louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06532097: Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients
Official title: Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients: a Pilot-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unmedicated, depressed patients (mildly or moderately depressed).

Brief summary: It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.


Eligibility criteria: Inclusion Criteria:

* Written consent for voluntary study participation
* Between 18 and 65 years of age
* Current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to ICD-10 (F32.0, F32.1)
* Internet access and email address to answer electronic questionnaires
* Ability to read German

Exclusion Criteria:

* Acute suicidality
* Pregnancy and breastfeeding
* Currently undergoing psychological treatment
* Current use of psychotropic medication
* Neurological or internal medical disease
* Diagnosis of a severe major depression or dysthymia according to ICD-10 (F32.2, F32.3, F33.2, F33.3, F34.1)
* Diagnosis of a psychotic disorder according to ICD-10 (F20-F29) in the life history
* Diagnosis of a bipolar disorder according to ICD-10 (F31) in life history
* Acute substance abuse (e.g., drug use or excessive alcohol and nicotine use)
* Diagnosis of dissociative disorder (F44) in life history

Primary outcomes:
measure: PHQ-9
timeFrame: pre to post: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
state: Bavaria
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Victor Spoormaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313997: The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain
Official title: The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain, A Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Disc Herniation
Keywords: chronic upper back pain
thoracic disc herniation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 18-65 years old
* admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.
* Diagnosed with TDH as a result of thoracic vertebral MRI

Brief summary: Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study.

Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program.

Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS).

The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.
* Diagnosed with TDH as a result of thoracic vertebral MRI

Exclusion Criteria:Patients with

* vertebral fracture,
* developmental spinal deformity,
* spinal infection or tumor,
* chronic widespread pain syndrome such as fibromyalgia,
* diabetes mellitus,
* polyneuropathy
* rheumatological disease
* under 18 years old
* over 65 years old
* who have had previous back and neck surgery

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Private Medar Hospital
Study officials:
affiliation: Kocaeli University
name: emine dundar ahi, ass professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581997: QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
Official title: A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Fibrosis Secondary to Systemic Sclerosis
Keywords: Pulmonary fibrosis, systemic sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-28
Enrollment: 8
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: This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
* Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening

Exclusion Criteria:

* Certain medical conditions may exclude patients from participation.
* Should not have participated in another clinical study within 4 weeks of study start
* Smokers are not eligible for participation
* Blood loss of donation of 400 mL or more within 2 months of study start
* Pregnant women or women who are breast feeding
* Past medical history of clinically significant ECG abnormalities
* Connective tissue disorders other than systemic sclerosis.
* Active infection or history of systemic parasitic infection
* History of immunodeficiency diseases, including a positive HIV test result
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: - Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
timeFrame: throughout the study
Secondary outcomes:
measure: - The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS.
timeFrame: throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458897: Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant
Official title: Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: bone marrow cellularity
bone marrow transplant
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 5 years.
* Diagnosis of SCD (\[Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sβ) genotype\].
* Patient is a candidate for an allogeneic HCT.
* Subject or guardians have given informed consent.

Exclusion Criteria

* The need for general anesthesia for MRI.
* Subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field.
* A subject who is pregnant.
* Previous HCT.

Primary outcomes:
measure: Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant
timeFrame: 110 days post transplant
Secondary outcomes:
measure: MRI and hemoglobin S.
timeFrame: 1 year post transplant
measure: MRI and neutrophil engraftment
timeFrame: 1 year post transplant
measure: MRI and chimerism
timeFrame: 1 year post transplant
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ghada Abusin, MBBS MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574297: An Observational Study on the Natural Course of Chronic Pancreatitis
Official title: The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pancreatitis
Genetic Mutation
Smoking, Tobacco
Drinking, Alcohol
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 798
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014

Brief summary: To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

Detailed description: The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of chronic pancreatitis
* agree to join the study and provide informed consent

Exclusion Criteria:

* autoimmune pancreatitis
* pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
* the follow-up time less than 2 years
* patients presenting with diabetes and/or steatorrhea at onset of CP.

