louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002397: A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
Official title: An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
AIDS-Associated Nephropathy
Keywords: Kidney Failure, Chronic
HIV-1
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Lamivudine
Saquinavir
AIDS-Associated Nephropathy
Reverse Transcriptase Inhibitors
Viral Load
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

Detailed description: This is an open-label, non-comparative, randomized, single center, 24-week study. Patients are stratified into 3 groups (8 patients in each group) based on kidney function:

Group 1: Serum creatine less than 2 mg/dL. Group 2: Serum creatine 2-5 mg/dL. Group 3: Serum creatine greater than 5 mg/dL.

All 24 patients are randomized 1:1 to receive 1 of 2 study regimens:

Arm A: Saquinavir SGC plus d4T plus 3TC. Arm B: Saquinavir SGC plus nelfinavir plus d4T. Patients are seen at Weeks 4, 8, 12, and 24. At Week 24, a kidney biopsy is performed with patient consent.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Detectable HIV-1 RNA by Amplicor assay.
* Biopsy-proven nephropathy.

Exclusion Criteria

Prior Medication:

Excluded:

* Saquinavir and nelfinavir.
* d4T or 3TC within the past 4 months.

Required:

Stable antiretroviral therapy for more than 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT04127097: The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels
Official title: The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Anxiety
Fear
Keywords: anxiety
fear
nursing
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment.

Method: The population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. A total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the treatment. Anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. The anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.


Eligibility criteria: Inclusion Criteria:

* being healthy
* ability to express himself/herself verbally
* having no visual or auditory problems

Exclusion Criteria:

* mental disease
* neurological disease

Primary outcomes:
measure: Children Fear Scale
timeFrame: 1 minute
measure: Children Anxiety Scale
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman obstetrics and pediatric hospital
Study officials:
References:
Clinical trial NCT00050297: YM598 in Patients With Rising PSA After Initial Therapy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2002-12-04
Sex: MALE
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 determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Clinic AZ
city: Brussels
country: Belgium
facility: University Clinic UCL St. Luc
city: Jablonec nad Nisou
country: Czech Republic
facility: Private Urology Out-patient Ward
city: Králové
country: Czech Republic
facility: Clinic of Urology, University Hospital
city: Olomouc
country: Czech Republic
facility: Clinic of Urology, University Hospital
city: Prague
country: Czech Republic
facility: Clinic of Urology, University Hospital
city: Paris
country: France
facility: Hôpital Bichat, service de Urology
city: Bad Homburg
country: Germany
facility: Haingasse 22
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Urologie, Universitätsklinikum Carl-Gustav-Carus
city: Marburg
country: Germany
facility: Klinik u. Poliklinik für Urologie, Philipps Universität, Baldingerstraße
city: Marburg
country: Germany
facility: Krummbogen 15
city: Bydgoszcz
country: Poland
facility: Regional Hospital, Department of Urology
city: Gdansk
country: Poland
facility: MedSource Poland
city: Warszawa
country: Poland
facility: Bielanski Hospital, Department of Urology
city: Warszawa
country: Poland
facility: Oncology Center, Department of Urinary Tract Cancer
city: Wroclaw
country: Poland
facility: Medical University, Clinic of Urology
city: Corunna
country: Spain
facility: Complejo Hospitaliaro Juan Canalejo, Servicio de Urología
city: Madrid
country: Spain
facility: Fundacion Hospital Alcorcón, Servicio Urología
city: Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias, Servicio de Urología, Ctra.
city: Bristol
country: United Kingdom
facility: Department of Urology, Bristol Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Department of Urology, Gartnavel Hospital
city: Norwich
country: United Kingdom
facility: Department of Urology, Norfolk & Norwich Hospital
city: Taunton
country: United Kingdom
facility: Department of Urology, Taunton & Somerset Hospital
Study officials:
References:
Clinical trial NCT00321997: A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
Official title: A PHASE II/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Age-Related Macular Degeneration
Keywords: AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
pegaptanib sodium
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-05-04
Enrollment: 540
Sex: ALL
Minimum age (years): 50
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 compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.


Eligibility criteria: Inclusion Criteria:

Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.

Exclusion Criteria:

Any prior subfoveal thermal laser therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Boyer DS, Goldbaum M, Leys AM, Starita C; V.I.S.I.O.N. Study Group. Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study. Br J Ophthalmol. 2014 Nov;98(11):1543-6. doi: 10.1136/bjophthalmol-2013-304075. Epub 2014 Jul 4.
Clinical trial NCT04024397: A Study to Evaluate Unintended Prolonged Opioid Use
Official title: Unintended Prolonged Opioid Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-07-18
Enrollment: 1796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual that receives an opioid prescription.

Brief summary: Researchers are trying to better understand how people who are prescribed opioids for short-term use, go on to receive this type of medication on a longer-term basis.

Detailed description: Identify incident cases of UPOU and prospectively assess their characteristics in comparison to new opioid users who do not progress to UPOU. At each site, opioid-naïve adults who receive opioid prescriptions will be enrolled. Opioid prescriptions (both written and filled) and self-reported opioid use will be followed, and those subjects progressing to UPOU will be identified in real time. Matched samples of patients who do and do not develop UPOU will be recruited for assessment of framework elements related to patient characteristics,including biochemical confirmation of opioid use, pain-related measures (including psychological variables), and medical and social histories. Using the information gathered in Aim 1, structural equation modeling will be utilized to evaluate the associations UPOU and the patient domain.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* No use of opioids for 6 months prior to the issuance of the initial opioid prescription
* Willingness to participate in all aspects of the study including use of the Hugo platform on their personal smartphone

Exclusion Criteria:

* Cancer-associated pain
* Concurrent treatment for cancer (e.g., chemotherapy, radiation therapy)
* Residence in an extended care facility
* Any operation or hospitalization within the past 6 months
* Mental health disorders that could impede functioning in an ambulatory care setting (e.g., schizophrenia, dementia)
* Non-English speaking individuals
* No smartphone
* Use of a pharmacy that is not compatible with the Hugo platform.

Primary outcomes:
measure: Assess the rate of long-term opioid use
timeFrame: Six months
Secondary outcomes:
measure: Assess patient factors associated with development of long-term opioid use
timeFrame: Six months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: W. Michael Hooten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104883: The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
Official title: The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: Adductor-Canal-Blockade
postoperative pain
US-guided nerve block
total knee arthroplasty
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
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 determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Total Knee Arthroplasty in spinal anaesthesia
* ASA 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of strong opioids
* Unable to complete the Timed Up and Go test preoperatively

Primary outcomes:
measure: Total morphine consumption
timeFrame: 0-24 hours postoperative
Secondary outcomes:
measure: Total morphine consumption
timeFrame: 0-26 hours postoperative
measure: Pain during rest
timeFrame: 0-26 hours postoperative
measure: Pain during 45 degrees active flexion of the knee
timeFrame: 0-26 hours postoperative
measure: A change in pain in the placebo group
timeFrame: 24-26 hours postoperative
measure: Postoperative nausea
timeFrame: 0-26 hours postoperative
measure: Zofran consumption
timeFrame: 0-26 hours postoperative
measure: Sedation
timeFrame: 0-26 hours postoperative
measure: Mobilisation
timeFrame: 20-26 hours postoperative
measure: Postoperative vomiting
timeFrame: 0-26 hours postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark
state: Frederiksberg
city: Glostrup
country: Denmark
facility: Department of Surgery and Anaesthesia, Glostrup Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jæger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
Clinical trial NCT02139683: Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Official title: High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Fibroadenoma
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
Collaborators: name: King's College London
First posted: 2014-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Detailed description: Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age
* Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients \<25 and ultrasound plus core-biopsy in patients \>25 (Graded B2 or less)
* Visible on ultrasound (Graded U2/U3)
* Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).

Exclusion Criteria:

* Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
* Pregnant or lactating women
* History of laser or radiation therapy to the targeted breast

Primary outcomes:
measure: Changes in size of fibroadenomata as recorded on ultrasound imaging
timeFrame: Month 1, Month 3, Month 12
Secondary outcomes:
measure: Adverse Events
timeFrame: Month 1, Month 3, Month 12
measure: Patient recorded outcomes measures
timeFrame: Month 1, Month 3, Month 12
measure: Mean treatment time
timeFrame: Treatment visit date
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
Study officials:
affiliation: King's College London
name: Michael Douek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828983: Telephone Support During Overseas Deployment for Military Spouses
Official title: Telephone Support During Overseas Deployment for Military Spouses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Personnel
Family Members
Resilience, Psychological
Deployment
Keywords: Telephone
Support groups
Social support
Depression
Lead sponsor: Memphis VA Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2013-04-11
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Deployment impacts both service member and family, and the cost can be high. Spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. The study will compare telephone support groups to online education sessions. The study will enroll 160 spouses. In the Telephone Support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. Education Only online sessions will provide the same education content, without skills building or support. Content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. Outcomes will include resilience, depression, anxiety and coping behaviors. Telephone data collection will be conducted at baseline, six and twelve months.


Eligibility criteria: Inclusion Criteria:

* spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member
* deployed at least six months

Exclusion Criteria:

* living as married for at least one year before deployment

Primary outcomes:
measure: Spouse Self-report of Resilience
timeFrame: Baseline, 6 months
measure: Spouse Self Report of Anxiety
timeFrame: baseline, and 6 months
measure: Spouse Self Report of Depression
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Memphis VA Medical Center
state: Tennessee
Study officials:
affiliation: Memphis VA Medical Center and University of Tennessee Health Science Center
name: Linda O Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Health Science Center and Memphis VA Medical Center
name: Jennifer L Martindale-Adams, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670683: Observational Study of Patients With Diabetes Using Levemir® FlexPen®
Official title: Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 797
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients

Brief summary: This study is conducted in Asia. This study is a prospective, open, uncontrolled, observational surveillance study with Levemir® FlexPen® conducted in Korea.

The aim of this observational study is to evaluate the short term and the long term safety and efficacy of Levemir® FlexPen®. The study is planned and conducted as per requirement from Korea Food and Drug Administration (KFDA).


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus

Exclusion Criteria:

* Contra-indication based on local label

Primary outcomes:
measure: Incidence of adverse events
timeFrame: for the duration of the trial
Secondary outcomes:
measure: Weight
timeFrame: for the duration of the trial
measure: FBG (Fasting Blood Glucose)
timeFrame: for the duration of the trial
measure: 2hr-PPBG (2hr-Post Prandial Blood Glucose)
timeFrame: for the duration of the trial
measure: HbA1c
timeFrame: for the duration of the trial
measure: Adverse events
timeFrame: for the duration of the trial
measure: Clinical laboratory abnormality
timeFrame: for the duration of the trial
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06913283: Outcome of Pulpotomy With MTA and Biodentin in Permanent Teeth With Caries Exposure
Official title: Outcome of Pulpotomy Using Mineral Trioxide Aggregate and Biodentin in the Mature Permanent Teeth With Carious Exposure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral trioxide aggregate.


Eligibility criteria: Inclusion Criteria:

* mature permanent teeth

Exclusion Criteria:

* Teeth with restorations

Primary outcomes:
measure: Number of participants treated with MTA
timeFrame: 6 months
measure: Number of Participants treated with Biodentine
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Altamash Institute of Dental Medicine
state: Sindh
Study officials:
References: