louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02026817: Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg
Official title: An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.

Detailed description: An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age 20\~55 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.

Primary outcomes:
measure: metformin, rosuvastatin Cmax
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: metformin, rosuvastatin AUClast
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Secondary outcomes:
measure: Metformin, rosuvastatin Tmax
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: Metformin, rosuvastatin T1/2
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
measure: Metformin, rosuvastatin AUCinf
timeFrame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jung-Ryul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476917: The ATLAST Long-Term Study
Official title: The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: ApniCure, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.


Eligibility criteria: Inclusion Criteria:

* Subject participated in the ATLAST Study, and completed the 28-day take-home period
* Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
* The study physician and investigator believe that study participation is appropriate for the subject.
* Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria:

* Female subjects who are pregnant or intend to become pregnant during the study period.
* Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
* Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System
* History of any OSA surgical treatment

Primary outcomes:
measure: Mean number of hours per night of device use over a 3-month period
timeFrame: Each night's use
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: REM Medical
state: Arizona
city: Burlingame
country: United States
facility: Penninsula Sleep Center (PSC)
state: California
city: Menlo Park
country: United States
facility: SRI International
state: California
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Columbia
country: United States
facility: SleepMed
state: South Carolina
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas (SMAT)
state: Texas
Study officials:
affiliation: Stanford Research Institute (SRI)
name: Ian Colrain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585117: Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: CNS Brain Metastases
Head and Neck Cancer
Lung Cancer
Prostate Cancer
Esophageal Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission


Eligibility criteria: Inclusion Criteria:

* Able to tolerated a PET/CT scan
* Age 18 or older
* Patient being considered for XRT for treatment of their cancer
* Able to provide written informed consent

Exclusion Criteria:

* severe claustrophobia or inability to tolerate the PET scan
* pregnant or breastfeeding women
* Patients that need supplemental oxygen
* Patients enrolled in experimental treatments

Primary outcomes:
measure: To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia
timeFrame: end of study
Secondary outcomes:
measure: To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans
timeFrame: end of study
measure: To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients
timeFrame: end of study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Jeraj, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563017: Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
Official title: Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia, Catatonic
Schizophrenia, Disorganized
Schizophrenia, Paranoid
Schizophrenia
Psychotic Disorders
Keywords: Catatonic Schizophrenia
Disorganized Schizophrenia
Paranoid Schizophrenia
Undifferentiated Schizophrenia
Schizo-affective disorders
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Janssen Pharmaceutica N.V., Belgium
First posted: 2007-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.


Eligibility criteria: Inclusion Criteria:

* Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
* Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
* Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
* Subject and/or patient's relative, guardian or legal representative has signed the informed consent form

Exclusion Criteria:

* First antipsychotic treatment ever
* On clozapine during the last 3 month
* Serious unstable medical condition
* History or current symptoms of tardive dyskinesia
* History of neuroleptic malignant syndrome
* Pregnant or breast-feeding female
* Female patient of childbearing potential without adequate contraception.
* Participation in an investigational drug trial in the 30 days prior to selection
* Known intolerance/non-responder to risperidone

Primary outcomes:
measure: Efficacy/ Clinical Global Impression
timeFrame: Week 0, 4, 8,12
measure: Personal and Social Performance Scale
timeFrame: Week 0, 12
measure: Extrapyramidal Symptom
timeFrame: Week 0, 4, 8,12
Secondary outcomes:
measure: +Quality of life SF-36
timeFrame: Week 0,12
measure: Pain assoicated with injection VAS
timeFrame: Week 0, 4, 8, 12
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Kwai Chung Hospital
Study officials:
affiliation: Yaumatei Psychiatric Center, Kwai Chung Hospital
name: Wing King Lee, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03972917: Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
Official title: Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma
Uterine Bleeding, Dysfunctional
Uterine Bleeding Heavy
Dysmenorrhea
Endometrium Hyperplasia
Keywords: ulipristal acetate
myoma
leiomyoma
endometrial patterns
symptomatology
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Italian fertile women who are eligible for conservative treatment for uterine fibroids

Brief summary: A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.


Eligibility criteria: Inclusion Criteria:

* number of myomas from 1 to 4
* heavy menstrual bleeding
* conservative treatment request

Exclusion Criteria:

* concurrent endometrial pathology
* post-menopausal status
* hepatic pathology
* endocrine or metabolic disorders

Primary outcomes:
measure: Dysmenhorrea (VAS score)
timeFrame: 12 months
measure: Endometrial thickess (mm)
timeFrame: 12 months
measure: Myoma's diameter (mm)
timeFrame: 12 months
Secondary outcomes:
measure: Live birth rate (LBR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Gaetano Riemma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06806241: Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery
Official title: Investigation of the Effects of Tranexamic Acid Solution Irrigation on Bleeding, Surgical Field Visibility, and Postoperative Edema in the Extraction of Horizontally Impacted Third Molars
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bleeding
Tooth Extraction
Keywords: bleeding
tranexamic acid
wisdom teeth removal
edema
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Tranexamic acid (TXA) is an effective hemostatic agent used to reduce blood loss and the need for transfusion. It is a relatively safe drug with minimal significant side effects. The most commonly reported complications include nausea, diarrhea, and occasional orthostatic reactions. The increased risk of thromboembolic events associated with the drug is the most serious complication; however, this has not been reported in most clinical studies and remains uncertain. Based on experience from other types of surgeries, tranexamic acid appears to be safe for use without an increased risk of venous thrombosis. To mitigate systemic absorption and minimize undesirable side effects, TXA can be applied topically rather than intravenously, reducing the risk of venous thromboembolism.

Detailed description: Topical TXA irrigation has recently begun to be used intraoperatively. In a study conducted by Eftekharian et al., the application of intraoperative 1% TXA irrigation solution during bimaxillary orthognathic surgery was found to be significantly associated with a reduction in intraoperative blood loss compared to placebo. Additionally, the topical application of TXA to the maxillary sinus during endoscopic sinus surgery has been shown to reduce intraoperative blood loss. In the current literature, the use of tranexamic acid irrigation during tooth extraction under local anesthesia has not been reported. Our study aims to demonstrate the effectiveness of TXA irrigation during the extraction of bone-retained teeth and its effect on postoperative edema.

Eligibility criteria: Inclusion Criteria:

1. Indicated for the Extraction of Bilaterally Impacted Third Molars with Bone Retention.
2. Systemically healthy patients aged 14-40 years with no bleeding disorders.

Exclusion Criteria:

1. Patients with systemic diseases affecting general health.
2. Patients diagnosed with any bleeding disorder.
3. Patients with advanced infection or cysts associated with the impacted tooth.

Primary outcomes:
measure: postoperative edema
timeFrame: 3 days
Secondary outcomes:
measure: intraoperative bleeding
timeFrame: during the surgery time
measure: intraoperative vision scale
timeFrame: during the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Universty
state: Fatih
Study officials:
References:
Clinical trial NCT05454241: CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
Official title: Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematological Malignancies
Keywords: T-ALL/LBL
AML
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed CD7 positive relapsed/refractory hematological malignancies.
2. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
4. The estimated survival time is more than 3 months;
5. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria:

1. Patients with history of epilepsy or other central nervous system diseases;
2. Patients with prolonged QT or severe heart disease;
3. Pregnant or lactating women
4. Patients with uncontrolled active infection.
5. Positive for any of the following etiological tests: HIV, HBV, HCV
6. Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial

Primary outcomes:
measure: Overall Response Rate(ORR)
timeFrame: 1 Year
Secondary outcomes:
measure: Duration of overall response (DOR)
timeFrame: 1 Year
measure: Overall survival(OS)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Hematology Hospital, Chinese Academy of Medical Sciences
name: Ying Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928341: Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo
Official title: Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal in Uvira, Democratic Republic of Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholera
Diarrhea
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 4556
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the impact of a large-scale urban water supply improvement intervention on cholera and other diarrhoeal diseases. The study uses a step wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention on cholera centre admission rates and confirmed cholera cases. A nested cohort study will examine changes in water-related practices following the intervention.


Eligibility criteria: Inclusion Criteria:

* Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira

Exclusion Criteria:

* Any patients admitted during the period of intervention implementation in each cluster

Primary outcomes:
measure: Admission rate to the Uvira Cholera Treatment Centre
timeFrame: 36 months
Secondary outcomes:
measure: Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases
timeFrame: 36 months
Other outcomes:
Locations:
city: Uvira
country: Congo, The Democratic Republic of the
facility: Centre de Traitement du Cholera, Hôpital General de Reference d'Uvira, Sud-Kivu, République Démocratique du Congo
state: Sud-Kivu
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver Cumming, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Karin Gallandat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallandat K, Jeandron A, Ross I, Mufitini Saidi J, Bashige Rumedeka B, Lumami Kapepula V, Cousens S, Allen E, MacDougall A, Cumming O. The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation. Trials. 2021 Jun 21;22(1):408. doi: 10.1186/s13063-021-05249-x.
citation: Williams C, Cumming O, Grignard L, Rumedeka BB, Saidi JM, Grint D, Drakeley C, Jeandron A. Prevalence and diversity of enteric pathogens among cholera treatment centre patients with acute diarrhea in Uvira, Democratic Republic of Congo. BMC Infect Dis. 2020 Oct 9;20(1):741. doi: 10.1186/s12879-020-05454-0.
Clinical trial NCT03695341: 500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI
Official title: Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Endocrine Therapy
Fulvestrant
Everolimus
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 130
Sex: FEMALE
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: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: 500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Detailed description: Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
2. Patients who were refractory to previous Aromatase Inhibitors
3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01
4. Available medical history

Exclusion Criteria:

1.Incomplete medical history

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Xie Y, Gong C, Zhao Y, Zhang J, Zhang S, Wang L, Chen S, Hu X, Wang B. Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. Ther Clin Risk Manag. 2020 Jun 30;16:607-615. doi: 10.2147/TCRM.S255365. eCollection 2020.