cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

The study is being conducted worldwide.

It consists of 4 segments:

* Segment A: 7-day run-in (screening)
* Segment B: 12-week double blind treatment
* Segment C: 40-week open treatment extension
* Segment D: 2-week run-out period

Eligibility Criteria:
Inclusion Criteria:

* Out patients
* Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria
* Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks.
* Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
* Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion Criteria:

* Females who are lactating or pregnant
* Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
* Patients presenting with acute or chronic pain resulting in insomnia
* Patients with history of epilepsy or seizures
* Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
* Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
* BMI \>32
* Acute or chronic pain resulting in insomnia
* Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
* Clinically significant and abnormal EKG (QTc interval \>500 msec)
* Positive for hepatitis B or C
* Serious head injury or stroke within 1 year
* Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
* Participation in another trial within two month before the screening visit
* Use of any substance with psychotropic effects or properties known to affect sleep/wake
* Unable to complete the study questionnaires
* Night shift workers, and individuals who nap 3 or more times per week over the preceding month
* History of:

  * Primary hypersomnia
  * Narcolepsy
  * Breathing-related sleep disorder (such as sleep apnea)
  * Circadian rhythm sleep disorder
  * Parasomnia (somnambulism)
  * Dyssomnia (such as periodic leg movements)
Pregabalin In Adolescent Patients With Fibromyalgia

The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access

To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance.

Patients needing an USGPIV will be randomized into long or short axis orientation. Emergency Medicine residents will place the IV using an ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable patients requiring placement of an USGPIV.

Exclusion Criteria:

* Hemodynamically unstable
* Unable to consent
Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment

This study will assess differences in inflammatory proteins, lipoprotein composition, cholesterol efflux and HDL-proteome in moderate-to-severe pediatric psoriasis who at baseline begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 6-17 years of all races/ethnicities with plaque and/or extensive guttate psoriasis for at least 6 months and on topical or systemic therapy
* Patients in the systemic group can be starting a medication for the first time OR transitioning from another systemic if unresponsive and on that previous treatment for ≤ 3 months.
* Patients may concurrently have psoriatic arthritis if initiation of a systemic medication is warranted by skin severity.
* Children ages 6-17 years of all races/ethnicities with acne being treated with isotretinoin
* Children ages 6-17 years of all races/ethnicities without plaque or guttate psoriasis and history of severe acne or treatment with isotretinoin as controls.

Exclusion Criteria:

* Patients less than 6 years of age or 18 years and older
* Patients with congenital heart disease, prior cardiac catheterizations/surgeries, or on cardiac medications in the past two years other than for hypertension (eg, calcium channel-blockers, beta-blockers and vasotropic medications).
* Patients who have other systemic inflammatory diseases (including atopic dermatitis, severe acne, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue diseases and/or other autoimmune diseases).
* Patients who have active infection or malignancy or have suffered from infection requiring oral or parenteral antibiotic in past 2 weeks.
* Patients and parents/caregivers unable to give written informed consent.
Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.

Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years of age or older
* Biopsy-confirmed cervical squamous-cell carcinomas
* Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas
* No spread to lumbo-aortic lymph nodes
* No prior pelvic radiotherapy
* No prior cancer treatment
* WHO Performance status less than or equal to 1
* Beneficiary of a health insurance
* Must provide her signed and informed consent

Exclusion Criteria:

* Reccurent or Metastasized cancer
* History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)
* Any contraindication to MRI
* Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients
* Pregnant or breast feeding patients
* Participation in any other clinical trial that could interfere with the study results
* Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment
Enhancing the Health Extension Workers Capacity for Promotion of Maternal and Child

Background: Maternal and child nutrition is a lingering public health concern, affecting the lives of the most vulnerable individuals, in particular mothers and children. To counteract the burden, the Ethiopian government has applied various strategies, including incorporating the promotion of nutrition as one package of primary health care provided by the health extension workers (HEWs). However, the provider's knowledge, promotion skill, and competency for promoting maternal and child nutrition have not been examined. Moreover, health extension workers have been promoting using the traditional model of education and indicating the need for continuous professional development to strengthen the workforce. Thus, the study is aimed to assess and enhance the health extension worker's capacity in promoting maternal and child nutrition through comprehensive and evidence-based capacity-building training.

Methods: A quasi-experimental study will be employed among 92 health extension workers. A baseline study, involving both qualitative and quantitative studies will be conducted to identify the gaps in maternal and child nutrition promotion. The knowledge, promotion as well as counseling skills of the HEWs will be assessed using a self-administered questionnaire and observational checklist, respectively. The intervention will involve training, supportive supervision, and coaching in a real environment. A four-day training will be given, which will be followed by supportive supervision of expert supervisors. Further, the greet, ask, listen, identify, discuss, recommend, and agree counseling model with Pender's health promotion model will be applied to enhance HEWs promotion skill. A post-test aimed at assessing the knowledge and counseling competency will be conducted and the pretest and posttest results will be compared using a t-test. Factors affecting both knowledge and counseling capacity will be assessed using binary logistic and linear regression, respectively. Similarly, a qualitative study will be used to explore promotion skills.

Discussion: Given there are problems associated with the knowledge and counseling skills of HEWs in Ethiopia, nutrition education using a well-designed and comprehensive strategy would bring a positive impact on professionals' promotion capacity thereby improving mothers/caregivers' behavior regarding child and maternal nutrition. The evidence will also enforce nutrition programmers and the Amhara regional health bureau to end maternal and child undernutrition.


Eligibility Criteria:
Inclusion Criteria:

-All health extension workers working in the study area will be included.

Exclusion Criteria:

* Not any
Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal

Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.

First episode patients have a greater potential for therapeutic response than multi-episode patients, and many of them also havea great desire to rejoin the workforce. Unfortunately, first episode patients become non-compliant or intermittently compliant with prescribed antipsychotic treatment at least as frequently as multi-episode patients. We believe that assured treatment with Risperal CONTSTA will provide first episode patients wiwth their best opporutnity for continued improvement in cognitive function beyond 3 months of treatment and that improvements in cognitive function will be associated with a greater likelihood of employment, real-world outcomes, such as independent living, as well as measures of brain function.

Eligibility Criteria:
Inclusion Criteria:

* male or female between 18-40 years of age
* meet DSM-IV criteria for first-episode schizophreniform, schizophrenia or schizoaffective disorder

Exclusion Criteria:

* pregnant \& breast-feeding women
* patients with known sensitivity to oral Risperdal
Use of Activated Recombinant FVII in Spinal Surgery

This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective spinal fusion surgery.

Exclusion Criteria:

* History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis)
* Any trauma within the last 3 months leading to hospitalization \> 24 hours
* Angina or known coronary artery disease
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.

PRIMARY OBJECTIVE:

I. Tolerability.

SECONDARY OBJECTIVES:

I. Tolerability in prespecified subpopulations.

II. Prostate-specific antigen (PSA) response at 7 months.

OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference.

ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

After completion of study intervention, patients are followed up for a total of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign an informed consent form
* Histologically confirmed prostate adenocarcinoma
* Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
* Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
* Performance status 0 - 2 (Karnofsky ≥ 50%)
* Age ≥ 18 years at time of consent
* Life expectancy ≥ 6 months per investigator discretion
* Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study

Exclusion Criteria:

* Have been on either abiraterone or darolutamide for \> 28 days prior to initiating enrollment
* Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial
Effect of Denosumab in Erosion Healing in RA

To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.

This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* DAS28 ≤5.1
* without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT

Exclusion Criteria:

* RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
* treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
* pregnancy or premenopausal women planning pregnancy
* previous use of denosumab, zoledronic acid or teriparatide
* Hyperparathyroidism
* contraindications to denosumab
* Bisphosphonate, biologic DMARDs and the use of oral glucocorticoid \>10 mg/day (prednisolone equivalent)
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Men or women aged 18 to 75 years
* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis)
* Toxic megacolon
* Screening stool positive for germs causing bowel disease
* Malabsorption syndromes
* Celiac disease
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding
Tissue Sealant Use in LASIK Enhancement Surgery

The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery

Participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the participant will be informed and given an appropriate referral. If the participant is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The participant will undergo LASIK flap lift eye surgery.

Tissue sealant will be applied at to the edge of the LASIK flap at the conclusion of the surgery. A bandage contact lens will also be placed. The bandage contact lens is used in the usual and customary fashion as in non-study LASIK flap lift surgery.

The participants will be seen on the day of surgery, post op day one, one month, and three months. The participant will receive topical antibiotics in each eye for one week following the procedure. The participant will receive pred forte 1% ophthalmic drops for one week after treatment. The participant will also receive vigamox ophthalmic drops for seven days after treatment. All of this is within the usual and customary standard of care for the treatment of participants undergoing LASIK surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 21 and older
* Subjects with healthy eyes
* Subjects who have previously undergone LASIK surgery
* Subjects with residual refractive error.

Exclusion Criteria:

* Subjects under the age of 21.
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectatic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place.
* Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and Disease Characteristics
* Documented physician diagnosed asthma for at least 6 months prior to Visit 1.
* Documented treatment with total daily dose of either low, medium, or high dose ICS for at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020) with stable dose for at least 3 months prior to Visit 1.
* Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1
* Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).

Exclusion Criteria:

* History of any clinically significant disease or disorder other than asthma which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day 1).
* History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1).
* History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation.
* History of systemic corticosteroid use for the maintenance treatment of asthma within 6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.
* History of cancer.
* History of hypersensitivity or anaphylactic reaction to any biologic therapy.