cyrilzakka/clinical-trials huggingface dataset:
Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.

Population: The investigators will recruit 104 children ages 12-24 months from daycare centers in the Houston and surrounding areas.

Study design: The study will be conducted at daycare centers and will consist of three phases - a 'lead in period' (two weeks) where baseline measurements will be taken followed by an 'Introductory period' (three weeks) where the new food will be introduced on three days during snack time for three weeks. The introductory phase will be followed by the 'intervention period' (three weeks) where children will receive daily servings of hummus and vegetables.

Lead in period (two weeks): Two 24-hour dietary recalls will be conducted on each child (parent-report); one 24-hour dietary recall (over a weekend) will be conducted on each parent (self-report). Three dirty diapers will be collected within the time span of a week for microbiome analysis.

Introductory period (three weeks): Since children typically take several introductions of a new food to accept it, and the investigators wish to ensure a high acceptance of hummus, the investigators will spend three weeks introducing the food. The food will be provided on three days during snack time for three weeks. Prior to introducing the food, children will receive a 'lesson' involving information about vegetables using a combination of songs, rhymes and craft activities. Following the lesson, hummus and vegetables will be provided in the hummus group; vegetables only in the control group. Hummus will be provided in a pre-packaged 2 ounce serving cup; vegetables will conform to age-appropriate servings designated by the American Academy of Pediatrics (AAP) and will consist of soft vegetables (e.g., winter squash) and lightly steamed, but chilled, hard vegetables (e.g., carrots, broccoli).

Intervention period (three weeks): Similar to the introductory period, a serving of either hummus and vegetables or vegetables only will be provided to the children during snack time. The food will be provided daily for three weeks. In the final week of the intervention period, two 24-hour dietary recalls (one weekday and one weekend) will be conducted on the child (parent-report). In addition, one weekend 24-hour dietary recall will be conducted on the parent (self-report). Three dirty diapers will be collected on the child during the final week for microbiome analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 12 and 24 month old.
* Children attending daycare at least 3 days a week.
* Children with a parental-report of being hummus-naive.

Exclusion Criteria:

* Any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption.
* Children with parent-reported antibiotic use in the previous 6 months.
Impact of Estradiol Addback

Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.

Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in healthy aging men. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment. Tamoxifen blocks this effect of Te, suggesting involvement of E2 in GH's stimulation in men. E2 per se stimulates GH secretion in women. Because Te is converted to E2 by aromatization in the body, we postulate that E2 is the active moiety in men also. Moreover, we hypothesize that the decline of E2 in older men contributes to the fall in GH output. This has never been tested. From a clinical vantage, understanding the mechanistic basis of Te's drive of the somatotropic axis is especially relevant in boys with pubertal failure, adults with primary hypogonadism and men with aging-related hypoandrogenemia. In relation to aging in the male, testosterone and E2 bioavailabilities fall by 35-50% in the eighth compared with third decade of life. From a medical perspective, aging is accompanied by progressive osteopenia, sarcopenia and intra-abdominal obesity. These adverse outcomes are remediable by short-term replacement with Te and/or recombinant GH, thus linking GH/Te/E2 availability with key body-compositional features.

Eligibility Criteria:
Inclusion:

* 60 healthy men (ages 60 to 80 y);
* BMI 18-30 kg/m2
* Community dwelling; and voluntarily consenting

Exclusion:

* Recent use of psychotropic or neuroactive drugs (within five biological half-live);
* Obesity (outside weight range above);
* Laboratory test results not deemed physician acceptable, cholesterol \>250, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin \<12.0 gm/dL
* Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
* Acute or chronic organ-system disease;
* Endocrinopathy, other than primary thyroidal failure receiving replacement; untreated osteoporosis
* Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
* Acute weight change (loss or gain of \> 2 kg in 6 weeks);
* Allergy to peanut oil (used in some injectable Te preparations)
* Unwillingness to provide written informed consent.
* PSA \> 4.0 ng/mL
* History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy.
* History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence.
* History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
* History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
* Gynecomastia \> 2 cm, untreated
* Untreated gallbladder disease
* History of smoking greater than one ppd.
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 .
2. Male and female subjects.
3. English and non-English speakers.
4. Subjects aged 18 years old to 65 years old will be considered

Exclusion Criteria

1. Patients under 18 years old will be excluded.
2. Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation,
3. Active skin infection at the proposed injection site.
4. Concomitant neuromuscular disorder.
5. Pregnant or lactating.
6. Missing incisors.
7. treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..
Initial Fixation of Bisphosphonate-coated Dental Implants

16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.

The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).

Eligibility Criteria:
Inclusion Criteria:

Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy

Exclusion Criteria:

Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.
Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles

Context: Alarm fatigue is a threat to hospital patient safety. National surveys reveal that high alarm rates interrupt patient care, reduce trust in alarms, and lead clinicians to disable alarms entirely. Safety huddles offer an appropriate forum for reviewing alarm data and identifying patients whose high alarm rates may necessitate safe tailoring of alarm limits.

Objectives: To evaluate the impact of a focused physiologic monitor alarm reduction intervention integrated into safety huddles that involves discussing safe monitor parameter adjustments on the physiologic monitor alarm rates of individual patients with high alarm rates who meet "low acuity" criteria.

