louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00205231: A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
Official title: A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Immunex Corporation
First posted: 2005-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.


Eligibility criteria: Inclusion Criteria:

* Adults greater than 18 years of age with documented HIV infection
* Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks.
* CD4 greater than 200 at time of study enrollment
* Stable monitoring labs (hematology survey with differential, ALT, creatinine)
* Absolute neutrophil count within normal limits

Exclusion Criteria:

* AIDS defining illness within the last 6 months
* Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections
* Women who are pregnant or nursing
* Hypersensitivity to etanercept
* Previous use of etanercept
* Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma)
* History of active or latent tuberculosis
* History of demyelinating nerve disease
* History of seizure disorder
* Latex allergy
* Subject has any of the following laboratory values within 30 days of baseline:

  * hemoglobin concentration \< 10.0 g/dl for men and \< 9.0 g/dl for women
  * platelet count \< 75,000/mm3
  * AST or ALT \> 5x upper limit of normal (ULN)
  * serum creatinine \> 2.5x ULN
  * serum pancreatic amylase \> 1.5 ULN
* Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon
* Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.

Primary outcomes:
measure: changes in CD4 counts
measure: changes in HIV-RNA levels
Secondary outcomes:
measure: development of infections
measure: degree of TNF inhibition by measuring TNF levels
measure: changes in hematologic and biochemical laboratory tests
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: Andrew Urban, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170131: MMF Influence on HCV Viral Evolution After Liver Transplantation
Official title: The Influence MMF on 5UTR HCV Quasispecies Variation: A Potential Factor in the Natural History of Post-OLT x HCV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV Infection
Liver Transplantation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled into - An Open Randomized, Prospective Multicenter Study to Compare the Efficacy and Safety Among Three Immunosuppressant Treatment Regimens in Patients Receiving a Liver Transplant for End-Stage Liver Disease Caused by Chronic Hepatitis C Infection

Brief summary: Samples from a large clinical trial comparing three immunosuppression regimens, two of which contained MMF, are used to identify the HCV viral quasispecies behaviour after liver transplantation


Eligibility criteria: All patients enrolled into - An Open Randomized, Prospective Multicenter Study to Compare the Efficacy and Safety Among Three Immunosuppressant Treatment Regimens in Patients Receiving a Liver Transplant for End-Stage Liver Disease Caused by Chronic Hepatitis C Infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Hugo E. Vargas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508531: Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy
Official title: Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Controlled randomized study
Primary purpose: TREATMENT

Brief summary: Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

-Elective laparoscopic Cholecystectomy, ASA status 1-2 -

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding diathesis
* Use of any anti-coagulants
* Inability to provide informed consent
* Severe kidney or liver disease
* Inability to operate PCA system
* Patient with psychiatric disorders

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
Study officials:
affiliation: Maltepe University faculity of medicine
name: Serkan Tulgar, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aksu C, Gurkan Y. Ultrasound-guided bilateral erector spinae plane block could provide effective postoperative analgesia in laparoscopic cholecystectomy in paediatric patients. Anaesth Crit Care Pain Med. 2019 Feb;38(1):87-88. doi: 10.1016/j.accpm.2018.03.008. Epub 2018 Apr 6. No abstract available.
citation: Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
Clinical trial NCT04181931: Neo-TACE-HAIC for PVTT-HCC
Official title: Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Portal Vein Thrombosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years;
* Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein;
* Child-Pugh A or B (7 score) liver function;
* With more than 3 months expected survival;
* The volume of residual liver more than 30%

Exclusion Criteria:

* Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus
* With extrahepatic metastasis or unresectable HCC
* Pregnant woman or sucking period;
* With other malignant cancer;
* Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.

Primary outcomes:
measure: Progression-free survival, PFS
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival, OS
timeFrame: 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424431: Methods of Pancreatic Stump Closure for Distal Pancreatectomy
Official title: Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatectomy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.

Detailed description: The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
* Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.

Exclusion Criteria:

* Patients undergoing surgeries by other primary clinical teams during the same period.
* Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
* Patients who violate the requirements of the study protocol.
* Patients with incomplete data collection in the hospital's diagnostic and treatment system.

Primary outcomes:
measure: Postoperative pancreatic fistula
timeFrame: perioperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04057131: FIRAZYR General Drug Use-Results Survey (Japan)
Official title: FIRAZYR General Drug Use-Results Survey (Japan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2019-08-15
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hereditary angioedema (HAE) patients in Japan who receive FIRAZYR for first time in the real world clinical setting are eligible for enrollment in this survey.

Brief summary: The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).


Eligibility criteria: Inclusion Criteria:

* Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.

Exclusion Criteria

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to end of the study (up to approximately 68 months)
measure: Number of Participants With Adverse Drug Reaction
timeFrame: Baseline up to end of the study (up to approximately 68 months)
measure: Time to Treatment for Attack
timeFrame: Up to 3 months
measure: Time to First Symptom Relief
timeFrame: Up to 3 months
measure: Time to Complete Resolution of Attack
timeFrame: Up to 3 months
measure: Total Duration of Attack
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya-city
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi-city
state: Aichi
city: Maebashi
country: Japan
facility: Maebashi-city
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa-city
state: Hokkaido
city: Fukagawa
country: Japan
facility: Fukagawa-city
state: Hokkaido
city: Rumoi
country: Japan
facility: Rumoi-city
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo-city
state: Hokkaido
city: Kasama
country: Japan
facility: Kasama-city
state: Ibaraki
city: Maizuru
country: Japan
facility: Maizuru-city
state: Kyoto
city: Kishiwada
country: Japan
facility: Kishiwada-city
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki-city
state: Osaka
city: Kawagoe
country: Japan
facility: Kawagoe-city
state: Saitama
city: Soka
country: Japan
facility: Soka-city
state: Saitama
city: Numazu
country: Japan
facility: Numazu-city
state: Shizuoka
city: Shimada
country: Japan
facility: Shimada-city
state: Shizuoka
city: Yaezu
country: Japan
facility: Yaezu-city
state: Shizuoka
city: Tachikawa
country: Japan
facility: Tachikawa-city
state: Tokyo
city: Niigata
country: Japan
facility: Niigata-city
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01156831: PET-CT Based Radiotherapy in Esophageal Cancer Patients
Official title: Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Keywords: Esophageal cancer
PET-CT planning
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.

Detailed description: The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
* Local curable disease able to undergo Chemoradiotherapy.

Exclusion Criteria:

* Metastasized disease.
* Previous or concurrent malignancies.

Primary outcomes:
measure: Locoregional control
timeFrame: 2 years and 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years and 5 years
measure: Disease Free survival
timeFrame: 2 years and 5 years
measure: Tumor regression grade
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Hospital
city: Maastricht
country: Netherlands
facility: University Medical Center
city: Roermond
country: Netherlands
facility: St. Laurentius Hospital
city: Sittard
country: Netherlands
facility: Maasland Hospital
city: Weert
country: Netherlands
facility: St. Jansgasthuis
Study officials:
affiliation: Radiation Oncology, Maastro Clinic
name: Guido Lammering, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Hospital Heerlen
name: Meindert Sosef, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745531: A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Official title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperphosphatemia Patients on Hemodialysis
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 100
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: A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia


Eligibility criteria: Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
2. Patients aged \>=18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4)
4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL.

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Primary outcomes:
measure: Achievement rate of the target serum phosphorus level
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in serum concentration of phosphorus
timeFrame: Up to Week 8
measure: Concentration of corrected serum calcium
timeFrame: Up to Week 8
measure: Serum Ca × P product
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01526031: Bee Venom Acupuncture for the Treatment of Frozen Shoulder
Official title: Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frozen Shoulder
Keywords: frozen shoulder
bee venom acupuncture
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
First posted: 2012-02-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 evaluate the effectiveness of combined bee venom acupuncture (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose effective.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of frozen shoulder by orthopedist
* Must have shoulder pain of more than VAS 5 over 1 month and under 12 months
* Marked limitation of active and/or passive motion range in one shoulder

Exclusion Criteria:

* history of major shoulder injury or surgery
* other musculoskeletal pain
* cervical neuropathy, paralysis, neurological disorder
* hypersensitivity reactions by bee venom skin test
* renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders

Primary outcomes:
measure: the Shoulder Pain and Disability Index (SPADI)
timeFrame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS) for pain intensity
timeFrame: Changes from baseline in VAS at 2, 4, 8, 12 weeks
measure: passive Range of Motion (pROM)
timeFrame: Changes from baseline in pROM at 2, 4, 8, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Yonghyeon Baek, OMD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Hospital at Gangdong
name: Byung-Kwan Seo, OMD, Ph.D
role: STUDY_DIRECTOR
References: