cyrilzakka/clinical-trials huggingface dataset:
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.


Eligibility Criteria:
Inclusion Criteria:

* Adults: men and women
* Stable diet for at least 24 months (omnivorous or a vegan diet).

Exclusion Criteria:

* Pregnancy and lactation
* Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)
* Renal diseases
* Liver diseases
* Patients with cancer (or cancer history)
* Pre-study treatment with vitamin B12 or folate
Self-Management for Youth and Families Living With SCD - SMYLS

The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)


Eligibility Criteria:
Inclusion Criteria:

* children ages 8 - 17 years and parent or primary caregiver 18 years or older
* child with sickle cell disease, as reported by clinician at MUSC Pediatric Sickle Cell Clinic

Exclusion Criteria:

* Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
* Lack of wi-fi access
Schizophrenia Imaging

Schizophrenia is a common disorder with a lifetime prevalence of about 1%.Genetic studies strongly suggest a genetic component to the inheritance of schizophrenia. Structural neuroimaging studies have provided consistent evidence for brain abnormalities in schizophrenia. The timing of brain abnormalities in schizophrenia has not been determined yet.

The investigators hypothesize that brain structural changes can be detected in neonatal life. The investigators hypothesize that offspring of schizophrenic patients will have higher rates of brain structural changes in the neonatal period. The investigators propose to study early development of fetuses in offspring of patients with schizophrenia. The study is a multi-center prospective trial.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who carry an offspring of a schizophrenia patient: whether the mother, the father or both suffer from schizophrenia.

Exclusion Criteria:

* Alcohol or drug abuse of pregnant woman
* Past history or present occurrence of major neurologic or somatic illness
* Genetic disease
* Other psychiatric disorders other than schizophrenia such as Mental retardation
* Bipolar Disorder and Delusional Disorder
A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol
* Moderately active disease in line with the protocol
* A pre-defined number of swollen joints in line with the protocol
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* No evidence of respiratory disease.

Exclusion Criteria:

* A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA
* A history of, or current, inflammatory joint disease other than RA
* Previous treatment with the investigational drug
* Discontinuation of a biologic DMARD due to lack of efficacy
* Non-compliant concurrent medications
* Non-compliance with medical history criteria.
Non-operative Treatment in First-time Patellar Dislocation

Study to evaluate the conservative treatment of patients after their first episode of primary lateral patellar dislocation. Randomized controlled trial with 2 groups: standard treatment (2-weeks with brace) followed by physical therapy, compared with knee taping and physical therapy. 1-year follow-up. Measurements include physical exam, radiographs and MRI. Outcomes: recurrence, lateral patellar tilt, functional scores, apprehension, pain.

Hypothesis: less recurrence in the knee taping group, as well as better functional scores.

Patients between 10-40 years old with first patellar dislocation are invited to participate in this conservative treatment study.

Patients are excluded if they have bilateral acute patellar dislocation, previous surgeries in the affected knee, osteochondral fracture, open patellar dislocation.

This is a randomized controlled trial with four groups of treatment:

1. Standard treatment (2-weeks with a knee brace) and physical therapy
2. Knee taping and physical therapy (1-week with knee brace)

Sample size: 50 patients / knees Outcomes of interest: recurrence in patellar dislocation, functional scores (Banff, Norwich), return to sport, patellar tilt

Eligibility Criteria:
Inclusion Criteria:

- Patients with first episode of acute lateral patellar dislocation during the last 7 days.

Exclusion Criteria:

\* Patients with acute bilateral patellar dislocation.

* Patients with open patellar dislocation.
* Patients with previous knee surgery in the same knee.
Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo)

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude ("Säntis"; 2500m above sea level) on pulmonary artery pressure and right heart function (echo)

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

Several times within the exposure, the pulmonary artery pressure (PAP) and the right heart function will be assessed by echo.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial Oxygen pressure (PaO2) ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kilopascal (kPa))
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring

This study evaluates the effectiveness of a breast ultrasound method for the diagnosis of breast cancer. Diagnostic procedures, such as breast ultrasound, may help find and diagnose breast cancer, and may help measure a patient's response to earlier treatment. The purpose of this research is to test the effectiveness of a new investigational breast ultrasound method to detect an abnormality in the breast, and assess response to breast cancer treatment.

PRIMARY OBJECTIVES:

I. Determine the diagnostic performance of the proposed method in a population of pre-biopsy patients with suspicious breast masses and correlate the proposed method results with pathology as the gold standard.

II. Assess and predict the response to preoperative chemotherapy and/or endocrine therapy in breast cancer patients using the proposed method and compare the results to magnetic resonance imaging (MRI) as control and surgical pathology for pathological complete response (PcR).

III. Determine the diagnostic performance of the proposed method in identifying metastatic axillary lymph node in patients with suspected or known breast cancer lesions; correlate the results with pathology as the gold standard.

OUTLINE:

AIM 1: Participants undergo a breast ultrasound over 15 minutes.

AIM 2: Participants undergo breast ultrasounds over 15 minutes before starting the chemotherapy and/or endocrine therapy, 2 months after start of chemotherapy and/or endocrine therapy, and after the completion of chemotherapy and/or endocrine therapy before surgery. Participants may also undergo breast ultrasounds at 2 weeks after start of chemotherapy and/or endocrine therapy and 1 month after start of chemotherapy and/or endocrine therapy .

AIM 3: Patients with suspicious breast masses or known breast cancer who are scheduled for axillary lymph node biopsy undergo ultrasound over 15 minutes at the same visit of the breast mass study.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1: Patient volunteers, ages \>= 18 with suspicious breast masses scheduled for breast biopsy, or at least two weeks or more after breast biopsy
* AIM 2: Patient volunteers, ages \>= 18 who have biopsy proven breast cancer and are going under neoadjuvant chemotherapy and/or endocrine therapy had their baseline MRI and/or ultrasound

Exclusion Criteria:

* Patients with breast implants or any condition that does not allow proper use of ultrasound (US)
Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety

Aims and objectives The purpose of this study was to develop an atlas to explore the effect of micro-instrument cleaning on the safety of cataract surgery.

Background Cataract surgery safety is affected by many factors, the most influential of which is the quality of instrument cleaning. Previous studies focused on the reaction in the eye after cataract surgery. None offered a solution for manually cleaning ophthalmic micro-instruments or response data for surgical instruments after cataract surgery.

Design The study was designed to collect quantitative data derived from postoperative ocular evaluation.

Methods We developed an atlas that details micro-instrument cleaning that could be used to train nurses to have this skill. A total of 120 cataract patients were divided evenly into experimental and control groups. In the experimental group, cataract surgery was undertaken using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the patients underwent the same postoperative tests: anterior chamber cell counts and visual and intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.

A single surgeon conducted all of the surgery and follow-up all patients

Eligibility Criteria:
Inclusion Criteria:

* Cataract patients

Exclusion Criteria:

* Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.
Biliary Complications in Live Donor Liver Transplantation

The study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated.

The invastigators will record the age, gender, weight, diagnosis, presence of hcc (hepatocellular carcinoma), whether transcatheter embolization (transarterial radiolabelization) is performed, meld score, age of donor, gender, graft hepatic artery diameter, bile duct diameter and number before surgery.

During the operation,

The duration of ischemia will be evaluated as three stages.

During the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.

The time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.

The time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.

The duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter

After the surgery,

The use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.

During the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.

If the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.

Since the study is observational, normal treatment will not be involved.

Participants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.

Participants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.

When the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.

The demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Live donor liver transplantation Emergency Live donor liver transplantation Multiple or single bile duct anastomosis in liver transplantation

Exclusion Criteria:

Hepaticojejunostomy Cadaveric liver transplantation Pediatric liver transplantation Cmv infection presence Hepatic arterial thrombus Porta thrombus Acute rejection
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal and in general good health
* In a stable relationship with a male partner for at least 6 months
* Willing to attempt sexual activity once a week with your partner
Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.

The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology.

The main questions it aims to answer are :

* how often are newborns infected by viruses in neonatology ?
* how does the microbiome develop during first weeks of life ?
* how does microbiome and viruses interacts together ?
* is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.


Eligibility Criteria:
Inclusion Criteria:

* newborn hospitalised in neonatal intensive care unit during the inclusion period
* parents have been informed about the study (speaking french) and have signed the informed consent.
* affiliated to the social security system.

Exclusion Criteria:

* parental refusal
* minor parents or under judicial protection
* newborn who already have been discharded home before inclusion
* hospitalisation after the first 48 hours of life
* only palliative care
Double Stimulation in Women With Low Prognosis in ART

The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.

The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.

_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 40.
* AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
* OR 3 ≤ AFC ≤7.
* Normal shape of uterus (based on ultrasound).
* Body mass index within 28 - 37 kg/m2

Exclusion Criteria:

* Asherman's syndrome.
* Endometriosis.
* Leiomyomas distorting the endometrium
* Sperm extracted from surgical procedures (i.e. PESA, TESE).
* Patients refuse to continue participating in the study.
* Patients injected with wrong dose of gonadotropins during the treatment.
* Serious complications or accidents arise forcing the patients to discontinue the treatments.
* Ovarian surgery
* Previous chemotherapy or pelvic irradiation
VitaFlow LIBERTY Europe

This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.

Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of age≥ 18 years
2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.

Exclusion Criteria:

1. Pre-existing mechanical heart valve in aortic position
2. A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
3. Ongoing sepsis, including active endocarditis
4. Anatomically not suitable for the VitaFlow Liberty TAV system
5. LVEF\<20%
6. Estimated life expectancy of less than 12 months
7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A

The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes requiring nutritional therapy (tube feeding or parenteral feeding).

All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values to patient and study personnel and POC (point-of-care) plasma glucose will be used for adjusting diabetes treatment) or intervention (isCGM blood glucose values will be used to aid with glucose management during the hospitalization). The study personnel will work with the patient's care team.

Eligibility Criteria:
Inclusion Criteria:

* Expected length of hospital stay of at least 48 hours
* Diagnosed with diabetes
* Literate in Danish
* Nutritional therapy using tube feeding or parenteral nutritional therapy
* Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.

Exclusion Criteria:

* Pregnancy
* Patient unable to provide informed consent
* Patient unable to use mobile phone for reading isCGM sensor
* Known allergy to adhesives
* Anticipated MRI during the hospital admission
* Patients using CGM prior to hospital admission