louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06474611: Evaluation of a Patient 'nudge' on Engagement in Lung Cancer Screening
Official title: Evaluation of a Patient 'nudge' on Engagement in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 894
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this quality improvement project is to conduct and evaluate the effect of sending an electronic reminder message to patients who qualify for lung cancer screening, haven't had a screening previously, and who have an upcoming scheduled appointment with their doctor.

Detailed description: United States Preventive Services Task Force (USPSTF) lung cancer screening (LCS) guidelines recommend LCS for those aged 50-80 with at least 20 pack-years smoking history, who currently smoke or quit within the last 15 years. In 2023, our study team found that there are approximately 6,000 - 8,000 Kaiser Permanente Colorado (KPCO) members who are unscreened and eligible for lung cancer screening (LCS). In support of KP's Population Health priority initiative to expand lung cancer screening participation for those who are eligible, our study team was selected to move this work forward in 2024 with feasible implementation opportunities for the KPCO LCS Operational/Institute for Health Research partnership at its core. The primary objective of this project is to conduct and evaluate a randomized quality improvement pragmatic intervention of a 2-arm electronic message outreach to unscreened LCS members who are eligible for LCS and who have an upcoming scheduled Primary Care Provider (PCP) visit.

Eligibility criteria: Inclusion Criteria: Qualifies for Lung Cancer Screening based on USPSTF criteria (aged 50-80, at least 20 pack years smoking history, currently smoke or quit in the last 15 years); have an upcoming, scheduled Primary Care visit in a KP clinic in the coming 7-14 days, have not completed a low-dose CT scan.

Exclusion Criteria:

* None

Primary outcomes:
measure: The proportion completed a visit with a Primary Care provider by receipt of an electronic letter or paper letter
timeFrame: 12 months
measure: The proportion receiving an order to get a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
timeFrame: 12 months
measure: The proportion completing a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Debra Ritzwoller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455728: A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
Official title: International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorders
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 3690
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children treated with NutropinAq in the specialised paediatric endocrinology centres

Brief summary: This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.

Detailed description: The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.

Eligibility criteria: Inclusion Criteria:

* Children of either sex who are treated with NutropinAq® for the treatment of growth failure
* Patients who are willing to comply with follow-up appointments throughout study participation
* Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable

Exclusion Criteria:

* Patients not treated with NutropinAq®
* Patients with closed epiphyses
* Patients with active neoplasia

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Every 3 months until study completion
Secondary outcomes:
measure: Treatment height measurements until epiphyseal closure is achieved.
timeFrame: Every 3 months until study completion
Other outcomes:
Locations:
city: Slough
country: United Kingdom
facility: Ipsen Central Contact
state: Berkshire
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Coutant R, Bosch Munoz J, Dumitrescu CP, Schnabel D, Sert C, Perrot V, Dattani M. Effectiveness and Overall Safety of NutropinAq(R) for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq(R) European Registry (iNCGS). Front Endocrinol (Lausanne). 2021 May 25;12:676083. doi: 10.3389/fendo.2021.676083. eCollection 2021.
Clinical trial NCT02014428: Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrophic Vaginitis
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2013-12-18
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.


Eligibility criteria: Inclusion Criteria:

* at least 12 months postmenopausal
* mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

Primary outcomes:
measure: Atrophic vaginal changes
timeFrame: Change from baseline epithelium at 3 months
Secondary outcomes:
measure: Assessment of Itching
timeFrame: Change from baseline Itching at 3 months
measure: Assessment of Burning
timeFrame: Change from baseline Burning at 3 months
measure: Assessment of Dyspareunia
timeFrame: Change from baseline Dyspareunia at 3 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
Study officials:
References:
Clinical trial NCT04466228: Non-invasive Transcranial Electrical Stimulation in MS
Official title: Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Impairment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 60
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: TREATMENT

Brief summary: The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.

Detailed description: The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.

Eligibility criteria: Inclusion Criteria:

* age 18-65,
* diagnosis of MS
* Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
* a minimum of 3 months since the last relapse
* Beck Depression Inventory\<19
* normal hearing
* and no changes in MS or symptomatic medications in past 2 months

Exclusion Criteria:

* prior brain surgery
* clips in brain
* epilepsy or other neurological or non-affective psychiatric disorders
* pregnancy

Primary outcomes:
measure: Processing Speed Change From Baseline Assessment
timeFrame: Baseline (pre-stim) and post-stimulation (up to 2 hours)
measure: EVO Performance Change From Baseline Assessment
timeFrame: Baseline (pre-stim) and post-stimulation, up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Sandler Neurosciences Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05920928: Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer
Official title: Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Rectal Carcinoma
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.


Eligibility criteria: Inclusion Criteria:

Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .

Exclusion Criteria:

Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)

Primary outcomes:
measure: Clinical complete response
timeFrame: Week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03821428: Acupuncture for Relief of Gag Reflex
Official title: Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gagging During Transesophageal Echocardiography
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is better than placebo acupuncture in treatment of gagging in patients undergoing elective transesophageal echocardiography (TEE)

Detailed description: Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort because of active gagging reflex, which sometimes preclude the performance of TEE and requires additional medication. According to existing literature, needling of acupoint CV24 effectively prevents gagging during dental procedures. We are going to use this phenomenon in patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and reduce the need for additional sedative medication. Within this investigation the patients will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or placebo procedure immediately before TEE examination. As outcome the incidence and intensity of gagging, total dose of additional sedative medication and hemodynamic parameters will be recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective ambulatory transesophageal echocardiography (TEE) without sedation
2. TEE time does not exceed 30 minutes
3. Patients without previous opioid and psychotropic medication
4. Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm
5. Patients who have given written informed consent

Exclusion Criteria:

1. Current psychiatric disease
2. Local skin infection at the sites of acupuncture
3. Aged \< 30 or \> 65 years
4. TEE time more than 30 min
5. Patients who consumed opioid medication at least 6 months before surgery
6. Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy.
7. Patients who are unable to understand the consent form or to use visual analogue scale 100 mm

Primary outcomes:
measure: Incidence of gagging during probe insertion
timeFrame: 10 minutes after TEE probe insertion
Secondary outcomes:
measure: Gagging score
timeFrame: 10 minutes after TEE probe insertion
measure: Rescue medication
timeFrame: 10 minutes after TEE probe insertion
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
affiliation: University Medicine of Greifswald
name: Taras Usichenko
role: STUDY_CHAIR
References:
Clinical trial NCT00928928: Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer
Official title: Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: Lipid peroxidation
Protein peroxidation
DNA peroxidation
RNA peroxidation
Cytokines
hsCRP
Oxidative stress markers
Open surgery
Laparoscopic surgery
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
Collaborators: name: University of Ioannina
First posted: 2009-06-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer


Eligibility criteria: Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* metastases
* recurrent disease
* chronic diseases

Primary outcomes:
measure: Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach
timeFrame: preoperative, intraoperative, 6h postop, 24h postop
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: G Hatzikosta General Hospital
Study officials:
References:
citation: Pappas-Gogos G, Tellis C, Lasithiotakis K, Tselepis AD, Tsimogiannis K, Tsimoyiannis E, Chalkiadakis G, Chrysos E. Oxidative stress markers in laparoscopic versus open colectomy for cancer: a double-blind randomized study. Surg Endosc. 2013 Jul;27(7):2357-65. doi: 10.1007/s00464-013-2788-8. Epub 2013 Feb 13.
Clinical trial NCT04591028: A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
Official title: Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gastric Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 and ≤ 75 years of age.
* Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
* Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
* No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
* American Society of Anesthesiology score (ASA) class I, II, or III.
* Written informed consent.

Exclusion Criteria:

* Patients ≤ 18 and ≥ 75 years of age.
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
* History of allergy to iodine agents.
* History of other malignant disease within past five years.
* Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
* Patients intraoperatively/postoperatively confirmed as T4b.
* Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.

Primary outcomes:
measure: Positive ICG fluorescence lymph nodes
timeFrame: Approximately 30-90 days after surgery
measure: Disease positive lymph nodes
timeFrame: Approximately 30-90 days after surgery
measure: Number of lymph nodes removed for each lymphatic station of gastrectomy
timeFrame: Approximately 30-90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Enrique F Elli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02620228: Identification of Liver Tumours Using BIP - Biopsy System
Official title: INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Biopsy
Keywords: Bioimpedance
Biopsy
Liver tumour
Biopsy needle guidance
Lead sponsor: Injeq Ltd
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This clinical device investigation is conducted by performing liver biopsies using the BIP - Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours from surrounding tissue. In addition, user feedback is obtained to improve the usability of the investigational device. The study does not affect the traditional treatment procedure and only the patients in clinical need for diagnosis by liver biopsy are included on voluntary basis. The invasive products used in actual biopsy operation are designed so that their performance is essentially equal to the currently used biopsy devices, the only difference is the measurement capability of biopsy needle and connection to measurement device.


Eligibility criteria: Inclusion Criteria:

* Consenting adults undergoing ultrasound-guided core liver biopsy to diagnose liver tumour or other abnormalities
* Identifiable non-tumorous liver tissue along the planned needle injection path.

Exclusion Criteria:

* Inability to give informed consent
* Being under aged
* Being pregnant
* Being high risk patient
* Lack of identifiable non-tumorous liver tissue along the injection path to the tumour location
* Known contraindications to liver biopsy.

Primary outcomes:
measure: Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue
timeFrame: During liver biopsy (couple of minutes/patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Department of Radiology
state: HUS
Study officials:
affiliation: Helsinki University Hospital, Department of Radiology
name: Kirsti Numminen, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426528: R.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population
Official title: UR.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population: Study Protocol for a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Personal Satisfaction
Health Behavior
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This cluster randomized trial will test the affect of individual participation in culturally- and socially-related activities on health and well-being, in comparison also with the classic individual determinant, in relation to urban renovation schemes. Investigators will using a questionnaire based on several areas such as individual psychological well-being (PGWBI), individual happiness positioning (Keyes Scale) and health status perception (SF-12 Health Survey). Secondary outcomes will be related to social capital density (relationships and trust), culture (participation) and religion. The survey will be undertaken in a mid-size Italian metropolitan area, namely the Metropolitan City of Bologna.


Eligibility criteria: Inclusion Criteria:

* Gender: men and women;
* Age range between 18 and 75 years old;
* Residency: in an area of 2 square kilometers surrounding the Casa del Popolo

Exclusion Criteria:

* participants no having the previous features

Primary outcomes:
measure: PGWBI (The Psychological General Well-Being Index)
timeFrame: after 24 months (end of study)
Secondary outcomes:
measure: MHC-SF (Mental Health Continuum - Long Form MHC-LF)
timeFrame: after 24 months (end of study)
measure: SF-12 Health Survey
timeFrame: after 24 months (end of study)
Other outcomes:
Locations:
Study officials:
References: