cyrilzakka/clinical-trials huggingface dataset:
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS

The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation \[serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)\] levels.

Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.

Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.

The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):

  1. Oligomenorrhea or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries (by ultrasound)

Exclusion Criteria:

* Smoking
* Pregnancy
* Diabetes mellitus
* Renal failure (serum creatinine \>1.5)
* Congenital adrenal hyperplasia
* Hyper or hypothyroidism
* Sex hormone therapy or antiandrogen therapy during the last three months
* Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above normal range
* Any systemic or febrile illnesses
* Use of glucocorticoid or anti-inflammatory drugs during the last three months
* Androgen secreting tumor
* Malignancy
tDCS for Treatment Resistant Obsessive Compulsive Disorder

It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
* No current depressive and suicidal risks
* No epileptic pathology
* Age: Participants will be both males and females, 18-70 years of age included.
* Chronic Obsessive compulsive disorder ( Total Y-BOCS\>20 or Y-BOCS one subscale \> 15)
* Obsessive compulsive disorder resistant to pharmacology treatment :

  1. at least 2 antidepressants (IRS type) (\> 12 weeks)
  2. cognitive and comportment therapy since at least one year
* Treatment stability (antidepressants) for more than 12 weeks without significant improvement.
* Affiliation to a social security system (recipient or assignee),
* Signed written inform consent form

Exclusion Criteria:

* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
* Patient under curators
* Patient hospitalized under duress
* Meets another diagnosis of axe 1 of DSM-IV
* Current depressive or suicidal risks
* Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash)
* Epileptic patient
* Patient with a medical history of cranial trauma
* Patient unable to give his or hers informed consent
Analysis of Genetic Factors Which May Influence the Course of HIV Infection

Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.

Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HIV

Exclusion Criteria:

* under 18 years of age
In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder

The purpose of this study is to describe the rates of elevated post void residual (PVR) (defined as \>200mL) in Cincinnati Urogynecology Associates patients following Botox injection, as well as to document how many patients required treatment with clean intermittent self-catheterization (CISC).

Approximately 16% of all women have symptoms of overactive bladder (OAB), whereas 30% of the elderly population are affected. Patients who do not respond to, or cannot tolerate, first and second line therapy with behavioral modifications and pharmacotherapy are offered additional treatment options. Third line therapy involves injection of onabotulinumtoxinA (Botox©, Allergen) into the bladder detrusor muscle.

Botox was approved for use for the diagnosis of OAB in 2013. Cincinnati Urogynecology Associates (CUA), TriHealth Inc. has incorporated intravesical Botox injections into the management algorithm for refractory OAB, since 2014. Currently, patients who fail to improve after a trial of first and second line therapy are offered treatment with Botox.

The standard practice is to request patients return to the office for a routine PVR measurement using straight catheterization within approximately two-four weeks following their Botox injection. This is done regardless if patients are exhibiting symptoms of urinary retention. Patients with an elevated PVR are treated with CISC if they are symptomatic.

Nevertheless, many studies suggest that patients are accurately able to self-identify symptoms of urinary retention, and treating asymptomatic urinary retention may not be necessary.

The investigators aim to describe how many patients with PVR \>200mL had symptoms following intravesical injection of Botox for OAB.

Eligibility Criteria:
Inclusion Criteria:

* OnabotulinumtoxinA injections in the bladder for overactive bladder
* Completed a post injection appointment at which time PVR was collected (approximately 10 to 28 days following Botox injection)
* Age \>18
* English speaking

Exclusion Criteria:

* OnabotulinumtoxinA injection for any other cause than overactive bladder
* Patients requiring self-catheterization at baseline
* Failure to complete a postoperative appointment within 4 weeks of Botox injection
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.

Background:

A malignant cerebral infarction causes edema resulting in a threatening increase of the intracranial pressure (ICP). Standard of care is a surgical removal of a part of the skull above the ischemic brain, the so-called decompressive hemicraniectomy (DCE). DCE allows the brain to swell, after detumescence of the brain parenchyma (usually several months later) the patients undergo a second surgery with implantation of either their own preserved bone flap or a bone flap substitute (a procedure referred to as cranioplasty (CP)).

Objective:

Despite its proven life-saving benefits, the strategy of DCE followed by CP carries several risks, among others

* Exposure of the brain parenchyma
* Various neurological deficits subsumed under the syndrome of the trephined
* Bone resorption: As shown in a previous prospective cohort study the above-mentioned risks may be prevented using an intraoperatively molded space-expanding protective shield, which is implanted and fixed directly after having performed (a so far customary) DCE. This shield allows the brain to swell while still providing protection.

SPACE SHIELD investigates whether the single-stage strategy of implanting a space-expanding shield represents a viable alternative to the standard DCE followed by CP."

Methods:

The inclusion of patients is planned to take place from January 2025 to December 2029. The study duration for the individual patients is 6 months. While the intervention group will be treated with the above-described space-expanding shield the control group will be treated with the customary DCE and following CP. The CP will be performed either with the original bone flap stored in customary manner or with a PMME bone flap. Examinations of the patients are planned after 1 - 7 days, 6 weeks, 3 months and 6 months after the initial surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke 19
* ≥ 18 and \< 70 years of age
* Availability of consent either from the patient or a legal representative

Exclusion Criteria:

* Hyperacute need for DCE due to rapid neurological decline
* Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy
* Pregnancy and active breast-feeding
* Patients with a former history of DCE and/or CP
* Active pulmonary or cranial infection
* Known coagulopathy independent of medication
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure


Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
2. Between 18 and 70 years of age.
3. Estimated fat harvesting of at least 300 milliliters.
4. Provided written Informed Consent.

Exclusion Criteria:

1. Pregnant or intending to become pregnant during the course of study.
2. Current smoker.
3. Presence of known malignancy.
4. Active infection in the treatment area.
5. History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\]).
6. History of connective, metabolic, or atrophic skin disease.
7. History of keloid scarring.
8. Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
9. Subjects with immune system diseases.
10. Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
2. first treatment for pancreatic cancer
3. performance status 0 or 1
4. adequate one marrow function
5. adequate renal function
6. obtained informed consent

Exclusion Criteria:

1. other active concomitant malignancies
2. other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
3. pregnant women
4. no informed consent
Electrical Stimulation During Immobilization

In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training in the previous 6 months
* Hypertension (according to WHO criteria) \[46\] and/or cardiovascular disease
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Use of any prescribed medication
* Type 2 diabetes mellitus
* Any family history of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants
Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study

Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their efficacy on markers of bone formation and resorption and for the incidence and severity of headache they cause.

Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in bone remodeling against the common side effect of headache.

NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with alendronate, risedronate or zoledronate.


Eligibility Criteria:
Inclusion Criteria:

NABT:

* Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
* Women without a uterus will be eligible after age 55

NABT-B:

* Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
* Women without a uterus will be eligible after age 55
* Previously treated with alendronate but stopped within 2 years of study commencement; or previously treated with risedronate but stopped within 1 year of study commencement; or previously treated with zoledronate.

Exclusion Criteria:

NABT:

* A previous fracture of the hip, wrist, spine or ankle within the last 3 months; or a diagnosis of osteoporosis;
* A history of bone disorders such as hyperparathyroidism or Paget's disease;
* Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater);
* Treatment with any antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks within the last three years;
* Previous treatment with intravenous zoledronate or parathyroid hormone;
* Current treatment with nitrates;
* A history of migraine headaches;
* A history of angina or cardiovascular disease;
* Inability to give informed consent;
* Hypersensitivity to nitroglycerin.

NABT-B:

* A previous fracture of the hip, wrist, spine or ankle; or a self-reported diagnosis of osteoporosis;
* A history of bone disorders such as hyperparathyroidism or Paget's disease;
* Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater);
* Treatment with etidronate or denosumab use for at least four weeks within the last three years and any previous treatment with parathyroid hormone;
* Current treatment with nitrates;
* A history of migraine headaches;
* A history of angina or cardiovascular disease;
* Inability to give informed consent;
* Hypersensitivity to nitroglycerin.
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial

This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.


Eligibility Criteria:
Inclusion Criteria:

* Parents' Informed Consent (IC) obtained before any trial-related activities
* Obtained child's assent (when possible)
* Type 1 diabetes
* Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
* HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%

Exclusion Criteria:

* History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
* Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
* Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
* Any other condition that the Investigator (trial physician) feels would interfere with trial participation or evaluation of results
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.

Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Exclusion Criteria:

-
Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs

The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees of UMass Memorial Health Care in which 350 participants (control group) receive standard wellness and medical benefits and services for UMass Memorial Health Care employees and in which 350 participants (intervention group) receive these same standard benefits and services as well as the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the intervention group will be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence. They will also be offered support in tying these behaviors to their health goals, including blood pressure management, blood sugar management, cholesterol management, weight loss, smoking cessation, etc.

The hypothesis is that those employees in the intervention group will experience improved results compared to those in the control group. It is believed that they will have improved health behaviors, improved biometrics, and lower total healthcare costs (fewer complications, fewer hospitalizations, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Employed by UMassMemorial Health Care
* Receive benefits from UMassMemorial Health Care
* Have a smartphone

Exclusion Criteria:

* Pregnant
* Unable to consent
* Non-English speaking
Baclofen as a Perioperative Analgesic Adjuvant

The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>= 19 y.o.) scheduled for kidney stone-related surgery

Exclusion Criteria: (note - there were no patients requiring exclusion)

* History of allergy to baclofen
* Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)
* Active history of cancer
* Potential for difficult airway as judged by attending anesthesiologist due to concerns there could be muscle weakness from the drug with consequent respiratory depression