Study Design: A prospective, quasi-experimental pilot study of the impact of the huddle intervention on the alarm rates of low acuity high alarm rate individual patients discussed in huddles in the PICU. The huddle intervention will consist of a script to facilitate the discussion of the alarm data.

Setting/Participants: Participants will include all low acuity patients and their providers in the PICU at The Children's Hospital of Philadelphia.

Study Interventions and Measures: The primary outcome is the rate of crisis and warning alarms per patient day for intervention cases as compared with others in the high alarm / low acuity cohort. Safety measures will include unexpected changes in patient acuity or code blue events within one week of monitor change or discharge.


Eligibility Criteria:
Eligible primary participants will be the physicians and nurse practitioners caring for the PICU patients who are discussed as part of the huddle interventions. Eligible secondary participants will include all low acuity patients in the PICU at The Children's Hospital of Philadelphia.

Inclusion Criteria Primary Subjects: Any physician or nurse practioner caring for an intervention patient or control patient in the PICU at CHOP

Secondary Subjects:

* Low acuity patients as determined by Optilink Guidelines
* High alarm patients (top 10-20%)
* Admission to the PICU

Exclusion Criteria Primary Subjects: None

Secondary Subjects: Patients who are medically ready for transfer out of ICU or discharge home (status continuously tracked by charge nurse). Patients who are medically ready for transfer out have an accepting service in place and a bed ready on the floor.
CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

Eligibility Criteria:
Inclusion criteria：

1. The treat history meeting the following criteria:

   Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG score≤2;
4. To be aged 1 to 18 years;
5. More than a month lifetime from the consent signing date

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
SEARCH SAPPHIRE Phase B

This study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on HIV incidence, as well as other health outcomes, in a community randomized trial design.

In the "evaluation" Phase B, the SEARCH SAPPHIRE study will evaluate the effects of Dynamic Prevention and Dynamic Treatment intervention packages based on data from Phase A (NCT04810650) and new advances from outside the study delivered in a precision community health model, on HIV incidence and other health outcomes, in a pair-matched community randomized design.

The Phase B precision community health intervention will consist of a three part intervention: 1) Community-enhanced reach activities 2) Person-centered care delivery; and, 3) Data-enhancement to improve precision of interventions.

The study hypothesis for the Phase B population level study is: A Precision Community Health Model leveraging existing facility-based outreach and community health workers, enabled by dynamic choice prevention/treatment multi-disease approaches and interactive data systems -will reduce HIV infections, deaths and improve health.

Structured stakeholder consultations are formally incorporated in the study design and leverage regular and ongoing collaborations the study team has with the HIV, non-communicable disease and general health leads in Kenya and Uganda Ministries of Health and PEPFAR implementing partners at the national and the regional level.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 15 years
2. Living in SEARCH study communities
3. Provided informed consent

Exclusion Criteria:

1. \<15 years of age
2. Living outside SEARCH study communities
3. Unable to provide consent or parental co-consent as per country guidelines
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.

In this study, the investigators aim to compare the effect of Nifedipine and MgSO4 therapies on Doppler parameters of the uterine, umbilical, middle cerebral arteries, and ductus venous in the first 48 hours of therapy in pregnancies with preterm labor threat and also compare perinatal outcomes after delivery between the groups.

Eligibility Criteria:
Inclusion Criteria:

* pregnancies with preterm labor threat between 28-34 weeks gestational ages

Exclusion Criteria:

* Cervical dilatation at \> 4 cm and/or cervical effacement \>80%,
* Multiple pregnancies,
* Pregnancy complications including preeclampsia, ablatio placenta, intrauterine growth restriction, placenta previa, gestational diabetes
Menstrual Cycle Characteristics of Healthcare Professionals

The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. The aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.

The Covid-19 pandemic has impacted healthcare workers physically and psychologically. Healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. Increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. All of these factors may negatively affect their menstrual cycle.

The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. Second aim is to investigate whether there is an association between Covid 19 infection and menstrual cycle changes.

This cross-sectional study is conducted with healthy female participants who are working at Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic inpatient and outpatient clinics. The participants who are sure about their pertinent information are enrolled in the study. The exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation.

After informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. The questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated.

Eligibility Criteria:
Inclusion Criteria:

* Working at Covid 19 Pandemic Hospital
* Being at between 18 and 47 years old
* Having menstruation

Exclusion Criteria:

* Oral contraceptive users
* Pregnants
* Having malignancy
* Having primary amenorrhea
* Being at menopause
* Lactation
Clinical Investigation of the Medtronic Concerto™ Device

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).

Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.

The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who require the implantation of an Implantable Cardioverter Defibrillator
* Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
* Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)

Exclusion Criteria:

* Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
* Subjects who are post-heart transplant
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia

This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 20 years old and above (upper limit of age: 80 years old)
2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
3. a+b

   1. IPSS ≥ 12 and QoL ≥ 3
   2. Maximum Flow Rate \<15 mL/s (Voiding volume) ≥ 120mL)
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
2. In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
3. In female, the history of anti-incontinence operation.
4. Patients with cancer of any type including cancer of the prostate or bladder
5. Patients with urethral stricture or bladder neck contracture