cyrilzakka/clinical-trials huggingface dataset:
MLE4901 vs. Placebo for the Treatment of PCOS

This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.

Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject

Eligibility Criteria:
Inclusion Criteria:

1. Oligo-/amenorrhea
2. At least one of the following during Screening:

   * Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
   * Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
   * Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume \>10 mL (without a cyst or dominant follicle) in either ovary
3. Body mass index (BMI) 22 to 45 kg/m2, inclusive
4. Must be willing to avoid use of all hair removal procedures and products during study participation
5. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
6. Must be willing to avoid the use of all hair growth procedures and products during study participation
7. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) \>2 years or male partner(s) has had a vasectomy \>2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.

Exclusion Criteria:

1. Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) \>10 IU/L
2. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
3. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
4. Uncontrolled hypo- or hyperthyroidism
5. Post-hysterectomy or endometrial ablation
6. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
7. Medical history of type 1 or type 2 diabetes mellitus
Undermining During Cutaneous Wound Closure

The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.

The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Incarceration
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
* Wounds with diameter \> 3 cm
* Wounds unable to be fully closed without undermining
Enhanced Implementation of Low Back Pain Guidelines in General Practice

The aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy.

Introduction:

There is a need for more knowledge on how to introduce new guidelines effectively in general practice. A new low back pain treatment guideline is implemented in Denmark. This guideline demands that patients with low back pain who have not improved after eight weeks of primary care treatment should be referred to a secondary care spine centre.

Methods:

This is a cluster randomized trial. One hundred general practices define clusters and are randomly allocated to enhanced or usual implementation of the new guideline. The practices are all situated in the North Denmark Region and count two hundred general practitioners (GPs).

General practices in the control group will receive normal implementation of the new guideline, which include newsletters and briefings. In contrast the intervention group will receive an enhanced implementation strategy, adding visits from a consultant, two different stratification tools and feedback on guideline compliance. The two stratification tools: The STarT back screening tool (STarT) and a "Social and Occupational Screening" tool (SOS). The two screening tools subgroups patients and aids the clinicians in their choice of treatment.

Discussion:

To evaluate how change in behaviour may improve guideline adherence and patient treatment we plan two Ph.d. studies in relation to this study; one focusing on the clinical and an one on the economic aspects of the study. In addition a qualitative study is planned for patients refered to specialists in social medicine.

Eligibility Criteria:
Inclusion Criteria:

* Provider number in the North Denmark Region (Practice level)
* ICPC coded: L02, L03, L84, and L86 (Patient level)
* Age 18-65 years (Patient level)

Exclusion Criteria:

* No signed written consent form (Practice level)
* Earlier participation in project testing (Practice level)
* Already included (Patient level)
* Patients with "red flags"/signs of serious pathology (Patient level)
* Pregnancy (Patient level)
* Insufficient Danish language skills (Patient level)
Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?

The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with prolonged length of mechanical ventilation, prolonged intensive care (ICU) and hospital stay, increased ICU and hospital mortality, and prolonged impairment in physical function and quality of life. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days.

The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with poor outcome, and limitations of functional recovery. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days. The study is testing a nutrition complement (HMB) that is included in feeding products registered for medical nutrition by Swiss Federal Authorities, but who do not provide sufficient protein quantities.

On days 4 and 15 after ICU admission, specific investigations will include: Ultrasound measurement of the muscle quadriceps femoris (CSA), bioimpedance analysis (BIA) of body composition, protein synthesis and catabolism using amino acid tracers. On D30 and D60: telephone contact to assess global health and mobility (SF-12).

Eligibility Criteria:
Inclusion Criteria:

* likely length of stay \>5 days
* on mechanical ventilation
* likely survival \>7 days
* full treatment
* functional gastro-intestinal tract
* presence of a central venous catheter

Exclusion Criteria:

* absence of consent
* less than 18 years patients
* gastro-intestinal dysfunction
* major burns \>20% body surface
* admission for cardio-respiratory arrest or brain injury
* pregnancy or lactation
* diabetes mellitus (I and II)
* statin treatment
* patient on parenteral nutrition
* absence of central venous line
* participation in another interventional trial
3D Sonohysterography vs Hysteroscopy: Study for the Evaluation of Intrauterine Abnormalities

Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. Many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most of the articles are from the last decade, but the subject has been laid aside in the recent years. Antonio Simone Lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies.

Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. Many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most of the articles are from the last decade, but the subject has been laid aside in the recent years. Antonio Simone Lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies.

Purpose of the study:

Comparison of the sensitivity, specificity, and the amount of information between diagnostic hysteroscopy and sonohysterography (Two and three-dimensional, in abdominal and vaginal access).

The comparison will be will be made immediately after the completion of diagnostic hysteroscopy test, while using liquid drizzled earlier during the hysteroscopy, in order to simulate sonohysterography which is considered less intrusive and is made As part of standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 to 70 who were referred by a physician to perform diagnostic hysteroscopy.

Exclusion Criteria:

* refusal to sign a consent form
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test

To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.

Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD).

Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD.

The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a clinical indicated stress SPECT MPI
* Adequate IV access in both arms

Exclusion Criteria:

* History of coronary angioplasty or stent placement
* History of coronary bypass surgery
* Angiographic history of flow-limiting CAD
* Documented history of elevated cardiac markers
* Documented history of injury or infarct on ECG
* Absence of sinus rhythm
* Current history of renal insufficiency
* Known allergy to contrast dye
* Pregnant
Clozapine and Olanzapine Treatment of Aggression

This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and haloperidol. We compared these three medications in the treatment of aggressive behavior over a 12 week period.

Objective: The purpose of our study was the investigation of the effect of atypical antipsychotic agents on interpersonal violence and aggression.

We compared the efficacy of two atypical antipsychotic agents, clozapine and olanzapine with one another and with haloperidol in the treatment of physical assaults and other assaultive behaviors in physically assaultive patients with schizophrenia and schizoaffective disorder.

Method: The subjects were 110 physically assaultive inpatients diagnosed with schizophrenia or schizoaffective disorder.

They were randomly assigned to treatment with clozapine (N=37), olanzapine (N=37) or haloperidol (N=36) in a 12-week, double-blind trial. Incidents of overt aggression were recorded and their severity was scored with the Modified Overt Aggression Scale (MOAS). Psychiatric symptoms were assessed through the Positive and Negative Syndrome Scale (PANSS). We also assessed various side effects and monitored vital signs and drew bloods.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 60 years.
* Diagnosis of schizophrenia or schizoaffective disorder.
* Aggression: One episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the Positive and Negative Syndrome Scale (PANSS) Hostility Item.

Exclusion Criteria:

* Patients who were hospitalized for more than a year
* Patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
* Patients who had a history of clozapine, olanzapine, or haloperidol intolerance
* Patients who had medical conditions that would be adversely affected by any of these three medications.
* Patients who received a depot antipsychotic within 30 days before randomization.
Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care

This Pilot-RCT is part of a feasibility study that aims to learn if the IPS-psychosocial care intervention and an RCT on its efficacy are feasible in patients, relatives and staff on icu wards. The Pilot-RCT will examine outcomes, that might indicate an improvement in psychosocial safety climate and other health- and wellbeing-related measures due to the administration of the intervention that is described in the following. The main question the Pilot-RCT aims to answer is:

Is there evidence that the IPS intervention improves the psychosocial safety climate and other components of psychosocial well-being in ICU teams, patients and their relatives?

Researchers will compare four intervention groups (icu wards with implementation of the IPS-Intervention) with four control groups (icu wards with regular supply of psychosocial care) to see if the comparison of two groups in this RCT is feasible.

The IPS-Intervention consists of a ward psychologist who works as part of the ICU team and takes care of the staff, patients and relatives in accordance to the intervention manual that was developed in a prior phase of this project.


Eligibility Criteria:
Inclusion Criteria:

* Affiliation to one of the 8 participating ICU wards during the duration of the study, either by: occupation as a healthcare professional, admission as a patient, relation to an admitted patient

Exclusion Criteria:

* Age under 18 years old
* Inability to give informed consent
Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses

The aim of this study is to collect clinical and radiographic data from the case histories of patients surgically treated for radio-capitellar fracture and undergoing prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute, in order to evaluate the clinical and radiographic results at least 10 years after surgery.

The aim of the study is to collect clinical and radiographic data from the case history of patients (about 30 cases) surgically treated from 2003 to 2011 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute for radio-capitellar fracture with prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem in order to evaluate the clinical and radiographic results at least 10 years after treatment. Patients will be contacted to perform a clinical examination and radiographic control at the Rizzoli Orthopaedic Institute.

This is an interventional study with clinical and radiographic evaluation, at FU of at least 10 years, of patients treated surgically with prosthetic replacement for radio-capitellar fracture at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of radial capitate implantation surgery
2. Males and Females
3. Patients surgically treated for radial capitellum fracture undergoing prosthetic replacement with smooth-stemmed modular metal radial capitellum prosthesis at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute from 2003 to 2011.

Exclusion Criteria:

1. \< 18 years old at the time of surgery
2. Patients treated with radial capitellum prosthesis implantation in fracture outcomes (e.g., secondary instability)
3. Patients who at the time of telephone contact have contraindications to the execution of radiographic examination
4. All available patients will be invited to perform the clinical examination and radiographic examination. If some patients are unable to undergo radiography due to possible contraindications, they will still be seen to collect the primary clinical outcome.
The Effects of Playing High School Football on Later Life Cognitive Functioning and Mental Health

The purpose of this study is to assess the effect of playing high school football on later in life cognitive functioning and mental health. This is an observational study that will use data from the Wisconsin Longitudinal Study to compare high school football playing graduates in 1957 with comparable non-high school football playing graduates on cognitive functioning and mental health measures when participants are in their 60s.

The investigators will use data from the Wisconsin Longitudinal Study (WLS) of graduates from Wisconsin high schools in 1957 to investigate the link between playing high-school football and later life depression and cognitive impairment. The WLS has a number of attractive features that make it well-suited for such a study. First, it records whether study participants participated in high school football and also includes detailed measurements of later-life mental health, psychological well-being, and cognition. Second, it includes a rich set of baseline covariates which the investigators will use to construct matched sets of treated and control individuals, including family background, adolescent characteristics, educational and occupational achievement and aspirations. Third, the WLS is one of the few longitudinal data sets that includes an administrative measure of childhood cognition. In short, the WLS provides a large data set that facilitates comparing the later life mental health and cognitive ability of men who played high school football to those who did not, after carefully controlling for a range of potential confounders. The investigators will compare the primary outcomes of the treated subjects to the primary outcomes of the control subjects, after controlling for baseline covariates via full matching with a propensity score caliper. The primary outcomes are depression (modified CES-D score) and cognitive functioning (average of z-scores for letter fluency and delayed word recall) when participants are age 65. Secondary outcomes that include cognitive scores on various domains, the Spielberger anger index, the Spielberger anxiety index and a hostility index will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

-- Male.

Exclusion Criteria:

* No yearbook information available to determine football playing status
* Activity participation in yearbook was not recorded under senior photo or in an index.
* Did not played football but played another high contact sport (soccer, hockey, lacrosse or wrestling).
Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes

PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.

IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not clarified.

Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP reduction may be due to secondary induced PGs.

Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.


Eligibility Criteria:
Inclusion Criteria:

1. normal healthy eye
2. not applicable for IOP level
3. not wearing contact lenses
4. not applicable for the presence of the ocular surface diseases in case the treatment was not needed

Exclusion Criteria:

1. the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
2. the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
3. the eyes with difficulty for the measurement of IOP with the applanation tonometer
4. the subjects with the allergy for PG-analogues or benzalkonium chloride
5. the subjects using the eyedrops excluding those in this study
6. the subjects treated with oral carbonic anhydrase inhibitor
7. the subject with Sjogren syndrome
8. the subjects who can not drop periodically
9. the subjects with the advanced glaucoma or the terminal stage of glaucoma
10. the subjects with the severe ocular complications
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of this Trial is to compare leflunomide (LEF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis of this trial is that LEF is non-inferior to AZA.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Biopsy-proven proliferative lupus nephritis
* Disease activity, SLEDAI score ≥ 8 points
* Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
* Signed informed consent

Exclusion Criteria:

* Allergy to the LEF, CTX, AZA
* Recent treatment with high-dose glucocorticoids
* Weight \<45kg
* Recent treatment with immunosuppressive drugs
* CNS( Central Nerve System) Lupus patients
* Hepatic failure patients
* Severely abnormal renal function or end-stage renal failure
* More exclusion criteria in the protocol