louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03807609: Energy Intake and Exercise Timing
Official title: Does Exercise Timing Modify Post-exercise Energy Intake in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: appetite control
obesity
Adolescents
exercise timing
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule
name: SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand
name: Université d'Auvergne
First posted: 2019-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.

Detailed description: The present study will compare the nutritional response to the realisation of an acute exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 180 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria: Inclusion Criteria:

* - BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Energy intake measured during an ad libitum buffet meal (in kcal).
timeFrame: at day 1
Secondary outcomes:
measure: Hunger feelings
timeFrame: at day 1
measure: Food reward
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine DUCLOS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fillon A, Mathieu ME, Masurier J, Roche J, Miguet M, Khammassi M, Finlayson G, Beaulieu K, Pereira B, Duclos M, Boirie Y, Thivel D. Effect of exercise-meal timing on energy intake, appetite and food reward in adolescents with obesity: The TIMEX study. Appetite. 2020 Mar 1;146:104506. doi: 10.1016/j.appet.2019.104506. Epub 2019 Oct 31.
Clinical trial NCT03352609: Accelerated rTMS for the Reduction of Nicotine Craving
Official title: Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nicotine Use Disorder
Nicotine Dependence
Keywords: TMS
rTMS
Transcranial Magnetic Stimulation
Smoking
Nicotine
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, control
Primary purpose: TREATMENT

Brief summary: The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Outpatient Adults aged 18-70
* Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of \>10ppm day of visit.
* Ability to provide informed consent

Exclusion Criteria

* Current treatment with varenicline or bupropion
* Currently making a smoking quit attempt (not currently smoking).
* Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
* Current episode of major depression determined by MINI interview.
* Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.
* Current daily consumption of alcohol or current alcohol use disorder.
* Current substance use disorder except for nicotine or cannabis use disorder.
* Currently pregnant or lactating.
* Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion.
* Unstable medical conditions
* Suicidal ideation or history of suicide attempt within the last six months.
* Inability or unwillingness of subject or legal guardian/representative to give informed consent

Primary outcomes:
measure: Tolerability Measured by Percent of Participants Completing the rTMS Course
timeFrame: 1 day (single visit)
measure: Decrease in Cue Induced Nicotine Craving
timeFrame: During the one day visit
Secondary outcomes:
measure: Reduce in Self Reported Smoking
timeFrame: 1 week and 2 weeks after rTMS
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Institute of Psychiatry
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: David Friedrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00085956: Effects of Arzoxifene on Bone Mass and the Uterus
Official title: Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Bone Loss
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2004-06-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study are to determine:

* The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
* The effects of arzoxifene on the uterus (womb) in postmenopausal women.
* The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
* The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
* The safety of arzoxifene and any side effects that might be associated with its use.


Eligibility criteria: Inclusion Criteria:

* Female
* 45 to 60 years of age, inclusive
* At least 2 years since last menstrual cycle
* Intact uterus (womb).

Exclusion Criteria:

* Existing fracture of the spine.
* Bone disorders, other than low bone mass
* History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
* Abnormal or unexplained vaginal bleeding.

Primary outcomes:
measure: The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
measure: The effects of arzoxifene on the uterus (womb) in post menopausal women
measure: The safety of arzoxifene and any side effects that might be associated with its use
Secondary outcomes:
measure: The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
measure: The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
measure: The effects of arzoxifene on breast density
Other outcomes:
Locations:
city: San Diego
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01982656: Massage Technique for Pain, Anxiety and Delirium in SAH Patients
Official title: Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Anxiety
Pain
Delirium
Sleep
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 50
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: This research study seeks to explore the effects of massage techniques on pain and anxiety relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to decrease the overall medication use to treat pain and anxiety, and to determine the impact of massage on sleep duration, quality, and breathing. Our goal is to improve and promote comfort during the ICU stay as well as decrease the need for narcotic medication usage.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* Upper extremity deep vein thrombus
* Active alcohol or drug withdrawal

Primary outcomes:
measure: Change in Pain Score
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: Sleep quantity
timeFrame: 5-14 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sara Hocker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zolfaghari M, Eybpoosh S, Hazrati M. Effects of therapeutic touch on anxiety, vital signs, and cardiac dysrhythmia in a sample of Iranian women undergoing cardiac catheterization: a quasi-experimental study. J Holist Nurs. 2012 Dec;30(4):225-34. doi: 10.1177/0898010112453325. Epub 2012 Jul 24.
citation: Valiee S, Bassampour SS, Nasrabadi AN, Pouresmaeil Z, Mehran A. Effect of acupressure on preoperative anxiety: a clinical trial. J Perianesth Nurs. 2012 Aug;27(4):259-66. doi: 10.1016/j.jopan.2012.05.003.
citation: Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
Clinical trial NCT03615456: Sutureless Versus Conventional Thyroidectomy
Official title: Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goiter
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel


Eligibility criteria: Inclusion Criteria:

Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:

* Solitary thyroid nodule (STN)
* Multinodular goiter
* Controlled toxic goiter
* Inflammatory goiter (thyroiditis)
* Early-stage thyroid cancer.

Exclusion Criteria:

* Patients unfit for surgery
* patients unwilling to participate in the study
* Pregnant women
* Thyroid cancer with lymph node or distant metastasis.
* Patients with psychiatric disturbances.

Primary outcomes:
measure: Volume of postoperative drainage
timeFrame: At 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sabry Mahmoud, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00174356: PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
Official title: A Phase 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 39
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 main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.


Eligibility criteria: Inclusion Criteria:

* At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)

Exclusion Criteria:

* Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.

Primary outcomes:
measure: The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6
Secondary outcomes:
measure: To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03651856: Atomoxetine for Freezing of Gait in Parkinson's Disease
Official title: A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Freezing of Gait
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
2. A positive response to item 14 of the UPDRS, part 2.
3. Age range 18-80
4. Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
5. Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
6. Stable on PD medications for ≥ 3 months

   -

Exclusion Criteria:

1. Intolerance to drug class
2. Mini-Mental Status Examination \<26/30
3. No observable episodes of freezing of gait despite common visual cues
4. Not on stable PD medications for 3 months
5. Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
6. Current use of monoamine oxidase inhibitor (MAO-I)
7. Hypersensitivity to drug class
8. Narrow angle glaucoma
9. Pheochromocytoma
10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
11. Patients with uncontrolled hypertension.
12. Patients with a history of symptomatic tachyarrhythmias.
13. Presence of uncontrolled depression and suicidal ideation.

    -

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Gonzalo J Revuelta, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253056: Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting
Official title: Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Fasting
Caloric Restriction
Focus is to observe effects of fasting in healthy volunteers.
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Immanuel Hospital, Berlin, Germany
First posted: 2014-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this pilot study is to evaluate the effects of one regular fasting day per week over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.

Detailed description: Participants in the intervention group receive an initial group training for fasting. Then all participants will observe one fixed fasting day per week (monday) over a total period of eight weeks.

Participants in the control group receive an initial group training for healthy diet according to current German guidelines (DGE). Moreover, they will receive the same offer as in the intervention group at the end of the 8-week study period. Until then the control group participants follow a regular healthy diet.

Eligibility criteria: Inclusion Criteria:

* age 18 -65 yrs
* written informed consent

Exclusion Criteria:

* severe chronic comorbidity
* eating disorders
* pregnancy
* planed pregnancy
* simultaneous participation in other trials

Primary outcomes:
measure: Insulin-like growth factor 1 and brain-derived neurotrophic factor
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: Quality of life questionnaire: WHO-5
timeFrame: Baseline, 8 weeks, 6 month
measure: Profile of mood states questionnaire: POMS
timeFrame: Baseline, 8 weeks, 6 month
measure: Anxiety and depression questionnaire: HADS
timeFrame: Baseline, 8 weeks, 6 month
measure: Flourishing questionnaire
timeFrame: Baseline, 8 weeks, 6 month
measure: Visual analogue scales and Likert-scales
timeFrame: Baseline, 8 weeks, 6 month
measure: Body Impedance Analysis (BIA)
timeFrame: Baseline, 8 weeks
measure: Body weight and abdominal circumference
timeFrame: Baseline, 8 weeks
measure: Systolic and diastolic bloodpressure
timeFrame: Baseline, 8 weeks
measure: Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Immanuel Hospital Berlin
Study officials:
affiliation: Charité Medical University
name: Andreas Michalsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768456: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
Official title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.

The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.


Eligibility criteria: Inclusion Criteria:

* eligible for elective vaginal hysterectomy
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alcohol or medical abuse
* allergies to local anesthetics
* age \< 18 yrs.
* intolerance to opioids

Primary outcomes:
measure: Postoperative pain
timeFrame: 32 h
Secondary outcomes:
measure: PONV
timeFrame: 32 h
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References: