louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00033046: Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
Official title: Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Drug Administration Schedule
Infusions, Intravenous
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Detailed description: Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Eligibility criteria: Inclusion Criteria:

Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

Exclusion Criteria:

Additional criteria available during screening at the site

Primary outcomes:
measure: pharmacokinetic parmaters at steady state
measure: BP, HR
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: Robert Malcolm, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982046: A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
Official title: A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lenses
Keywords: contact lenses
disinfection solutions
contact lens care
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.

Detailed description: This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Adapted contact lens wearer for at least one month.
* Spherical prescription range between +6.00 to -8.00 diopters.
* Astigmatism of less than or equal to 1.00 diopter in at least one eye.
* Normal eyes with no evidence of abnormality or disease.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
* Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
* Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
* Eye injury or surgery within 8 weeks prior to study.
* Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Modulus
timeFrame: 2 weeks
measure: Bulbar hyperemia
timeFrame: 2 weeks
measure: Corneal staining type
timeFrame: 2 weeks
measure: Upper palpebral roughness
timeFrame: 2 weeks
measure: High contrast visual acuity
timeFrame: 2 weeks
measure: End of day comfort
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Visioncare Research Ltd.
state: Surrey
Study officials:
References:
citation: Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.
Clinical trial NCT03930446: Alcohol, Behavior, and Brain Imaging
Official title: Alcohol, Behavior, and Brain Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Binge Drinking
Drinking Behavior
Substance-Related Disorders
Ethanol
Physiological Effects of Drugs
Central Nervous System Depressants
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.


Eligibility criteria: Inclusion Criteria:

* 21-29 years old
* 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
* At least one binge episode (4 for females/5 for males) per month
* No 'flushing' reaction to alcohol
* Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
* BMI 19-26
* High school education or greater, fluent in English
* No night shift work
* No current or past year Axis I psychiatric disorder including drug/alcohol dependence
* No current psychopharmacological treatment
* No lifetime ADHD or prescription for ADHD medication
* No abnormal EKG, cardiovascular illness, high blood pressure
* No medical condition or pharmacological treatment for which alcohol is contraindicated
* Not pregnant, lactating, or planning to become pregnant
* Smoke \<6 cigarettes per day
* No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM

Primary outcomes:
measure: Stop Signal Task (SST)
timeFrame: Within an hour post-stimulation condition
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Jessica Weafer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Murray CH, Weafer J, de Wit H. Subjective Effects of Alcohol Predict Alcohol Choice in Social Drinkers. Alcohol Clin Exp Res. 2020 Dec;44(12):2579-2587. doi: 10.1111/acer.14476. Epub 2020 Nov 17.
Clinical trial NCT00122746: Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Official title: Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of the Cervix
Keywords: Cervical Cancer
AIDS
External Beam Radiotherapy
Brachytherapy
Cisplatin
Lead sponsor: International Atomic Energy Agency
Sponsor class: OTHER_GOV
First posted: 2005-07-22
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers plan:

* To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer;
* To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules;
* To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.

Detailed description: Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer. External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis, October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions). Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3 fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.

Eligibility criteria: Inclusion Criteria:

* Cancer of the cervix
* AIDS

Exclusion Criteria:

* Unable to give informed consent

Primary outcomes:
measure: 3 year recurrence free survival
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of Grade 3 acute toxicity
timeFrame: 3 months
measure: Pelvic control rates
timeFrame: 3 years
measure: Tumour response at 3 months.
timeFrame: 3 months
measure: Cancer specific survival rates.
timeFrame: 3 years
measure: Overall survival rates.
timeFrame: 3 years
measure: Acute and late toxicities after the treatment.
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dept. of Atomic Energy, Tata Memorial Centre
city: Johannesburg
country: South Africa
facility: Johannesburg Hospital
city: Dar Es Salaam
country: Tanzania
facility: Ocean Road Cancer Institute
city: Kampala
country: Uganda
facility: Radiotherapy Centre
city: Harare
country: Zimbabwe
facility: Radiotherapy Centre
Study officials:
affiliation: International Atomic Energy Agency
name: Eduardo H. Zubizarreta, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04302246: Immune Function Following Liver Transplantation
Official title: Immune Functional Profile as Predictor of Infective Complications Following Pediatric Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 61
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child admitted for liver transplantation

Brief summary: Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.

Detailed description: Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.

Eligibility criteria: Inclusion Criteria:

* Child under 18 admitted for liver transplantation
* Signature of consent by the two holders of parental authority.
* Informing children as far as their age and condition allow.
* Affiliation to a social protection

Exclusion Criteria:

* Children under 6 kg
* Children transplanted for primary graft dysfunction
* Children scheduled for liver-kidney transplants

Primary outcomes:
measure: Immune functionnal profile
timeFrame: pre-operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique des Hopitaux de Paris
name: Pierre TISSIERES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646646: The Effect of Sedation on Eye Movements
Official title: The Effect of Sedation on Eye Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saccadic Eye Movements
Keywords: Sedation
Eye Movements
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-03-28
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether sedation affects saccadic eye movements.


Eligibility criteria: Inclusion Criteria:

* Healthy, human volunteers, age 19-65.
* American Society of Anesthesiology (ASA) class I-II for inclusion criteria

Exclusion Criteria:

* Pregnancy
* Respiratory disease (severe asthma, emphysema)
* Cardiac disease (coronary artery disease, congestive heart failure)
* Symptomatic reflux disease
* Advanced rheumatic disease involving cervical spine
* Propofol or egg allergy
* Neurological disease (stroke, intracranial processes)
* Severe anemia

Primary outcomes:
measure: Dynamic Eye Movement Measures
timeFrame: baseline to Sedation State (approx. 1 hr)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: General Clinical Research Center
state: Alabama
Study officials:
References:
Clinical trial NCT01647646: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
Official title: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
SMART
fixed dose
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

Detailed description: 1. All not-well controlled asthma patients would include the study.
2. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
3. We will evaluate the efficacy/safety for these not-well controlled patients.

Eligibility criteria: Inclusion Criteria:

* asthma not well control

Exclusion Criteria:

* COPD

Primary outcomes:
measure: the percentage of asthma total and well control
timeFrame: one year
Secondary outcomes:
measure: percentage of asthma acute exacerbation
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05608746: Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
Official title: Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gødstrup Hospital
First posted: 2022-11-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.

Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.

Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.


Eligibility criteria: Inclusion Criteria:

* Male \> 18 years
* Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
* Adequacy in written and spoken Danish
* Cognitively well-functioning
* Able to understand the study procedures and willing to provide signed informed consent

Exclusion Criteria:

* Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
* No possibility to use a smartphone or tablet.

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Protocol adherence, assessed by study-specific questionnaire
timeFrame: 12 months
measure: Number of participants who received the nutritional and mental health intervention.
timeFrame: 12 months
measure: Retention rate
timeFrame: 12 months
Secondary outcomes:
measure: 6-minute-walk-test (6MWT)
timeFrame: 12 months
measure: 30 seconds sit-to-stand test (30STS)
timeFrame: 12 months
measure: Grip strength test
timeFrame: 12 months
measure: Self-reported physical activity
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: 12-Item short form Health Survey (SF-12)
timeFrame: 12 months
measure: 5-Item International Index of Erectile Function (IIEF-5)
timeFrame: 12 months
measure: 24-hour Pad Weigh Test
timeFrame: 6, 24 and 50 weeks post surgery.
measure: Nutritional Risk Screening
timeFrame: At baseline (4 weeks before the surgery).
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regional Hospital Goedstrup
Study officials:
References:
Clinical trial NCT02098746: Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Official title: Sonias Combination Tablets LD Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 294
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.

Detailed description: This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day).

The usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with pioglitazone/glimepiride combination tablets is considered necessary

Exclusion Criteria:

* (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides

Primary outcomes:
measure: Frequency of Adverse Drug Reactions
timeFrame: 12 months
measure: Frequency of Serious Adverse Drug Reactions
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final assessment
measure: Change From Baseline in Fasting Blood Glucose Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final assessment
measure: Change From Baseline in Fasting Insulin Level
timeFrame: Baseline, Months 3, 6, 9, 12 and at Final assessment
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: