cyrilzakka/clinical-trials huggingface dataset:
Autologous Bone Marrow-derived Mesenchymal Stem Cells for Atrophic Endometrium in Patients With Repeated IVF Failures

Investigators will examine safety and efficiency of the cell product of autologous bone marrow-derived mesenchymal stem cells (MSC) for patients with repeated IVF failures and hypoplastic or/and fibrosis process of endometrium

Sixty patients eligible for the study will be divided to two groups (experimental and control) according to randomization (envelope) procedure in 1:1 ratio.

For patients of the main group bone marrow stem cells will be extracted from the crest of the ilium using standard methodology. After extraction and cultivation final product of autologous bone marrow-derived mesenchymal stem cells will be transplanted to endometrial cavity on menstrual cycle day 5-6. Meanwhile patients will receive three cycles of hormonal replacement therapy (4 mg Progynova (Bayer Pharma, Germany) daily on menstrual cycle day 5-25 in combination with 20 mg Duphaston (Abbott Healthcare Products, B.V., Netherlands) daily from day 15 to day 25. On day 20 of hormonal replacement therapy (HRT) of the last (third) cycle Pipelle-biopsy of endometrium will be performed. Obtained material will be analyzed by immunohistochemistry with the assessment of estrogen and progesterone receptors, VEGFa, GM-CSF, CD133+, CD34 and CD56. Ultrasound characteristics of endometrial quality will be registered on day 9-10 and day 19-21 of every cycle. When morphological and echographic parameters of endometrium are found satisfactory for embryo transfer, the HRT for endometrial preparation for frozen/thawed embryo transfer cycle will be initiated. If acceptable endometrial characteristics are not achieved, patients could be offered to undergo repeated (not more than 3) transplantation of MSC procedures.

Control group will receive three standard cycles of HRT following hysteroscopy before frozen/thawed embryo transfer. If endometrial characteristics are found unsatisfactory, gestational surrogacy might be offered.

Eligibility Criteria:
Inclusion Criteria:

* Repeated IVF attempts with high and good quality embryo transfer in fresh and frozen IVF cycles;
* Age 20-44 years;
* Endometrial thickness less than 6 mm in 2 or more of HRT cycles for endometrial preparation for embryo transfer
* Hysteroscopic evidence of fibrosis processes of uterine cavity with the absence of positive dynamics of HRT in 3 months following operation;
* Signed informed consent.

Exclusion Criteria:

* Contraindication for pregnancy;
* Absence of cryopreserved embryos, stored at clinic's cryobank;
* BMI \> 30 kg/m2;
* Impaired carbohydrate metabolism according to glucose tolerance test;
* Thrombosis in anamnesis;
* Oncological diseases in anamnesis;
* Diagnosed inherited thrombophilia;
* Uterine fibroids of more than 4 cm or more than 2 fibroids of 2.5 cm diameter;
* Nodal form of adenomiosis;
* Ovarian cysts more than 4 cm in diameter.
Intelligent Cataract Screening With Portable Slit-lamp

Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 100 years old

Exclusion Criteria:

* (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study
Tissue Sodium in Autoimmune Disease

This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na) magnetic resonance imaging-determined skin sodium concentrations in patients with systemic lupus erythematosus (SLE) and improve blood pressure and inflammation

This pilot study will test the hypothesis that a low sodium diet will decrease 23Na magnetic resonance imaging-determined skin sodium concentrations in patients with SLE and improve blood pressure and inflammation. Investigators plan to enroll 21 participants who will be randomized to low salt or high salt diet. Participants will eat the first diet for 28 days, and after a 2 week washout, Participants will eat the second diet (whichever the participant was not randomized to for the first phase). Participant will know what diet participant is on, study coordinator who does the assessment will be blinded to diet.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients 18 and over
* meets 2012 International criteria for the diagnosis of SLE
* have stable disease activity as evidenced by no significant change in immunomodulating therapy in last month
* provide written informed consent

Exclusion Criteria:

* Pregnancy
* Receiving dialysis
* Organ or bone marrow transplant
* Uncontrolled hypertension, BP\> 160/100 mm Hg at screening
* Severe edema as judged by investigator
* Diabetes mellitus requiring drug therapy
* Major surgery within the previous 3 months
* Severe co-morbid conditions such as active cancer likely to compromise study participation
* unwillingness or other inability to cooperate
* Conditions that alter sodium homeostasis substantially including heart failure, clinically evident liver disease, clinically evident renal dysfunction (creatinine clearance \< 50 nl/min or \> 2+ proteinuria, or being treated for lupus nephritis
Development and Piloting an Avatar-based Intervention to Support Patients Undergoing Stem Cell Transplantation

The goal of this research study is to provide an avatar-based technology during a subject's stay for participants who have been admitted to the hospital for reduced-intensity conditioning (RIC) allogeneic transplant. The intervention received will be the care.coach technology.

This research study is a Pilot Study, which means the investigators are studying the application in a smaller group of people to understand whether the technology, care.coach, is easy to use.

This is a single site study at Dana-Farber Brigham and Women's Cancer Center.

* Aim 1 of the study will be an 8 - 10 participant focus group of nurses, navigator nurses, physicians, and NPs/PAs to refine the avatar protocols.
* Aim 2 of the study will be a pilot of 18 participants undergoing RIC allogeneic HCT in the hospital.

  * The research study procedures include screening for eligibility, a brief call with a research assistant during use of care.coach avatar, and a survey after study completion.
  * The avatar is designed to communicate with participants regarding transplantation education and provide reminders for eating, drinking, and activity.
  * care.coach is a digital, avatar-based technology that communicates using natural speech software.
  * care.coach is supporting this research by providing Dana-Farber access to its technology. The National Cancer Institute (NCI) also supports this research.

Eligibility Criteria:
Inclusion Criteria for HCT focus group:

* Age 18+.
* DFCI/HCC HCT nurse navigators, inpatient HCT nurses, and HCT physicians and extenders (NP/PA).

Inclusion Criteria for care.coach pilot:

* Age 18+.
* Admitted for reduced-intensity conditioning (RIC) allogeneic HCT

Exclusion Criteria for care.coach pilot:

Deemed by clinical staff or RA to be unable to converse with an avatar, due to:

* Severe, uncorrectable hearing impairment and simultaneous severe, uncorrectable vision impairment.
* Severe speech impairment that precludes understanding by staff (and by extension, by the avatar).
* Not fluent in English.
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress

The purpose of this clinical research study is to learn the biodistribution of injection of BMS747158 at stress and assess the safety of two doses of BMS747158


Eligibility Criteria:
Inclusion Criteria:

* age 18-40
* BMI 18-30 kg/m2
* No active or chronic illnesses
* If female: not pregnant, use of birth control or not of child-bearing potential

Exclusion Criteria:

* Significant active or chronic illness
* Any neurological disorder
* GI disease within 3 months
* Recent infection
* Major surgery within 4 weeks
* Donation of blood within 4 weeks
* Blood transfusion within 4 weeks
* Recent history drug/alcohol abuse
* Head trauma
* Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
* Prescription or OTC drugs within 2 weeks
* Exposure to any other investigational
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).


Eligibility Criteria:
Key inclusion criteria

* Recipients of first kidney transplant

Key exclusion criteria

* Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels \>20%, and those considered by investigators to be at relatively higher risk for acute rejection
* Human leukocyte antigen-identical donor-recipient pairs
* Cold ischemia time \>36 hours (donor kidney)
* Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus
* A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis
* Any active infection that would normally exclude transplantation
* Recipients of multiple organ transplants
* Donor age \>60 or \<6 years or donors whose hearts were not beating
* Recipients with underlying renal disease of (due to risk of rapid disease recurrence in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura
* A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum
* A history of true allergy to intravenous iodinated roentgenographic contrast agents
* Participants with life expectancy severely limited by disease state or other underlying medical condition
* A history of cancer (other than nonmelanoma skin cell cancers cured by local resection) within the last 5 years
* Mammogram film with any clinically significant abnormality requiring further investigation or biopsies
* History of substance abuse (drug or alcohol) or psychotic disorders that were not compatible with adequate study follow-up
* A currently functioning, nonrenal transplant
* Previous treatment with basiliximab for any reason
* Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
* Those who had used any investigational drug within 30 days before the Day 1 visit.
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy

Based on previous data published on the SERM properties of Femarelle, the investigators hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA) symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA symptoms in symptomatic post-menopausal women.

Post-menopausal women aged 54-77, with vaginal atrophy (\< 5% superficial cells on cervical cytology) with at least one moderate-to-severe VVA symptom (dryness, irritation, soreness, dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label pilot study. The study protocol was approved by Schulman Associates IRB.Femarelle will be given twice daily and subjective symptoms as well as objective measures like inspection and vaginal pH will be measured.

Eligibility Criteria:
Inclusion Criteria:

Healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus \& one of these symptoms must be moderate to severe as determined by patient, Moderate: discomforting and aware of it with activities. Severe: discomforting enough to interfere with activities Activities include sitting, walking, running, urinating, as well as sexual activity

* BMI 18-34 (inclusive).
* Patients having a LMP at least one year ago, either natural or surgical.
* Patients with a normal mammogram within 9 months prior to enrollment.
* Patients able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Patients who provide written informed consent to participate in the study.
* FSH \> 40 mIU/m.
* Estradiol \< 20 pg/ml.
* Vaginal PH \> 5.
* \< 5% superficial cells as assessed by vaginal cytology.
* Normal pelvic and breast exams by investigator.

Exclusion Criteria:

Patients using HRT (cannot have used for past 3 months).

* Patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms.
* Any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, COPD), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
* Patients with any clinically significant abnormality upon examination at screening visit.
* Patients with a known history of drug or alcohol abuse.
* Known hypersensitivity and/or allergy to soy or flax.
* Participation in another clinical trial within the past 30 days.
The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries

This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.

This study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. The research will compare resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer (lamination technique). The randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. The primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. Assessments will occur at baseline, 6, 12, and 18 months using modified USPHS criteria.

The rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. The bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. The research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. The study is self-funded and will be conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with appropriate ethical approvals and informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Patient age range from 18-55 years
* Presence of anterior cervical caries on the labial surface (ICDAS 4 \& 5)
* High caries risk
* Good general health

Exclusion Criteria:

* Severe or chronic periodontal disease
* Bruxism
* Non-vital teeth
* Fractured or cracked teeth
* Defective restorations
* Pregnancy and/or lactation
* Allergy to the main components of the products to be used in the study
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy

The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are:

1. How does melatonin affect central macula thickness in CSCR?
2. How does melatonin affect visual acuity in CSCR? Researchers will compare placebo (a look-like substance that contains no drug) to see if melatonin works to treat CSCR.

Participants will:

1. Take melatonin or placebo twice a day for one month
2. Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests
3. Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks
2. Patients with minimum age of 18 years old
3. Consent to participate in the study

Exclusion Criteria:

1. A history of vitrectomy
2. A history of laser surgery in the eye being studied in the past 3 months
3. A history of anti-VEGF injection in the eye being studied in the past 3 months
4. History of patient suspicious for choroidal neovascularization (CNV)
5. Pregnant or nursing patients
6. Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition
7. Patients participating in any other investigational drug study
8. Inability to obtain OCT photographs
Study of a Pandemic Influenza Vaccine in Children

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged greater or equal to 6 months to less than 9 years
* Normal gestation period

Exclusion Criteria:

* History of clinically significant medical conditions
* History of Guillain Barre syndrome or active neurological disease
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.

The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Vitamin D deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system. Infants born at 24+0/7 weeks to 32+6/7 weeks of gestation will be considered for inclusion. Cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin D level measurements. Parathyroid hormone and interleukin-6 levels will be measured. Infants will be randomized to the monitored group (i.e., initial dose of 1000 IU/day and possible modification) or the controlled group (i.e., 250 IU/day or 500 IU/day dose, depending on weight). Supplementation will be monitored up to postconceptional age 35 weeks. The primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin D levels at 28±2 days of age. 25-Hydroxyvitamin D levels will be measured at postconceptional age 35±2 weeks. Secondary objectives include the incidence of sepsis, osteopenia, hyperparathyroidism, and elevated interleukin-6 concentration. The aim of this study will be to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic
* preterm infants with a gestational age of 24+0/7 to 32+6/7 outborn and admitted to our intensive care unit within 48h after delivery
* written informed consent form caregivers for the mother and the child to participate in the study

Exclusion Criteria:

* infants born at \>32 weeks of gestation
* infants with major congenital abnormalities or other severe congenital malformations
* infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival
* infants with diagnosed cholestasis
* the absence of written informed consent and challenges in communication with caregivers
The NaBu Effect on Menstruation in Women

The purpose of this study is to evaluate the effect of once-daily Sodium butyrate (NaBu) on menstrual symptoms in women. The investigators posit that the use of NaBu will reduce menstrual symptoms after taking NaBu for 12 weeks.

The general symptoms of menstruation include abdominal and/or pelvic cramping, lower back pain, bloating, mood swings, and irritability. The exact etiology of these symptoms is not well described. Many pathologies that lead to dysmenorrhea are associated with estrogen-dependent cells, such as endometrial cells, linking estrogen production at the cellular level with symptoms of menstruation.

Sodium butyrate (NaBu) is a food supplement readily available in the US in stores and online. It has been shown to inhibit aromatase, a key enzyme in the estrogen biosynthesis pathway, through a mechanism specific to endometrial cells. The transcription process of estrogen is regulated by up to 10 different promotors, depending on the tissue (Attar, 2006; Simpson, 2002). Aromatase transcription in ovarian endometrioma-derived cells \& extra-ovarian endometrioma-derived cells is mediated by Promotor II (Attar 2006). NaBu works by inhibiting the phosphorylation and binding of Activating Transcription Factor 2 (ATF2) to promotor II (Deb, 2006). Thus, NaBu has the potential to reduce estrogen synthesis via the inhibition of the aromatase pathway in cells that use promotor II and in no other tissues.

In this study, the investigators will evaluate the effect of daily NaBu on the baseline symptoms of menstruation in women.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Menstruating regularly or irregularly
* Experiencing menstrual symptoms with an average baseline symptom score of at least 3 on a scale of 0 to 10 for at least one symptom during the initial pre-study rating period.

Exclusion Criteria:

* Pregnant or breastfeeding patient, attempting or anticipating pregnancy.
* Patient with a history of bloating or a sensitive gut (food intolerance) who needs lower fiber levels.
* Patients with known lactose intolerance, other fermentable oligo-, di-, and mono-saccharides, and polyols (FODMAP) intolerances, or small intestinal bacterial overgrowth (SIBO).
* Patients who would require taking daily antacids for the duration of the study.
* Patients with known or suspected chronic hypertension.
* Post-menopausal patients