cyrilzakka/clinical-trials huggingface dataset:
Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.

The purpose of this study is two fold;

1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.

The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-75 with Metabolic syndrome
* Abdominal circumference \> 35 in
* Hypertriglyceridemia \> 150mg/dl
* HDL \<50
* Blood Pressure \>130/85
* Fasting Glucose \>100

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 6-12 months
* Receiving lipid-lowing drugs
* Obstructive hepatobiliary disease or serious hepatic disease
* Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery
* Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations
* Documented allergic reaction to statin in past
* unexplained elevation in creatinine kinase levels \> 3 times upper limit
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.


Eligibility Criteria:
Inclusion Criteria:

* Not sexually active and agree to remain sexually inactive throughout the course of the study
* First menstrual period at least one year ago
* No menstrual period in the last 6 months

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Known or suspected pregnancy
* Medical history of any disorder that contraindicates the use of oral contraceptives
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora

The demand for alternatives to dairy products has increased in recent years and a lot of proposals for vegetable milk and yogurt products have taken place in the market. Quinoa is a plant from South America that has growth in popularity in recent years as many sought out nutritious and healthier eating, the herb is known for its high nutritional value. It is complete protein source containing all the essential amino acids. If this herb were fermented with probiotic bacteria, there is a potential for a product that is lactose free, gluten free and cholesterol free.

The probiotic potential of quinoa milk, fermented with food associated lactic acid bacteria will be investigated. This includes a study that examines how daily consumption of this vegetable drink changes the composition of the oral and intestinal flora. Therefore, healthy people are now seeking to participate in the study, which will be for just over 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years and healthy volunteers

Exclusion Criteria:

* Participants that have any kind of diseases, such as colon inflammation
The Effect of Anti-epileptic Drugs on Mitochondrial Activity

This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid) have an effect on the mitochondrial oxidative phosphorylation.

The objective of this study is to evaluate this effect in an accessible tissue-human peripheral white blood cells.

Antiepileptic drugs adverse reactions, including hepatotoxicity, are rare but potentially fatal, especially among children. Although the mechanism of the liver toxicity remains elusive, mitochondrial oxidative stress, has been hypothesized to play a role.

Most of the studies addressing antiepileptic drug effects on the mitochondria discuss the effect of valproic acid. The exact mechanisms involved in the drug-induced effects on oxidative phosphorylation are still far from being resolved. Most of the studies investigated the effect of valproic acid by using animal models or different in vitro methods.Mitochondrial diseases should be considered as a risk factor for valproic acid-induced hepatotoxicity, and there is a consensus for avoiding the administration of the drug for these patientsIs it possible that other antiepileptic drugs have similar effects? The knowledge regarding the effects of other antiepileptic drugs on the mitochondria is relatively scarce.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 3 and 18 years old, who suffer from new onset epilepsy as diagnosed by a certified pediatric neurologist, who do not suffer from a ''metabolic'' disorder, are treated by a single antiepileptic drug, and are not receiving any other type of medication on a chronic basis were included

Exclusion Criteria:

* Children younger than 3 years of age or older than 18 years of age, children who were suspected or known to suffer from a ''metabolic'' disorder or liver dysfunction, children who were under treatment, by any medication on a chronic basis, at the time of the study were excluded.
Right Side of Heart Function After Lung Surgery

The purpose of this study is explore the impact of lung cancer surgery on the function of the right side of the heart.

Lung cancer is the second most common cancer in the UK. In suitable cases the best chance of cure is surgical resection. Studies suggest that lung resection is associated with right ventricular (RV) dysfunction, predisposing to complications and post-operative dyspnoea. Studies of RV function following lung resection have been hampered by the limitations of the techniques used. In addition the mechanism of RV dysfunction has remained elusive.

In this prospective observational study the RV response to lung resection will be characterised by sequential assessment of right ventricular ejection fraction (RVEF) measured using cardiovascular magnetic resonance (CMR). CMR is non-invasive, involves no ionising radiation and due to its high spatial resolution is the gold standard for assessing RV volumes. Comprehensive CMR and echocardiographic assessment of the pulmonary vascular - RV axis will allow us to interpret peri-operative changes in RVEF in the context of RV contractility and loading indices. In addition, contemporaneous blood samples will be taken for measurement of biomarkers of myocardial and endothelial dysfunction and systemic inflammation.

With increased understanding of the mechanisms involved, it may be possible to prevent RV dysfunction; reducing complication rates, hospital stay and costs and ameliorating long term dyspnoea.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Age \>16 years
3. Planned elective lung resection by lobectomy

Exclusion Criteria:

1. Pregnancy
2. On-going participation in any investigational research which could undermine the scientific basis of the study
3. Contraindications to magnetic resonance imaging:

   i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in an part of the body
4. Wedge / segmental / sub-lobar lung resection
5. Pneumonectomy
6. Isolated right middle lobectomy
The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?

The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.

Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Major Depressive disorder

Exclusion Criteria:

* Neurological disease
* Mental retardation
* Seizure disorder
The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans

Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure

MSCs in passage-2 culture will be washed with PBS and detached with trypsin/EDTA (0.25%). After that, the cells will be suspended at a density of 20×106 cells/ 2 ml normal saline and loaded into 3 ml sterile syringes.

The cells should be infused within 2 hours of release. Tests and follow up are to be monthly.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent
2. Married female, 18-38 years old
3. Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 20 IU/L) and/or Primary or secondary amenorrhea at least for 6 months
4. Evidence of low ovarian reserve defined as: AMH \< _0.3 ng/ML \& FSH \>20 IU/L, AFC \< 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
5. Normal karyotype 46, XX.
6. Presence of at least one ovary
7. Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
8. Agree to report any pregnancy to the research staff immediately.
9. Cooperative patient
10. Negative for infectious panel (HIV, HBV, HCV, and VDRL)

Exclusion Criteria:

1. Currently breast-feeding
2. Has a history of, or evidence of current malignancy
3. Major mental health disorder that precludes participation in the study
4. Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
5. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
6. Significant anemia (Hemoglobin \<8 g/dL).
7. Untreated deep venous thrombosis, and/or pulmonary embolus
8. Known heart disease (New York Heart Association Class II or higher).
9. Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)\>2 times normal, or total bilirubin \>2.5 mg/dL).
10. Known Renal disease (defined as Blood urea nitrogen (BUN)\>30 mg/dL or serum creatinine \> 1.6 mg/dL).
11. Clinically active autoimmune condition
Physiological Changes With High-Flow Nasal Cannula

To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).

After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled.

All subjects will have physiologic data and electrical impedance tomography collected at:

1. Baseline nCPAP for 15 minutes
2. Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period
3. Then upon return to baseline NCPAP for a final 15 minutes of data collection.

Eligibility Criteria:
Inclusion Criteria:

* 23 to 28+6 weeks gestational age at birth
* Corrected gestational age less than or equal to 30 weeks
* Over 72 hours of life
* Stable on Nasal CPAP of 5-7cm H20
* Hemodynamically stable
* Tolerating routine handling
* Nares size appropriate for Fisher \& Paykel Optiflow Jr 2 HFNC size XS or small
* Successfully extubated for 12 hours after administration of surfactant
* Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
* Transcutaneous monitoring in place
* Stable blood gas (pH\>/= 7.25 and PaCO2 \<60 mmHg torr)

Exclusion Criteria:

* Prior pneumothorax or evidence of pulmonary interstitial emphysema.
* Prior or current pulmonary hemorrhage
* Congenital airway malformations
* Major cardiopulmonary malformations
* Congenital Diaphragmatic hernia or untreated bowel obstruction
* Poor respiratory drive unresponsive to CPAP therapy
* Requirement of a nCPAP of \>8 cmH20 or FiO2 \> 0.3 to maintain oxygen saturations between 90-95 percent.
* Receiving positive pressure breaths or SIPAP on prongs
* Conflicting clinical trial
* Clinically unstable per physician discretion
Virtual Reality Exposure Therapy for Acrophobia

The aim of this study is to examine the efficacy of virtual reality exposure therapy (VRET) as a treatment for specific phobia (acrophobia). The study will randomly assign 42 participants with acrophobia to one of two conditions: a) the experimental condition (consisting of 3 sessions of virtual reality exposure) or b) a control condition. Both groups will receive short information session about general principles of exposure therapy before the start of the study. After the end of the study, the waitlist group will be invited to attend the short version (one or two-sessions) of the VRET. Both groups will receive a final follow-up questionnaires 2 months after the last session.


Eligibility Criteria:
Inclusion Criteria:

* individual meeting ICD-10 criteria for diagnosis of specific phobia
* fluent in Czech

Exclusion Criteria:

* currently receiving psychological treatment for acrophobia
* psychotropic medication (unless on stable dosage for the previous 1 month and stabilized for the duration of the study)
* another severe mental disorder, such as bipolar disorder or psychotic disorder
* contradictions to using a virtual reality (e.g., epilepsy, balance problems)
Hair Transplantation in Cicatricial Alopecia

follicular unit extraction as a method of hair transplantation in cicatricial alopecia

The study will include 20 patients with cicatrical alopecia.Patients will be randomly assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.

Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:

* Preoperative Investigations including complete blood count, coagulation profile and hepatitis viral markers.

  1-Group(A): will undergo (FUE)
* Washing the scalp with antiseptic shampoo before the procedure.
* Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted with 20 cc saline in addition to adrenaline.
* Creation of micropunches(0.7-1 mm) using micromotor.
* After removal of the punch,the follicular unit is extracted with Jweler's forceps.
* Extracted grafts are then placed on chilled saline gauze for maximum four hours until ready for transplantation.
* The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades 0.9 mm.
* Implantation using fine tipped jweler's forceps.
* Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage is applied.

  2-Group (B): FUE+PRP
* The same procedure will be done but grafts will be placed in Prp solution.
* Prp session one week before transplantation then monthly for 3 monthes after (FUE).
* Preparation of PRP
* 10 cc blood will be aspirated in test tube contained a modified solution of anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH will reached to preserve the platelet integrity.
* The first spin of whole blood sample will be at 2500 rpm for 4 minutes
* The second spin at 4000 for 20 minutes for obtained plasma.
* Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The resulting suspension is used as PRP.
* Prp is injected in the recipient area. 4-Follow up:
* Follow up clinically by digital photographs and trichoscopy 1 week after operation, after 3 months and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with unacceptable visible scarring alopecia.

  * Adequate donor area.
  * patient free of signs of disease activity evidenced by trichoscopy.
  * Patients having inadequate laxity for a strip excision (too tight skin).
  * When previous scars of strip surgeries make further strips impossible.

Exclusion Criteria:

* • Inadequate donor area.

  * Signs of active disease or infection.
  * Patient who is not willing for long sessions for several hours or multiple sessions as needed due to the slowness of the process
  * Contraindications for surgical procedure as bleeding tendency.
  * Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological disorders and neoplasms).
Disclosure Intervention for People in Treatment for Opioid Use Disorder

The goal of this clinical trial is to test a disclosure intervention among people in treatment for opioid use disorder. The main question it aims to answer is whether people who receive a disclosure intervention have better treatment- and recovery-related outcomes one year after receiving the intervention. Participants will complete a brief disclosure intervention designed to help them (1) make key disclosures related to disclosure and (2) build skills to disclose. Researchers will compare results to participants in a waitlist comparator condition, who receive the intervention at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Client of Brandywine Counseling \& Community Services
* Receiving opioid use disorder treatment at Brandywine Counseling \& Community Services
* Considering disclosing one's opioid use disorder history and/or treatment to someone new

Exclusion Criteria:

* Diagnosis of schizophrenia
* Participation in pilot study of intervention
Safely Disposing of Surplus Prescription Opioids

This study evaluates two interventions intended to increase the safe disposal of leftover prescription opioids, compared to no intervention. Participants will receive an informational sheet describing how to safely dispose of leftover prescription opioids, an informational sheet with a drug disposal kit, or no intervention. Participants will be randomized by day for pragmatic reasons.

Many persons who receive a prescription for opioids report having leftover opioids once the prescription is finished. Leftover prescription opioids serve as a reservoir of products for misuse, given 90% of people who misuse prescription opioids report obtaining the opioids from a friend, family member, or a legitimate prescription. The best way to increase the rate of safe disposal of leftover opioids is unclear. The present study will generate evidence comparing how well a drug disposal system compares with providing an informational handout on properly disposing of leftover prescription opioids. Participants will be randomized by day to one of two disposal interventions or no disposal intervention. Disposal interventions include a drug disposal kit or an informational sheet describing how to safely dispose of leftover prescription opioids. Storage and disposal characteristics for leftover prescription opioids will be measured using standardized telephone calls with participants at 3 weeks after filling the opioid prescription. If therapy is not concluded at 3 weeks or participants are not available, then a second standardized telephone call with participants will take place at 6 weeks after filling the opioid prescription.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (age ≥ 18 years) who pick up a prescription for themselves or a family member at a Johns Hopkins pharmacy
* English speaking
* Residential address and phone number in the United States
* Filling a new prescription consisting of an immediate release opioid medication (i.e., immediate release morphine, oxycodone, hydromorphone, hydrocodone, tramadol; alone or in combination with acetaminophen) with ≤ 7 days' supply

Exclusion Criteria:

* Age \< 18 years
* Non-English speaking
* Residential address and/or phone number outside the United States
* Opioid medication listed in participant's active medication list prior to prescription fill
* Filling any prescription consisting of any opioid with 8 or more days' supply
* Filling any prescription consisting of any extended-release / long-acting opioid medication (i.e., extended-release morphine, oxymorphone, oxycodone, hydromorphone, fentanyl, methadone, buprenorphine)
* Filling an opioid prescription indicated for cough or shortness of breath
Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)

Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).

Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients:

1. Poor responders.
2. Normo-responders
3. High responders Comparing both the number and the quality of achieved oocytes.

During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.

On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval.

Different strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents.

Among the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.

So, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for IVF treatment.
* First ovarian stimulation
* Two ovaries present
* No previous ovarian surgery
* No contraindication for any of the assigned treatments

Exclusion Criteria:

* Previous ovarian surgery.
* Previous IVF treatments.
* Absence of one ovary
* Presence of an endometrioma