louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03335098: Study of VTD in Waldenstrom's Macroglobulinemia
Official title: A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Waldenstrom Macroglobulinemia
Lymphoplasmacytic Lymphoma
Keywords: Waldenstrom's macroglobulinemia
Lymphoplasmacytic lymphoma
Bortezomib
Thalidomide
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2017-11-07
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.


Eligibility criteria: Inclusion Criteria:

* Age of 19 or older
* Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma
* Previously untreated with chemotherapy
* ECOG performance status of 2 or lesser
* Peripheral blood white blood cell count ≥ 3,500/uL
* Peripheral blood neutrophil count ≥ 1,000/uL
* Peripheral blood platelet count ≥ 20,000/uL
* Peripheral blood hemoglobin ≥ 6.0g/dL
* Serum total bilirubin ≤ 2.0 mg/dL
* Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit)
* Serum alanine aminotransferase ≤ 2.5 x (upper normal limit)

Exclusion Criteria:

* Diagnosed with other malignancy within 5 years before enrollment
* Prior hematopoietic stem cell transplantation
* Prior organ transplantation
* Uncontrolled central nervous system involvement
* Congenital immunodeficiency
* Acquired immune deficiency syndrome (AIDS)
* Pregnancy
* Uncontrolled epilepsy
* Uncontrolled psychological disease
* Peripheral neuropathy of grade 3 or higher

Primary outcomes:
measure: Overall response rate
timeFrame: at 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: at 3 years
measure: Overall survival
timeFrame: at 3 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01781598: Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty
Official title: Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty: Logistics, Learning Curve, and Postoperative Radiological Results in 70 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alignment
Keywords: Total knee arthroplasty
Patient specific instruments
Patient matched cutting blocks
Alignment
Learning curve
VISIONAIRE
Lead sponsor: Orthopedic Clinic Gersthof
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with GENESISII prothesis using VISIONAIRE are enrolled in the study

Brief summary: Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure

Detailed description: The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year.

The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks \[PMCB\]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant.

This study is a observational monocentric prospective study.

Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment

The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.

As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Indication for TKA
* Genesis II endoprosthesis
* Operated using patient specific instruments (VISIONAIRE)

Exclusion Criteria:

* contraindication for MRI
* varus/ valgus deformity \>15 degrees

Primary outcomes:
measure: Alignment
timeFrame: Postoperative x-ray (7-10 days after surgery)
Secondary outcomes:
measure: Learning curve
timeFrame: Intraoperative and early postoperative period (up to 14 days after surgery)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopedic Clinic Gersthof
Study officials:
References:
Clinical trial NCT01940198: Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
Official title: Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Atazanavir
long-term
primary care setting
sydney
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2013-09-12
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of HIV-1 positive patients attending Holdsworth House Medical Practice who have commenced ATV as a component of ART will be identified from review of current database.

Data will be collected retrospectively from patient electronic medical records for HIV-1 positive patients that have commenced ATV from year 2002 - 2008.

Brief summary: This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

Detailed description: This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting.

3. OBJECTIVES OF THE STUDY i. Primary objective Long-term (2 years or greater) atazanavir experience in HIV-1 infected patients in a primary care setting through retrospective data collection.

ii. Secondary objectives

1. To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients.
2. To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients.
3. To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV.
4. To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.

Eligibility criteria: Inclusion Criteria:

1. HIV-1 positive
2. Have commenced ATV between 2002-2008 (Baseline)
3. Follow-up data (clinical and laboratory) available from baseline

Exclusion Criteria:

1. Patients not commenced ATV between 2002-2008
2. No follow-up data (clinical and laboratory) available from baseline
3. Patient 'lost to follow-up' with \< 2 years of follow-up data (Clinical and laboratory)

Primary outcomes:
measure: Proportion of HIV-1 infected participants with atazanavir experience
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of HIV-1 infected participants with atazanavir experience
timeFrame: 1 year
measure: Proportion of HIV-1 infected participants with atazanavir experience
timeFrame: 1 year
measure: Proportion of HIV-1 infected participants with atazanavir experience
timeFrame: 1 year
measure: Proportion of HIV-1 infected participants with atazanavir experience
timeFrame: 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Holdsworth House Medical Practice
name: Mark Bloch, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146198: Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Postoperative pain
Inguinal Hernia Repair
Capsaicin
Lead sponsor: AlgoRx Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 40
Sex: MALE
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: Hernia repair is one of the most common operations. Whilst there are few complications, pain may last for several weeks and extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following hernia repair.

Detailed description: Inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the United States. Whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. The purpose of this study is to determine whether a single dose of ALGRX 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.

Eligibility criteria: Inclusion Criteria:

• The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.

