cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Genetics in Nutritional Rickets

The purpose of this study is:

1. To compare the response of rickets to calcium with and without vitamin D.
2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
3. To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
4. To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.

Previous studies of Nigerian children with rickets demonstrated the superiority of calcium over vitamin D in producing healing. It is not known whether the addition of vitamin D to calcium will produce a better response to treatment than calcium alone in Nigerian children. A previous study suggested the possibility that vitamin D may augment the effect of calcium. We will compare the response of rickets to calcium with and without vitamin D. In addition, very little human data clearly demonstrates the effect of supplemental vitamin D on calcium absorption. We will assess whether oral vitamin D increases the already high calcium absorption even further.

Recent published data indicate that the increase in serum 25-hydroxyvitamin D may be more sustained with vitamin D3 than with vitamin D2. We will compare the response of Nigerian children with and without rickets to orally administered vitamin D3 and vitamin D2.

Because nutritional rickets tends to run in families, we will also examine amplified DNA for evidence of mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. Families possessing a recently identified 25-hydroxylase mutation will be given oral vitamin D2 and vitamin D3 to determine the functional status of the 25-hydroxylase enzyme.

Eligibility Criteria:
Inclusion Criteria:

* Clinical features of rickets
* Active rickets on X-ray

Exclusion Criteria:

* Treatment with calcium or vitamin D in preceding 30 days
Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial.

The main questions the study aims to answer are:

Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable?

Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement.

Participants will:

Undergo a single treatment session with either the investigational device or the control device.

Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes.

The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited.
2. Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria.
3. The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent.

Exclusion Criteria:

1. Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied.
2. Patients with implanted electrical devices (e.g., pacemakers, AICDs).
3. Those with a history of hypertrophic scars, keloids, or severe allergic reactions.
4. Individuals with excessive facial fat requiring surgical treatment.
5. Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
6. People with abnormal coagulation function or those taking anticoagulant medications (e.g., aspirin, warfarin) within 1 week of screening.
7. Individuals treated with fillers or botulinum toxin within the last 6 months or permanent fillers in the treatment area.
8. Those who have received skin treatments (e.g., deep exfoliation, lasers, light therapy) in the treatment area within 6 months.
9. Pregnant or lactating women, or women of childbearing potential not using medically accepted contraception.
10. Persons deemed inappropriate by the investigator to participate in this clinical trial.
Developing and Testing an Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding

Although breastfeeding provides the infant with all the nutrients necessary for its development, it has been observed that in Panama there are low rates of Exclusive Breastfeeding. Educational interventions, that support exclusive breastfeeding, which begin before delivery and continue to the postnatal period, have been shown to be effective.

The main objective of the study is the development and testing of an educational intervention through web based platform, to support exclusive breastfeeding up to 6 months. This educational intervention will provide guidance with the help of an audiovisual format, with information and breastfeeding techniques, which mothers can reproduce as many times as necessary.

The main objective of the study is the development and testing of an educational intervention through AmiHealth, to support exclusive breastfeeding up to 6 months.

A pilot study will be conducted on a non-random convenience sample.

The team leveraged a user-centered design (UCD) approach to design and develop the initial version of the breastfeeding app. An agile development methodology for content and technology development which integrates feedback from all key stakeholders in the development process to refine the app over time, including the content and app.In parallel with the app design, the educational content for the intervention was developed with experts in the field.

The contents that will be develop for the breastfeeding module, Data operating system will be used for data management and analytical and projection tools.

Eligibility Criteria:
Inclusion Criteria:

1. First pregnancy
2. Third trimester

Exclusion Criteria:

* twin pregnancies fetal defects or newborns with malformations
Diaphragmatic Atrophy Related to Mechanical Ventilation

Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy.

The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit).

The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
* Group 2 : under Non-invasive Ventilation
* Group 3 : Spontaneous Ventilation
* Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)

Exclusion Criteria:

* Known diaphragmatic paralysis
* Neurologic pathology with motor deficit
* Pregnancy or breast-feeding woman
Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)

Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years of age.
* Patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received R-CHOP (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
* Measurable disease as defined by Cheson et al 2007 criteria.
* One fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
* World Health Organization (WHO) performance status 0 to 1.

Exclusion Criteria:

* Treatment with nitrosurea, mitomycin C, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
* With the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
* Uncontrolled hypertension (defined as \>140mmHg systolic and/or \> 90 mmHG diastolic at baseline with or without antihypertensive therapy.
* Evidence of tuberculosis (TB).
* Inadequate boen marrow reserve.
ARTISAN 2.0: Deconstructing the Integrative Efficacy of a Multimodal Art-based Intervention

To address perceived loneliness via citizen empowerment, ARTISAN (Aspiration and Resilience Through Intergenerational Storytelling and Art-based Narratives) was developed by the Principal Investigator in partnership with the National Arts Council and the National Museum of Singapore. A 2018 pilot study was conducted with the aim to establish ARTISAN's intervention framework, as well as to evaluate the effectiveness of the intervention in promoting resilience, social connectedness, wellbeing, personhood and nationhood. The current research builds on the empirical foundation of the pilot study and seeks to deconstruct the ARTISAN intervention for gaining a deeper understanding of its underlying mechanisms for promoting positive life changes among youth and senior participants such as reduced loneliness, enhanced resilience, psychological wellbeing, social connectedness and sense of nationhood.

Objective: The core objective is to critically investigate and assess the independent and combined efficacy of each key intervention components of ARTISAN's multimodal framework, which consist of: 1) full ARTISAN condition; 2) intergenerational participatory arts condition; 3) intergenerational art space condition; 4) intergenerational storytelling condition; and 5) control condition of physical activity.

Methods: Utilizing a five-arm, multicentre randomized controlled trial (RCT) design, 70 youths and 70 seniors (N=140) from 10 collaborating sites will be invited to participate in a 5-weeks intervention programme under one of five conditions (ARTISAN condition, Participatory Arts condition, Art-space condition, Storytelling condition, Control condition). Quantitative measurements will be taken at baseline, immediately after the intervention, and ten week post baseline the interventions.

Significance: The results generated will serve to illuminate the intricate pathways in which arts and heritage can cultivate positive life changes, and address misconceptions and about the pivotal roles that arts and heritage play in health promotion.

Eligibility Criteria:
Inclusion Criteria:

* Youth between the age of 16 to 35
* Community-dwelling seniors above the age of 60
* Fluent in verbal English or Mandarin

Exclusion Criteria:

* Individuals who are unable to provide informed consent (or parental consent where applicable)
* Individuals diagnosed with major mental illness or cognitive impairment (If deemed appropriate, potential senior participants will be screened by the NTU research team using the Mini-Mental State Examination (MMSE))
* Participants who had engaged in the ARTISAN pilot study
Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory or recurrent endometrial cancer.

OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients.

OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line chemotherapy Bidimensionally measurable disease by physical exam or medical imaging techniques (sonography acceptable if lesion(s) are clearly defined and measurable in two dimensions) Ascites and pleural effusions are not measurable

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: At least 4 weeks since any prior therapy directed at malignant endometrial tumor(s) At least 4 weeks since prior folate-containing vitamins No concurrent folate-containing vitamins No other concurrent anticancer therapy
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale

Eligibility Criteria:
Inclusion Criteria:

* Children 4-10 years old
* ASA grade I or II
* General anesthesia
* Elective surgery

Exclusion Criteria:

* Children who have had previous surgery history
* Local anesthesia or emergency surgeries
* Premature or congenital disease history
* Having visual and hearing impairment
* Mental and developmental retardation
* Having a history of epilepsy and seizures
* Patients taking psychoactive drugs
Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding

To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).

The Maternal Attachment Inventory (MAI) measure maternal love attachment (9). Muller tested the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).

Eligibility Criteria:
Inclusion Criteria:

* natural pregnancy (without any Assisted reproductive technology (ART) method)
* aged 18 to 45 years
* no adverse obstetric history

Exclusion Criteria:

* psychiatric diagnosis
* history of psychiatric drug use
* postpartum blues
* known complications during pregnancy
Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.

This is a randomized, comparative, prospective, double Blind study.

The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Do IVF cycle with donor eggs
* Will adjust to protocol for the study.
* Have signed informed consent

Exclusion Criteria:

* Clinically significant systemic disease, hypothalamic or pituitary tumors
* ovarian, uterine or breast cancer
* hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment.
* known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner.
* Uterine Factor(submucosal fibroids, intramural fibroids\> 4 cm)
* Hydrosalpinx
* Patients receiving immune treatment
* Positive Diagnosis Thrombophilia
* preimplantation genetic diagnosis needed
* In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation\> 45%
* Pregnancy contraindication
* Known allergy to preparations containing estrogens or any of its excipients.
* Simultaneous participation in another clinical trial with medication.
* Do not want or can not adjust to study protocol.
Reducing Wrinkles Around the Eyes Using the Ulthera® System

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Mild to moderate rhytids in the periorbital region.
* Willingness and ability to comply with protocol requirements and return for follow-up visits.
* Not pregnant.
* Provide written informed consent and HIPAA authorization.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face.
* Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
* Excessive hooding, with or without redundant skin, in the areas to be treated.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne on the face.
* Presence of a metal stent or implant in the facial area to be treated.
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\] over three consecutive cycles of 28-days treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will also be compared, as well as explored over multiple treatment cycles.

Study patients participating in Mpex 209 will be given the option to participate in a six-month open label extension phase of the Mpex 209 protocol. The open label extension will allow enrolled patients to receive three additional courses of MP-376 (levofloxacin inhalation solution, Aeroquin™).

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* \> 12 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa within the past 12 months
* Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening
* Have received at least 3 courses of inhaled tobramycin over the preceding 12 months
* Clinically stable with no changes in health status within the last 28 days
* Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

* Use of any nebulized or systemic antibiotics within 28 days prior to baseline
* History of hypersensitivity to fluoroquinolones or inhaled or systemic aminoglycosides including tobramycin or any excipients
* Evidence of acute upper within 10 days or lower respiratory infections within 28 days prior to dosing
* CrCl \< 20 at Screening
* History of lung transplantation

Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator.