louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06606080: The Relationship Between Time Perspective, Fear of Cancer Recurrence, Rumination, and Catastrophizing in Gastric Cancer Survivors
Official title: The Formation Pathway of Fear of Cancer Recurrence in Gastric Cancer Survivors From a Time Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer Patient
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Select elderly gastric cancer patients who were receiving medical treatment at a tertiary hospital

Brief summary: The temporal perspective provides a theory oriented to temporal insights that can shed light on the role of cognitive coping styles in the formation of fear of cancer recurrence. The self-regulatory executive function model elucidates the central role of rumination thinking, catastrophizing cognitive coping styles in the formation of cancer recurrence fear. Therefore, this study will rely on both theoretical models to construct a cognitive appraisal coping model to explore the formation pathway of cancer recurrence fear


Eligibility criteria: Inclusion Criteria:

* Preoperative gastroscopy and pathological diagnosis of gastric cancer;
* Aged 18 years or older
* There is no history of recurrent disease or new primary cancer
* Received surgical resection of cancerous tissues or radiotherapy treatment
* Conscious, with normal communication and comprehension ability
* The patients were aware of their own condition and diagnosis, and informedly agreed to participate in this study

Exclusion Criteria:

● History of mental or cognitive impairment prior to cancer diagnosis

Primary outcomes:
measure: Time perspective
timeFrame: through study completion, an average of 1 year
measure: Catastrophizing
timeFrame: through study completion, an average of 1 year
measure: Rumination
timeFrame: through study completion, an average of 1 year
measure: Fear of cancer recurrence
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu
state: Jiangsu
Study officials:
References:
Clinical trial NCT02401880: Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology
Official title: Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 89
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.

This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.

Detailed description: This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria.

Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days.

Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.

Eligibility criteria: Inclusion Criteria:

1. Male or female subject with diabetes mellitus type 2
2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
3. HbA1c 7.0%-9.9%, both inclusive
4. Diabetes duration of at least 24 months)

Exclusion Criteria:

1. History of diabetes mellitus type 1
2. GFR (as calculated by the Cockcroft-Gault equation) \< 60 ml/min at Screening
3. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening

Primary outcomes:
measure: • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)
timeFrame: 30 days
Secondary outcomes:
measure: • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)
timeFrame: 30 days
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co. KG
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
References:
Clinical trial NCT01279980: Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery
Official title: Continuous Wound Infiltration With Local Anaesthetic vs. Epidurals in an Enhanced Recovery Protocol: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: ERAS
Local anaesthetic wound catheter
Painbuster
Epidural
colorectal surgery
enhanced recovery program
Lead sponsor: Scarborough General Hospital
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic wound catheter) can be used instead of epidurals for patients having bowel surgery in an enhanced recovery programme. The investigators want to find out whether or not using this device means people need to stay in hospital for less time after surgery.


Eligibility criteria: Inclusion Criteria:

* All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant females
* Patients undergoing an abdominoperineal resection
* Patients unable to understand English

Primary outcomes:
measure: Length of hospital stay
timeFrame: determined on discharge from hospital
Secondary outcomes:
measure: Postoperative complications
timeFrame: Whilst an inpatient
measure: Episodes of hypotension in the postoperative period
timeFrame: whilst an inpatient
measure: Postoperative pain
timeFrame: as an inpatient
measure: Amount of postoperative IV fluid administered
timeFrame: as an inpatient
measure: Body composition
timeFrame: Tests will be performed daily until the epidural or Painbuster® has been removed.
measure: Postoperative analgesic requirement
timeFrame: As an inpatient
measure: Postoperative stress response
timeFrame: As an inpatient
measure: Anaesthetic time required
timeFrame: On the day of operation
measure: Postoperative mobility
timeFrame: as an inpatient
measure: Day of return of gut function
timeFrame: As an inpatient
Other outcomes:
Locations:
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: North Yorkshire
Study officials:
affiliation: Scarborough General Hospital
name: Eleanor R Richards, BM Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02322580: An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients
Official title: Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: anti-TNF
therapeutic drug monitoring
immunogenicity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-12-23
Enrollment: 56
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: Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)

Brief summary: The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.


Eligibility criteria: Inclusion Criteria:

* Age from 18 years on, male or female
* Established diagnosis of psoriasis
* Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.
* Patients who give informed consent for this study

Primary outcomes:
measure: trough serum etanercept concentration
timeFrame: one year
measure: anti-etanercept serum concentration
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01569880: Pre-flight Evaluation of Adult Patients With Cystic Fibrosis
Official title: Pre-flight Evaluation of Adult Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Blood gas response
Exercise
Gas exchange
Hypoxia altitude simulation test
Pulmonary function
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cystic fibrosis

Brief summary: The purpose of the study is to investigate the relationship between hypoxemia achieved during Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis
* \> 16 years
* Sputum test negative for Burkholderia cepacia and/or methicillin resistant Staphylococcus aureus

Exclusion Criteria:

* Ongoing infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Bjørn Skrede, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edvardsen E, Akero A, Skjonsberg OH, Skrede B. Pre-flight evaluation of adult patients with cystic fibrosis: a cross-sectional study. BMC Res Notes. 2017 Feb 6;10(1):84. doi: 10.1186/s13104-017-2386-2.
Clinical trial NCT05115240: The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception
Official title: The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.

Detailed description: This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.

Eligibility criteria: Inclusion Criteria:

* fluent in the German language
* ability to give informed consent

Exclusion Criteria:

* cardiovascular disease (previous myocardial infarction, hypertension)
* neurological disorders (epilepsy, stroke, multiple sclerosis)
* continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
* pregnancy

Primary outcomes:
measure: Change in affect
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Secondary outcomes:
measure: Change in perceived stress
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
measure: Change in heart rate variability (HRV)
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
measure: Change in interoceptive accuracy
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
measure: Change in state anxiety and depression
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
state: Hessen
Study officials:
References:
Clinical trial NCT00774540: Acute Pain and Inflammation After Surgery
Official title: Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Injuries
Keywords: Acute pain
Inflammatory pain
Inflammatory mediators
Pain relief
Microdialysis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is

1. to observe acute pain after surgery and measure the natural course of inflammatory mediators
2. study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

Detailed description: Randomizized controlled trial

Eligibility criteria: Inclusion Criteria:

* Day case surgical patients above 18 years old
* Non pregnant

Exclusion Criteria:

-

Primary outcomes:
measure: Pain relief local anti-flammatory effects
timeFrame: 2 h
Secondary outcomes:
measure: Rescue analgesic consumption
timeFrame: 2 h
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Division of Emergencies and Critical Care
Study officials:
affiliation: Oslo University Hospital
name: Leiv Arne Rosseland
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333540: A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity of TD-1211 in Subjects With Opioid-Induced Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-induced Constipation (OIC)
Keywords: constipation
opioid induced
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 69
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: A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* Subjects with documented OIC on stable opioid regimen
* Willingness to stop all laxatives throughout run-in and treatment period

Exclusion Criteria:

* Any clinically significant findings in subjects with OIC
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of chronic constipation prior to opioid therapy in OIC subjects
* Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Primary outcomes:
measure: Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
timeFrame: Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks
Secondary outcomes:
measure: Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels
timeFrame: Continuous assessments for up to six weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Clinical Research Unit
state: Utah
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03271840: Registry for Primary Ciliary Dyskinesia
Official title: Registry for Primary Ciliary Dyskinesia: : Systematic Data Collection on Incidence, Clinical Presentation, Treatment and Course of the Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ciliary Dyskinesia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PCD

Brief summary: Primary Ciliary Dyskinesia (PCD) is a rare disease, which means that any single PCD center has experience with a limited number of patients. PCD Registry is the collection of data about PCD from many centers and countries who treat children with PCD. Collecting data about PCD increase the knowledge on PCD, better describe the course of the disease, and help to better understand the progression of the disease and be used to develop new treatments.

In the PCD registry of Alberta, important information about PCD such as time of diagnosis, symptoms, and tests which led to the diagnosis, state of health at diagnosis, the progression of lung function, the occurrence of severe infections, tests and treatments data will be collected from the patients' medical records.

Detailed description: In order to better characterize the clinical course, and improve the diagnosis and treatment of PCD, the investigators propose to establish a provincial PCD registry in Alberta. This registry will be securely linked to the currently existing International Registry for PCD and will allow more researchers to use the information to do research on PCD.

The investigators will collect demographic data: current age, sex, age, diagnostic findings and symptoms at diagnosis; in addition, clinical data about PCD which are recorded during the past and future clinical visits and encounters (e.g. lung function, weight, height, infections, treatments, and complications) will also be collected.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PCD
* Abnormal findings in at least two of the following tests:

High-frequency video microscopic finding, transmission electron microscopy finding, immunofluorescence finding, low nasal NO concentration/production, demonstration of biallelic disease-causing mutations by genotyping.

Exclusion Criteria:

• Failure or unwillingness to give written informed consent.

Primary outcomes:
measure: Age of diagnosis
timeFrame: 2017-2030
measure: Lung Function
timeFrame: 2017-2030
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Israel Amirav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012440: Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Official title: Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 5
Sex: FEMALE
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: TREATMENT

Brief summary: The purpose of this study is:

1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Detailed description: Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Eligibility criteria: Inclusion Criteria:

* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)

Exclusion Criteria:

* Children (\< 18 years old)
* Pregnant or Lactating women
* Diabetic patients (Type I or II)
* Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
* Patients who have NOT undergone a standard of care bilateral breast MRI

Primary outcomes:
measure: Reduction in Tumor Size
timeFrame: 1-2 weeks post treatment onset
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: The University of Chicago Medical Center
name: Kirti Kulkarni, M.D.
role: PRINCIPAL_INVESTIGATOR
References: