cyrilzakka/clinical-trials huggingface dataset:
Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles

Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles and hence progesterone supplement adjustments remain debatable in current literature. This prospective randomized study aims to investigate the effect of monitoring and follow-up of serum progesterone, estradiol \& luteinizing hormone (LH) levels and progesterone supplement adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles in comparison with ultrasound only in control group

Progesterone (P4) is a steroidal hormone that is required for successful embryo implantation and maintenance of the pregnancy in natural cycles, fresh in vitro fertilization cycles, and frozen embryo transfer (FET) cycles. Women undergoing FET in programmed cycle are unable to provide adequate endogenous P4 and require progesterone supplementation to initiate and maintain the secretory endometrium and pregnancy. There has been previous research into luteal phase support in frozen cycles, which has demonstrated that supplementation of progesterone does impact outcome in FET. Despite this evidence for the role of progesterone, there is surprisingly little data on the optimal values for serum P4 during the luteal phase and specifically on the day of embryo transfer in frozen cycles. Following years of a prevalent belief that the higher values of P4 are better, it seems that there may be an optimal window for P4 values during the luteal phase in bovine IVF. Though progesterone levels on the day of transfer have not yet been studied extensively in humans, tailoring the time of transferring a frozen embryo based on serial P4 values rather than cycle day number alone results in higher pregnancy rates. By direct action on the endometrium, a rise of LH might interfere with endometrial receptivity during a FET cycle, in which no pituitary suppression is used. The significance of LH level on the day before addition of progesterone is not yet well defined. The aim of this study is to investigate the effect of monitoring and follow-up of serum progesterone, estradiol \& luteinizing hormone levels on day of embryo transfer on pregnancy outcomes for FET in programmed HRT cycles in comparison with ultrasound only in control group and to evaluate the effect of progesterone supplements adjustments depending on serum progesterone levels on day of FET in affecting clinical pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

1. Age of female patient 42 years or less
2. Normal uterine cavity
3. All embryos are day 5 or day 6 frozen blastocysts

Exclusion Criteria:

1. History of recurrent implantation failure
2. Previously known major thrombophilia factors
3. Non-compliance to given protocol
4. Endometrial thickness \< 7mm after 13 days of priming with estradiol valerate
5. pre-existing metabolic diseases (Diabetes Mellitus \& Hypertension).
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)

Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults

The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.

The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.

In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).

The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.

Eligibility Criteria:
Main inclusion Criteria:

* Patient with OSA (treated or not with nCPAP) and still complaining of EDS
* Epworth Sleepiness Scale score \> or = to 11

Main exclusion Criteria:

* Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease

The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able and willing to provide informed consent to participate in the study.
* The patient's implanted DBS system shall be the Medtronic, Inc. Activa® System. The Medtronic Activa System may consists of either, Soletra®, Kinetra® Activa® RC, or Activa® PC Neurostimulator(s) and two DBS Leads (Model 3387 or 3389).
* Patient shall have bilateral DBS of the subthalamic nucleolus (STN).
* Patient shall have stable DBS stimulation without changes in stimulation parameters for no less than 3 months prior to enrollment.
* Patient shall have stable and optimal regimen of antiparkinson drug therapy for no less than 3 months prior to enrollment.
* Patient, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study (e.g. no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule).
* Availability, from the patient's medical records, of a Pre-op MRI and high resolution CT with artifact reduction no less than six (6) weeks post-op.
* Patient shall have Hoehn and Yahr stage III or worse when off stimulation and off medication.
* Patient shall have demonstrated good response to L-DOPA, defined as no less than a 30% improvement in a UPDRS-III motor exam following the administration of L-DOPA during their screening neurological exam.
* Patient shall have demonstrated good response to DBS following the administration of DBS while off medication, defined as an improvement in UPDRS-III motor scores better than their improvement to L-DOPA (as determine in above) or no less than 20% worse of an improvement.

Exclusion Criteria:

* Evidence of secondary or atypical Parkinsonism as suggested by: stroke, encephalitis, exposure to toxins, neuroleptic antipsychotics, neurologic signs of upper motor neuron or cerebellar involvement, or supranuclear palsy.
* Dementia as evidenced by a mini-mental state examination of 24 or below (MMSE ≥ 24).
* Prior participation in the Intelect Medical GUIDE study.
OrthoPulse 2.0 and 2.1 Feasibility Evaluation

OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent must be obtained before any assessment is performed
* Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
* Presence of permanent dentition
* Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
* Good oral hygiene
* Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
* Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data

Exclusion Criteria:

* Patient is currently enrolled in another clinical study
* Periodontally involved teeth, acute oral infection or periodontal disease
* Use of bisphosphonates (osteoporosis drugs) during the study
* Use of drugs that may cause photosensitivity
* History of photosensitivity
* History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
* Epilepsy
* Patient plans to relocate over the treatment period
* Smoker or use of any tobacco containing products per the discretion of the PI
Ankle Fracture Treatment in the Elderly

The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older

Eligibility Criteria:
Inclusion Criteria:

* at least 55 years of age at time of surgery
* receiving treatment for ankle fractures

Exclusion Criteria:

* none
Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.

Opioids is known that produce not only analgesia but also hyperalgesia through activation of central glutaminergic system-GABA. At the same time, recently it was found that the main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during oocyte retrieval.

The main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during ultrasound-guided oocyte retrieval. It will be measured the level of cortisone before and 15min after iv administration of fentanyl on blood and on oocyte fluid.

Eligibility Criteria:
Inclusion Criteria:

* American Physical Status I-III, BMI\<30,

Exclusion Criteria:

* Heart failure
* hepatic failure, hepatitis,
* drug abuse
* receiving b blockers
* receiving b agonists (even bronchodilators)
Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream

This clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification.

This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. Group A will receive pretreatment in the form of 0.05% tretinoin cream which is used as much as one fingertip unit every night, and group B will receive the same cream which should be used as much as two fingertip units. This cream will be used for two weeks before the patients receive a chemical peeling therapy using 30% trichloroacetic acid. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 35-60 years old
* Patients with Glogau II-III skin classification
* Patients are willing to participate in the study and sign an informed consent form

Exclusion Criteria:

* Patients with hypertrophic scars or keloid on the face
* Patients with open wound or infection on the face
* History of other topical treatment on the face within 1 month of enrollment
* Pregnant or breastfeeding mother
* Patients and/or their families are not willing to participate in the study.
Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction

To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects erectile function in men


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiography
* No previous statin use
* Age \> 18 years old
* No PDE5-1 use in the past 6 months

Exclusion Criteria:

* Patients with an Acute Coronary Syndrome
* Patients with Cardiogenic shock
* Patients \> 30% coronary stenosis
* Patients with unexplained muscle pain
* Patients with acute liver disease
* Patients receiving immunosuppressant therapy, azoles, macrolide antibiotics, niacin, L-arginine
* Patients with serum creatinine \> 2.0
* Patients with total cholesterol \> 200 mmol/l
* Patients on current statin therapy or clinically indicated to be on statin therapy
PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The proposed PCI Suite is a new software package which can be used during coronary interventions. The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping.

The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigation as part of the standard care. These angiograms will be automatically processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in PCI Suite. The primary objective of this prospective, mono-center, randomized clinical trial is to evaluate the amount of contrast medium used during percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* hemodynamically relevant type A or B lesion

Exclusion Criteria:

* hemodynamically relevant type C lesion
* NSTEMI/STEMI
* declined to participate
Understanding Non-Response in Spine Fusion Surgery

To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).


Eligibility Criteria:
Inclusion Criteria:

* Subject has diagnosis of degenerative disc disease
* Subject is undergoing lumbar spine fusion surgery

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject is not fluent in English
* Subject requires a caretaker for medical decision making
Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.


Eligibility Criteria:
Inclusion Criteria:

* Sub-Obstructive Adenotonsillar Hypertrophy lasting from at least six months and associated with sleep disordered breathing (respiratory pauses or sleep-apnea) and/or recurrent sero-mucus otitis
* Suspension for more than 3 months from the date of any immunosuppressive treatments (cyclosporin, systemic steroids)

Exclusion Criteria:

* Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma.
* Iodine allergy
Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology

This study evaluates how adolescent and young adults with cancer in the U.S. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions

PRIMARY OBJECTIVES:

* To refine patient-reported outcome assessment tools of body image, fertility, and financial burden for PROMIS and evaluate assumptions for IRT consistent with PROMIS Scientific Standards (e.g., unidimensionality, local independence).
* To examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (DIF).

Secondary Objective

* To create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs.

OUTLINE: This is an observational study.

Participants complete surveys on study.

Eligibility Criteria:
Inclusion Criteria:

AYAs WITH A CANCER HISTORY:

* AYAs will be eligible for this sample if they:
* Are 15 to 39 years of age
* Were first diagnosed with cancer at 15 to 39 years of age
* Are able to read and understand English
* Live in the United States
* Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 10 years post-treatment.

AYAs WITHOUT A CANCER HISTORY:

AYAs will be eligible for this sample if they:

* Are 15 to 39 years of age
* Are able to read and understand English; and
* Live in the United States.

CAREGIVERS OF AYAs WITH CANCER:

* Caregivers of AYAs will be eligible for this sample if they:
* Are 18 years of age or older
* Are able to read and understand English
* Live in the United States
* Have a child/ward/partner for whom they have provided care, AND
* Their child/ward/partner is 15 to 25 years of age and meets the other eligibility criteria as an AYA participant with a cancer history (described above).

Exclusion Criteria:

AYAs WITH A CANCER HISTORY:

AYAs will be excluded if they (1) were diagnosed with basal cell skin cancer; or (2) are currently receiving hospice care.

AYAs WITHOUT A CANCER HISTORY:

AYA patients will be excluded if they (1) have ever been diagnosed with cancer; or (2) are currently receiving hospice care.
Email-based Reminders Promoting Recommended Pediatric Preventative Visits

The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders.

Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively.

In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder.

The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days).

Eligibility Criteria:
Inclusion Criteria:

* Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months
* No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18)
* Has an email address on record
* Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit)

Exclusion Criteria:

* Did not opt out of emails
Follow-up of Oncology Patients After Hospitalization in ICU

"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

"Nature of evaluated care: Longitudinal follow-up of post- resuscitation intensive care Concerned population: adult patients with active solid tumor out alive from the ICU and following-up in oncology in the same hospital as the resuscitator investigator.

Main objective: Measure the influence of ICU for patients with solid cancers to continue with optimal anti -cancer treatment, defined before or during hospitalization in intensive care.

Secondary objective: Assess the physical and psychological consequences of ICU stay of patients Evaluation criteria : Primary endpoint: proportion of patients living, out from ICU and hospital, can receive optimal cancer treatment later.

Research Methodology : Prognostic study of routine care, national, prospective, cohort type."

Eligibility Criteria:
Inclusion criteria:

* Patient with progressive solid tumor hospitalized in intensive care and got out alive
* Oncology patients followed in the same hospital as the investigator resuscitator
* Age ≥ 18 years
* Affiliate of social insurance
* Agree to participate

Exclusion criteria :

* Patient hospitalized for programed surgery
* Hospitalization for securing procedure
* Pregnancy or breastfeeding woman