louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00313391: Risperdal Consta and Health Care Utilization in Patients With Schizophrenia
Official title: The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Janssen, L.P. - Investigator Initiated Studies Program
First posted: 2006-04-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of schizophrenia or schizoaffective disorder
* 4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year
* Medicaid recipient
* Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)

Exclusion Criteria:

* Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder
* Drug or alcohol dependence
* Serious, unstable medical illness or any acute medical condition
* Pregnant or lactating females
* Prior Risperdal Consta treatment
* Non-English speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Dragana Bugarski-Kirola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379791: Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly
Official title: Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly - a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Fractures
Keywords: surgical site infections
wound complications
operatively treated ankle fractures
delayed wound healing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ankle fractures surgically treated at the University Hospital Basel starting with the patients operated in 2017 and then going backwards in time, until 120 patients with a surgical site infection or a wound complication are found. Then randomly collection of 120 controls among the remaining investigated patients .

Brief summary: This study is to analyse risk factors for wound complications or surgical site infections and to analyse whether risk factors for wound complications or surgical site infections are also factors for other complications. Based on the data from this study it will be investigated whether a risk score can be build up to predict individual risk for a complication after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 50 years with ankle fractures surgically treated at the University Hospital Basel
* Sufficient Follow up at the University Hospital Basel in order to judge wound healing complications over a 4 weeks period and fracture related infection over a 3 months period

Exclusion Criteria:

* Existence of a documented dissent.
* Distal tibia fractures and Pilon fractures
* Followed up at another institution or with no follow up at our institution for any other reason

Primary outcomes:
measure: association between single risk factors and outcome (wound healing complication, surgical site infection)
timeFrame: at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Dep. of Orthopedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Dep. of Orthopedics and Traumatology, University Hospital Basel
name: Henrik Eckardt, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180491: A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Keywords: Discoloured and deformed nails resulting from onychomycosis
Lead sponsor: Moberg Pharma AB
Sponsor class: INDUSTRY
First posted: 2010-08-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 years or older
* 25%-75% of the target nail altered as a result of onychomycosis
* Signed written informed consent

Exclusion criteria

* Proximal subungual onychomycosis
* Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
* Other conditions known to cause abnormal nail appearance
* Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
* Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
* Known allergy to any of the tested treatment products

Primary outcomes:
measure: Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04656691: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Official title: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Covid19
Keywords: COVID19
bamlanivimab
UnitedHealth
Lead sponsor: UnitedHealth Group
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: Optum, Inc.
First posted: 2020-12-07
Enrollment: 139
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Primary purpose: TREATMENT

Brief summary: This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.


Eligibility criteria: Inclusion Criteria:

* UnitedHealthcare member
* confirmed COVID-19 positive
* located in an area where Bamlanivimab (LY3819253) is available for infusion

Exclusion Criteria:

* current (from first symptom report) hospitalization for COVID-19
* prior administration of Bamlanivimab or other COVID-19 therapies
* previous COVID-19 diagnosis
* prior receipt of a COVID-19 vaccine
* not authorized for patient use per the EUA

Primary outcomes:
measure: Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
timeFrame: Days 1-28 after at-home infusion of Bamlanivimab
Secondary outcomes:
measure: Safety - Documenting Adverse Events After Infusion
timeFrame: Days 1-28 after at-home infusion of Bamlanivimab
Other outcomes:
Locations:
city: Minnetonka
country: United States
facility: QueryLab
state: Minnesota
Study officials:
affiliation: ProHealth New York - UnitedHealth Group
name: Dan Griffin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Clinical trial NCT02120391: Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Official title: Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.

Detailed description: Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-adherence in patients in clinical remission is high with rates around 60%. Non adherence in patients in clinical remission can have significant impact because it can lead to higher rates of clinical flares and increased health care cost.

This will be a single-blinded randomized controlled trial to evaluate if patients randomized to an iPphone application vs. control can increase the adherence of their maintenance medication. The trial will last three months and we hope to enroll 99 patients.

The primary outcome will be adherence measured by the medication possession ratio. The secondary objective will be to evaluate if a validated adherence questionnaire can predict adherence in patients with inflammatory bowel disease.

Having an intervention that can increase adherence can provide better care for patients. Also having a validated survey tool can accurately identify non-adherence in inflammatory bowel disease patient would be a valuable tool for patient care.

Eligibility criteria: Inclusion Criteria:

* At least 18 -65 years of age.
* Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
* On a stable dose of mesalamine for at least two months prior to entering the study
* Have an iPhone (personal iPhone)
* Patient may receive steroid or mesalamine enemas during the study only on an as needed basis

Exclusion Criteria:

• Are on more than one medication for their inflammatory bowel disease

Primary outcomes:
measure: Medication adherence using iPhone App
timeFrame: 3 months
Secondary outcomes:
measure: Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Freddy Caldera, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322591: Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced NSCLC Patitnts: the POSEIDON Trial
Official title: Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer ( Poseidon Study）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: PD-L1 ;RET Fusion Lung Cancer Patients
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RET Fusion Positive Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS

Brief summary: This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer.

Detailed description: This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus the PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer. We aim to enrolled 100 patients in this study, the primary endpoint was PFS.

Eligibility criteria: Inclusion Criteria:

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* RET Fusion Positive
* First Diagnosis and Treatment
* Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria:

* - Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: may 2020- may 2021 (1 year)
Secondary outcomes:
measure: ORR
timeFrame: may 2020- may 2021 (1 year)
measure: OS
timeFrame: may 2020- may 2021 (1 year)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782691: Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.
Official title: Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: FDG-PET segmentation tools
Head-and-neck cancer
Histological validation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.

Brief summary: Various methods of FDG-PET signal segmentation will be validated by correlation of histopathologically measured tumor dimensions in lymph node dissection specimens of head-and-neck cancer patients.


Eligibility criteria: Inclusion Criteria:

* All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection.
* Age \>18 years.

Exclusion Criteria:

* Pregnancy.
* Women breast feeding

Primary outcomes:
measure: How accurate are the various FDG-PET segmentation tools?
timeFrame: Measurements are performed in conjunction with the clinical pathologist directly postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
References:
Clinical trial NCT05786391: Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy
Official title: Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Integrity
Bladder Function
Ureteral Integrity
Ureteral Function
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective:

The investigators seek to compare the efficiency of the cystoscopy with two interventions:

1. patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. Abdominal insufflation (insufflation versus no insufflation)

Detailed description: This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.

The investigators seek to compare the efficiency of the cystoscopy with two interventions:

1. patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. Abdominal insufflation (insufflation versus no insufflation).

Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.

Eligibility criteria: Inclusion Criteria:

- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).

Exclusion Criteria:

* Pregnancy
* Known urologic anomaly
* Unplanned cystoscopy
* Cancer surgery
* Urogynecology surgery
* comorbidities including cardiac disease, chronic hypertension, any stage kidney disease (including abnormal creatinine level), and use of diuretics.
* Undergoing extensive ureterolysis
* Blood loss more than 500 milliliters (mLs)
* Contra-indications to position change and insufflation

Primary outcomes:
measure: Time in Seconds to Complete the Cystourethroscopy
timeFrame: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Randa Jalloul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03428191: Target Effect-site Concentration of Remifentanil in Transperineal Prostate Puncture
Official title: The Research About the Target Effect-site Concentration of Remifentanil Inhibiting Stress Reaction of the Perineal Prostate Puncture When Dexmedetomidine Being Continuous Pumping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia, Intravenous
Keywords: dexmedetomidine
remifentanil
prostate puncture and biopsy
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2018-02-09
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of perineal prostate puncture

Brief summary: The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping

Detailed description: Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.

Eligibility criteria: Inclusion Criteria:

* patients of perineal prostate puncture

Exclusion Criteria:

* sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid

Primary outcomes:
measure: the target effect-site concentration of remifentanil
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433
name: Liu Yi, D.M
role: STUDY_DIRECTOR
References: