cyrilzakka/clinical-trials huggingface dataset:
Thyroid Dysfunction and Obstetric Complications

Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications.

Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.


Eligibility Criteria:
Inclusion Criteria:

women attending the emergency room and/or hospitalised or followed for:

* Spontaneous and/or repeated miscarriage
* Foetal death
* Pre-eclampsia
* Retroplacental haematoma
* Post-partum haemorrhage
* Premature delivery
* who consent to participate in the study.
* Assessment of these women will include blood samples for a laboratory work-up and anti-thyroid antibodies.

Exclusion Criteria:

* normal pregnancy
Study of Human Brain-Gut Axis and Gut Microbiome in Patients with Brain Lesions - Repository for Neuroscience Research

This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.

PRIMARY OBJECTIVES:

I. To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.

II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer.

III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy.

OUTLINE: This is an observational study.

Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.

Exclusion Criteria:

* Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.
Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery

The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for planned lung surgery
* Patients are capable
* Able to talk and understand Danish

Exclusion Criteria:

* Patients with colostomy and / or ileostomy
* Neurological or abdominal diseases
* Feed through a tube
Evaluation of STARgraft-2 for Hemodialysis Access

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.

This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included control implants of commercially available standard ePTFE grafts approved for the same use.

The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:

1. Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
2. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.

It is intended to enroll 25 subjects in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, \> 18 years or age.
2. Patient has given informed consent to participate in the trial.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Able to effectively communicate with study personnel.
5. Candidate for a new arterio-venous graft placed in the upper arm.
6. Life expectancy judged to be at least 2 years.
7. Axillary vein of greater than or equal to 7 mm in diameter.
8. Brachial artery of greater than or equal to 4 mm in diameter.
9. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%)
10. Systolic blood pressure equal to or greater than 120 mmHg.
11. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up.
2. Pregnancy.
3. Clinically morbid obesity.
4. Anatomical limitations.
5. Immunodeficiency syndrome.
6. History of bacterial infection within 8 weeks prior to graft implantation.
7. History of hypercoagulation or bleeding disorders.
8. Elevated platelet count \> 1 million per microliter of blood.
9. History of heparin-induced thrombocytopenia syndrome (HIT).
10. Medically confirmed stenosis of the veins downstream of the implant site.
11. Inadequate arterial flow or pressure proximal to the implant site.
12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
13. Fever greater than 38° C.
14. Prior allergic reaction to silicone.
15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms
Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury

The purpose of this study is to determine if use of new imaging technology termed "3D fluoroscopy" will lead the surgeon to change the position of the fractured bones to a more accurate position.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.

Exclusion Criteria:

* Patients skeletally immature;
* Patients less than age 18 years and more than age 75;
* Patients with previous ankle trauma to either ankle;
* Patients with bilateral ankle injuries;
* Patients with previous osseous injuries to the tibia or fibula; and
* Patients with isolated syndesmotic injury and no fracture (i.e. high ankle sprains)
Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment

This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination.

Our objective is to compare the process and outcomes of C\&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C\&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C\&P examination process, 2) develop research tools, instruments and methods for C\&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C\&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.

Eligibility Criteria:
Inclusion Criteria:

1. Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
2. Informed consent

Exclusion Criteria:

1. Mentally impaired, not able to give informed consent
2. English speaking
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.

This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).

Eligibility Criteria:
Inclusion Criteria:

* Adult individual 18 years of age or older.
* Cognitively intact and capable of giving informed consent.
* Clinical diagnosis of Systemic Lupus Erythematosus.
* Subject has mesenchymal stem cells banked at Hope Biosciences.
* The patient accepts to receive treatment and to comply with follow-up visits.

Exclusion Criteria:

* Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine diseases that in the opinion of the investigator may increase the risks associated with study participation.
* Active Alcohol or Drug addiction.
* Participation in concurrent interventional research studies during this study.
* Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
* Unwillingness to return for follow-up visits.
Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age

Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers.

In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse

Exclusion Criteria:

* Maternal Diseases Fetal anomalies Placenta previa, placental anomalies and poor visualization of the placenta Multiple pregnancies Unreliable gestational age
Manual Lymph Drainage

Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. This technique promotes reuptake of interstitial fluid along the pathways of the lymphatic system. This technique promotes healing, decrease swelling, and decrease pain.

Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. Edema can limit function, range of motion (ROM) and increase pain after surgery. Studies have shown that decreasing edema can increase knee strength and functional performance on various standardized measures. MLD has been shown to be effective in patients with hind foot operations and increases ROM post total knee replacement (TKR) surgery. The aim of this study is to determine whether MLD on a sample of patients with TKR will decrease edema, increase ROM and decrease pain as compared to TKR patients who do not receive MLD.

Eligibility Criteria:
Inclusion Criteria:

* s/p total knee replacement
* Primary diagnosis of osteoarthritis or degenerative joint disease
* Able to read and understand English to consent
* Acceptance of the study protocol procedure

Exclusion Criteria:

* Active infection
* Tumor
* Metastatic or systemic malignancy
* Acute thrombus
* History of pulmonary embolism
* Major cardiac pathology such has angina
* Heart attack or uncompensated congestive heart failure (CHF)
* Body mass index (BMI) \> 40
* Pregnant or lactating women
* Renal dysfunction
* Joint revision
* Hospitalization length of stay less than or greater than 3 days
* Previous knee replacement
* Bilateral knee replacement
Treatment Effect of Cross-frequency Transcranial Alternating Current Stimulation on the MUD

The purpose of this research is to evaluate the efficacy of multiple sessions of theta-gamma cross-frequency transcranial alternating current stimulation in patients with methamphetamine (MA) use disorders.

Previous evidence suggests that different aspects of cognitive function are associated with activities of distinct EEG frequency bands. Gamma oscillatory has been found in clinical studies to reflect the processing of rewards in patients with drug dependence, whereas medial prefrontal theta oscillatory characterizes prefrontal response inhibition capacity to downstream reward arousal. Interestingly, impaired response inhibition or impaired evaluation of rewards in patients with drug dependence have been found to correlate with the arousal of psychological craving and the emergence of relapse. Here we aim to find causal evidence supporting these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands (theta-gamma) previously shown to be addiction-relevant. In a randomized control clinical trial design, we stimulate subjects with either theta-gamma or sham tACS. Electroencephalography will be collected before and after each treatment session. Besides, the scale and behavior task data will also collected before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
2. Normal vision and hearing
3. Dextromanual
4. Use MA not less than 1 year, and the last of MA use no less than 3 months

Exclusion Criteria:

1. Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
2. Have cognitive-promoting drugs in the last 6 months
3. Other substance abuse or dependence in recent five years (except nicotine)
4. Meet the DSM-5 criteria for other mental disorders
5. Physical disease
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

• Specific objectives:

* To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children.
* To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery.
* To investigate the effects of different anesthetic agents on microvascular reactivity during CPB.
* To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity.
* To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels.
* To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines.
* To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

Eligibility Criteria:
Inclusion Criteria:

* infants and children with congenital heart defects scheduled to corrective cardiac surgery

Exclusion Criteria:

* age inferior to 3 months and superior to 6 years
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 80 to 120 days inclusive on the day of inclusion.
* Born at full term of pregnancy (\> 37 weeks)
* Informed consent form signed by the parent(s) or other legal representative according to local regulations
* Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).

Exclusion Criteria:

* Rectal temperature ≥ 38.0°C
* Moderate or severe acute illness with or without fever
* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
* Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
* History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
* Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
* Vaccination planned in the 6 weeks following any trial vaccination
* Known HIV seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures or progressive, evolving or unstable neurological condition
* Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
The Effect of Palatal Brushing on Denture Stomatitis

Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.

However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.

After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).

Tested Hypotheses:

* There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
* There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.


Eligibility Criteria:
Inclusion Criteria:

* Good general health.
* Completely edentulous maxilla.
* Currently wearing complete upper dentures.
* A clinical diagnosis of denture stomatitis.

Exclusion Criteria:

* Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
* Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
* Previous palatal brushing habit.
* Changing of the existing prosthesis during the trial.
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or chronic glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Hypersensitivity to study medications
Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis according to the criteria from Porto - based on the clinical condition as well as imaging and endoscopic examinations with histopathological assessment;
* failure to achieve the remission despite the use of standard treatment in accordance with international guidelines;
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* intolerance of enclosed spaces;
* contraindications for hyperbaric therapy: otolaryngological (otitis media, sinusitis); cardiac (clinically significant defects or arrhythmias); pneumological (clinically significant defects)
* exacerbation of inflammatory bowel disease during the therapy;
* contraindications for hyperbaric therapy in a patient's caregiver in a situation, where the patient requires his/hers presence inside the hyperbaric chamber during the session.