellitus
* Mental retardation
* Antidepressant use
* Autoimmune diseases
Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly

previous studies indicated that sensory input can have positive impacts on finger force control in the elderly. Additionally, according to previous reports, apart from pharmacotherapy, nonpharmacologic interventions, such as psychosocial-environmental treatments, are emerging for the behavior and affective symptoms in AD . Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with AD. Therefore, this study aims to develop novel virtual visual and haptic stimulation systems for the elderly to enhance their finger force control.


Eligibility Criteria:
Healthy elderly

Inclusion Criteria:

* Aged ≥ 65
* Healthy adult (no skeletal muscle, neurological disease that will affect training).

Exclusion Criteria:

* Neurological disorders
* Musculoskeletal problems
* History of surgery Patients with Alzheimer's disease

Inclusion Criteria:

* Diagnosed with Alzheimer's disease.
* No skeletal muscle, neurological disease that will affect training.
Inflammatory Biomarkers in Ocular Surface in Primary Open Angle Glaucoma or Ocular Hypertension Under Topical Prostaglandins

Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure.

Prostaglandin derivatives are the most effective topical drugs in reducing intraocular pressure (IOP). Among these, latanoprost was the first agent of this type to be approved for use in patients with glaucoma or ocular hypertension.

These eye drops are available with and without preservatives. There are two commercial brands in our environment, Xalatan®, which contains 0.005% latanoprost and 0.2 mg/ml benzalkonium chloride (BAK) and Monoprost®, which contains the same amount of latanoprost but does not carry a preservative. The prostaglandin analog with a lower concentration of active ingredient available in Spain without preservative is tafluprost 0.0015%, commercially available under the name Saflutan®.

The long-term use of hypotensive eye drops with preservatives generates changes in the ocular surface, such as instability of the tear film, conjunctival inflammation, subconjunctival fibrosis, apoptosis of the conjunctival epithelium and deterioration of the corneal surface, causing symptoms such as stinging, tearing, sensation foreign body, photophobia and blurred vision.

This research will evaluate the changes in the ocular surface and in the expression of inflammatory molecules that occur in the conjunctiva in patients with a diagnosis of glaucoma and ocular hypertension who are under ocular hypotensive treatment with tafluprost, comparing it with the two commercial preparations of latanoprost.

These three groups of patients will have a control group of patients with a diagnosis of ocular hypertension who will not have any topical hypotensive medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial
* \> 18 years old
* Signed informed consent
* 3 or more months under monotherapy treatment with tafluprost 0.0015%, latanoprost 0.005% with BAK 0.2mg/ml or latanoprost 0.005%.
* Untreated patients with ocular hypertension must be treatment naïve for the pathology.
* No presence or history of previous ocular diseases other than glaucoma or ocular hypertension, started before the use of hypotensive medication.

Exclusion Criteria:

* Ocular surgery in the previous 6 months.
* Any ocular surface disease not related to inclusion criteria or related issues active within the last 6 months.
* Any topical treatment other than the evaluated in this study in the last 3 months.
* In case of artificial teardrops use, only non conservative ones are allowed, with no more than 4 times per day use, and treatment must be suspended 5 days before inclusion.
* Use of contact lenses in the las 4 weeks.
* Any mental or physical disease that may prevent performing the required tests for the study.
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years and older
* Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
* Able to apply lotion to treatment area at least twice daily during radiation course
* All surgical sites healed
* No evidence of infection
* No history of sensitivity to any component in Aquaphor or Difensa53

Exclusion Criteria:

* Prior history of radiation therapy (RT) to that site
* Known dermatologic conditions affecting skin in radiation port
* Concurrent chemotherapy
* Skin infection in radiation port
* History of sensitivity to Aquaphor or Difensa53 component
Patient Survey as a Tool to Quality Assurance and Quality Improvement

One goal of the investigators of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic.

The project aims to quality assurance and quality improvement of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin .

The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis).

The survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin from the patient point of view.

In order to achieve a meaningful data collection, a response rate of 50 percent should be achieved.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey
* aged \>= 1 years

Exclusion Criteria:

* unconscious patients,
* refusal by patient / parents
Per-Oral Endoscopic Myotomy

This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.


Eligibility Criteria:
Inclusion:

1. Diagnosis of achalasia
2. Age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a POEM procedure

Exclusion:

1. Pregnant women
2. Any prior surgical treatment for achalasia
Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery

The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary heart surgery and heart transplantation

Exclusion Criteria:

* myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin \> 140)
Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg

The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years and older
2. Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

1. Institutionalized subjects will not be used.
2. Social Habits:

   1. Use of any tobacco products within one year prior to dosing.
   2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
   3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
   4. Any recent, significant change in dietary or exercise habits.
3. Medications:

   1. Use of any medication within the last 14 days prior to the initial dose of study medication, including over-the-counter medications.
   2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:

   1. History of any significant chronic disease and/or hepatitis.
   2. History of drug and/or alcohol abuse.
   3. Acute illness at the time of either the pre-study medical evaluation or dosing.
   4. A positive HIV, Hepatitis B, or Hepatitis C test result.
5. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
   2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to finasteride or other related products.
9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Autonomic Nervous System and Nitric Oxide Interactions

The investigators are interested in the role of the autonomic nervous system in the regulation of endothelial function among obese hypertensive subjects. In particular, the investigators will study how endothelial function (response to intra-arterial acetylcholine) changes during autonomic withdrawal.


Eligibility Criteria:
For lean healthy volunteers:

* 20 subjects (10 males and 10 females) aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \< 25Kg/m2 .
* Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.

For Obese subjects with high blood pressure.

* 20 subjects (10 males and 10 females) aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \> 30 and less than 40 Kg/m2

  \*High blood pressure (systolic=130 and diastolic = 85 mmHg)
* Female volunteers of childbearing potential will undergo serum HCG pregnancy test at screening and urine HCG pregnancy test again on the study day.

Exclusion criteria:

* Pregnant females
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs or anemic
* Subjects with a recent medical illness
* Subjects with a history of coronary heart disease
* Subjects with known kidney or liver disease
* Subjects with recent weight loss or consuming low carbohydrate diet
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
* Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Colorectal Carcinoma
2. Presence of bilateral pulmonary metastases
3. 3 or more lung lesions in total
4. Age 70 years or less
5. ECOG 0-2
6. Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment.

Exclusion Criteria:

1. Patient has previously received more than 1000 mg of oxaliplatin
2. Left Ventricular Ejection Fraction \<50%
3. History of significant pulmonary disease or pneumonitis
4. Pregnant or lactating females
5. Age 71 or older, or less than 18 years
6. Inability to understand the informed consent process
7. Hypersenstivity to oxaliplatin
8. Patients with Heparin-induced thrombocytopenia (HIT)
9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or another reason can be included but will not receive the drug they cannot tolerate
10. Current participation in another therapeutic clinical trial
Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide

Prospective, observational pilot study of ten post-transplant patients presenting with diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once the diagnosis is confirmed, the patients will then be treated with a short course of subcutaneous Octreotide which has been shown to cure this type of diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 75 years old who are solid organ transplant recipients followed at Toronto General Hospital on MMF referred to gastroenterology for diarrhea.

Exclusion Criteria:

1. Subjects with a known history of IBD or GVHD of the bowel.
2. Any subject receiving Octreotide for another indication.
3. Any patient unable to undergo endoscopy.
4. Any patient with a contraindication to Octreotide therapy.