Exclusion Criteria:

* The subject has undergone a lower abdomen surgical procedure in the past.
* The subject is currently scheduled to undergo bilateral inguinal hernia repair.
* Personal or familial contraindications in undergoing general anesthesia.
* Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg

Primary outcomes:
measure: The average daily VAS pain scores, assessed on a 100 mm VAS during movement upon arising in the morning and retiring in the evening, during the first week after surgery.
Secondary outcomes:
measure: Time to supplemental medication usage
measure: Average daily VAS pain scores, assessed during movement upon arising in the morning and retiring in the evening, during the first 4 weeks after surgery
measure: Safety and tolerability
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: Dagkirurgisk Klinik
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903498: The Maintenance Treatment of UFT in Advanced Gastric Cancer
Official title: Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: disease control survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 58
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: The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG PS 0-2
* At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
* Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

* Receiving more or more than 2 regimens of chemotherapy
* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: six weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: six weeks
measure: Number of Participants with Adverse Events
timeFrame: six weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Xiaodong Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770198: sgp130 in Chronic Human Liver Disease
Official title: Study of IL-6 Transsignaling in Chronic Human Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Disease
Chronic Hepatitis C Virus Infection
Keywords: liver
alcohol
HCV
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of Erasme University Hospital

Brief summary: Chronic liver disease are characterized by increased levels of plasma IL-6, but the bioactivity of this cytokine in this disease is not well known. IL-6 receptor complex is regulated by multiple receptors subunits: the soluble form of IL-6 Receptor enhance IL-6 signal by a process called trans-signaling on cells expressing few membrane IL-6 receptors. Soluble gp130 is the natural inhibitor of IL-6 trans-signaling. The aim of this study is to characterize circulating and liver levels of theses compounds of IL-6 receptor complex, to unravel the bioactivity of IL-6 in this disease.

Detailed description: Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver IL-6R compounds mRNA levels.

Eligibility criteria: Inclusion Criteria:

* Alcohol excess intake and suspected liver disease
* Alcohol excess intake and clinical liver cirrhosis
* chronic hepatitis C virus infection and suspected liver disease
* chronic hepatitis C virus infection and clinical liver cirrhosis

Exclusion Criteria:

* other (superimposed) liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme - Dpt of Gastroenterology
Study officials:
affiliation: Erasme Hospital, Gastroenterology Dpt
name: Arnaud Lemmers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01728298: A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
Official title: A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: House Dust Mite
allergy
rhinitis
asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-11-19
Enrollment: 219
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: The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or older
* Moderate to severe persistent HDM allergic rhinitis with or without asthma
* Moderate to severe HDM allergic rhinitis symptoms during a baseline period
* Positive skin prick test response (wheal diameter ≥ 3 mm)
* Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)

Exclusion Criteria:

* Previous treatment with immunotherapy with House dust mite immunotherapy
* Ongoing treatment with any allergen specific immunotherapy product
* Reduced lung function
* Clinical history of uncontrolled asthma
* Inflammatory conditions in the oral cavity with severe symptoms
* History of anaphylaxis with cardiorespiratory symptoms
* History of recurrent generalised urticaria
* A history of drug induced facial angioedema or hereditary angiooedema
* Any clinically relevant chronic disease (≥3 months duration)
* Systemic disease affecting the immune system
* Immunosuppressive treatment
* Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors

Primary outcomes:
measure: Change from baseline in IgE-blocking factor after 6 months of treatment
timeFrame: 6 months
Secondary outcomes:
measure: Number of subjects with treatment related adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Proffesor Alain Didier
Study officials:
affiliation: Hôpital Larrey, Toulouse
name: Alain Didier, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216798: Client and Provider Preferences for HIV Care
Official title: Client and Provider Preferences for HIV Care: Implications for Implementing Differentiated Service Delivery in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 370
Sex: MALE
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: Men who have Sex with Men or Transgender women who have been tested HIV-positive in the Community Led Test and Treat Study and are receiving ART.

Brief summary: This study will investigate preferences for HIV care among participants enrolled in the "Study to evaluate the feasibility of Community-based Test and Treat strategies among men who have sex with men and transgender women to increase the uptake of HIV testing and treatment services in Thailand" through a model involving linked strategies: The study takes place in four provinces at six sites affiliated with the Thai Red Cross AIDS Research Center (TRCARC): Bangkok (RSAT and SWING), Chiang Mai (CAREMAT), Chonburi (SWING and Sisters) and Songkhla (RSAT). These are all community-based drop-in centers, targeting MSM and TGW.

Participants who are enrolled in the study at any of the TRCARC affiliated sites and who were tested HIV-positive will be invited to participate in the current questionnaire study.

Detailed description: This will be a cross-sectional questionnaire study. A self-administered questionnaire will be used to assess their satisfaction with current clinical services, preferences for location, frequency and provider of HIV services, as well as expectations and concerns.

Furthermore, staff working at the different HIV-care to community-based organizations (CBOs) and the health care workers providing HIV services will be invited to participate as well. They will also be asked to complete a self-administered questionnaire to assess knowledge and attitude, preferences for location, frequency and provider of HIV services, as well as expectation and concerns.

All data collected, from patients, as well as from staff, will be anonymous.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Community Led Test and Treat Study at either RSAT or SWING
* According to the inclusion criteria of the Community Led Test and Treat Study, participants will be at least 18 years of age
* HIV-infected and receiving ART
* Willing to participate in the survey

Exclusion Criteria:

N/A

Primary outcomes:
measure: Preferences for differentiated models of service delivery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
Study officials:
affiliation: Thai Red Cross AIDS Research Centre (TRCARC)
name: Nittaya Phanuphak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: