louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01581814: Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients

Detailed description: Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients

Eligibility criteria: Inclusion Criteria:

* age 18-35
* hyperinsulinemic PCOS

Exclusion Criteria:

* chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

Primary outcomes:
measure: CD4+CD28null frequency
timeFrame: five minutes
Secondary outcomes:
measure: the area under the curve for insulin (AUCi) and lipid profile.
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli
Study officials:
References:
citation: Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2651-4. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.
Clinical trial NCT02242214: REgistry of MisOprostol 200 µg Vaginal dElivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labour
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Academic and peripheral hospitals in the Netherlands

Brief summary: The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated
* Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product Characteristics (SmPC)
* Willingness and ability to provide written informed consent

Exclusion Criteria:

* Misoprostol 200 µg VDS is contraindicated according to the SmPC

Primary outcomes:
measure: Time to vaginal delivery of the neonate in hours
timeFrame: From insertion until vaginal delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01563614: A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain
Official title: Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Leptomeningeal Metastasis From Malignant Melanoma
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Mundipharma Research GmbH & Co KG
First posted: 2012-03-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.


Eligibility criteria: Inclusion Criteria:

* Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
* CSF flow abnormalities must be excluded
* Males or females ≥ 18 years of age
* Karnofsky Performance Status \> 50%
* Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)

Exclusion Criteria:

* Unresected parenchymal brain metastases with a diameter \> 3 cm
* Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
* Prior intrathecal chemotherapy
* Prior treatment with systemic cytarabine or nitrosureas
* The patient ist pregnant or breast feeding
* Severe, active co-morbidities

Primary outcomes:
measure: Safety/Tolerance
timeFrame: 30 weeks
Secondary outcomes:
measure: Delay of treatments
timeFrame: 30 weeks
measure: Response rate
timeFrame: 30 weeks
measure: Progression
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Neurologische Universitaetsklinik Bonn
Study officials:
affiliation: Neurologische Universitaetsklinik Bonn
name: Martin Glas, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02425514: Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
Official title: Evaluation of Bone Union Following Anterior Cervical Fusion Using a Bioactive Glass-Ceramic Spacer (NovoMax™): Comparison With a PEEK Cage Filled With β-Tricalcium Phosphate (Cervios ChronOs™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Keywords: Anterior cervical discectomy and fusion
NovoMax
Bioactive Glass-ceramic Intervertebral Spacer
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.


Eligibility criteria: Inclusion Criteria:

* The patient who is expected to receive anterior cervical discectomy and fusion operation.
* Volunteer for this study with written consent.

Exclusion Criteria:

* Patient with cervical spine fracture, infection and malignant tumor
* Below -3.5 T-score by DEXA bone densitometry
* Patient who is not suitable for this study judged by principal investigator

Primary outcomes:
measure: Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
timeFrame: at 6 months after surgery (ACDF)
Secondary outcomes:
measure: VAS of Neck Pain(Post operative 6 Months)
timeFrame: at 6 months after surgery (ACDF)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin Sup Yeom, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00557414: Serial Changes of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) Levels in Patients With Acute Respiratory Distress Syndrome
Official title: Serial Changes of sTREM-1 Levels in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: acute respiratory distress syndrome
soluble triggering receptor expressed on myeloid cells-1
prognosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted into ICU of a medical center in Taiwan

Brief summary: The purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory distress syndrome (ARDS)

Detailed description: The triggering receptor expressed on myeloid cells-1 (TREM-1), a member of the immunoglobulin superfamily, is upregulated on phagocytic cells in the presence of bacteria or fungi infection and weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form (sTREM-1) in body fluids. The level and serial change of a serum sTREM-1 from cirtical ill patients has been shown to be a good diagnostic and prognostic indicator of ventilation associated pneumonia (VAP) and severe sepsis.

Eligibility criteria: Inclusion Criteria:

* Fulfill clinical diagnosis of ARDS
* Require mechanical ventilation support

Exclusion Criteria:

* Pregnant
* Immunocompromised

Primary outcomes:
measure: all cause mortality
timeFrame: 28 days
measure: Septic or non-septic etiology
timeFrame: At enrollment
Secondary outcomes:
measure: CRP, lactate, WBC count, APACHE II score, LIS, SOFA score
timeFrame: At enrollment
measure: IL-1 beta, IL-8, TNF-alpha
timeFrame: serial follow up at Day 1, 3, 5, 7, 14
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital
name: Chao-Chi Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04889014: Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum
Official title: Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 233
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We investigated the effect of PGET on student knowledge, comfort, and attitudes related to pharmacogenomics (PGx) in a non-blinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during four subsequent years of a PGx course.
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the use of personal genomic educational testing (PGET) on student knowledge and clinical skills surrounding pharmacogenomic testing to ensure it is of educational benefit to our student population. Students will be provided the opportunity to opt-in to test their own pharmacogenomic panel while participating in the standard curriculum. Students will have the option of using their own reports or dummy reports during classroom activities. Our hypothesis is that those students who have their own pharmacogenomics tested will show better overall performance.


Eligibility criteria: Inclusion Criteria:

* Willingness to provide informed consent for participation in the study
* Enrolled in 3rd year Doctor of Pharmacy course

Exclusion Criteria:

* Unwilling or unable to provide consent for participation

Primary outcomes:
measure: Change in Pharmacogenomics Knowledge Assessment
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Change in Self Assessment Questionnaire
timeFrame: 8-12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03561714: Cardiometabolic Care-team Integration Improves Outcomes in Diabetes
Official title: Cardiometabolic Care-team Integration in Primary Care Improves Outcomes in Diabetes: a Pragmatic, Case-controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardio-metabolic Care-Team Intervention (CMC-TI)
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - All patients with type 1 and type 2 diabetes within two primary care clinics at Scripps Coastal Medical Group.

Brief summary: A pragmatic, quasi-experimental (non-randomized) design was used to evaluate clinical and cost outcomes among patients with type 1 or 2 diabetes (T1D or T2D) at two primary care clinics (n=1 intervention, n=1 usual care) between March 2012 and September 2014. At the intervention clinic, the 12-month Cardio-metabolic Care-Team Intervention (CMC-TI) was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months, and a process evaluation gauged CMC-TI feasibility and satisfaction.


Eligibility criteria: Inclusion Criteria:

* All patients with type 1 and type 2 diabetes

Exclusion Criteria:

* None

Primary outcomes:
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Hospital/ER costs
timeFrame: 12 months
measure: LDL
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01845714: Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
Official title: Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Corneal cross Linking
Topo guided PRK
Quality of Life
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.


Eligibility criteria: Inclusion Criteria:

* be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
* present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.

Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:

* an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
* an increase of 1.00 D or more in manifest cylinder
* an increase of 0.50 D or more in manifest refraction spherical equivalent.

Exclusion Criteria:

* glaucoma
* suspicion for glaucoma
* IOP-lowering medications
* central corneal thickness (CCT) less than 400μm
* K-readings more than 60D
* history of herpetic keratitis
* corneal scarring
* severe eye dryness
* pregnancy or nursing
* current corneal infection
* or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450μm.

Primary outcomes:
measure: Vision Specific quality of Life (VS-QoL)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: 10.1097/ICO.0b013e318296e13c. No abstract available.
Clinical trial NCT00184314: Follow-up of Eating Disorder Patients From a 15-year Period.
Official title: Follow-up Eating Disorder Patients and Their Parents Leaving Treatment From 1988 to 2002 at Child and Adolescent Department at Levanger Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorder Symptoms
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: former eating disorder patients

Brief summary: Retrospective follow-up study of former eating disorder patients in child- and adolescent psychiatry on psychiatric symptoms and social intelligence.

Detailed description: Former patients and their parents were contacted 3 to 15 years after their completed treatment for eating disorders at Levanger Hospital, Child and Adolescent Psychiatry Department, in the period from 1988 to 2002. Interviews focusing on general psychiatric symptom, specific eating disorder symptoms, social intelligence and consumer satisfaction. Parents were also contacted and interviewed on consumer satisfaction.

Eligibility criteria: Inclusion Criteria:

* Eating disorder symptoms or disorder

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Child Psychiatry Department, Levanger Hospital, Levanger
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dep of Neuroscience, Center For Child And Adolescent Mental Health
name: Tormod Rimehaug, ass.prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wanderås C. Do Individuals with Eating Disorders Have Lower Emotional Intelligence?: Are Eating Disorders Comorbid with Low Emotional Intelligence? Doctoral dissertation, Institute of Psychology, Aarhus University, 2005
Clinical trial NCT00969514: Robotic-Assisted Laparoscopic Cystectomy
Official title: Robotic-assisted Laparoscopic Cystectomy: Our Center's Clinical Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystectomy
Keywords: Robotic cystectomy
Bladder
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing robotic cystectomy

Brief summary: Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences.

Detailed description: Robotic Cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Our objective is to investigate our results from this novel procedure.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing robotic cystectomy at Beaumont Hospital

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospitals_RO
state: Michigan
Study officials:
affiliation: Beaumont Hospitals-RO
name: Don BUI, MD
role: PRINCIPAL_INVESTIGATOR
References: