louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00368771: A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome
Official title: A Six-Month Study to Compare Outcome Differences and Visceral Response in Subjects Randomized to a Psychological Intervention for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Abdominal Pain
Abdominal Discomfort
Diarrhea
Constipation
IBS
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2006-08-25
Enrollment: 163
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 purpose of this study is to assess the effect of participation in one of the following interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational Training on improving IBS associated symptoms. It is anticipated that this research will provide information on the usefulness of psychological approaches in treating IBS and will help scientists better understand the disorder.


Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome

Exclusion Criteria:

* GI pathology (organic disease) that affects bowel transit
* Co-morbid pain disorders
* Current or recent history (within 24 months) of drug or alcohol abuse
* Clinical evidence (including physical exam, laboratory tests) of significant medical disease that may interfere with the patient successfully completing the trial
* Planned use of drugs or agents that affect GI motility and/or perception

Primary outcomes:
measure: Changes in Symptoms
timeFrame: 14 days
Secondary outcomes:
measure: IBS-specific Quality of Life increase
timeFrame: 14 days
measure: IBS-Specific Beliefs and Coping
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University of California Los Angeles, West Los Angeles VA Healthcare System
name: Bruce D Naliboff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Michelle G Craske, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craske MG, Wolitzky-Taylor KB, Labus J, Wu S, Frese M, Mayer EA, Naliboff BD. A cognitive-behavioral treatment for irritable bowel syndrome using interoceptive exposure to visceral sensations. Behav Res Ther. 2011 Jun;49(6-7):413-21. doi: 10.1016/j.brat.2011.04.001. Epub 2011 Apr 19.
Clinical trial NCT06014671: The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS
Official title: The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS at Mettu Karl Referral and Bedele Hospital, Southwest Ethiopia, 2022: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breif Description: Patients' Quality of Life of
Lead sponsor: Mattu University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quality of life (QOL) is a significant importance for people living with HIV/AIDS by modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia, interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for quality of life. The objective of the study was to assess the effects of interpersonal psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital, southwest Ethiopia, 2022.


Eligibility criteria: Inclusion Criteria:

* PLWHA who were 18 years of age or above were included in the study

Exclusion Criteria:

* PLWHA who are either currently or previously used IPT and acute physical or mental disturbances will be excluded

Primary outcomes:
measure: The effect of Interpersonal Psychotherapy on quality of life among people living with HIVAIDS
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Mattu University
state: Oromia
Study officials:
References:
Clinical trial NCT05514171: Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline
Official title: PROSPECTIVE REGISTRY OF PATIENTS WITH BORDERLINE AND RESECTABLE PANCREATIC ADENOCARCINOMA IN CATALONIA (PaNLoCat)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy Effect
Pancreas Cancer
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 300
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: Any patient who has been diagnosed of ADK resectable or borderline and assessed in a multidiscliplinary tumor board between 2017 and 2021

Brief summary: Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival.

Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.


Eligibility criteria: Inclusion Criteria:

* resectable or borderline pancreas ADK
* with or without radiotherapy
* any type of approach
* any type of surgery

Exclusion Criteria:

* locally advanced ADK
* No consent

Primary outcomes:
measure: Disease free survival
timeFrame: Three years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT05596071: Whether Opioids Are Factor That Induced POD?
Official title: Whether Opioids Are Factor That Induced Postoperative Delirium?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Keywords: opioid
POD
gastric cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .

Detailed description: Postoperative delirium (POD) is a common postoperative complication of the elderly caused by a variety of factors. POD is an acute neuropsychiatric disorder characterized by disturbance of attention consciousness and cognitive function fluctuation, and more than 40% of elderly patients have symptoms of hypoactivity POD.The incidence of POD is as high as 17% to 61% in patients with neurocognitive impairment and patients undergoing complex or emergency surgery, which usually occurs between 1 and 3 days after surgery. POD will lead to prolonged hospital stay, functional impairment and even death. How to prevent and treat POD is an urgent clinical problem to be solved at present.

Opiates are commonly used perioperative sedatives and analgesics, which may be associated with the occurrence of postoperative POD in elderly patients and increase the risk of POD. It is not clear whether perioperative use of low doses of opioids could reduces the incidence of POD in elderly patients. In this study, reducing-opioids anesthesia was defined as the use of 1/3 of the conventional opioid dose to observe whether reducing-opioids anesthesia affected the incidence of POD in elderly patients undergoing gastric cancer surgery

Eligibility criteria: Inclusion Criteria:

* Patients' age ≥65 years
* Underwent elective radical gastrectomy

Exclusion Criteria:

* Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy \<18, primary school \<21, junior school and above \<25
* Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
* History of alcohol abuse or a history of drug dependence
* Have brain surgery or trauma
* Cannot with the completion of tests of Postoperative Cognitive Dysfunction
* Refused to participate in the study

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 3 days after surgery
measure: Incidence of postoperative delirium
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: 3 days after surgery
measure: Anaesthesia related adverse event
timeFrame: 3 days after surgery
measure: blood pressure
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: chaoqun Fei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183271: Proton Boost for Locally Advanced HEAD AND NECK TUMORS
Official title: Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelial Tumor, Malignant
Neuroendocrine Tumors
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 20
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: TREATMENT

Brief summary: The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Detailed description: Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy \[RBE\] in 2-3 Gy \[RBE\] per fractions for 8-15 total fractions.

PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy \[RBE\].

Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.

Eligibility criteria: Inclusion Criteria:

* Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour
* Inoperable tumour, locally advanced stage
* Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx
* At least one lesion measured according to the RECIST criteria
* Enrollment for irradiation with IMRT up to 50-60 Gy RBE\] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.

Exclusion Criteria:

* Metastasis
* Previous radiotherapy
* Any metallic implants or other conditions such to prevent an adequate imaging of target volume
* Unavailability of previous IMRT first phase radiotherapy plans

Primary outcomes:
measure: Local response
timeFrame: 90 days
measure: Acute toxicity
timeFrame: 90 days
Secondary outcomes:
measure: Local control
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Late toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
Study officials:
References:
Clinical trial NCT06040671: Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Official title: Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eyelid Ptoses
Ectropion Eyelids
Entropion;Eye
Keywords: Vectra M3 device
Eyelid Ptoses
stereo photographic system
eyelid surgery
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be divided into two groups.
Primary purpose: DIAGNOSTIC

Brief summary: An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very difficult - although it is possible to use different measuring parameters (distance of pupillary reflexes from the edges of the eyelid), comparing different distances on the face, exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods are based either on the subjective assessment of the examiner or on the correctness of the attached ruler, and their objectivity is therefore very low.

Detailed description: The goal of the project is to develop a methodology for evaluating the results of operations using a stereo photographic system, to objectively evaluate the functionality and results of various eyelid operations, and subsequently to expand the use of the device in other ophthalmological indications.

Different files will be created where the effect of different operations will be monitored in parallel.

Lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery through an anterior approach will be evaluated in the second group.

In all patients, the position of the eyelids, their change before and after surgery, the periorbital volume, and the relation of the eyelids to the periorbital landscape will be assessed metrically.

The Vectra M3 device will be used for the measurement.

The expected cohort size is 40 patients in each group.

Eligibility criteria: Inclusion Criteria:

* Eyelid ptosis
* Eyelid entropion
* Eyelid ectropion

Exclusion Criteria:

* Refusal to participate in the study
* Not signing the Informed Consent Form
* Inability/reluctance to cooperate in the study

Primary outcomes:
measure: Distance between anatomical points on the face
timeFrame: 6 months
measure: Periorbital volume measurement
timeFrame: 6 months
Secondary outcomes:
measure: The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
timeFrame: 3 years
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Adam Kopecký, MD,PhD,FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604471: Lipid-lowering Therapy Individualization
Official title: Lipid-lowering Therapy Individualization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2018-07-27
Enrollment: 75
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 study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.

Detailed description: Atorvastatin is widely prescribed for the treatment of hypercholesterolemia to prevent the risk of cardiovascular diseases, a leading death cause in industrialized countries. There exists considerable inter-individual variability in response to statins, reflected by differences in lipid-lowering effect or risk of presenting adverse drug reaction; mainly myotoxicity. A plethora of different factors (demographic, genetic, physiopathologic, environmental...) have been tested to explain this variability but it lacks of pharmacokinetic (PK) data and/or replications of observations are rare and results remain inconclusive, probably because of non-adapted designs and no-clear driven-hypothesis but also due to a lack of scientific rationale and deep mechanistic understanding. This clinical study will explore individual factors influencing statin PK in a cohort of 150 patients treated with atorvastatin. The collection of meticulous clinical PK data and a rigorous statistical analysis will allow quantifying the effect of each identified parameter on statin PK and eventually, defining a population-based PK model taking into account the combined effect of all covariates in a quantitative approach. This innovative prospectively designed clinical study will ultimately allow predicting atorvastatin PK fluctuations and anticipating any inadequate dosing in clinical care.

Eligibility criteria: Inclusion Criteria:

* Treatment with atorvastatin (any dose)

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Atorvastatin population pharmacokinetics
timeFrame: 18 months
measure: Atorvastatin metabolites population pharmacokinetics
timeFrame: 18 months
Secondary outcomes:
measure: Cholesterol
timeFrame: 18 months
measure: Creatine kinase
timeFrame: 18 months
measure: Occurrence of adverse drug events
timeFrame: 18 months
measure: Pharmacogene genotype
timeFrame: 18 months
measure: Triglycerides
timeFrame: 18 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Luc Balligand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06408571: Study on the Pathogenesis of Retinal Vascular Diseases Based on Body Fluid Metabolomics
Official title: Study on the Pathogenesis of Retinal Vascular Diseases Based on Body Fluid Metabolomics
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolomics; Retinopathy; Etiology
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 3900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RVO and DR Who were admitted to Zhongnan Hospital of Wuhan University from January 2018 to August 2023 (about 3600 cases)

Brief summary: Through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored.

Detailed description: 1. Clinical data of patients with RVO and DR Were retrospectively studied to analyze their pathogenesis. 2. Metabolomic studies were conducted on body fluids (intraocular fluid and peripheral blood) of patients with RVO and DR And control group to find out the differences and find new targets for the prevention and treatment of RVO and DR.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Confirmed diagnosis of retinal vein obstruction and diabetic retinopathy through ophthalmic specialist examination

Exclusion Criteria:

* Severe systemic diseases
* Pregnant and lactating patients

Primary outcomes:
measure: Screening of prognostic markers and model validation
timeFrame: 1/12/2024-30/12/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT04608071: A Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube.
Official title: Efficacy and Safety of a Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube：a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty-three patients with dysphagia from Department of Rehabilitation, the Second Affiliated Hospital of Zhejiang University School on January 1, 2017 to January 1, 2019. All the patients included in this study were in accordance with the guide of diagnosis and treatment of swallowing disorders of diagnostic criteria.

Brief summary: To compare efficacy and safety of a new modified post-pyloric feeding tube bedside catheterization with Corpak 10-10-10 protocol and electromagnetic guided catheterization for treatment of patients with dysphagia and at high-risk of aspiration pneumonia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. A total of 63 patients were treated with the non-gravity type CORFLO gastrointestinal feeding tube between 2017.1 and 2019.1 using different procedures: in the M group, patients underwent modified post-pyloric feeding tube bedside placement; in C group, patients underwent conventional Corpak protocol; in EM group, patients received standard electromagnetic guided tube placement.


Eligibility criteria: Inclusion Criteria:

* All patients had dysphagia that could not be alleviated within 48 hours
* High-risk status with aspiration pneumonia, including consciousness disorder caused by various diseases, severe dementia, bed rest, gastroesophageal reflux, hiccup, gastric retention, achalasia of pyloric.
* Can't receive nasogastric tube feeding.

Exclusion Criteria:

* The previous history of upper abdominal surgery.
* Gastroduodenal ulcer and esophagogastric varices;
* Severe sinusitis and nasal bone fracture;
* Patients with recent gastrointestinal bleeding, intestinal obstruction, ischemic bowel disease, and epistaxis;
* Patients with electromagnetically-guided catheterization should additionally exclude implantable cardiac defibrillator, implantable cardiac pacemaker or diaphragm pacemaker.

Primary outcomes:
measure: The success rate of NIT placement
timeFrame: 2019.10
Secondary outcomes:
measure: Operation time of tube insertion
timeFrame: 2019.10
Other outcomes:
measure: The time for passing pylorus and the depth of insertion
timeFrame: 2019.10
measure: Serious complications
timeFrame: 2019.10
Locations:
Study officials:
affiliation: Department of Rehabilitation, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, PR China.
name: Xiong Bing, M.M.D
role: PRINCIPAL_INVESTIGATOR
References: