louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03603704: A Study of LY3209590 in Japanese Participants With Type 2 Diabetes
Official title: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.


Eligibility criteria: Inclusion Criteria:

* Have T2DM diagnosed at least 1 year ago
* Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and \<7.0% with FPG ≥144 mg/dL at screening
* Have body weight ≥54 kilograms and a body mass index \>18.5 and ≤40.0 kilograms per square meter at screening

Exclusion Criteria:

* Have received a total daily dose of insulin \>1.2 units per kilogram at screening
* Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
* Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction
* Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 28
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590
timeFrame: Baseline through Day 28
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590
timeFrame: Baseline through Day 28
measure: Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
timeFrame: Baseline through Day 15
Other outcomes:
Locations:
city: Hachioji
country: Japan
facility: P-one clinic
state: Tokyo
city: Sumida-ku
country: Japan
facility: Sumida Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Hakata Clinic
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 NCT03684304: The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
Official title: The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Organ Prolapse
Abdominal Surgery
Laparoscopic Surgery
Post Operative Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older.
* Willing and able to provide informed consent.
* Patients must be undergoing scheduled pelvic surgery.
* Patients must be admitted overnight (at least one night) after surgery.

Exclusion Criteria:

* Patients who are younger than 18 years old.
* Patients who are unable or unwilling to provide informed consent.
* Patients who are illiterate.
* Patients who are non-English speaking or reading.
* Patients who are unwilling to be contacted by phone after surgery.
* Patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night.
* Patients who are having surgery for any other indication other than pelvic surgery.
* Patients with a chronic pain syndrome (as evidenced by daily intake of opioids).

Primary outcomes:
measure: To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery
timeFrame: 7 days
Secondary outcomes:
measure: To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.
timeFrame: 1 day
measure: To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder.
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
References:
Clinical trial NCT01469104: Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Official title: Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2011-11-10
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.

Detailed description: In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* C-peptide \> 1.5 ng/ml

Exclusion Criteria:

* Body mass index \> 40
* hematological abnormalities
* liver disease
* kidney disease
* congestive heart failure
* life threatening malignancies

Primary outcomes:
measure: Change in plasma glucose concentration
timeFrame: 24 hour profile:before and after meals, or traditional meal times
Secondary outcomes:
measure: Change in serum insulin concentrations
timeFrame: 24 hour profiles: before and after meals or traditional meal times
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Frank Q. Nuttall, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Mary C. Gannon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuttall FQ, Almokayyad RM, Gannon MC. The ghrelin and leptin responses to short-term starvation vs a carbohydrate-free diet in men with type 2 diabetes; a controlled, cross-over design study. Nutr Metab (Lond). 2016 Jul 22;13:47. doi: 10.1186/s12986-016-0106-x. eCollection 2016.
citation: Nuttall FQ, Almokayyad RM, Gannon MC. Comparison of a carbohydrate-free diet vs. fasting on plasma glucose, insulin and glucagon in type 2 diabetes. Metabolism. 2015 Feb;64(2):253-62. doi: 10.1016/j.metabol.2014.10.004. Epub 2014 Oct 8.
Clinical trial NCT02158104: Soreness After Deep Dry Needling of One Latent Myofascial Trigger Point
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain After Dry Needling
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjetct. Community sample from university.

Brief summary: Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed during a 72 hours follow up period. Factors that may contribute to higher levels of pain or sensitivity will be evaluated.


Eligibility criteria: Inclusion Criteria:

The latent MTrP diagnosis was based upon the following criteria:10

1. presence of a palpable taut band in the muscle
2. presence of a hypersensitive tender spot in the taut band
3. palpable or visible local twitch response with snapping palpation of the tout band
4. referred pain elicitation in response to compression.

Exclusion Criteria:

1. presence of coagulation disorders
2. neck or facial pain
3. previous application of a dry needling technique
4. MTrP therapy in head or neck within the previous 3 months
5. fibromyalgia
6. an insurmountable fear of needles as a reason of refusing the treatment
7. history of surgery in the head or neck area.

Primary outcomes:
measure: Pain
timeFrame: 72 hours
Secondary outcomes:
measure: Sensitivity
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04109404: Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin
Official title: Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma
Keywords: meningioma,
progestin,
cyproterone acetate
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 6 men/110, 104 women/110 sex ratio 17.5:1 average duration of follow up: 5.5 years average age at diagnosis: 54 +/- 13 years

Brief summary: Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest

Detailed description: Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment

Eligibility criteria: Inclusion Criteria:

* minimum 18 years
* medical follow up in CHRU of Brest
* treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception
* meningioma after treatement by progestin or CYPROTERONE ACETATE

Exclusion Criteria:

* history ofbreast cancer
* history of cerebral radiotherapy
* history of neurofibromatosis
* meningioma before treatement by progestin or CYPROTERONE ACETATE
* minor patient

Primary outcomes:
measure: Diagnosis of meningiomas caracteristics
timeFrame: 12 months
Secondary outcomes:
measure: prescription status of progestogenic treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Département de Nutrition - CHRU de Brest
Study officials:
affiliation: Service d'Endocrinologie-Diabétologie - CHRU de Brest
name: Véronique KERLAN, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12.
citation: S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.
Clinical trial NCT01614704: Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Official title: Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Fertility
Keywords: Breast cancer
Fertility
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young female, treated for non metastatic breast cancer

Brief summary: Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate.

On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.

Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.

Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.


Eligibility criteria: Inclusion Criteria:

* 18 ≤ age \< 38
* breast cancer histologically proved
* under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy
* verbal agreement given

Exclusion Criteria:

* age ≥ 38
* metastatic breast cancer
* non able to follow the design of the study (geographic, social or psychological reasons)

Primary outcomes:
measure: change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months
timeFrame: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months
measure: change from baseline of account of antral follicles (CFA) rate to different time points until 24 months
timeFrame: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months
Secondary outcomes:
measure: amenorrhea chemotherapeutically induced (weeks)
timeFrame: 4 years
measure: correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)
timeFrame: 4 years
measure: correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)
timeFrame: 4 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
state: Nord Pas De Calais
Study officials:
affiliation: Oscar Lambret Center
name: Audrey MAILLIEZ, MD
role: STUDY_CHAIR
affiliation: CHRU LILLE
name: Christine DECANTER, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03419104: Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
Official title: Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Weaning Failure
Keywords: bariatric surgery
extubation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.


Eligibility criteria: Inclusion Criteria:

patients between 18-60 years old patients with BMI \> 40 patients undergoing Laparoscopic Sleeve Gastrectomy

Exclusion Criteria:

patients with Chronic obstructive pulmonary disease (COPD) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)

Primary outcomes:
measure: extubation
timeFrame: one hour postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
Study officials:
References:
citation: Gupta PK, Gupta H, Kaushik M, Fang X, Miller WJ, Morrow LE, Armour-Forse R. Predictors of pulmonary complications after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):574-81. doi: 10.1016/j.soard.2011.04.227. Epub 2011 May 13.
Clinical trial NCT04772404: Repercussion of the COVID-19 Pandemic on Physical Activity, Psychological State and Sleep
Official title: Repercussion of the COVID-19 Pandemic on Physical Activity, Psychological State and Sleep
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy people

Brief summary: The COVID-19 outbreak in our environment has caused significant changes in the population. The main objective of this research project is to evaluate the level of physical activity, psychological state and sleep during the COVID-19 pandemic in different populations.


Eligibility criteria: Inclusion Criteria:

• Healthy people

Exclusion Criteria:

* Cognitive impairment.
* Diagnose of autism spectrum disorder or severe intellectual disability
* Physical or functional impairment that limits the performance of evaluation

Primary outcomes:
measure: Knowledge of COVID
timeFrame: Baseline
measure: Fear of COVID-19 Scale
timeFrame: Baseline
measure: COVID-19 Anxiety Scale (CAS)
timeFrame: Baseline
measure: COVID Stress Scales
timeFrame: Baseline
measure: Burn-Out de Maslach Inventory
timeFrame: Baseline
measure: Steps per day
timeFrame: Baseline
measure: International physical activity questionnaire
timeFrame: Baseline
measure: Barriers to being active quiz
timeFrame: Baseline
measure: Questionnaire of the transtheoretical model of change of physical exercise
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Connor-Davidson Resilience Scale
timeFrame: Baseline
measure: COPE-28
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Morningness-eveningness questionnaire (MEQ)
timeFrame: Baseline
measure: Epworth sleepiness Scale
timeFrame: Baseline
measure: Insomnia severity index
timeFrame: Baseline
Secondary outcomes:
measure: EuroQoL-5D
timeFrame: Baseline
measure: Charlson Comorbidity Index
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
References:
Clinical trial NCT02384304: Guided and Unguided Internet Treatment for Problematic Alcohol Use
Official title: Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Addiction
Keywords: randomized controlled trial
alcohol
internet
internet based therapy
cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 80
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 was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

Detailed description: Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* access to the Internet
* problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

• not adequately fluent in Swedish

Primary outcomes:
measure: Time Line Follow Back (TLFB)
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline and 10 weeks
measure: Hamilton Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 10 weeks
measure: EQ5
timeFrame: Baseline and 10 weeks
measure: WHOQOL-BREF
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.
citation: Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.