louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01857921: Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 290
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties. In addition, previous reports showed that trimetazidine was effective in reducing intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the evaluation of these combination effects of statin and trimetazidine on patients with aspirin monotherapy who had previously received CABG and were free of the major adverse cardiac events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that atorvastatin 40mg/day would be more effective in the prevention of the further late adverse cardiac and cerebrovascular events than other statin. To test this hypothesis, the investigators will perform a multi-center, randomized, prospective trial aimed at demonstrating the superiority of combination of high dose atorvastatin therapy and trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG surgery in real world practice.


Eligibility criteria: Inclusion Criteria:

* Patients who had previously received CABG 12 months ago
* Patients who were free of death, MI or repeat revascularization within first 12 months after CABG
* Patients with mono antiplatelet therapy with aspirin alone
* Age of 20 years or older
* Patients with signed informed consent

Exclusion Criteria:

* History of DES or BMS implantation within 12 months
* Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
* Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
* Pregnant women or women with potential childbearing
* Life expectancy ≤ 2 year

Primary outcomes:
measure: Occurrence of the composite of death from any cause
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01280721: A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Official title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 135
Sex: ALL
Minimum age (years): 23
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).


Eligibility criteria: Inclusion Criteria:

* Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
* Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
* Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria:

* Patients with eGFR of less than 15 mL/min/1.73 m2
* Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
* Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
* Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study

Primary outcomes:
measure: Total Kidney Volume
timeFrame: Baseline, Month12, Month24, and Month36
measure: Renal Function Test (eGFR)
timeFrame: Baseline, Month12, Month24, and Month36
measure: Renal Function Test (Cys-C)
timeFrame: Baseline, Month 12, Month 24, and Month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
References:
citation: Muto S, Okada T, Yasuda M, Tsubouchi H, Nakajima K, Horie S. Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial. Drug Healthc Patient Saf. 2017 Oct 25;9:93-104. doi: 10.2147/DHPS.S142825. eCollection 2017.
Clinical trial NCT00630721: Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Official title: Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of MS
* Age 18-60 years, inclusive
* Expanded disability status of 0-6.5
* Give written informed consent prior to any testing under this protocol

Primary outcomes:
measure: Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present
timeFrame: 2 years
Secondary outcomes:
measure: Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Silva Markovic-Plese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06397521: Gingival Margin Stability Following Esthetic Crown Lengthening Utilizing a Double Periodontal Surgical Guide
Official title: Gingival Margin Stability Following Esthetic Crown Lengthening by Electrocautery, Diode Laser, or a Scalpel Blade Utilizing a Double Periodontal Surgical Guide. (A Prospective Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crown Lengthening
Keywords: Digital
Surgical guide
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three techniques for aesthetic crown lengthening
Primary purpose: TREATMENT

Brief summary: In patients with excessive gingival display, esthetic crown lengthening procedure by means of scalpel, diode laser or electro-surgery could result in the same gingival marginal stability at 3 and 6 months follow up.

Detailed description: Scalpel crown lengthening has been recommended as the gold standard for treating excessive gingiva. Two other established tools used for gingivectomy procedures are electrosurgery and lasers. Laser crown lengthening may have the advantages of less bleeding during the procedure, faster healing, and less pain following the procedure. Electrosurgery which involves the application of a high- frequency electric current to the gingiva has been shown to produce minimal bleeding, ease and speed of cutting and reduced postoperative pain. The null hypothesis that the three techniques for aesthetic crown lengthening (ACLP) would show equivalent gingival margin stability at 3 and 6 months follow up.

Eligibility criteria: Inclusion Criteria:

* Altered passive eruption as presence of quadratic anterior teeth \[crown width/length ratio

  * 0.85 \].
* Gingival margin located coronal to the tooth cervical convexity and \>2 mm of gingival band display during maximum smile.
* Patients with treated periodontal disease (i.e., stage I of periodontitis);

Exclusion Criteria:

* Patients with systemic contraindications for oral surgery as uncontrolled diabetes.
* patients on drug therapy related with drug-associated gingival enlargement.
* Areas in which the remaining amount of keratinized gingiva after the submarginal incision is less than 3 mm.
* Previous surgical treatment in the same area.

Primary outcomes:
measure: position of the gingival margin
timeFrame: 3 and 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Adel Salah Khattab
state: Abbassia
Study officials:
affiliation: Associate Professor Faculty of Dentistry, Ain Shams University
name: Doaa Adel-Khattab, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00609921: A Phase 1 Study of ARQ 197 in Patients With Solid Tumors
Official title: A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.


Eligibility criteria: Inclusion Criteria:

* Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists.
* Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Patients with adequate organ function

Exclusion Criteria:

* Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197
* Known symptomatic brain metastases
* Pregnant or breastfeeding
* Uncontrolled intercurrent illness

Primary outcomes:
measure: Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197
Secondary outcomes:
measure: Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile
Other outcomes:
Locations:
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05531721: HLH Patients - a Retrospective Study
Official title: Retrospective Analysis of the Outcome of Patients Diagnosed With Hemophagocytic Lymphohistiocytosis (HLH) Treated at the S.C.Pediatric Oncohematology of the Regina Margherita Torino Hospital (OIRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophagocytic Lymphohistiocytoses
Lead sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 39
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients with HLH

Brief summary: Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.

Detailed description: retrospective data collection to study: type of HLH familial vs secondary, sex, age, presence of infectious cause, involvement central nervous system ( SNC), hepatic involvement, presence of hemophagocytosis, presence of splenomegaly, presence of involvement of other organs, the value of neutrophils (PMN), the value of hemoglobin, platelets, albumin, triglycerides, ferritin, LDH, type of therapy and the response to therapy after 2 months

Eligibility criteria: Inclusion Criteria:

* Have received HLH diagnosis according to HLH 2004 criteria
* age ⥶18 years.
* followed at our facility between January 2004 and December 2021
* Whose parents have consented to participation and data processing

Exclusion Criteria:

* The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria

Primary outcomes:
measure: physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Study officials:
affiliation: AOU Città della Salute e della Scienza di Torino - OIRM
name: Franca Fagioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01220921: Neurosurgery Patient Outcomes in Treating Spinal Disorders
Official title: Neurosurgery Patient Outcomes in Treating Spinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Lumbar Disc Herniation
Symptomatic Grade I Lumbar Spondylolisthesis
Lead sponsor: Greenwich Hospital
Sponsor class: OTHER
Collaborators: name: American Association of Neurological Surgeons
First posted: 2010-10-14
Enrollment: 198
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: HEALTH_SERVICES_RESEARCH

Brief summary: The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .


Eligibility criteria: Inclusion Criteria:

* Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

Exclusion Criteria:

* History of previous lumbar spine surgery
* Significant motor weakness (3/5) (i.e. foot drop)
* Cancer, infection, or fracture
* Pregnancy

Primary outcomes:
measure: SF-36 version 1
timeFrame: 1-Year
measure: Site and Physician Compliance
timeFrame: 1 Year
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 1 Year
measure: Visual Analog Pain Score
timeFrame: 1 Year
measure: Return to Work
timeFrame: 1 Year
measure: 30 day complications
timeFrame: 30 days
measure: Delayed Surgical Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Newark
country: United States
facility: University of Medicine and Dentistry - New Jersey
state: New Jersey
city: New York
country: United States
facility: Columbia University - Neurological Institute
state: New York
city: Charlotte
country: United States
facility: Carolina Spine
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary - Alberta Health Sevices
state: Alberta
Study officials:
affiliation: Yale University
name: Zoher Ghogawala, MD FACS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03265821: Influence of Smoking on Periodontal Healing One Year After Active Treatment
Official title: Influence of Smoking on Periodontal Healing One Year After Active Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Smoking
Keywords: Smoking
Periodontal treatment
Periodontal disease
Healing
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 4227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 20-85 years, referred to the specialised clinic for periodontal treatment at Gavle County Hospital, Sweden between the years of 1980 and 2015.

Brief summary: The aim of this study was to investigate whether cigarette smoking had any impact on the clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680 individuals 20-85 years, referred to the specialised clinic for periodontal treatment at Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals filled in a questionnaire regarding their medical health, medication and smoking habits.

Excluded were edentulous individuals and where clinical data 1-year after active treatment, or smoking habits were missing (n=1453). Complete data for analyses was available for 4227 individuals.


Eligibility criteria: Inclusion Criteria:

* Individuals referred to a specialist clinic for periodontal treatment

Exclusion Criteria:

* edentulous individuals

Primary outcomes:
measure: Probing pocket depth
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05401721: Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Official title: Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis and ascites

Brief summary: Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of SBP will be based on the presence of at least 250 cells/ml PMNLs in the ascitic fluid, with or without positive ascitic fluid culture in the absence of hemorrhagic ascites and secondary peritonitis

Exclusion Criteria:

* Patients with heart failure, coronary insufficiency, advanced chronic respiratory disease, polyuria-polydipsia syndrome and hypotension or shock.

  * Patients with chronic kidney disease treated with hemodialysis before admission.
  * Patients with previous liver or kidney transplantation.
  * Patients with intraabdominal malignancy.
  * Patients with severe infection other than SBP.
  * Patients who had received antibiotics before hospital admission.

Primary outcomes:
measure: compare serum levels of copeptin in cirrhotic patients with and without SBP
timeFrame: 6 months
Secondary outcomes:
measure: assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
References:
Clinical trial NCT01269021: An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
Official title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgA Nephropathy (IgAN)
Keywords: MMF treatment IgA Nephropathy (IgAN)
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid .

Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.

Detailed description: To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).

Eligibility criteria: Inclusion Criteria:

1. Patients who signed written informed consent form
2. age between 18-60 years, female or male
3. diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
4. renal biopsy had: 10%\< crescents\<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis\<50%,
5. proteinuria\>1g/24h for two times

Exclusion Criteria:

1. secondary IgA Nephropathy (IgAN);
2. eGFR\<30ml/min/1.73m2.( MDRD formula)
3. liver disfunction;
4. uncontrolled hypertension
5. WBC \<3000/mm3
6. Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
7. diabetes or obesity(BMI\>28) ;
8. severe infection or central nervous system symptoms.

Primary outcomes:
measure: the rate of complete remission (CR) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: the rate of overall response (CR+ partial remission [PR]) at 6 months
timeFrame: 6 months
measure: the median time to CR
timeFrame: from the start of enrollment to the day of complete remission
measure: the relapse rate after stopping the treatments
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
name: Zhihong Liu, Master
role: PRINCIPAL_INVESTIGATOR
References: