louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01125397: Behavior Therapy Prior to Bariatric Surgery
Official title: The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: bariatric surgery
behavioral weight management
psychosocial outcomes following bariatric surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated that at most surgical centers about 30 percent of patients will not achieve significant weight loss following surgery. It has been proposed that participation in preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence for this premise is lacking. The current study is a pilot project designed to conduct a prospective randomized trial to examine the impact of participation in a 12-week standardized preoperative behavioral weight management program on percentage of excess weight loss and psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The cost of bariatric surgery is not covered by this study and only patients local to the Rochester, Minnesota area are eligible to participate.

It is hypothesized that patients who complete the 12-week behavioral program will experience greater weight loss and improved psychosocial and medical outcomes compared to controls.


Eligibility criteria: Inclusion Criteria:

* BMI between 40 and 60
* age 25 to 65
* ability to participate in weekly LEARN groups for 3 months at Mayo Clinic (local to the Rochester, MN area)
* seeking RYGB procedure

Exclusion Criteria:

* patients seeking surgical revision of a previous bariatric procedure
* diagnosis of schizophrenia
* diagnosis of bipolar disorder
* diagnosis of borderline personality disorder
* non-local patients

Primary outcomes:
measure: Percent excess weight loss following bariatric surgery
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Psychosocial outcomes
timeFrame: 6 months post-surgery
measure: Resolution of medical comorbidities
timeFrame: 6 months post-surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karen B Grothe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937897: Unilateral Massage as a Potential Treatment for Depression
Official title: Unilateral Massage as a Potential Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Unilateral Massage
Depression
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the left hemisphere. In this study a moderate pressure massage will be conducted by a trained professional on one of the following conditions: the right side of the body, the left side of the body, or both sides of the body (a traditional massage on the back of the body) while EEG measurements of brain activity are recorded and mood ratings are obtained.


Eligibility criteria: Inclusion Criteria:

* Medically and mentally healthy, right-handed participants will be eligible for participating in this study. The age range for enrollment in the study is not restricted by any variables but will be set between 18 and 50 years of age.

Exclusion Criteria:

* Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).

Primary outcomes:
measure: Non-invasive EEG recording
timeFrame: Collected 4 minutes after the unilateral massage has ended.
Secondary outcomes:
measure: PANAS (Postitive and Negative Affect Schedule)Questionnaire
timeFrame: Collected immediately following the unilateral massage.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Charles Raison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Clemens Janssen, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784497: Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Related Quality of Life
Keywords: Health Related Quality of Life (HRQL)
Living Donor Liver Transplantation(LDLT)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the next 6 months.

Brief summary: Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

Detailed description: This Study Aims to Evaluate:-

1. Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
2. Impact of post transplant medical and psychiatric complications on quality of life

Eligibility criteria: Inclusion Criteria:

* Adult Egyptian patients
* 18-60 years old
* Patients transplanted for HCV related disease and /or HCC
* Informed consent

Exclusion Criteria:

* Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).

Primary outcomes:
measure: Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
timeFrame: 6 months
Secondary outcomes:
measure: Impact of post transplant medical and psychiatric complications on quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university
Study officials:
References:
Clinical trial NCT02340897: Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT
Official title: Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycobacterium Infections, Nontuberculous
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis

Brief summary: The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.

Detailed description: To elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest CT, two pulmonologists and two chest radiologists were requested to interpret chest CT of patients nontuberculous mycobacterial lung disease satisfying diagnostic criteria of American Thoracic Society as well as British Thoracic Society, or pulmonary tuberculosis. Two pulmonologists and two chest radiologists \> 10 years of clinical experiences at a tertiary referral hospital participated as raters in this study. They were blinded to the any clinical information of the patients including the specific diagnosis, except age and sex. The interpretations of four raters were analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* Nontuberculous mycobacterial patients satisfying diagnostic criteria suggested by American Thoracic Society
* Patients with bacteriologically confirmed pulmonary tuberculosis
* Patients with bronchiectasis, confirmed by clinically as well as radiographically

Exclusion Criteria:

* None

Primary outcomes:
measure: Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease
timeFrame: baseline
Secondary outcomes:
measure: Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease
timeFrame: baseline
measure: Specificity for the diagnosis nontuberculous mycobacterial lung disease
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018597: The Relationship of Sevoflurane Consumption With Metabolic Age
Official title: The Relationship of Sevoflurane Consumption With Metabolic Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sevoflurane
Keywords: Sevoflurane Consumption, Metabolic Age, Tanita
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-65 AGE

Brief summary: The aim of this clinical study is to determine the consumption of sevoflurane, which is one of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained general anesthesia were measured preoperatively. The relationship between the amount of sevoflurane consumption and the measured data of the patients in the postoperative period was examined.

Detailed description: Standard monitoring, BIS, TOF (train of four) were performed from the premedication application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of these components will be recorded. Chronological age, metabolic age, BMR, height, weight, ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period of the patients. Values, ASA scores and demographic data will be recorded for the operation process, cutting time, anesthesia time, extubation time, total sevoflurane consumption throughout the case, and the relationship with basal metabolism and metabolic age will be evaluated.

Eligibility criteria: Inclusion Criteria:

Between the ages of 18-65 who are scheduled for rhinoplasty or septoplasty with ASA I-II Cases lasting 1 to 3 hours

Exclude Criteria:

Patients at high risk of malignant hyperthermia, with a history of allergy to general anesthesia or any of the drugs to be used in the study, accepted as ASA III- ASA IV

Primary outcomes:
measure: consumption of sevoflurane
timeFrame: patients during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu universitesi
Study officials:
References:
citation: St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
citation: Ng JCM, Schooling CM. Effect of Basal Metabolic Rate on Cancer: A Mendelian Randomization Study. Front Genet. 2021 Sep 9;12:735541. doi: 10.3389/fgene.2021.735541. eCollection 2021.
Clinical trial NCT02104297: Effect of Deksmedetomidine and Remifentanil in Extubation Agitation
Official title: The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Agitation
Keywords: Nasal septum operation
agitation
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

Detailed description: Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.

Eligibility criteria: Inclusion Criteria:

* Adult patients

Exclusion Criteria:

* patients with any sensitivity each drug

Primary outcomes:
measure: To asses postoperative agitation score by Riker sedation agitation scale
timeFrame: Postoperative first hour
Secondary outcomes:
measure: Yo asses postoperative side effects emesis, vomitting or pain
timeFrame: Postoperative first hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Reyhan Polat
Study officials:
affiliation: Yildirim Beyazit Education and Research Hospita
name: Reyhan Polat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831297: Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with syncope

Brief summary: This study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.


Eligibility criteria: Inclusion Criteria:

* patients with syncope and planned tilting table investigation
* male and female patients aged at least 18 years
* persons being able to understand and to follow the study stuff´s instructions

Exclusion Criteria:

* pregnancy or breast feeding
* patients not being able to consent
* cardiac pacemaker / defibrillator
* illness of skin

Primary outcomes:
measure: data about possible correlation
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Univeristy Hospital Aachen
state: North Rhine Westfalia
Study officials:
References:
Clinical trial NCT03775005: Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Abdominal Cancer: an Interventional, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdomen Tumors
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Symptomatic abdomen lesions
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 82
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: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions

Detailed description: Standard treatment for abdomen lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic abdomen malignant lesions (primary solid tumor or metastases from solid tumor)
* age\>18 years
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme
timeFrame: 3 months
Secondary outcomes:
measure: acute toxicity in the two treatment groups
timeFrame: 3 months
measure: late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04261205: Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
Official title: Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Keywords: Chronic hemodialysis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 years of age who consecutively benefit from plasmapheresis sessions by double cascade filtration system during hospitalization at the University Hospital of Nîmes, within the framework of the usual indications retained in the department for a period of 12 months.

Brief summary: A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

Detailed description: The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

Eligibility criteria: Inclusion Criteria:

Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.

Exclusion Criteria:

Under guardianship or curatorship Refusal to participate

Primary outcomes:
measure: Apheresis by DFPP and biological efficiency
timeFrame: over a period of one year
Secondary outcomes:
measure: Clinical side effects
timeFrame: within 1 hour of all session
measure: Biological side effects
timeFrame: within 1 hour of all session
measure: variation of Hb, platelet and albumin before and after session
timeFrame: within 1 hour of all session
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes, Hôpital Universitaire Caremeau
Study officials:
affiliation: CHU Nîmes
name: Olivier Moranne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02347605: Medicinal Nicotine for Preventing Cue Induced Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.


Eligibility criteria: Inclusion Criteria:

* Smoking a minimum number of cigarettes per day
* General good health

Exclusion Criteria:

* unstable medical or psychiatric conditions
* history of severe motion sickness (due to virtual reality equipment used to present cues)
* women who are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not participate

Primary outcomes:
measure: Craving Symptom Severity Score Assessed Via Questionnaire
timeFrame: approximately 15 minutes
measure: Withdrawal Symptom Severity Score Assessed Via Questionnaire
timeFrame: approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Kotlyar, PharmD
role: PRINCIPAL_INVESTIGATOR
References: