cyrilzakka/clinical-trials huggingface dataset:
ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

This is a pilot study of the Emerald device in Rett syndrome patients diagnosed with a confirmed MECP2 mutation. MC10 BioStamp nPoint patches will also be assessed with the goal to develop Rett-specific breathing algorithms

The study consists of two sequential cohorts with a total of approximately 20 patients enrolled. Patients in each cohort may participate for up to 4 weeks. Each participant will have up to 2 Emerald devices installed in their home for monitoring sleep, breathing and movement, and will use between 3 and 9 nPoint patches for determining proper patch placement for detecting breathing signals.

The study will consist of a Screening visit, an Observation period, and a Follow-up phone call. The Screening Period will be one day in clinic, the Observation period will be up to 4 weeks at home and the Follow up phone call will be performed at the completion of the Observation Period.

Eligibility Criteria:
Inclusion Criteria:

1. Prior to the conduct of any study-specific procedures, the parent/caregiver/LAR must provide written informed consent. If the caregiver attending the clinic visits is not the parent or LAR, written consent must be obtained from the parent or LAR for the caregiver's participation in the study.
2. Diagnosis of typical Rett Syndrome according to the revised Clinical Diagnostic Criteria1 and presence of a disease causing MECP2 genetic mutation.
3. The patient's parent/caregiver/LAR must be able to understand the nature of the study and to allow for the completion of study assessments. The same parent/caregiver/LAR must be capable of providing reliable information about the patient's condition.
4. Live within approximately 50 to 60 miles of MIT.
5. Primary language English.
6. Approximately 4 people or less living in the home. This does not include visiting caregivers.
7. Must have home access to Wi-Fi.

Exclusion Criteria:

1. Inability of patient to sleep alone in their own room.
2. Pets in the home, or caregivers unwilling to keep pets out of the bedroom monitored by Emerald during the Observation Period.
3. Plans to take a prolonged vacation or to otherwise be out of the home during the Observation Period.
4. Participation in another device study that could interfere with this study.
5. Active implantable devices such as pacemakers or defibrillators.
6. Known allergies or hypersensitivities to adhesives.
7. Patients with any condition that, in the opinion of the principal investigator, might interfere with the conduct of the study, confound interpretation of the study results, endanger their own well-being, or who may otherwise not be suitable for the study.
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne

The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.

This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.

Eligibility Criteria:
Inclusion Criteria:

* Stage 1 only: healthy subjects
* Stage 1-4: male or female subjects age 18 years or older
* Stage 2: subjects with sebum excretion rate of 4 or higher on forehead
* Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead
* Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead

Exclusion Criteria:

* Poor skin condition on back (Stage 1) or face (Stage 2 \& 3)
* Severe facial acne, acne fluminans/conglobata, or nodulocystic acne
* Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0
* Stage 2-4: previous treatment of isotretinoin or other oral retinoids
Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). The study will be based on already available data from the Pharmachild juvenile idiopathic arthritis (JIA) registry which holds the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal.

This is an international, non-interventional, single-armed, pharmacovigilance registry study on long-term safety of Kineret utilizing already available data from the ENCePP certified Pharmachild JIA registry.

The Paediatric Rheumatology International Trials Organisation (PRINTO) is a non-profit, non-governmental, international research network with the goal to foster, facilitate and co-ordinate the development, conduct, analysis, and reporting of multi-centers, international clinical trials and/or outcome standardization studies in children with paediatric rheumatic diseases.

The Pharmachild JIA registry, maintained by PRINTO, is a registry collecting data from patients with JIA including patients with SJIA. In the Pharmachild JIA registry 40 countries are participating of which 15 countries have collected data on Kineret treatment.

This study includes secondary use of data already available in the Pharmachild JIA registry.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a diagnosis of SJIA as per the International League of Associations for Rheumatology (ILAR) classification criteria
* Included in the Pharmachild registry
* Ever treated with Kineret subsequently to SJIA diagnosis

Exclusion Criteria:

No specific exclusion criteria will be applied.
Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface

Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.

Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.

Eligibility Criteria:
Inclusion Criteria:

* The tracheostomized patient requiring the convenient oxygen therapy.

Exclusion Criteria:

* Under 18 years;
* history of esophageal, gastric or lung surgery;
* The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy

This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects above age 18 of any ethnicity will be enrolled in this study.

Exclusion Criteria:

* Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects.
* Since the study instructions are in English, Non-English speakers will be excluded.
* Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded.
* In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded.
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents

Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).

Children or adolescents with migraine and both parents are informed in detail about the study.Probands are advised to fill in a special childrens´ diary for migraine daily. After a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. Afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 days of migraine per month

Exclusion Criteria:

* not able to communicate in german or english language
* any disease that forbids the participation in the trial according to the investigators assessment
* pregnancy
* no willingness to participate in the trial
* known allergy to fish or soya
RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* Willing and able to comply with the requirements for study specific procedures and visits.
* Able to complete a written questionnaire in English.

Exclusion Criteria:

* Pre-existing macular disease in either eye.
* Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
* History of uveitis in either eye.
* Evidence of ectasia in either eye.
* Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus in either eye.
An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months \& willing to stop using it to participate in the study
* Must be willing to get off of hormonal birth control for the study period
* Must be able to track their menstrual cycle
* BMI under 40
* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study
* Willingness to adhere to the dietary supplement regimen
* Willingness to refrain from any other dietary supplements targeting the menstrual cycle and hormone control during the study period
* Is able to communicate in English
* Is willing and able to share feedback via the used technology portal
* Must provide written informed consent (ICF)

Exclusion Criteria:

* History of oncological (including ovarian cancer) or psychiatric conditions
* History of uncontrolled health conditions
* History of hysterectomy or ovariectomy
* History of diabetes \& thyroid disorders
* Smoker
* More than 3 servings of alcohol a day
* Undergoing hormonal therapy of any kind
* Menopausal or peri-menopausal
* Not starting any other form of contraceptive other than condoms, abstinence, planned sexual intercourse
* Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle or hormonal balance
* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
Study of Predictive Factors of Chemoresistance in Ovarian Cancer

Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but most often a recurrence occurred in the first 18 months. Early recurrence signs chemoresistance and palliative treatment. The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years of age
* patient with histological proven epithelial ovarian cancer

Exclusion Criteria:

* patients who can not give their own consent
* patients without ovarian cancer
Outcome Study of Highly-cross Linked Polyethylene vs. Standard Polyethylene for Primary Posterior Stabilized (PS) Total Knee

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

This prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. Intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE tibial insert. Both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. Postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained at each visit. Clinical data forms will be completed at each visit. At the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* all patients indicated for primary total posterior stabilized knee arthroplasty

Exclusion Criteria:

* patients who refused participation
* patients who did not comprehend the English language to give informed consent
* patients with severe knee deformity thought to require a primary constrained condylar prosthesis
Peri-Operative Steroid Management in Patients

During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.

Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches.

Objectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes

Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection.

Exclusion Criteria:

* Patients with Cushing's Disease (pituitary tumor which secretes ACTH)
* Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism)
* Patients on long term glucocorticoid therapy
* Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes

This study is being done to investigate strategies that may improve patient's knowledge of type 2 diabetes during reproductive age and improve knowledge and engagement in self-care activities.

Our Promoting REproductive Planning, And REadiness in Diabetes (PREPARED) strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. Specifically, PREPARED will leverage electronic health record (EHR) technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt patient-provider preconception counseling and reproductive planning, and \[3\] deliver low literacy print tools to reinforce counseling and promote goal-setting for diabetes self-care activities. Post-visit, a widely-available text messaging platforms will be used to: \[4\] encourage healthy lifestyle behaviors through goal-setting and daily reminders. Our randomized trial will assess the effectiveness and fidelity of a technology-based strategy to promote preconception care and diabetes self-management among women with type 2 diabetes in primary care.

Aim 1: Test the effectiveness of PREPARED, compared to usual care, to improve patient: a) knowledge of reproductive risks associated with T2DM and recommended self-care activities b) engagement in self-care behaviors, including: i) diet, ii) physical activity, iii) adherence to diabetes medications; and use of iv) folic acid, and v) most or moderately effective contraception, when indicated; and c) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.

Aim 2: Assess whether PREPARED reduces disparities in the above outcomes versus usual care.

Aim 3: Evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling, and to deliver patient education and post-visit support of diabetes self-care behaviors.

Eligibility Criteria:
Inclusion Criteria:

* female
* age 18-44
* English or Spanish-speaking
* have a chart diagnosis of type 2 diabetes
* not currently pregnant
* not infecund, sterilized, or in a monogamous relationship with a sterilized partner
* have a private cell phone with text messaging capability.

Exclusion Criteria:

* severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

-