cyrilzakka/clinical-trials huggingface dataset:
Effects of TUDCA on Endothelial Function in Type 2 DM

The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.

This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial function.All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period. The study will consist of four visits (screening visit and three study visits), and last up to 2 weeks for individual subjects, depending on the time between visits. It is estimated that the study will last two years from IRB approval through data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus defined as fasting glucose greater than or equal to 120 mg/dL, HgA1C ≥6.5% or ongoing treatment with hypoglycemic medication.
* Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion Criteria:

* Women lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
* Treatment with an investigational product within the last 30 days.
* Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
* Inability to provide informed consent.
* Clinical instability that would preclude withholding medications as determined by the study physician.
Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous patients who have an indication for office hysteroscopy

Exclusion Criteria:

* Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone
The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment

Study Goals:

1. Finding the prevalence of bacteria of the sperm in an innovative and more accurate methode
2. Understanding the effect of microbes on the process of capacitation
3. The impact of microbes in the sperm on IVF success rate
4. Finding the incidence of vaginal bacteria and their relationship to bacteria of the sperm
5. The impact of vaginal flora on IVF success rate

Prospective non interventional study in the Department of Life Sciences, Bar-Ilan University and IVF Unit at Meir Hospital.

The control group consisting of 50 semen samples from men with no sperm problems and 50 vaginal samples from their partners.

The study group consisting of 50 semen samples from men with male fertility problems and 50 vaginal samples from their partners.

The semen taken from the remains after fertilization of the IVF laboratory. (Liquid otherwise routinely thrown).

Vaginal samples taken from women undergoing IVF treatment under anesthesia after informed consent.

Enrollment also collect the following data: age, race, chronic illnesses, past surgeries and former fertility treatments. Data will be collected through anamnesis of the patient or the medical file after consent.

Eligibility Criteria:
Inclusion Criteria:

* Male and female undergoing fertility treatments

Exclusion Criteria:

* Male and female not undergoing fertility treatments
Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S

The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection.

The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult, 18-45
* Available for duration of study (9 months)
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21
* Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine
* Administration of chronic immunosuppressants
* Chronic use of antibiotics
* History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination
* Known exposure to malaria within the past 12 months or planned travel to malarious area during the study period
* Confirmed or suspected immunosuppressive or immunodeficient condition
* Family history of congenital or hereditary immunodeficiency
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
* Chronic or active neurologic disease including seizures
* History of splenectomy
* Seropositive for hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV), or other abnormal labs such as significant anemia, elevated creatinine
* Hepatomegaly, or right upper quadrant abdominal pain
* Pregnant or lactating female
* Chronic or active drug or alcohol use
* History of severe reactions to mosquito bites
* Any history of anaphylaxis to vaccinations
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 65 years (inclusive) at Screening.
2. Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)

Exclusion Criteria:

1. Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
2. History of a condition associated with significant immunosuppression, or chronic administration (\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).
A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green

The goal of this clinical trial is to exploring the use of Mannitol 20% as a solvent to prepare ICG solution, combining with Voluven, forming a hybrid small-large molecular weight solvent for protecting ICG in monomer form and stimulating lymphatic uptake simultaneously in early breast cancer patients who is indicated to undergo sentinel lymph node biopsy. The main question it aims to answer is:

* Will adding Mannitol with Voluven as ICG solvent improve the fluorescence signal of the lymph nodes, comparing with using pure Voluven?
* Which proportion of Mannitol-Voluven delivers the best image quality when used as solvent of ICG?

Researchers will compare the following arms with different solvent (all arms' final ICG concentration are 0.25mg/mL):

* Pure Voluven
* Mannitol:Voluven = 1:10
* Mannitol:Voluven = 1:8
* Mannitol:Voluven = 1:6
* Mannitol:Voluven = 1:4 to see if increased Mannitol:Voluven ratio as ICG solvent translates to better fluorescence image quality.

Participants will be invited in a group of 3, and be blindly assigned to each concentration group sequentially. Participants will undergo ICG fluorescence guided sentinel lymph node biopsy with the assigned solution formula. The endpoints included number of lymph nodes obtained, fluorescence signal-to-background ratio of the lymph nodes, lymphatic uptake rate, lymphatic drainage speed, detection method, lymph node pathology, and any intra- or post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult females aged 20 to 70 years old.
* Pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy.

Exclusion Criteria:

* History of allergy to iodine, ICG, blue dye, Voluven, or Mannitol.
* History of hyperthyroidism, thyroid cancer, etc.
* Current pregnancy, lactation, or breast infection.
* Individuals with impaired mental capacity or belonging to vulnerable populations.
* Patients who have undergone neoadjuvant chemotherapy prior to surgery.
Transcutaneous Pulsed Radiofrequency in Migraine

The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine.

Migraine is the second most common primary headache. Greater occipital nerve (GON) block is an effective method in the treatment of migraine. Transcutaneous pulsed radiofrequency (RF) therapy is used in the treatment of pain. However, its use in headaches is not widespread yet.

Investigator aimed to compare the efficacy of transcutaneous pulsed radiofrequency therapy applied through the GON trace and GON block therapy. A 60-patient study was designed. GON block was planned for 30 patients and transcutaneous pulsed RF was planned for 30 patients. The block will be applied once at the level of C2 vertebra with ultrasound.Transcutaneous pulsed RF will be applied twice, once a week, for 8 minutes.All patients will have pre-treatment migraine disability assessment score (MIDAS) scores filled. A headache diary will be provided to all patients. Frequency and severity of pain will be followed for 1 month. Pain intensity will be evaluated on the visual analog scale (VAS).

Investigator aimed to evaluate the efficacy of transcutaneous pulsed RF therapy, which is a noninvasive method, in migraine.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Migraine

Exclusion Criteria:

* Other headaches will not accompany (tension-type headache, cluster...)
* Pregnancy
Human Blood Cell Disorders Tissue Bank

The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of tissue containing populations of human blood cells from patients with various types of lymphoid, myeloid, and erythroid proliferative diseases as well as other associated conditions. The tissue bank will continue to be an invaluable asset for understanding of the biology of multiple blood cell disorders involving several cell types as well as the physiology of normal cellular counterparts affected in these disorders. Internal and external investigators will be able to utilize this tissue to test hypotheses relating to the immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as normal cells from normal unaffected family members or normal aged matched subjects to provide better comparisons.


Eligibility Criteria:
Inclusion Criteria:

* Participants or participant's Legally Authorized Representatives (LAR) must be able to understand and render voluntary, written informed consent.
* Patients must be able to contribute the required amount of blood and/or tissue without compromising their well-being or care.
* Participants must be willing to be contacted again for consideration of additional studies in the future, such as a blood draw or another action (e.g., bone marrow aspiration and/or biopsy) that would be done as part of their standard of care.

Exclusion Criteria:

* Patients who are known to be anemic, with hemoglobin \<8.0g/dl.
* Patients who are known to be infected with HIV.
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood

Although some causal factors in allergy development such as allergen exposure and environmental pollution have decreased during recent years, the incidence of the allergic diseases has increased in the Western world. Since the genetic predisposition to develop allergies cannot change in such a short time it is conceivable that, instead of the emerging of some new and unknown risk factors, some protective factors seem to have disappeared in the Western world.

Allergic disease is a tendency to develop allergies to allergens in the surrounding environment. The most common symptoms are eczema and food allergy in the early life, bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during school age and adolescence, the so-called allergic march. Some person may develop only one, but others some or all of the symptoms. Inheritance, environment and allergen exposure are important factors affecting this march but there are important factors that predict later development of diseases. Sensitization to egg (positive skin prick test or specific IgE to egg in the serum) combined with skin problems in infancy predispose strongly to the development of allergic asthma in later life.

The purpose of this work is to supply children with early development of IgE associated eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the effect of the supplementation on the future development of skin symptoms, food allergy, sensitisation against inhalant allergens and asthma in these children. We will also assess immunological markers of Th2-skewed immunity in relation to clinical effect of the supplementation.

Families with children younger than 12 months referred to the paediatric department at Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical examination by a paediatrician and assessment of disease severity with SCORAD will be performed by a research nurse at inclusion. The children will be assessed every six months by a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical assessment will be performed yearly until age 7.


Eligibility Criteria:
Inclusion Criteria:

* Eczema and sensitisation to food allergens

Exclusion Criteria:

* Fish allergy within family
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres \< 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were to have completed primary vaccination course. A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Pregnant or lactating female.
Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation

Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Dapagliflozin, an SGLT2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. Some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. Therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.


Eligibility Criteria:
Inclusion Criteria:

- Age: Patients aged 18 years and older. Presence of type 2 diabetes or heart failure. Diagnosis of Atrial Fibrillation: Confirmed atrial fibrillation through ECG or Holter monitoring.

First-time Catheter Ablation: Patients undergoing their first atrial fibrillation catheter ablation.

Voluntary Participation: Patients willing to participate and sign informed consent.

Exclusion Criteria:

- Presence of urinary tract infection Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant.

Allergy to Dapagliflozin or Similar Drugs: History of allergic reactions to dapagliflozin or other SGLT2 inhibitors.

Other Contraindications to Dapagliflozin: Any other contraindications for dapagliflozin use.

Kidney Function: eGFR \< 45 ml/min/1.73m², with severe kidney disease.
Long-term Impact in Intensive Care Survivors of Coronavirus Disease (COVID-19)

The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19.

Recent data suggests that survivors of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or (COVID-19) report adverse health status, including neurological and cognitive deficits and impaired pulmonary function, even months after discharge. Adult COVID-19 survivors after ICU stay, who are noted to have increased mortality and organ failure, are at higher risk of long-term disabilities and impaired quality of life. This study is one branch of a multi-site study coordinated by Gilead Sciences, in which participants who were critically ill with COVID-19 will be followed at three and nine months after discharge to test pulmonary function, cognitive function, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected or laboratory confirmed COVID-19 infection by real-time PCR
* Admission to an intensive care unit for COVID-19 and discharge

Exclusion Criteria:

* Pregnancy
* Participants unable to complete long-term follow-up due to logistical problems
* Participant paralyzed before being admitted to hospital for COVID-19
* History of pulmonary resection
* Previous pulmonary transplant
* Documented advanced neurologic order for which the patient is unable to carry out 6 minute walk test
* Documented psychiatric disease for which the patient is unable to carry out interview
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia

Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.

* Background: Identification of malignant potential of oral epithelial dysplasia (OED) is virtually impossible on histopathological grounds alone. Inactivation of p16 gene by CpG methylation is an early frequent event during oral carcinogenesis. To investigate the predictive value of p16 methylation on malignant potential in OED, we carried out the prospective cohort study.
* Methods: 101 patients with histologically confirmed mild or moderate OED were included in the present study. Baseline information of p16 methylation status of the OED lesions from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions was examined in 78 cases histologically during the 45.8 months double-blind followup survey (78/93). The association between p16 methylation and progression of OED was analyzed with SPSS13.0 software. All P-values were two-sided.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of mild or moderate grade OED; and
* enough amount of tissue sample from OED lesion for genomic DNA extraction; and
* available of methylation status of p16 CpG island in the extracted DNA sample.

Exclusion Criteria:

* histological diagnosis of severe grade OED or malignant disease; or
* amount of tissue sample is not enough for preparation of genomic DNA (20ng); or
* quality of the prepared DNA is not good enough for detection of p16 methylation; or
* OED treatment history by LASER, radiotherapy, or chemotherapy
HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.


Eligibility Criteria:
Inclusion Criteria:

1. Tumor cell phenotype consistent with B-CLL
2. Patients with active B-CLL and with an indication for treatment
3. Failing at least one fludarabine-containing treatment regimen
4. Failing at least one alemtuzumab-containing treatment regimen
5. ECOG Performance Status of 0, 1, or 2
6. Life expectancy of at least 4 months

Exclusion Criteria:

1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
2. Previous autologous stem cell transplantation within 6 months prior to Visit 2
3. Allogeneic stem cell transplantation
4. Radioimmunotherapy
Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.


Eligibility Criteria:
Inclusion Criteria:

* Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
* English Speaking
* Consent given by parent and assent by child

And any one or more of the following:

* Score of 29 or above on the Child Food Neophobia Scale
* Underweight
* Current diagnosis of ARFID
* Dependent on nutritional supplements to achieve sufficient calories for optimal growth
* Avoiding activities due to eating rated at least almost always

Exclusion Criteria:

* Child is known to have a severe intellectual disability based on medical chart review
* Meets diagnostic criteria for anorexia nervosa or bulimia nervosa
* Is currently enrolled in a treatment study or receiving active treatment for ARFID
* Taking medications known to affect appetite