cyrilzakka/clinical-trials huggingface dataset:
The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

The goal of this project is to test our central hypothesis that the spinal cord neuroplasticity in females will be modulated by the level of estradiol concentration. under aim 1 we will determine the influence of estradiol fluctuations on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy females and males. We will use an established repetitive peripheral nerve electrical stimulation with a stimulation intensity below the motor threshold to prime the spinal motor circuits. under aim 2 we seek to characterize the input output property of spinal circuit excitability after descending drive (motor) mediated priming in young healthy male participants. in aim 3 we will examine the influence of estradiol fluctuations on descending drive mediated motor priming in young healthy females.


Eligibility Criteria:
FEMALES

Inclusion Criteria:

* Ages 18-39 years
* Eumenorrheic (regular monthly cycles of 24-35 days)
* Moderately active (less than 7 hours of vigorous physical activity per week)
* History of pregnancy is allowed if patient is in post-lactation phase

Exclusion Criteria:

* History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot
* History of neurological injury of the peripheral or central nervous system
* Current smoker
* History of disordered eating
* History of stress fracture in the lower limb
* History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease)
* Pacemaker, metal implants in the head and spine region
* Pregnancy
* On a hormonal contraceptive regimen (oral, transdermal or vaginal)
* History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease)
* Started or stopped taking oral contraceptives within the previous 6 months
* Exercise vigorously more than 7 hours per week or currently participating in competitive level sports.

MALES

Inclusion Criteria:

* Ages 18-39
* Moderately active (less than 7 hours of vigorous physical activity per week)

Exclusion Criteria:

* History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot
* History of neurological injury of the peripheral or central nervous system
* Current smoker
* History of disordered eating
* History of stress fracture in the lower limb
* History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease)
* Pacemaker, metal implants in the head and spine region
Basal Insulin Strategies Before Surgery

Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors hypothesized that a 25% reduction in BI dose the evening before surgery will result in better perioperative blood glucose control compared with our institutional 50% decrease.

A total of 40 subjects diagnosed with T2DM taking once-daily evening BI, scheduled to undergo elective surgery under general anesthesia will be consented and randomized in a 1:1 ratio to received either 50% or 25% reduction of their regular evening BI dose on the evening before surgery. Blood glucose levels (BGL) will be recorded perioperatively according to institutional guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have volunteered and consented to participation in the study during their outpatient preoperative anesthesia appointment.
* Type II Diabetics taking once-daily evening basal insulin (glargine or detemir)
* Patients that will undergo general anesthesia
* Patients who have been on basal insulin for ≥ 3months

Exclusion Criteria:

* Inability to read, comprehend, and sign informed consent
* Patients with Type I Diabetes
* Patients who take short-acting insulin boluses which make up greater than 20% of their total daily insulin dose
* Patients who have been on chronic steroids ≥ 5 mg/dl prednisone daily or equivalent for ≥ 1 month within the past 12 months
* Pregnant patients
* Patients on twice-daily dosing of basal insulin
* Patient who take basal insulin in the morning
* Patients with a history of severe hypoglycemia, defined as any event in the previous year requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions
* Patients that will undergo cardiac, transplant, or brain surgeries
* Prisoners
Safety and Efficacy Study of Gamaline+Hipericin in PMS

GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).

This protocol wants to show the advantages for the mixture GAMALINE 900mg+HIPERICIN 300mg - 2 herbal extracts for PMS treatment against the individual use of GAMALINE

Eligibility Criteria:
Inclusion Criteria:

* climacteric pre-menopausal women between 45 e 55 anos
* women between 25 e 44 anos

Exclusion Criteria:

* Age inferior 25 anos or superior 55 anos and/or decline invitation.
* Patients pos-menopause
* Under hormone therapy
* Thyroid disease
* Under psychiatric therapy or medication
* History for allergies and hypersensitivity to one or both extracts
* Breast feeding or pregnancy
* No knowledge for writing and/or reading
Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients

When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
* ImmunoCAP® titer \> 3.49 kUA/L for the house dust mite antigen.
* Determined to be suitable for clinical trials as a result of laboratory tests.

Exclusion Criteria:

* Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
* In case of lactation or pregnancy.
* If an infectious disease that may affect this study is identified.
* Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
* If the allergy skin prick test is negative for the house dust mite antigen.
Evaluation of Diabetes Care at Austrian GPs

This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are:

* To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP level,
* To evaluate representative profile of patient with T2D in Austria,
* To evaluate which medical therapies are used.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type II

Exclusion Criteria:

* Diabetes mellitus type I
* Gestation diabetes
* Induced diabetes
DOCE Study Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism

Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism. Also the difference between DOACs inducing both CYP3A4 and P-gp transporter (rivaroxaban and apixaban) and DOACs inducing the P-pg transporter only will be investigated. Thriomboembolic and bleeding events during the study duration will be registered and correlated to the measured DOAC plasma levels.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of nonvalvular atrial fibrillation or a diagnosis of venous thromboembolism who are taking direct oral anticoagulants according to current guidelines and concomitant enzyme inducers antiepileptic drugs; patients available for a 12 months follow up; patients who can sign informed consent

Exclusion Criteria:

* patients who stop antiepileptic drugs; age \<18 yo patients not willing to perform blood draw or not available for a 12 months follow up; patients who cannot sign informed consent
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients

Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition called anemia. Some symptoms of anemia include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in maintaining a healthy nervous system. Nerves are surrounded by an insulating material that helps them conduct impulses. Patients with low B12 levels who receive this vitamin in injection form, state that there quality of life is better. Anemia in Hemodialysis patients is treated with Epogen, a synthetic material which helps your body make blood cells. The investigators believe that if you have a low vitamin B12 level in your blood and the investigators give you the vitamin during dialysis your requirement for epogen will be lower and you will be able to produce blood cells better. When evaluating for Vitamin B12 deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood test that will be performed and when this level is high and your vitamin B12 level is in the low normal range the investigators can make a diagnosis of vitamin B12 deficiency.

BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population.

METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency. Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months. Post-treatment MMA levels and smears were obtained. Erythropoietin dosages were monitored throughout the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* · Patients on Hemodialysis for at least 6 months

  * Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.

Exclusion Criteria:

* · On B12 treatment

  * Hematological Cancer
  * Methotrexate use
  * Alcohol use greater then 2 drinks per day
  * Vegetarian Diet
  * Gastric Surgery
  * Inflammatory Bowel Disease
  * Pernicious Anemia
  * Recent transfusion
The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation

Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. In an attempt to preserve or increase the oxygenation, conventional mechanical ventilation is initiated in these patients. Unfortunately, patients frequently become refractory to standard ventilatory techniques and as such, gas exchange remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the other hand, is an advanced mode of ventilation which can be a salvage option in these patient cohorts as it has already been proven to improve gas exchange with success. The volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially available system to deliver HFPV. This ventilator mechanically ventilates the lung by administering small successive subtidal volumes or percussions at unconventional high frequencies to reach an optimal diffusive oxygenation.

Since it has been known that hypoxemia due to a reduced oxygenation results in secondary brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range has an ameliorative influence on hypoxic events and in turn leads to a better clinical outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation by means of a switch to HFPV automatically leads to an increment in the cerebral tissue oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will investigate whether this alternation of ventilation strategy is associated with a (beneficial) change of the cerebral tissue oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.

Exclusion Criteria:

* Age \< 18 years
* Patients with COPD (chronic obstructive pulmonary disease)
* Patients with asthma
Formula for Children With Cow's Milk Allergy

The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.


Eligibility Criteria:
Inclusion Criteria:

* Good health
* Parent/guardian must be willing to provide informed consent
* Parent/guardian agrees to feed study formula provided
* Confirmation of Cow's Milk Allergy

Exclusion Criteria:

* No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
* No medications that may interfere with or impact evaluation of the study assessments
* Allergy to extensively hydrolyzed casein formula
* Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
* Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
Twenty-Four Seven Functional Status in Total Hip Replacement

The goal of this observational study is to define digital remote monitoring measures for functional status (activities of daily living) in patients receiving total hip replacement. Functional status will be collected using a study iPhone and two wearable wrist monitors.

Approximately 25 participants will be enrolled in this study. The study consists of a 1-week Screening period, a 1-week Baseline period, up to 6-week assessment period (post-surgery), and an end of participation (EOP) visit. With the exception of in clinic visits at the beginning and end of study, this observational study will leverage fully remote data capture.

The categories of functional status and corresponding measures captured in this study include:

1. Physical activity and mobility, with outcome measures including hourly and daily step count, gait speed, and metabolic equivalent of task.
2. Vital signs, with outcome measures including heart rate, heart rate variability and blood pressure.
3. Sleep concept, with outcome measures including sleep duration, sleep quality, sleepiness and sleep timing.
4. HRQoL captured using validated instruments and diaries via electronic patient reported outcomes (ePRO) platforms, assessing aspects of health that are meaningful to individual's hip replacement such as disease- and treatment-related symptoms and the impact their physical health may have on activities of daily living, their work life, and socializing.

