cyrilzakka/clinical-trials huggingface dataset:
Natalizumab High Titer Immunogenicity and Safety

The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a relapsing form of MS
* Must fall within the therapeutic indications stated in the locally approved label for natalizumab
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Prior treatment with natalizumab
* Considered by investigator to be immunocompromised
* Other protocol-defined exclusion criteria may apply
Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

Acute respiratory failure (AFR) is a serious condition that requires prompt and appropriate intervention to prevent further deterioration and improve outcomes. Bronchoscopy is a commonly used diagnostic and therapeutic procedure in patients with respiratory failure. However, traditional low-flow oxygen supplementation during bronchoscopy may not provide adequate oxygenation and ventilation, leading to complications and worsening of the patient's condition.

High-flow nasal cannula therapy has improved oxygenation and ventilation in critically ill patients, making it a promising alternative to traditional oxygen supplementation during bronchoscopy. The bronchoscope is passed through the nose during all procedures in our center. HFNC oxygen therapy is applied to both nostrils. The bronchoscope occupies one of the nares receiving oxygen therapy during bronchoscopy. As a result, the application of HFNC needs to be optimized. Therefore, the investigators designed a modified HFNC with a single cannula. However, limited data exist on the safety and efficacy of modified HFNC therapy in patients with respiratory failure undergoing bronchoscopy.

Therefore, the aim of this study is to evaluate the impact of modified HFNC therapy on the outcomes of undergoing bronchoscopy in patients with ARF. The findings of this study will contribute to understanding the role of modified HFNC therapy in managing ARF and inform clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Bronchoscopy is required;
3. 150 mmHg ≤ PaO2/FiO2 \< 300 mmHg.

Exclusion Criteria:

1. Not tolerate HFNC oxygen therapy;
2. Obstruction of nasopharynx cavity;
3. Platelet\<60 × 109/L；
4. Need tracheal intubation;
5. The patient has received invasive ventilation.
Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage

This study examines the relationship between angiographic coronary collaterals (Rentrop grades) and post-reperfusion microvascular injury. This study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.


Eligibility Criteria:
1. Age 18-85 years
2. Index STEMI
3. Coronary angiogram with Primary coronary intervention
4. No contraindications for Cardiac MRI
A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
* Patient has no active medical problems other than essential hypertension that might affect blood pressure
* Patient has received no drug therapy that might affect blood pressure

Exclusion Criteria:

* Prior exposure to losartan
* History of stroke
* History of myocardial infarction
* Atrial flutter or atrial fibrillation
* History of congestive Heart failure
* Known Sensitivity to ACE inhibitors
* Known positive test for HIV/AIDS or Hepatitis B
* Patient is being treated for acute ulcer disease
* History of chronic liver disease
* Actively treated diabetes mellitis
* Any known bleeding or platelet disorder
* Absence of one kidney
* Women of childbearing potential or who are breastfeeding
* Patient is abusing or has a history of alcoholism or drug addiction
The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series

n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique. The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia. Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. The data of these questionnaires will be analyzed and published.


Eligibility Criteria:
Inclusion Criteria:

* Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
* e-TREPP performed

Exclusion Criteria:

* No emergency surgery (for instance, surgery day after admission or later).
* No e-TREPP performed
Heat Therapy and Omega 3 on Cardio-Metabolic Health

Currently, controlled studies are lacking which test the benefits of: 1) ω3 PUFA; and 2) heat therapy on improving vascular-metabolic-microbiota health in Hispanic American populations. The investigator's objective is to determine if this modality (heat therapy i.e., warm water immersion, hot tubs) combined with dietary interventions (increased fish and/or fish oil intake) may be feasible treatments to improve cardiovascular risk factors and reduced comorbidities in Hispanic populations.

In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments:

1. 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy
2. Placebo pill daily for 12 weeks with 6 weeks of heat therapy (HT)

non-obese healthy will only serve as controls and enroll in placebo and neutral control therapy conditions.

HT will entail 14 consecutive days of 1.5 hours passive heating (increase internal temperature 1.2°C above baseline), followed by 4 weeks of HT, 3 days per week.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>30-40,
* fasting glucose 100-125,
* blood pressure 130-139/80-89,
* Hispanic American,
* age 18-65 years

Exclusion Criteria:

* non-Hispanic,
* BMI\<30, \>40,
* fasting glucose \<100, \>125,
* blood pressure \<130,\>139 systolic, \>90 diastolic,
* age \<18, \>65 years
The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation

There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.

Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.

This study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.


Eligibility Criteria:
Inclusion Criteria:

* The subject has s female partner who participates in VMT study ( NCT04517487).
* The subject is defined by the woman as her male regular partner.
* Willing to use a condom as instructed by the protocol.
* Willing to comply with decolonization protocol.

Exclusion Criteria:

* A known skin disease involving the penile skin.
* A known sensitivity to chlorhexidine gluconate
* Any of the partners (female/male) has more than one sexual partner.
Protective Nerve Stimulation in Regional Anesthesia

Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or landmark technique or a combination of this techniques. Whether a regional block should be conducted with a combination of those different possibilities is highly discussed. In this study the investigators want to show the effectiveness of new standard way of combined use of ultrasound and nerve stimulation, they call protective nerve stimulation. According to ethical vote we are conducting an observational study.

All patients will get the regional block they need for the elective surgery. Before starting the block a standard monitoring will be established. After applying the monitoring the block will be performed by an experienced anesthetist in supervision of another experienced anesthetist. The nerve stimulator is set on a fixed current of 1.0 mA and a block without motoric response on this current is tried. Ultrasound images are saved. After performing the regional anesthesia the further anesthetic procedure will be carried out and the surgery will take place. After surgery the patients will be transported to the recovery room or Postanesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age of 18 or older
* elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia

Exclusion Criteria:

* existing contraindication for regional nerve blocks or the use of Protective Nerve Stimulation
* patients who undergo outpatient treatment
* allergy against local anesthetics
* age under 18 years
* Lacking willingness to take part in the study
* ASA PS score of 4 or more
* preexisting neural damage in the effect area
* Diabetes mellitus, alcohol use disorder
* Participation in other prospective clinical interventional trials
* Accommodation in an institution due to an official or judicial order
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of \<0.05 will be deemed significant. Using data from 462 subjects that had undergone cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The result was a power of 81.7%.

Charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. From each chart, the subject name, date of birth,and social security number will be recorded along with the state of residence and year of surgery. This information will be transferred to a CD that is encrypted and password protected. The CD will be sent via FedEx overnight to the Center for Disease Control(CDC), National Death Registry. The CDC will use the information on the CD to extract death outcomes for each subject's information provided. Once all information is complete, the CDC will transfer on to a CD that is encrypted and password protected and return to our office via FexEx overnight. The information on the CD will then be used to determine what the long term death rates were for subjects here at SUNY Upstate Medical University and stored in an anonymous database. Once the information is verified as accurate, the CD will be destroyed and no identifying information will be kept. The CDC will also destroy the information after 60 days, with no links to the identifying information.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older
* Subjects must have received either Aprotinin or Amicar during cardiac surgery

Exclusion Criteria:

* Cardiac surgery and did not receive Aprotinin or Amicar
Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.

The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI compared to placebo in mercury intoxicated patients.

Eligibility Criteria:
Inclusion criteria

1. Male or female subjects, age between 18 and 65 years, inclusive.
2. Urine-Hg ≥ 15 μg/L.
3. Mercury intoxication medical score sum (Doering et al. 2014) ≥ 5 or medical score sum ≥ 3 in combination with at least two of the following symptoms; social nervousness/withdrawal, irritability, memory loss, metallic taste, mental- and physical fatigue.
4. Has signed informed consent for participation.
5. Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.

Exclusion criteria

1. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. Known or a medical history of renal disorder, significant renal failure, or high risk of renal failure.
3. Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator.
4. Known or suspected neurodegenerative disorder including but not limited to stroke, polio, Parkinson's and Alzheimer's disease.
5. Known or suspected drug or alcohol abuse.
6. Positive pregnancy test in women.
7. Serious bacterial and chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus.
8. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to NBMI.
9. History of allergy/hypersensitivity to bisulphites (e.g. red/white wine).
10. Participation in any other clinical study that included drug treatment within three months of the first administration of investigational product.
11. Use of other therapies for mercury intoxication including metal chelators within three months.
12. Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.
Investigating Healthcare Disparities in Vitiligo

Vitiligo is an acquired, non contagious skin disorder characterised by depigmented patches of skin that may appear in a localised or very generalised distribution, and affecting 0.5-2.0% of the global population.There are however, limited population-based studies on the burden of vitiligo and disparities across people of different ethnicities and deprivation.

The overall purpose of this study is to provide an estimate of the lifetime risk of vitiligo in the population overall and by sociodemographic subgroups. Moreover, to do a subgroup analysis in the vitiligo population to identify health-related disparities across people in different sex, age, deprivation and ethnicity. A detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.

This study will provide estimate of the cumulative lifetime risk of vitiligo in the population overall, and by important sociodemographic groups, including age, sex, ethnicity and deprivation, which will prevalent key data to show the relative burden of vitiligo across the aforementioned groups. These approaches allow creation of cumulative lifetime risk plots which provide an excellent and accessible way to display the relative disease burden across groups.

The cumulative lifetime risk of vitiligo will be estimated at age 80 years (approximate lifetime expectancy in the UK) using survival models, with age as the timescale and accounting for competing risk of death.

This study will also perform a subgroup analysis in the vitiligo population to identify health-related disparities across people in different deprivation, sex and ethnic groups. The disparities that will be considered are: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment),

The assessment of any associations with baseline characteristics and the outcome of interest will be used using Cox proportional hazards models (time to event outcomes) and generalised linear models.

Eligibility Criteria:
Inclusion Criteria:

* The cohort for the endpoint analysis will consist of all adults and adolescents (aged 13+) contributing to OPCRD during the study period (2004-2020).
* The cohort for the lifetime risk analysis will consist of all people contributing to OPCRD during the study period.
* The vitiligo cohort consists of people newly diagnosed with vitiligo at any point during the study period.

Exclusion Criteria:

* People with the alternative non-vitiligo diagnoses (other hypopigmenting conditions).
* People with vitiligo diagnosis within 6 months of practice registration.
* People without vitiligo with less than 1 year of follow up within the dataset.
* People over the age of 95 (for those reaching age 95 during the follow up period follow up was censored at age 95).
* People who have opted out of record sharing.
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).
2. Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:

   * Moderate hot flush: warm sensation with sweating, does not disrupt activity.
   * Severe hot flush: hot sensation with sweating, disrupts activity.
3. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.

Exclusion Criteria:

1. Hypersensitivity to venlafaxine (Effexor or Effexor XR).
2. Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening.
3. History of a seizure disorder other than a single childhood febrile seizure.
Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg

Prospective cohort studies through clinical trials. Obtained a large amount of real-world data to explore the efficacy of PLCL/Fg dressings for specific clinical applications.

Published 1 relevant SCIE paper. Provide a large amount of data support for the application of PLCL/Fg dressing in diabetic foot ulcer wound repair through basic experimental and clinical experimental studies. It can provide a practical and effective biomaterial for the treatment of clinical skin wound structure and function reconstruction, make the patient's wound healing as soon as possible, benefit the general public, reduce medical expenditure, reduce the burden on the society, lay the foundation for the industrialization and marketization of national innovative medical devices, and help to improve the international status and value of the application.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 90 years; type 1 or type 2 diabetes mellitus; history of ulceration for more than 4 weeks at enrollment; wound area between 1 and 25 square centimeters; wound depth of Wagner grades 1 and 2; and an ABI of 0.7 to 1.3 on the affected lower extremity or a transcutaneous oxygen pressure of greater than or equal to 30 mmHg.

Exclusion Criteria:

* Wound healing percentage greater than 30% during wound preparation (7 days); any infection, osteomyelitis, or other condition that may affect wound healing, such as deep vein thrombosis, rheumatoid arthritis, systemic lupus erythematosus, or any other systemic inflammatory disease.