Primary outcomes:
measure: the Number of Patients Developing Pancreatic Insufficiency
timeFrame: 10 years
Secondary outcomes:
measure: Death
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References:
citation: Ru N, Xu XN, Cao Y, Zhu JH, Hu LH, Wu SY, Qian YY, Pan J, Zou WB, Li ZS, Liao Z. The Impacts of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1378-e1387. doi: 10.1016/j.cgh.2021.08.033. Epub 2021 Aug 28.
Clinical trial NCT03412097: (MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation
Official title: Assessing New or Worsening Symptoms (Aka Adverse Events for This Study) After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Manipulation, Spinal
Keywords: chiropractic
SMT
active surveillance reporting system
Lead sponsor: Parker University
Sponsor class: OTHER
Collaborators: name: University of Texas at Tyler
name: University of Alberta
name: Canadian Memorial Chiropractic College
First posted: 2018-01-26
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive Patients

Brief summary: To increase patient safety culture in spinal manipulation therapy (SMT) this study will assess the ability to implement an active surveillance reporting system for a chiropractic teaching clinic and determining preliminary incidence of adverse events (AE) following SMT performed by the chiropractic interns. Adverse events defined for the primary outcome of this study is any new or worsening symptom following a chiropractic encounter.

Detailed description: Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data on patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Eligibility criteria: Inclusion Criteria:

* Patients at the Parker University Wellness Clinic
* Agreed to participate

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Patient Encounters That Report a New or Worsening Symptom
timeFrame: Up to 7 days post treatment - Day 0-7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Parker University
name: Katherine A Pohlman, DC, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04004897: Optic Nerve Sheath Diameter in Preeclampsia
Official title: Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study targets to evaluate the ICP in patients with or without preeclampsia.

Detailed description: MRI studies have shown that brain edema due to an elevation in ICP develops in up to 70% of women with preeclampsia. Optic nerve sheath diameter is used to estimate the ICP and has been shown to correlate well with invasive ICP measurement. The present study aims to compare ICP using optic nerve sheath diameter in women with or without preeclampsia.

Eligibility criteria: Inclusion Criteria:

* Must be diagnosed as preeclampsia
* Age must be \> 18 years

Exclusion Criteria:

* History of previous intracranial pathology or surgery
* Glaucoma

Primary outcomes:
measure: ICP
timeFrame: At 6th hour of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Huseyin Kiyak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384097: An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery
Official title: An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Surgical Neck of Humerus
Colonic Tumor
Stage IIIB Ovarian Carcinoma
Neoplasm of Head of Pancreas
Keywords: haemodynamic
goal-directed therapy
surgery
anaesthesia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 774
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: Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection.

Brief summary: A systematic literature search a goal-directed haemodynamic algorithm was created. The hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and can improve clinical outcome.

Detailed description: After a systematic literature search a goal-directed haemodynamic algorithm was created. The algorithm was adapted to international standards and consensus was reached through a modified Delphi method at international meetings. The feasibility of using the algorithm for intraoperative haemodynamic management was tested and the resultant clinical data analyzed retrospectively for several types of surgery with the hypothesis that the goal-directed haemodynamic algorithm is feasible in the clinical setting and can improve clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection at the Charité - University Medicine Berlin, Campus Virchow Clinic
* 18 years and older

Exclusion Criteria:

* emergency procedures

Primary outcomes:
measure: hospital length of stay
timeFrame: a period of 60 days
Secondary outcomes:
measure: need for ventilator therapy
timeFrame: a period of 60 days
measure: monetary reimbursement for prolonged hospital stay
timeFrame: a period of 60 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01003197: Novel Preoperative Score Predicting Outcome Following Liver Resection
Official title: Novel Preoperative Score Predicting Outcome Following Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serious Complications Following Liver Resection
Keywords: Development
Validation
Prediction Score
Complication
Liver resection
develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HPB center Zurich, Switzerland

Brief summary: To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

Detailed description: Liver surgery is associated with a substantial rate of complications. Early identification of patients at risk of serious complications is important in order to adapt therapeutic strategies and to improve quality. The purpose of this study is to develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years
* liver resection

Exclusion Criteria:

* Trauma cases

Primary outcomes:
measure: develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
timeFrame: postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department of Visceral and Transplantation Surgery, University Hospital of Zurich
state: Zurich
Study officials:
affiliation: Department of Visceral and Transplantation Surgery, University Hospital of Zurich
name: Stefan Breitenstein, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: