louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487706: Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Official title: Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: Hemodialysis
HIV-infection
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.

Detailed description: The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.

Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.

Eligibility criteria: Inclusion Criteria

1. Age 1 years old or older.
2. HIV documented infection (western blot)
3. ESRD undergoing routine hemodialysis
4. Stable antiretroviral treatment (no changes within the prior 2 weeks)
5. Signature of informed consent

Exclusion Criteria:

1. Inadequate adherence to antiretroviral treatment (\<90% in the week prior to inclusion).
2. Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.

Primary outcomes:
measure: hemodialysis extraction ratio of dolutegravir
timeFrame: Day 5
measure: hemodialysis clearance of dolutegravir
timeFrame: Day 5
Secondary outcomes:
measure: percentage of patients presenting adverse events related to dolutegravir
timeFrame: From Baseline to day 5
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
Study officials:
References:
citation: Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.
Clinical trial NCT01490099: Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
Official title: A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker
* Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
* A history of alcohol or drug abuse

Primary outcomes:
measure: AUC0-36h, area under the serum insulin detemir concentration curve
timeFrame: From 0 to 36 hours
measure: Cmax, maximum serum insulin detemir concentration
Secondary outcomes:
measure: AUC, area under the serum insulin detemir concentration curve
measure: Time to maximum concentration (tmax)
measure: Terminal half life (t½)
measure: Area under the Curve Glucose Infusion Rate (AUCGIR)
measure: Adverse events
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000199: Piracetam for Treatment of Cocaine Addiction, Phase II - 4
Official title: Piracetam for Treatment of Cocaine Addiction, Phase II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to follow patients in Phase I of an inpatient study in an eight week open label assessment of piracetam in an outpatient treatment program.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Adverse effects
measure: Clinical status
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kyle Kampman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06610799: Study of IBI363 in Patients with Advanced First-line Gastric Cancer
Official title: Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: IBI363 + Chemotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, ≥ 18 years and ≤75 years.
2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
3. Subjects with at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
5. Expected survival time ≥ 3 months.

Exclusion Criteria:

1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
2. Active uncontrolled bleeding or a known bleeding diathesis.
3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through out the study (up to 2 years)
measure: Disease control rate (DCR)
timeFrame: Through out the study (up to 2 years)
Secondary outcomes:
measure: Progression Free Survival（PFS）;
timeFrame: Up to 2 years
measure: Overall Survival, OS）
timeFrame: Up to 2 years
measure: Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
timeFrame: Up to 90 days after the last administration
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01730599: A Longitudinal Study in Parkinson's Disease (PD) Patients
Official title: A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients carriers of the G2019S mutation in the LRRK2 gene

Brief summary: This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between genetic mutations in the known genes and their influence on disease manifestation over few years of follow up


Eligibility criteria: Inclusion Criteria:

* parkinson'd disease patients that already participated in a pasr cross sectional study

Exclusion Criteria:

* subjects with cognitive decline by the parameters defined in Diagnostic and Statistical Manual of Mental Disorders (DSM)- IV
* subjects with psychiatric disorder
* subjects unable to sign a consent form

Primary outcomes:
measure: change from baseline in updrs motor and total scores
timeFrame: the participants will be followed for 5 years. the measurements will be taken evry 18 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT05286099: The Surveillance of Hepatocellular Carcinoma
Official title: The Surveillance of Development and Progression of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatitis B, liver cirrhosis, or atypical hyperplasia nodules confirmed or suspected by enhanced imaging examination will be enrolled, the contrast-enhanced ultrasound and/or enhanced magnetic resonance imaging will be performed every three months or half a year to observe the size and contrast-enhanced features of the nodules. If the size or enhancement features change, there will a puncture biopsy under the guidance of ultrasound, and if malignant tumor cells are found, the follow-up will be terminated.

Brief summary: Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.


Eligibility criteria: Inclusion Criteria:

- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.

Exclusion Criteria:

- Can't tolerate the enhanced imaging examination Poor medical compliance

Primary outcomes:
measure: Effective detection of early hepatocellular carcinoma
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA general hospital
Study officials:
References:
Clinical trial NCT06094699: Improving Sleep in the Neurology In-Patient Population
Official title: Improving Sleep in the Neurology In-Patient Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). We will also conduct qualitative patient surveys to understand the impact of these interventions.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* 24 hours after admission to the general neurology (ward) service at the Hospital of the University of Pennsylvania
* Patients who are determined by the primary team to be clinically stable enough to forego serial overnight vital signs monitoring and neuro checks.
* Clinical stability criteria:
* Symptomatic stability \>24h after admission (no new or progressive neurologic symptoms for \>24 hours)
* Vital signs stability on admission for \> 24h while admitted
* Ability to verbally consent to study participation

Exclusion Criteria:

* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Any additional clinical factors felt by the team to be incompatible with specific orders including requiring serial vital signs monitoring and neuro checks overnight

Primary outcomes:
measure: Fitbit Sleep Duration
timeFrame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary outcomes:
measure: FitBit sleep score
timeFrame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
measure: Richard Campbell Sleep Questionnaire (RCSQ)
timeFrame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
measure: Patient reported Sleep Duration and Quality
timeFrame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Laura Stein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799199: Fingolimod Real World Experience: the French Grand-Est Cohort
Official title: Fingolimod Real World Experience: the French Grand-Est Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 1014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated with fingolimod for at least 6 months

Brief summary: Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.

Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.

Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.


Eligibility criteria: Inclusion Criteria:

* Patients with MS treated with Gilenya because of the disease

Exclusion Criteria:

* contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014

Primary outcomes:
measure: the course of the disease by magnetic resonance imaging (MRI)
timeFrame: assessed between January 2012 and September 2014, up to a total of 32 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04863599: Patient Experience With OMS Procedures Regarding Anesthesia
Official title: Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: General anesthesia
Sedation
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 178
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main purpose of the study is to know more about the experience/satisfaction of patients undergoing oral and maxillofacial surgery (OMS). Depending on the type of procedure, the patient will receive a sedation or a general anesthesia. At the first day post-operatively, patients will be contacted to complete a questionnaire. The questionnaire will be subdivided into anaesthesia-related discomfort and anaesthesia care in general.


Eligibility criteria: Inclusion Criteria:

* OMS procedure
* signed informed consent
* Age above 12 years

Exclusion Criteria:

* need for post-operative hospitalization
* mental disorder with no capability of filling in questionnaires

Primary outcomes:
measure: Bauer questionnaire at post-operative day 1
timeFrame: post-operative day 1
measure: Brice questionnaire at post-operative day 1
timeFrame: post-operative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Joris Vundelinckx
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06397599: Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control
Official title: Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental
Keywords: Denture adhesives, quality of life and OHIP-EDENT
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers.

Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Detailed description: 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Eligibility criteria: Inclusion Criteria:

* completely edentulous

Exclusion Criteria:

* no

Primary outcomes:
measure: patients satisfaction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03876899: RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain
Official title: Evening Primrose Oil for the Treatment of Breastfeeding Related Mastalgia: A Randomized, Double Blinded, Placebo-Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Feeding
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: Breastfeeding related mastalgia is a common post-partum complaint. We propose a double-blind, randomized, placebo-controlled trial that investigates the use of Evening Primrose Oil in the treatment of breastfeeding related mastalgia.


Eligibility criteria: Inclusion Criteria:

* currently breastfeeding
* recent delivery within the trailing 60 days

Exclusion Criteria:

* history of seizure disorder

Primary outcomes:
measure: Breastfeeding Related Mastalgia
timeFrame: 7 days
Secondary outcomes:
measure: Adverse events
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References: