cyrilzakka/clinical-trials huggingface dataset:
Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.The purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. Compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate.

The existing clinical research analysis is mostly limited to the down-regulating regimen, while the RCT study of high-quality with GnRH antagonist protocol is few. Therefore, the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

Eligibility Criteria:
Inclusion Criteria:

1. patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI)
2. under 38 years of age
3. number of AFC≥6, AMH\>1.1ng/ml
4. no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician)
5. number of available embryos(day 3)≥4
6. informed consent

Exclusion Criteria:

1. PGT
2. with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)

A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).


Eligibility Criteria:
Inclusion Criteria:

* Patient is a woman who is 65 years of age or older
* Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population
* Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)\<66

Exclusion Criteria:

* Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
* Patient has a history of certain types of cancer
Inspiratory Muscle Training in Children With Chest Burn

8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.

The primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 10 to 18.
* Following hospital discharge.- Total body surface area (TBSA) of 30% to 50%.
* Chest burns.
* Deep partial to full thickness burns.
* Subjects who had a skin graft or who healed completely were also included.

Exclusion Criteria:

* - Participants who had a nonhealing or open wound.
* Congenital diaphragmatic hernia.
* Chest wall deformity.
* Cardiac or pulmonary problems.
Outcome of Regenerative Endodontic Procedures

Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis.
2. an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible)
3. Pulp space not needed for post and core restoration
4. A cooperative and Compliant patient/ parent
5. Patients not allergic to medicaments necessary to complete the procedure.

Exclusion Criteria:

1. medically compromised patient,
2. teeth with vertical fractures,
3. periodontally involved teeth,
4. non-restorable teeth,
5. teeth when bleeding could not be induced.
A Study to Assess How Food Affects the Movement of Oral ABBV-101 Through the Body of Healthy Adult Participants

This study will assess the effect of food (high fat) on oral ABBV-101 and how ABBV-101 moves through the body in healthy adult participants


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
* Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 to 110
* Residence in Olmsted County. Note: if sufficient numbers cannot be reached using only Olmsted County, will expand to the 27-county region.

Exclusion Criteria:

* None
Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts

Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts.

We conduct an oral immunotherapy program with \~500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.

Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with \~500 patients so far. Patients with IgE-mediated food allergy that are \>4 years old are eligible.

In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained.

Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.

Eligibility Criteria:
Inclusion Criteria:

* age\>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT \>6 months ago

Exclusion Criteria:

* Non approval to participate
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images.

The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

The study was an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS.

The primary objective of the study was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).

Eligibility Criteria:
Inclusion Criteria:

* Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
* Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
* Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

Exclusion Criteria:

* No enhancing lesion visible on the gadoterate-enhanced MRI scan.
* Pregnancy or breastfeeding.
* Severe cardiovascular disease
To Determine the Role of Adding Campath-1H or ATG Given In-vivo in Addition to Fludarabine and Low Dose Busulfex on Outcome in Patients Treated With Reduced Intensity Conditioning

Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell transplantation from an HLA compatible donor.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AML or MDS, with no lower or upper age limit:
* a) Induction failure
* b) First or subsequent remission
* c) Untreated first relapse
* Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related or 10/10 molecular matched unrelated donor (A,B,C,DR,DRB1).

Exclusion Criteria:

* Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia).
* Evidence of bone marrow disease.
* Unable to donate bone marrow or peripheral blood due to concurrent medical condition.
Acupuncture in Adolescent Football Players

Is it feasible to perform acupuncture in the training field after sport performance in adolescent football players?

Does acupuncture provide a decrease in muscle soreness and improvement in overall sense of well-being in the adolescent football population?

Previous studies on the effects of acupuncture on performance and post-exercise recovery have shown that it reduces perceived pain arising from exercise induced muscle soreness and reduces muscle spasm. Acupuncture has also been shown to serve as an adjunct to improve muscle strength training and to accelerate recovery from workouts and injury.

The investigators' goal is to study approximately 50 high school football players in their true pre-season warm weather training environment. The investigators will measure the effects of acupuncture treatment on muscle soreness and overall sense of well-being by administering pre- and post-treatment surveys. Athletes will undergo five treatment sessions over the course of 2.5 weeks. The treatments will be performed by licensed acupuncturists employed at Mayo Clinic. The study has been approved by the Institutional Review Board at the Mayo Clinic.

Eligibility Criteria:
Inclusion Criteria

1. Male or female members of the two local high school football teams
2. Age 13-18 years
3. No current musculoskeletal injuries
4. Generally healthy individuals who plan to complete the season barring injury or other unexpected events.

Exclusion Criteria:

1. Acupuncture treatment within the past year
2. Known active musculoskeletal injury or condition, immunocompromised state, prosthetic heart valve, pregnancy or known history of bleeding disorder.
Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care

This study compares Virtual Reality versus Nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.

After cardiac surgery, the mediastinal and pleural drains are usually removed the second postoperative day, in the absence of complications. This procedure, realized by nurses, is a source of anxiety and pain for patients.

Nitrous oxide (Kalinox®) is commonly used to manage many situations of anxiety, including the removal of mediastinal and/or pleural drains, and has shown a greater effect than placebo in this indication.

Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares VR versus Kalinox® administration for the management of anxiety and pain related to post-cardiac surgery care, especially mediastinal and/or pleural drain removal.

Eligibility Criteria:
Inclusion Criteria:

* Extubated after cardiac surgery
* Sinus rhythm
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Pacemaker
* Visual acuity making impossible the use of virtual reality
* Intolerance to morphine
* Contraindication to Kalinox®
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound

This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.

Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.

Eligibility Criteria:
Inclusion Criteria:

* Female patients older than 1 month and less than 18 years
* Patients require IV crystalloid bolus fluids before a pelvic ultrasound

Exclusion Criteria:

* Known cardiac insufficiency or significant cardiac surgery
* Hepatic insufficiency
* Renal insufficiency
* Any known fluid overload states (ascites, pulmonary edema)
* On any diuretic or antihypertensive therapy
* Known pregnancy
Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers

This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.

PRIMARY OBJECTIVES:

I. To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.

SECONDARY OBJECTIVES:

I. To define the utility of the current PAI on various groups of human subjects.

II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.

III. When possible, via means of an existing data review, PAI will be compared to pathologic specimens.

IV. When possible, via means of an existing data review, PAI data will be correlated with outcomes of patients to therapies they receive.

OUTLINE:

Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* ALL GROUPS:
* No restriction on race or ethnic background.
* Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
* HEALTHY VOLUNTEERS:
* No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.
* No history of diabetes.
* No history of cancer to the body site to be imaged.
* BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS:
* Biopsy-proven aforementioned malignancy.
* SURGICAL FLAP PATIENTS:
* Need for plastic surgery reconstruction with a free or rotational flap.

Exclusion Criteria:

* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Unwilling or unable to follow protocol requirements or provide consent.
* Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to Screening and that has been clinically stable for 1 month.
* Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline.
* Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.
* Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3.

Exclusion Criteria:

* Clinically infected AD or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage AD.
* History of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%.
* History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin).
* Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the reason of lack of efficacy.