cyrilzakka/clinical-trials huggingface dataset:
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.

This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution in male and female subjects with androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia.

Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot.

Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area.

Subjects must agree to maintain the same hair style and hair care regimen during the study.

Exclusion Criteria:

Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.

Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy.

Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety.
Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration

This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.


Eligibility Criteria:
Inclusion criteria:

1. Male or female subjects 18 years of age or older diagnosed with type 1 diabetes mellitus
2. Glycated hemoglobin (HbA1C) of 6.5% to 11.0% and an estimated glomerular filtration rate (eGFR) greater or equal to 60 ml/min/1.73m² at screening
3. Subjects must be either experienced insulin pump users or be on multiple daily injections of any type of insulin

Exclusion criteria:

1. Evidence of macroalbuminuria or leukocyte positive urinalysis at screening
2. Any concomitant medication known to interfere with renin-angiotensin-aldosterone system (RAAS) activity or treatment with any other drugs to reduce blood glucose other than insulin
3. History of macrovascular disease or any other disease which would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement
Trial of IMO-8400 in Adult Patients With Dermatomyositis

The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.

This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).

Eligibility Criteria:
Inclusion Criteria:

* Has definite or probable DM based on the criteria of Bohan and Peter
* Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score ≥15
* Patients with muscle weakness are eligible; however having muscle weakness is not mandatory.
* Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit

Exclusion Criteria:

* Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening
* Has known hypersensitivity to any oligodeoxynucleotide
* Has a history of drug or alcohol abuse within one year of screening, or evidence of drug abuse by urine drug screening
* Has body weight \>140 kg
* Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g., overlap syndrome)
* Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):

  1. Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits)
  2. Intravenous corticosteroids within 12 weeks
  3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks
  4. Topical corticosteroids (excluding scalp) within 2 weeks
* Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years
* Has interstitial lung disease requiring the use of supplemental oxygen
Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of COPD

Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home spirometry


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD
2. Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia.
3. Patient able and willing to provide informed consent.
4. Patient can follow study procedures, including instructions for self-placement and operation of device

   a. Patient has experience using a smartphone
5. Accessible by telehealth/telephone upon discharge
6. Patient is able and willing to return to study site for study follow-up visits as necessary

Exclusion Criteria:

1. Patient unable or unwilling to provide informed consent
2. Diagnosis of COPD is uncertain
3. Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility)
4. Patient with end-stage medical condition with expected survival no more than 3 months
5. History of adverse reaction or allergy to TegaDerm®
6. Inaccessible by telehealth/telephone post discharge
21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial

The purpose of this study is to determine whether a supine breast MRI obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast MRI will provide sufficient tumor visualization to allow a Radiologist to define and outline the tumor edges ("segment" the tumor). Accurate segmentation will allow a 3-D image of the tumor to be generated to create a breast cancer locator (BCL) surgical device to in aid removal of breast cancers.

The clinical pre-operative breast MRI exam will be obtained in the prone position with intravenous (IV) Gadolinium (Gd) contrast injection per standard of care clinical protocol. After completion of the standard clinical prone breast MRI, the participant will be re-positioned and the investigative supine breast MRI protocol with a second dose of IV Gd will be obtained. A second dose of contrast equal to the first dose will be given, and additional images will be obtained in the supine position. Subtraction images will be generated for both the prone and the supine sequences. It is hypothesized that the second contrast injection will generate tumor-to-fibroglandular contrast differences such that supine subtraction images will allow visualization and segmentation of the tumor equal to prone segmentation images. It is expected that the addition of a second injection of contrast will improve the ability to visualize and accurately segment the supine post-Gd images. While the total dose of gadolinium delivered in two injections is twice the amount normally given during a clinical prone breast MRI, this total dose is equal to that administered for other clinical MRI studies such as cardiac MRI.

No additional imaging or testing will be required for this research study following the standard clinical MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Female gender.
3. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ.
4. Tumor size at least 1 cm in diameter as visualized on mammogram or US.
5. A staging, pre-operative breast MRI is considered to be clinically indicated.
6. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

1. Absolute contraindication to MRI, including presence of implanted electrical device. (pacemaker or neurostimulator incompatible with MRI), aneurysm clip, or metallic foreign body in or near eyes.
2. Severe claustrophobia.
3. Contraindication to the use of gadolinium-based intravenous contrast, including anaphylaxis. Any known history of nephrogenic systemic fibrosis (NSF).
4. History of median sternotomy.
5. Pregnancy. All women of child-bearing age will be questioned about possible pregnancy status. In women who are unsure of pregnancy status, a urine pregnancy test will be performed.
6. Patients who have received neoadjuvant chemotherapy for their current diagnosis.
7. Known compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury.
Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT)

To develop a mortality risk prediction model that can be applied to the wide spectrum of risks that are seen in the home care setting.

ABSTRACT

Introduction: Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning.

Objective: To develop a mortality risk prediction model for older adults in the home care setting. The final algorithm will be implemented as a web-based calculator that can be used by older adults needing care, as well as their informal and formal caregivers.

Design: Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from January 1, 2007, to December 31, 2013.

Participants: The derivation cohort will consist of approximately 437 000 home care recipients from January 1, 2007, to December 31, 2012. A split sample validation cohort will include approximately 122 000 recipients from January 1 to December 31, 2013.

Main outcome measures: Predicted survival from the time of an RAI-HC assessment. All deaths (N ≈ 245 000) will be ascertained through linkage to the provincial vital statistics records.

Statistical analysis: Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic characteristics, social support, health conditions, functional status, cognition, symptoms of decline, and prior healthcare use. Model performance will be evaluated for 6- and 12-month predicted risks, including measures of calibration (e.g., calibration plots) and discrimination (e.g., c-statistics). The final algorithm will be generated by combining development and validation data.

Eligibility Criteria:
Inclusion Criteria:

* Have received a structured RAI-HC assessment
* Between 50 and 105 years of age

Exclusion Criteria:

* Not eligible for Ontario's universal health insurance program (OHIP)
* Did not receive a structured RAI-HC assessment
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
* Have HbA1c 7.0% to 10% at study start.
* Have a body weight \>=50 kg.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
* Have been treated with any exogenous insulin within 90 days before study start.
* Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
* The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control

Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.

30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper Extremity Skills Test was used to assess upper extremity functions (QUEST).

Eligibility Criteria:
Inclusion Criteria:

* spastic hemiparetic and / or diparetic CP
* co-operative enough to understand test directives
* between 5 and 12 years of age
* Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)
* GMFCS I, II and III

Exclusion Criteria:

Have had previous orthopedic surgery to the upper extremity
The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined

After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined

Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose \> 7.0 mM, 2h glucose after OGTT \> 11.0 mM. BMI \> 35. HbA1c \< 8.5%. Fasting C-peptide \> 700 pM. Elegible for RYGB.

Exclusion Criteria:

* Dysregulated hypothyroidism, hyperthyroidism, anaemia.
Spinal Cord Stimulation (SCS) Dosing Study

This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

This feasibility study assessed the following outcomes:

* Patient satisfaction
* VAS pain scores

Eligibility Criteria:
Inclusion Criteria:

1. 22 years of age or older
2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
3. Has approproate SCS settings
4. Willing and able to provide signed and dated informed consent
5. Capable of comprehending and consenting in English
6. Capable of getting into the supine and sitting positions
7. Willing and able to comply with all study procedures and visits
8. On stable (no change in dose, route, or frequency) prescribed pain medications

Exclusion Criteria:

1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
3. Implanted with quadripolar lead
4. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
6. Has untreated major psychiatric comorbidity
7. Has serious drug-related behavioral issues
8. Has unresolved major issues of secondary gain
Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Eligibility Criteria:
Inclusion Criteria:

* Adult, at least 19 years of age.
* Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
* Patients requiring anti-dyslipidemia drug therapy \[based on the NCEP ATP III(2002)\]
* Drug compliance during Run-in period ≥70%
* Patients must willing to the study and signed an informed consent

Exclusion Criteria:

* Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
* Patients with acute arterial disease
* Patients with renal dysfunction or Serum creatinine level ≥2x ULN
* Patients with liver dysfunction or ALT, AST level \> 2xULN
* Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
* Patient with uncontrolled disease (diabetes mellitus as HbA1c level of \> 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
* Patients who have a history or presence of active malignancy within 5 years
* Patients with difficulty of stop taking lipid-lowering agents during run-in period.
* Patients who have taken another investigational drug within 4 weeks prior to screening visit.
Study of 9cUAB30 in Healthy Participants

This research study is looking at 9cUAB30 in healthy participants. Studying samples of blood and urine from healthy participants may help doctors learn more about how 9cUAB30 is used by the body.

PRIMARY OBJECTIVES:

I. To characterize the single-dose pharmacokinetics of 9cUAB30 in healthy volunteers.

SECONDARY OBJECTIVES:

I. To determine the toxicities of this drug in these participants. II. To correlate the pharmacokinetics with the toxicity of this drug in these participants.

OUTLINE:

Participants receive a single dose of oral 9cUAB30 on day 1. Blood and urine samples are collected at baseline, periodically on day 1, and then on day 8 for pharmacokinetic studies by high performance liquid chromatography.

After completion of treatment, participants are followed at days 8 and 30.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Karnofsky performance status (PS) 70-100% (ECOG PS 0-1)
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,000mm³
* Hemoglobin \> 10 g/dL
* Bilirubin ≤ 1.4 mg/dL
* AST ≤ 1.5 times normal
* Creatinine normal
* Sodium 135-144 mmol/L
* Potassium 3.2-4.8 mmol/L
* Chloride 85-114 mmol/L
* Bicarbonate \> 11 mEQ/dL
* Fasting triglycerides ≤ 1.5 times upper limit of normal (ULN)
* Fasting cholesterol ≤ 1.5 times ULN
* Not pregnant or nursing

  * No nursing during and for 30 days after completion of study treatment
* Negative pregnancy test
* Fertile participants must use effective contraception prior to, during, and for 1 month after completion of study treatment

  * No low-dose progesterone only birth control pills
* No concurrent uncontrolled illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatricillness or social situation that would limit compliance with study requirements
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to retinoids
* No other concurrent investigational agents
* No concurrent lipid-lowering agents
* No concurrent medications that may interact with 9cUAB30 (e.g., St.John's wort, ketoconazole, vitamin A, tetracycline, or oral corticosteroids)
* No other concurrent topical or oral retinoids (e.g., retinol, retinal, tretinoin \[Retin-A\], isotretinoin, alitretinoin, etretinate, acitretin,tazarotene, or bexarotene)
Alumina Matrix Composite Ceramic Bearing Total Hip Arthroplasty in Patients Younger Than 30 Years

This study will evaluate clinical outcome on patients who undergo cementless 4th generation ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip aArthroplasty ("THA") in patients younger than 30 years.


Eligibility Criteria:
Inclusion Criteria:

* younger than 30 years
* advanced hip disease

Exclusion Criteria:

* older than 30 years
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain

The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 20-70 years
* ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy

Exclusion Criteria:

* A history of allergy to any study drugs
* History of opioid use, obstructive sleep apnea
* Any psychological disorders
* hepatic or renal failure