Eligibility Criteria:
Inclusion Criteria:

1. Participants diagnosed with osteoarthritis of the hip or degenerative joint disease and have decided to undergo total hip arthroplasty
2. Patients willing to sign the informed consent form
3. Age 30 and older
4. Demonstrated ability to perform satisfactory at-home assessments as well as the mobile application to synchronize data collection and respond to questionnaires during the screening period

Exclusion Criteria:

1. Participants with clinically unstable serious diseases (e.g., heart or lung disease) that would deem them unfit for the study in the Investigator's opinion
2. Secondary total hip replacement on the same side
3. Hip replacement for neoplasm, proximal femoral fracture, or other causes than osteoarthritis
4. Contemporary bilateral replacement
5. History of substance abuse in the last 6 months, excluding medical or recreational non-inhaled marijuana
6. Current cancer
7. Presence of neurological diseases previous to and/or following surgery (peripheral neuropathy is generally acceptable)
8. Congenital abnormalities
9. Patients with active infection within last 30 days
10. Psychotropic drugs except for pain management and antidepressants
Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)

Primary angle closure glaucoma (PACG) is caused by contact between the iris and trabecular meshwork, which in turn obstructs outflow of the aqueous humor from the eye. This contact between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork until it fails to keep pace with aqueous production, and the pressure rises, and at last the optic nerve is damaged, the vision may be lost in some severe cases. Therefore, ocular pressure reduction is the key to treat the disease and prevent blindness. Trabeculectomy is the most common conventional surgery performed for glaucoma. This allows fluid to flow out of the eye through this opening, resulting in lowered intraocular pressure(IOP) and the formation of a bleb or fluid bubble on the surface of the eye.

Cataract surgery is common in the elderly. Cataract surgery is the removal of the natural lens of the eye (also called "crystalline lens") that has developed an opacification, which is referred to as a cataract. Cataract extraction includes intracapsular cataract extraction, extra capsular cataract extraction \& phacoemulsification, and phacoemulsification is the preferred method. It has been reported that IOP reduction could occur in cataract patients with PACG after the cataract surgery. For some cases with PACG, such IOP reduction may be insufficient for neuronal protection, and many patients still require glaucoma medication and incisional surgery such as trabeculectomy to control IOP. In such cases, a combined cataract-glaucoma procedure (phacotrabeculectomy) is a reasonable option. In keeping with this concept, previous studies have shown that phacotrabeculectomy could effectively and simultaneously reduce IOP and improve vision in patients with a coexistence of PACG and vision-threatening cataract. However, phacotrabeculectomy may heighten inflammatory response, result in a higher frequency of postoperative complications such as hyphema and fibrin in the anterior chamber, endophthalmitis, and increased scarring of the filtering bleb. Thus, it is unclear whether phacotrabeculectomy is as effective and safe as trabeculectomy in lowering IOP for PACG patients.

In the present study, the investigators compared the efficacy and safety of phacotrabeculectomy and trabeculectomy in patients with coexisting PACG and cataract.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary angle-closure glaucoma with co-existing cataract

Exclusion Criteria:

* secondary glaucoma
* history of any intraocular surgery, including laser iridectomy
Cardiovascular Treatment

Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.

The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 25-30
* Males, 35-45 years
* Healthy
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I \[\>2cm\] to IIIA) non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

1. Cytologically and/or histologically-documented NSCLC

   1. Stage I (\> 2 cm) to IIIA (for participants with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification
   2. Amenable to complete surgical resection
   3. Have not received any other therapy for this condition
2. Predicted forced expiratory volume in one second (FEV1) ≥ 50%
3. Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50%
4. ECOG 0 or 1
5. Adequate organ function

Exclusion Criteria:

1. Participants with small-cell lung cancer or mixed small-cell lung cancer
2. Participants who require or may require pneumonectomy
3. Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:

   1. Participants with vitiligo or alopecia
   2. Participants with hypothyroidism on hormone replacement
   3. Any chronic skin condition that does not require systemic therapy
   4. Participants without active disease in the last 5 years may be included but only after consultation with the study physician
   5. Participants with celiac disease controlled by diet alone
6. Pregnant or breast-feeding female
7. Major surgical procedure within prior 30 days
8. History of active primary immunodeficiency
9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
10. QTc interval (QTc) ≥ 470 ms
11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
12. Receipt of live attenuated vaccination within 30 days prior to study entry
13. History of another primary malignancy except for:

    1. Curative-treated malignancy with no known active disease \> 2 years before enrollment on the study
    2. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