louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01397266: Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence
Official title: Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Transcranial Magnetic Stimulation
Cocaine
impulsivity
rating scale
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.

Detailed description: reduction of the rating impulsivity

Eligibility criteria: Inclusion criteria:

1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
2. 20 days or less withdrawal
3. 18-35 years old.
4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
5. Fixed residential address in Sao Paulo

Exclusion criteria:

1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
2. organic brain disease, neurosurgery to implant metal clip or epilepsy.
3. severe uncontrolled clinical comorbidity.
4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
5. Changes clinically significant laboratory findings. 13
6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
7. Mandate that mandating the judicial treatment for cocaine dependence

Primary outcomes:
measure: The Short PROMIS Questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Adan Jardim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484366: Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
Official title: Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fractures of Radius and Ulna
Keywords: fractures of both radius and ulna
Lead sponsor: Florida Orthopaedic Institute
Sponsor class: NETWORK
First posted: 2011-12-02
Enrollment: 13
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 hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:

1. a lower rate of implant pain
2. a lower re-operation rate to remove painful hardware.

Detailed description: This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.

Eligibility criteria: Inclusion Criteria:

* Diaphyseal fractures of both radius and ulna
* Ulna fractures that are oblique or transverse
* Fractures may be closed or Grade I-IIIA open
* Patients must be over 18 and skeletally mature

Exclusion Criteria:

* Children under the age of 18
* Pregnancy
* Comminuted ulna fractures
* Those with associated bony elbow or wrist trauma
* Elbow dislocation
* Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)

Primary outcomes:
measure: implant pain
timeFrame: 1 year
Secondary outcomes:
measure: re-operation rate to remove painful hardware
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: St Josephs Hospital
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Roy Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646966: Trunkstability: a Predisposition for Armfunction
Official title: Trunkstability: a Predisposition for Armfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trunk Stability
Keywords: stroke
reaching
ADL
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2022-12-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.

Detailed description: Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength.

Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.

Eligibility criteria: Inclusion Criteria:

* BMI \< 30
* no orthopedic, neurologic disorder that can influence the reaching
* age between 18 and 70 yrs

Exclusion Criteria:

* BMI\>30
* orthopedic, neurologic disorder that can influence the reaching
* \< 18 yrs of age
* \>70 yrs of age

Primary outcomes:
measure: Electromyography to analyze muscle activation
timeFrame: 2 hours
measure: kinematics to analyze trunk involvement
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Revaki Ugent
state: Oost Vlaanderen
Study officials:
References:
Clinical trial NCT00515866: Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer
Official title: A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Neoplasms
Keywords: Advanced pancreatic cancer
Poly (ADP ribose) polymerases
Advanced Solid Tumours
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-14
Enrollment: 68
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 is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of pancreas
* Locally advanced or metastatic unresectable disease

Exclusion Criteria:

* No prior anti cancer chemotherapy, radiotherapy (except palliative \>4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

Primary outcomes:
measure: To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine
timeFrame: assessed at each visit
Secondary outcomes:
measure: To identify the dose-limiting toxicity of the combination therapy
timeFrame: assessed at each visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: The Sarah Cannon Cancer Center
name: Howard A Burris III, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Jane Robertson, BSc, MBCHB, MD
role: STUDY_DIRECTOR
References:
citation: Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7.
Clinical trial NCT00099866: Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Not currently on durg therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Adverse event profile after 52 weeks of treatment
measure: Change from baseline in body weight at 52 weeks
measure: Change from baseline in fasting lipids at 52 weeks
measure: Change from baseline in HOMA B at 52 weeks
Other outcomes:
Locations:
city: Investigative Sites
country: Germany
facility: Novartis investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
citation: Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
citation: Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
Clinical trial NCT05061966: The Digital Wellbeing Project
Official title: Piloting a Web App for Sexual and Gender Minority Youth Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Sexual and Gender Minorities
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: HopeLab Foundation
First posted: 2021-09-30
Enrollment: 270
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and depression.


Eligibility criteria: Inclusion Criteria:

1. Are between 13-19 years of age (inclusive)
2. Self-identify as a sexual or gender minority
3. Are English literate
4. Reside within the United States
5. Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Willingness to participate in study activities

Exclusion Criteria:

1. Not between 13-19 years of age (inclusive)
2. Does not self-identify as a sexual or gender minority
3. Is not English literate
4. Does not reside within the United States
5. Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Unwilling to participate in study activities

Primary outcomes:
measure: Coping Self-efficacy
timeFrame: 4-week follow-up
Secondary outcomes:
measure: Identity Affirmation
timeFrame: 4-week follow-up
measure: Internalization of Minority Stress
timeFrame: 4-week follow-up
measure: Sense of Belonging to the Queer Community
timeFrame: 4-week follow-up
measure: Anxiety Symptoms
timeFrame: 4-week follow-up
measure: Depression Symptoms
timeFrame: 4-week follow-up
measure: Cognitive and Behavioral Coping Skills
timeFrame: 4-week follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jose A Bauermeister, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauermeister J, Choi SK, Bruehlman-Senecal E, Golinkoff J, Taboada A, Lavra J, Ramazzini L, Dillon F, Haritatos J. An Identity-Affirming Web Application to Help Sexual and Gender Minority Youth Cope With Minority Stress: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Aug 1;24(8):e39094. doi: 10.2196/39094.
Clinical trial NCT02408666: EEG@HOME (Phase 1 of the Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Pilipili NV
name: Imec
First posted: 2015-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In Phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.

Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed.

The results of the interviews will be analysed by the design company pilipili nv.


Eligibility criteria: Inclusion Criteria:

* Epilepsy patient or EEG-technologist or neurologist

Exclusion Criteria:

* No experience with EEG

Primary outcomes:
measure: User wishes and expectations (questionnaire)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT01249066: Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma
Official title: Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Keywords: AMP-activated protein kinase
lung adenocarcinomas
Prognosis
Observation study
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer received lobectomy in CMUH

Brief summary: AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves as an energy guardian to help cells adapt to various metabolic stress including hypoxia. Because the role of AMPK in cancers has not been fully elucidated, in this study we investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and tissue.


Eligibility criteria: Inclusion Criteria:

* Lung cancer received operation lobectomy in CMUH

Exclusion Criteria:

* History of uremia, other malignant disease, and liver cirrhosis
* History of pneumonia and pulmonary tuberculosis
* History of long period of medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Fang Hsin Yuan
Study officials:
References:
Clinical trial NCT04709666: Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem
Official title: Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Condition
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be recruited at the UO of Gastroenterology and digestive endoscopy of the participating centers

Brief summary: Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation failure, which has been reported in about 11% of ERCP regardless of their indication and a relevant heterogeneity in definition of DBC is present in the available studies. More recently, DBC during ERCP has been precisely defined by the European Society of Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate after visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups of ERCP indications. In particular, the rate of DBC in the setting of distal malignant biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the complexity of the procedure as the tumor compression or infiltration alter the normal duodenal/papillary anatomy or determine duodenal rigidity.

In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.


Eligibility criteria: Inclusion Criteria:

* With an age above or equal to 18,
* From which informed consent has been obtained,
* patients undergoing ERCP carried out by expert operators for DMBO due to pancreatico-biliary malignancies.

Exclusion Criteria:

- Patients who do not meet all of the listed inclusion criteria will be excluded from this study

Primary outcomes:
measure: Rate of DBC
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References: