cyrilzakka/clinical-trials huggingface dataset:
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
2. A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
5. History of psoriasis unresponsive to topical treatments.
6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
Prescription and Persistence of Antithrombotic Agents in Acute Ischemic Stroke or Transient Ischemic Attack Patients With MCA(Middle Cerebral Artery) Disease

Prescription and Persistence of Antithrombotic agents in Acute Ischemic Stroke or Transient Ischemic Attack Patients with MCA(Middle Cerebral Artery) Disease.


Eligibility Criteria:
Inclusion Criteria:

* 19 years later, men and women

Exclusion Criteria:

* Subject who is judged to be ineligible by investigator
Neural Stem Cells Therapy for Cerebral Palsy

To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.

Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses, living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children with cerebral palsy. With full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older. Thus, the incidence of cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society. Recent clinical trials performed in countries outside China have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been registered with ClinicalTrials.gov. In China, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application. In October 2016, the National Health and Family Planning Commission and the Food and Drug Administration of China jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in China possible.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);
* Clinical manifestation of spastic tetraplegia;
* With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;
* Age 1-5 years, of either sex;
* Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;

Exclusion Criteria:

* Systemic diseases that possibly influence treatment or patient's compliance;
* Potentially life-threatening diseases involving various organ systems;
* Brain deformity;
* Abnormal behaviors or mood disorder;
* Allergies from blood products;
* Suffering from infectious disease;
* Subjected to craniocerebral operations prior to screening.
Position HTO Multicenter NIS

Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy


Eligibility Criteria:
Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K\&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K\&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension;

Exclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations
Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery

In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid accumulation. However, the guideline for perioperative fluid management has not been yet established. The investigators hypothesized that intraoperative fluid management according to SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those by CVP(Central Venous Pressure). Therefore, the study is trying to determine if intraoperative fluid administration based on SVV could reduce metabolic acidosis when compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9% normal saline as main fluid regimen.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing craniotomy due to brain tumor
* American Society of Anesthesiologists physical status I or II
* aged from 20 to 65

Exclusion Criteria:

* compromised cardiopulmonary function
* diabetes mellitus
* symptom or sign with increased intracranial pressure
* liver or renal disease
* pre-existing metabolic acidosis
* pregnant or breast-feeding
* patients who cannot understand the statements for subjects
Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Current Biofinity© lens wearer.
* Pregnant or breast-feeding.
* Other protocol-specified exclusion criteria may apply.
Urdu Version of Menstrual Attitude Questionnaire: A Reliability and Validity Study

To determine the validity and reliability of Urdu version of Menstrual Attitude Questionnaire

Menstrual Attitude Questionnaire has been distributed in 200 women who were recruited by convenience sampling technique under the pre defined inclusion and exclusion criteria after signing the informed consent forms .

This study's findings will assist determine the Menstrual Attitude Questionnaire's reliability and validity in individuals with neck pain and impairment. This scale's reliability will be evaluated utilising internal consistency and test-retest methods. Cronbach's alpha value checks internal consistency. The interclass correlation will be used to examine the test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

1. A history of lower abdominal pain for more than 6 menstrual cycle.
2. No elective treatment counting TENS inside 1 month earlier to enrollment within the ponder.
3. Provision of informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Pregnant or Breastfeeding
2. History of surgery of the lower abdomen.
3. Heart disease.
4. Cancer.
5. Severe mental disorder
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
* Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
* Males and Females, ages 18 and older

Exclusion Criteria:

* All participants previously discontinued from an elotuzumab study for any reason
* Participants not receiving clinical benefit from previous study therapy
* Participants who are not medically well enough to receive study therapy as determined by the investigator

Other protocol defined inclusion/exclusion criteria could apply
Trial of Minocycline to Treat Children With Fragile X Syndrome

This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.

This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.

The aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with FXS who are 3.5 to 16 years of age. At baseline, we will assess behavior and perceptual and cognitive development. After the children have been treated for 3 months with either minocycline or placebo, they undergo the same baseline testing. They will then cross over and be treated for a second 3 months. We will carry out testing again at the end of the second 3 month period. We will also assess the side effects of minocycline treatment throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have fragile X syndrome with molecular documentation
* Current pharmacological treatment regimen has been stable for at least 4 weeks

Exclusion Criteria:

* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
* subjects who are unable to take oral medication
* subjects who have been on minocycline previously
* subjects who are allergic to minocycline or tetracyclines
* subjects who are pregnant
* subjects with history of lupus or hepatic dysfunction
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, we have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the intestinal transporters, such as the novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit, during which they will take a single dose of gabapentin, and provide blood and urine samples over the course of 36 hours (5 terminal elimination gabapentin half-lives) for pharmacokinetic analysis.

Detailed description pending

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have previously participated in the "SOPHIE" study.
* Subjects will be between the ages of 18 and 40 years old
* Subjects will have been selected as healthy by medical history questionnaire and screening blood work (CBC, Comprehensive Metabolic panel).
* Subjects will be taking no regular medications and will have normal renal function.

Exclusion Criteria:

* Pregnant
* Have a new history indicating they are no longer healthy; Individuals with anemia (hemoglobin \< 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL), will be excluded.
* Taking a medication that could confound study results
* Do not consent to participate in the study.
Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

The control group will receive three HBO treatment sessions plus placebo. The treatment group will receive three HBO treatment sessions plus 10 mg Dexamethasone per day during HBO therapy (minimum of two doses, up to a maximum of five doses if participant stays for longer than three days). After three treatment sessions, the participant will be discharged home barring no other medical complications requiring further hospitalization. In two weeks, participants will return for follow-up testing and evaluation. Continued HBO therapy plus placebo as well as HBO therapy plus steroids for respective group members will be offered if participants are still dealing with CO poisoning sequelae as determined by our outcome measures. In addition, a 6 week and 12 week telephone follow-up will be conducted asking questions regarding memory, emotion, neurologic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization
* Age \>18 years
* Nebraska Medicine admission

Exclusion Criteria:

* Mechanical ventilation
* No hospital admission or admission to hospital Critical Care Medicine Service
* Allergy to dexamethasone
* Pre-Existing neurological condition confounding outcome determination
Interdisciplinary Falls Prevention for Seniors

With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.

Falls and fall injuries are common-potentially preventable-causes of mortality, morbidity, functional decline, and increased health-care use and cost among community-living seniors over 75 years of age.

The knowledge gained from this project will directly address the Canadian Patient Safety Institute's priority areas for research in the Applied Health Services Research Stream by evaluating an innovative approach to reducing adverse events in a community-based (home care) setting.

The project will also identify the prevalence, determinants and costs of falls and fall injuries among older people requiring home care services. The design will be a two-armed; single blind randomized controlled trial of 110 older people 75 years and over, at risk for falls receiving hom care in Ontario. Subjects will be randomly allocated to either usual home care (control) or the interdisciplinary team. In the interdisciplinary group, a team of professional home care service providers, with specialized training in falls prevention, will proactively provide a comprehensive, coordinated and evidence based approach to falls prevention. The results will inform policies and practice related to the allocation and delivery of home care services for falls prevention across Canada.

Eligibility Criteria:
Inclusion Criteria:

* Must be English speaking
* 75 years of age and over
* Newly referred to and eligible for personal support services
* Living at home in the community
* Identified as being at risk for falls

Exclusion Criteria:

* Refusal to give informed consent
* Unable to read/write English and a translator is not available
Optical Frequency Domain Imaging (OFDI) in Dermatology

This is a pilot exploratory study. The goal of this study is to evaluate a new imaging tool, optical frequency domain imaging (OFDI), to reveal the microvascular morphology of capillary malformations.

The subject population will be composed of 8 subjects meeting the inclusion and exclusion criteria. Up to 8 subjects may be enrolled for the study after obtaining written, informed consent prior to participation in the study. Recruitment will be performed by direct advertisement to subjects inside and outside Brigham and Women's Hospital (BWH), including the BWH dermatology clinic. The study patients will be managed using standard of care in practice at the BWH dermatology clinic. The study will be conducted at Brigham and Women's Hospital Dermatology Clinic where the pulsed dye laser is housed.

Patients referred to the BWH dermatology clinic will be eligible for recruitment. The study nurse/staff involved in patient enrollment will be familiar with the care of this type of patients. The medical history of these patients will be examined to determine if the study eligibility requirements are met. If the patient is selected as a potential subject, a letter will be sent about 7 days prior to their scheduled exam to ask if they would care to participate. This time frame should allow time for the patient to consider study participation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects: Fitzpatrick skin type I-VI, of either gender
2. Subjects must be between 18 and 80 years of age.
3. Subjects must have a not previously treated port wine stain of at least 1 cm2 on either a) trunk and extremities or b) face and neck.
4. Subjects are scheduled for PLD treatment of the port wine stain
5. Subjects must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

1. Subjects must not have active localized or systemic infections
2. Subjects must not be on aspirin.
3. Subjects must not be currently taking Accutane or be off Accutane for less than 6 months prior to initiation of the study.
4. Subjects must not be participating in potentially confounding research; e.g. a clinical study of any other unapproved investigational drug or device.
5. Subjects must not be pregnant or planning to become pregnant over the course of the study.