louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03542721: Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
Official title: A Placebo-controlled, Randomized, Double-blind, Parallel, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fatigue Symptom
Keywords: chronic fatigue symptom
blood circulation
Lead sponsor: Dong-A Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-05-31
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

Detailed description: This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Eligibility criteria: Inclusion Criteria:

* Rutherford's category 0/0 or Ⅰ/1
* ABI \<1.0
* CIS greater than 76
* HADS less than or equal to 10
* Subjects who have fatigue symptoms more than 1 month

Exclusion Criteria:

* Subjects who have diseases that can cause fatigue
* Subjects who are taking medication that can cause fatigue

Primary outcomes:
measure: CIS(Checklist Individual Strength) less than or equal to 76
timeFrame: 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: WhanSeok Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02039921: Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients
Official title: Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of Antiretroviral Treatment Regimen in HIV-positive Patients Between January 2011 and July 2012 in Spanish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012

Brief summary: The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patients with HIV
* Patients in antiretroviral regimen, that have changed the antirretroviral treatment.

Exclusion Criteria:

* Patients unable to sign the consent form
* patients that changing their treatment are going to take the same components in co-formulated
* patients that changing their treatment are going to take the same components separately
* Total or selective interrupts not indicated by the specialist
* Patients that after changing antiretroviral therapy between January 2011 and July 2012, and during the next year, again suffered another change of treatment

Primary outcomes:
measure: Number of patients that change the treatment and the reason for it
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital de Santiago de Compostela
state: La Coruña
city: Alcalá de Henares
country: Spain
facility: Hospital Príncipe de Asturias
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La paz
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References:
Clinical trial NCT01876121: Celecoxib Japan Observational Study for the Patients With Acute Pain
Official title: Celecoxib Japan Observational Study for the Patients With Acute Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain
Keywords: NSAIDs
Acute pain
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 784
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic pain, post-surgical pain and tooth extract pain

Brief summary: This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Detailed description: Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with traumatic pain, post-surgical pain and tooth extract pain

Exclusion Criteria:

* Hyperreactive to sulfonamide
* Aspirin asthma patients
* Peptidic ulcer patients
* Serious liver disease patients
* Serious kidney disease patients
* Serious heart failure patients
* End of pregnancy

Primary outcomes:
measure: Safety assessed by the incidence of adverse events and lab-tests
timeFrame: For 2 weeks
Secondary outcomes:
measure: Overall pain improvement assessed by visual analogue scale (VAS)
timeFrame: Baseline and week-2
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00452621: Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
Official title: A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Encephalitis, Tick-Borne
Keywords: blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
TBE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-03-27
Enrollment: 235
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of both sexes aged \>1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.

Primary outcomes:
measure: 1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage
Secondary outcomes:
measure: (2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Center 7
city: Bobingen
country: Germany
facility: Center 2
city: Eberbach /Neckar
country: Germany
facility: Center 11
city: Kaufering
country: Germany
facility: Center 4
city: Pegnitz
country: Germany
facility: Center 15
city: Weilheim i. OB
country: Germany
facility: Center 1
city: Wiesloch
country: Germany
facility: Center 8
city: Zirndorf
country: Germany
facility: Center 16
Study officials:
affiliation: Novartis
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT00655421: Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
Official title: Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toluidine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oral Cancer
Precancerous Conditions
Keywords: screening
oral precancers
tobacco users
VELScope
Visual Inspection
Toluidine Blue
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: American Cancer Society, Inc.
name: Emory University
First posted: 2008-04-09
Enrollment: 329
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.

Detailed description: Oral cancer is the most common cancer among men in India mainly due to the habit of using smokeless tobacco. Pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. Several methods of oral cancer screening have been tried over the past three-four decades with varying success. This study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: Unaided Visual Inspection, VelScope assisted examination and examination after application of Toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in Mumbai, India.

Eligibility criteria: Inclusion Criteria:

* The study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months),
* above 18 years of age,
* attending Preventive Oncology clinic.

Exclusion Criteria:

* Participants with frank oral cancers will not be recruited in the study.

Primary outcomes:
measure: To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
timeFrame: six months
Secondary outcomes:
measure: To estimate the test characteristics of each of the three oral cancer screening techniques.
timeFrame: Six months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Tata Memorial Hospital
name: Surendra S Shastri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017821: The Effect of Aerobic Endurance Training in Patients With Drug Addiction
Official title: The Effect of Aerobic Endurance Training in Patients With Drug Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Exercise
Oxygen Consumption
mental health
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.


Eligibility criteria: Inclusion Criteria:

* substance use disorder diagnosed ICD10
* written informed consent
* "residential treatment"

Exclusion Criteria:

* not been using drugs the last six months

Primary outcomes:
measure: change in maximal oxygen consumption (VO2 max)
timeFrame: from baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Trondheims Klinikken, St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eivind Wang, phd
role: STUDY_DIRECTOR
References:
citation: Flemmen G, Unhjem R, Wang E. High-intensity interval training in patients with substance use disorder. Biomed Res Int. 2014;2014:616935. doi: 10.1155/2014/616935. Epub 2014 Mar 2.
Clinical trial NCT03402321: Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting
Official title: Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Procedural
Keywords: alveogyl, gelatin sponge, free gingival graft, palate, pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
2. Systemically healthy

Exclusion Criteria:

1. Severe gagging reflex
2. Smokers
3. Occlusal trauma at site of graft
4. Pregnancy
5. Psychiatric disorder
6. Patients allergic to the used agents

Primary outcomes:
measure: pain score
timeFrame: 2 weeks
Secondary outcomes:
measure: healing
timeFrame: 4 weeks
measure: bleeding
timeFrame: 2 weeks
measure: analgesic consumption
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6.
Clinical trial NCT03323021: Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
Official title: A Single-Center Double Arm Single-Blinded Randomized Screening Clinical Trial to Evaluate the Use of Human Dehydrated Amnion/Chorion Membrane to Facilitate the Recovery of Renal Function Following Robotic Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Nephrectomy
Kidney Cancer
Renal Function Aggravated
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in the operated kidney. This is primarily due to the loss of healthy parenchymal volume during resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the procedure and ultimately renal function after partial nephrectomy, the single center double arm single-blinded randomized screening clinical trial will evaluate the ability of human amnion/chorion allograft to facilitate the recovery of renal function following robotic partial nephrectomy.

Detailed description: To determine whether Amniofix facilitates improved recovery of renal function at 12 months.

Eligibility criteria: Inclusion Criteria:

* Any individual with a diagnosis of a renal mass.
* All Patients undergoing partial nephrectomy as their definitive treatment for their renal mass.
* Ability to understand and the willingness to sign a written informed consent.
* Patients with a solitary clinical T1a renal mass.

Exclusion Criteria:

* Patients undergoing radical nephrectomy as their definitive treatment for their renal mass.
* Patients with Transitional Cell Carcinoma.
* Patients with known hereditary syndromes such Von Hippel-Lindau (VHL) syndrome, Lynch Syndrome, Birt-Hogg-Dube Syndrome.
* Patients with metastatic disease undergoing cytoreductive nephrectomy as their definitive treatment for metastatic disease.
* Patients with prior kidney surgery.
* Patients with a solitary or horseshoe kidney.
* Patients with a positive margin found during intra-operative frozen section done only when clinically indicated (i.e., macroscopic abnormality identified).
* Patients with multiple renal masses.
* Patients with greater than a clinical T1a renal mass.

Primary outcomes:
measure: Recovery of Renal Function
timeFrame: 12 months
Secondary outcomes:
measure: Preservation of Renal Parenchymal Volume
timeFrame: 12 months
measure: Cancer Control Rates
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: Mt. Sinai Medical Center
name: Ketan Badani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935021: Clinical Study of ATTR-CM
Official title: Clinical Study Protocol of Transthyroxine Protein Amyloidosis Cardiomyopathy and Its Gene Carriers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Transthyroxine Amyloidosis Cardiomyopathy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 100
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: In this study, patients with ATTR-CM or gene carriers were selected to study the diagnosis and treatment, and long-term follow-up was conducted.


Eligibility criteria: Inclusion Criteria:

* Patients and gene carriers of ATTR-CM confirmed in the Second Affiliated Hospital of Zhejiang University School of Medicine, regardless of gender, age 18-90 years old;
* Patients who have the ability to understand the test and can cooperate with investigators

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors

Primary outcomes:
measure: Rate of cardiovascular death, myocardial infarction, and stroke
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: xiaohong University PAN
state: Zhejiang
Study officials:
References:
Clinical trial NCT00832221: Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
Official title: An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: PET
Phase 1
Depression
SEROQUEL
Positron Emission Tomography
Drug profile comparison
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Normal MRI scan
* Body mass index 19-30 kg/m2 and weight of 50-100 kg
* Clinically normal physical findings, medical history and laboratory values

Exclusion Criteria:

* Trauma or sickness last 2 weeks before the first PET examination.
* A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
* Any previous participation in a PET study
* Subjects suffer from claustrophobia

Primary outcomes:
measure: Positron emission tomography using the radioligand [11C]raclopride
timeFrame: 5 visits
Secondary outcomes:
measure: Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.
timeFrame: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.
measure: Pharmacokinetics of quetiapine and its main active metabolite
timeFrame: 22 samples
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Ingemar Bylesjö, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Sophia Bengtsson
role: STUDY_DIRECTOR
References:
citation: Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D(2) dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11.